Just Transitions – Article by Ann M. Eisenberg

From Volume 92, Number 2 (January 2019)
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Just Transitions

Ann M. Eisenberg[*]

 The transition to a low-carbon society will have winners and losers as the costs and benefits of decarbonization fall unevenly on different communities. This potential collateral damage has prompted calls for a “just transition” to a green economy. While the term, “just transition,” is increasingly prevalent in the public discourse, it remains under-discussed and poorly defined in legal literature, preventing it from helping catalyze fair decarbonization. This Article seeks to define the term, test its validity, and articulate its relationship with law so the idea can meet its potential.

The Article is the first to disambiguate and assess two main rhetorical usages of “just transition.” I argue that legal scholars should recognize it as a term of art that evolved in the labor movement, first known as a “superfund for workers.” In the climate change context, I therefore define a just transition as the principle of easing the burden decarbonization poses to those who depend on high-carbon industries. This definition provides clarity and can help law engage with fields that already recognize just transitions as a labor concept.

I argue further that the labor-driven just transition concept is both justified and essential in light of today’s deep political polarization and “jobs-versus-environment” tensions. First, it can incorporate much-needed economic equity considerations into environmental decisionmaking. Second, it can inform a modernized alternative to the environmental law apparatus, which must evolve to transcend disciplines. Third, it offers an avenue for climate reform through coalition-building between labor and environmental interests. I offer guidance for effectuating the principle by synthesizing instances of its embodiment in law in the Trade Act of 1974 (assisting manufacturing communities), the President’s Northwest Forest Plan (assisting timber communities), the Tobacco Transition Payment Program (assisting tobacco farmers), and the POWER Initiative (assisting coal communities), among other examples.

TABLE OF CONTENTS

Introduction

I. What is a “Just Transition”? Background and Rhetoric

A. The Transition to a Low-Carbon Economy and the Transition’s Potential Consequences

B. Defining a “Just Transition”

II. Can a Law of Just Transitions Be Justified?

A. An Environmental Theory of Just Transitions

B. Fossil Fuel-Dependent Communities: An Exemplary
Case Study for Just Transitions

C. A Political Economy Theory of Just Transitions

III. Just Transitions as Law: Filling in the
Contours

A. Federal Transitional Policies

1. The Trade Act of 1974

2. The President’s Northwest Forest Plan

3. The Tobacco Transition Payment Program

4. The POWER Initiative

B. Synthesizing Federal Transitional Policies

C. Locally-Driven Transitions

D. Additional Considerations for Pursuing Just
Transitions

Conclusion

 

Introduction

Political obstacles notwithstanding, many in the United States agree that carbon emissions must be quickly and dramatically reduced in order to avoid further catastrophic effects of climate change. Whether the path to a decarbonized world is more winding or straightforward, the effects of a transition to a low-carbon society will fall unevenly on many communities, which raises serious normative questions of justice.[1] In response to this concern, many call for a “just transition” to a low-carbon future.[2] While this phrase has gained significant traction,[3] its meaning remains unclear.[4]

“Just transition” has at least two primary usages. First, the phrase is used to mean that the transition to a low-carbon society should be fair to the most vulnerable populations.[5] The current fossil fuel-based economy has been characterized by inequality and environmental injustice, or environmental hazards that are inequitably distributed.[6] The new, low-carbon economy should not repeat or exacerbate these injustices; in fact, the transition is a new opportunity, indeed an obligation, to counteract them.[7]

The second meaning of “just transition” calls for protecting workers and communities who depend on high-carbon industries from bearing an undue burden  of the costs of decarbonization.[8] It proposes that the shift to a low-carbon economy will affect certain livelihoods disproportionately, and that this impact should be mitigated.[9] As one labor advocate explains, a just transition “means tackling climate change in a way that respects workers.”[10]

This Article demonstrates that the latter, labor-driven concept of a just transition is not only justified but is key to overcoming many of the obstacles that plague climate reform. Environmental policy remains thwarted by a variety of problems old and new. Longstanding “jobs-versus environment” tensions persist, as well as the more general notion that environmental protection represents a zero-sum game with winners and losers.[11] Even before the current presidential administration, scholarship contemplated the future of environmental law in an era of legislative stagnation.[12] Many have called for environmental law to adapt to the times by reshaping itself in various ways—letting go of some of its traditional emphases,[13] crossing over into other doctrinal areas,[14] and becoming more malleable in one manner or another in order to better interact with the political, economic, and social realities of a complex world.[15]

The labor-driven concept of a just transition is powerfully poised to address these deep concerns if scholars and policymakers embrace it. First and most clearly, it reroutes jobs-versus-environment tensions into a principle of “jobs and environment,” taking one of the longstanding thorns in environmentalism’s side and marshaling it toward productive pathways.[16] Second, by blurring the boundaries between environmental law and labor law, it can help align environmental decisionmaking more with the realities of complex social-ecological systems.[17] Third, by aligning environmental interests with labor concerns, it creates potential for coalition-building, thus informing both the ends of climate policy and the ever-elusive means for achieving it.[18] Finally, in an age of dramatic populist alienation,[19] it would inject much-needed economic equity considerations into environmental decisionmaking.

The Article also demonstrates that it is worth choosing one meaning for this term and that the labor-driven meaning makes more sense than the alternative. “Just transition” is a term of art that evolved in the labor movement, first known as a “superfund for workers.”[20] Its specificity gives it potency, and it has already gained traction in other disciplines and with major international organizations.[21] The broader usage, while important, seems redundant alongside comparable but better-known concepts, such as climate justice and energy justice.[22] It is confusing and less productive for different disciplines, and different scholars within law, to use the same term with different understandings of its meaning.[23]

I therefore argue that in the context of climate change, the just transition concept should be defined as some form of help for fossil fuel workers. Yet the broadest theoretical impetus for this help goes beyond environmental law. The just transition is an equitable principle of easing the burden that publicly-driven displacement poses to workers and communities who are highly dependent on a particular industry, especially a hazardous one. The theory has flavors of an estoppel concept, an unclean hands argument, or something akin to a call for takings compensation.[24] It is a principle of distributive economic justice, insisting that those displaced should not alone sustain their economic losses. This idea arises most frequently in response to environmental progress, but it bears relevance to other contexts as well.[25]

The prospect of a law of just transitions raises many questions, however, some of which labor law scholar David Doorey has begun to explore in a germinal article examining the desirability of a potential new field combining aspects of labor law, environmental law, and environmental justice.[26] How would just transitions relate to other models of distributive justice, such as environmental justice, which maintains that the burdens of pollution should be less discriminatorily and more equitably distributed?[27] How would it relate to sustainable development, which aims to reconcile environmental and economic considerations?[28] Would it merely create new employment opportunities when climate-related regulations affect a certain sector, or is it what one union president called it—“a really nice funeral”?[29] Must there be a causal link between regulatory initiatives and impacts on jobs, or does a just transition also concern industry contractions that stem from market forces?[30] Can the two be meaningfully differentiated?[31]

This Article attempts to answer these questions. Part I provides background necessary for understanding the just transitions concepts, disambiguates the two different usages of the term, and argues that legal scholarship should embrace the labor-driven definition. Part II explores three avenues that could serve as theoretical justifications for the labor-driven just transition principle in the context of climate change. Based on a theory of distributive environmental decisionmaking, the history of injustice in coalfield communities, and principles of political economy and interest-group theory, the discussion concludes that the labor-driven just transition principle is indeed legitimate, consistent with relevant norms, and necessary in the face of climate change. Part III synthesizes major federal transitional policies of the past several decades and argues that an effective law and policy of just transitions, especially when targeting regional displacement, must do more to untangle and address the complex, intertwined factors that shape communities’ dependency relationships with particular industries.

The stakes of this inquiry are high. Coal miners have become a symbol for broader national divisions, and commentators still strive to understand the “urban/rural divide” that made its way into the national consciousness via the 2016 presidential election. This analysis offers insights for the plight of coal miners and other rural communities, as well as certain workers’ relationship with environmentalism and climate policy. It also implicates a reconsideration of work, workplace safety, well-paying jobs, abrupt societal change, and private and public accountability for many workers’ abject vulnerability in a period that has been contemplated as a “new Lochner era.”[32] Major social and economic changes will continue to come. Scholars and policymakers would be well-advised to contemplate more robust transitional policy and baseline protections in light of the despair and instability unmitigated transitions can yield.

I.  What is a “Just Transition”? Background and Rhetoric

A.  The Transition to a Low-Carbon Economy and the Transition’s Potential Consequences

The term “just transition” tends to arise in two contexts. Some use the expression to refer to more general principles of equity in the transition to a low-carbon economy.[33] In other words, the shift to a low-carbon economy is an opportunity to rectify the injustices of the fossil fuel economy, and to not do so, or to allow inequalities to worsen, would itself effectuate injustice. On the other hand, some use the expression to refer to the nexus of labor and environmental reform, or the approach of taking work and jobs into account in or after environmental decisionmaking.[34] Yet both meanings derive from overlapping circumstances.

First, the fossil fuel-based economy characterizing the past century has had many casualties.[35] They run the full gamut from a child developing asthma in rural Australia,[36] to executions of community advocates in Nigeria,[37] to fishermen’s damaged livelihoods in the U.S. Gulf,[38] to victims of geopolitical machinations, including war.[39] People of color, indigenous communities, and people living in poverty have borne the worst burdens of the fossil fuel economy, in large part because of energy production.[40] The ultimate “externality” is, of course, climate change, the impacts of which we are already beginning to feel.[41]

The global community is currently experiencing substantial momentum toward a low-carbon, “clean energy” economy.[42] This transition is driven in part by a prevalent desire to mitigate climate change, both in the United States and elsewhere.[43] While the U.S. federal government is hostile to environmental regulation,[44] many U.S. states, cities, and institutions have confirmed their ongoing commitment to reducing carbon emissions.[45] For instance, “[d]ays after President Trump announced that he would be pulling the U.S. out of a global agreement to fight climate change, more than 1,200 business leaders, mayors, governors and college presidents . . . signaled their personal commitment to the goal of reducing emissions.”[46] The transition is also driven by market forces and concomitant evolutions in policy forces—with “widespread recognition, including among utilities, that low-carbon policy drivers are here to stay.”[47] Internationally, countries have taken the opposite approach to the Trump administration’s, such as with China’s plan to invest $360 billion in renewable energy by 2020.[48] Altogether, these factors have compelled some commentators to deem the transition to a low-carbon society “inevitable.”[49]

Nevertheless, a world with low carbon emissions does not somehow transform into a utopia. A shift to a clean-energy economy stands to perpetuate or exacerbate current patterns of inequity. Those patterns could specifically relate to low-carbon industries, for instance, through land theft to develop wind and solar farms, forced labor to extract the natural resources necessary to create solar panels, or impositions of health hazards from biomass fuels.[50] The patterns could also arise in other contexts in the low-carbon world, such us through inequitable access to clean energy.[51]

While these novel risks have begun to receive more attention in dialogues on climate change and the clean-energy transition, so, too, has the slightly more controversial question of “jobs.” “Jobs versus environment” tensions surround nearly every environmental policy debate.[52] Industry advocates and workers argue frequently that environmental reform will destroy individual livelihoods and communities’ entire way of life.[53]

Environmental groups—who have good reason to be cynical—have historically responded to these claims with dismissiveness.[54] Environmental advocates have argued that concerns about jobs are either industry propaganda or misinformed in some way.[55] Complaints that environmental reforms undermine jobs thus often encounter arguments that job losses are not as bad as claimed, or even if they are, environmental reform provides a net benefit to all that outweighs the cost of a few lost jobs.[56]

This tension raises the question: do environmental regulations cause people to lose their jobs—with “lost jobs” often used as a rhetorical stand-in for lost good jobs?[57] And if they do, does the benefit to the greater good offset the lost jobs? These questions are more complicated than they may seem. A first, critical point is that the changes that are necessary for the United States to reduce its greenhouse gas emissions adequately are dramatic.[58] Thus, climate reform that is meaningfully suited to climate change is not the same as the incremental environmental reforms of the past. According to one interpretation, carbon emissions in the United States need to decline by 40% over the next twenty years.[59] Methane and other greenhouse gas emissions also need to be reduced at some level.[60] “To accomplish this goal will require across-the-board cuts in both production and consumption in all domestic fossil fuel sectors”[61] and likely, in other industries as well.[62]

The “transition” is therefore a new era, which could involve a relatively rapid restructuring of society. This rapid restructuring could involve quicker, more extreme contractions of certain industries. According to economists Robert Pollin and Brian Callaci, in this scenario, “workers and communities whose livelihoods depend on the fossil fuel industry will unavoidably lose out in the clean energy transition. Unless strong policies are advanced to support these workers, they will face layoffs, falling incomes, and declining public-sector budgets to support schools, health clinics, and public safety.”[63]

Yet even if the transition to a clean-energy economy involves more incremental changes, it is worth contemplating whether the environmental movement has itself periodically had a misinformed stance on the question of work. As many have pointed out, environmental regulations have been shown not to result in a net loss of jobs for a given society and may in fact produce net gains in employment.[64] This may seem to support the “greater good” argument. Indeed, the clean-energy transition is anticipated to yield dramatic growth in the ever-burgeoning green energy sector, creating millions of new jobs over the course of the coming decades.[65]

However, regulations and other measures have at times also been shown to catalyze job losses for discrete regions and sectors.[66] Viewed through a legal geographies lens—which holds that questions of scale, scope, and place may show that what is “just” at one level is “unjust” at another[67]—this collateral damage of environmental reform does seem more problematic. As one commentator articulated, “[i]f you’re a coal miner in West Virginia, it’s not a great comfort that a bunch of guys in Texas are employed doing natural gas.”[68] While industry advocates undoubtedly exploit, or sometimes invent, such harms, it is possible that the environmental movement has also turned a blind eye to them.

Do job losses that are not clearly the proximate cause of legal reform, but that stem from the evolution of market forces, also deserve attention? Society did not, after all, provide special support to the employees of Blockbuster when mail-order DVDs and online streaming took their place because those services were more convenient and in demand. Why should workers who lose in the transition to a low-carbon economy be given preferential treatment over the many other workers who lose in diverse, market-driven scenarios, if policymakers are not intentionally causing them to lose for the greater good?

The question of causation is addressed in more depth in the subsequent discussion, in which I argue that, especially in the energy sector, it is very difficult to disentangle causal forces among law, policy, and market operations. But further, workers’ dependency relationship with a particular industry and lack of alternative options may be what trigger the need for a just transition; in other words, equitable factors may drive this theory just as much, if not more, than causal ones. Yet, again, these tensions also raise the question of a possible choice between more robust transitional policies and more robust protections for workers and communities in general.

B.  Defining a “Just Transition”

The idea of a just transition originated with the labor movement in the late twentieth century, in part in response to the environmental movement.[69] Labor and environmental activist Tony Mazzocchi is credited with coining the term, with the original version called a “Superfund for Workers.”[70] Referencing the superfund—a federally-financed program to clean up toxic wastes in the environment—suggested Mazzocchi’s proposal was an analogous remedial measure, but for human beings. It was based on the idea that workers who had been exposed to toxic chemicals throughout their careers should be entitled to minimum incomes and education benefits to transition away from their hazardous jobs.[71] Mazzocchi believed “that both nuclear workers and toxic workers, ‘because of the danger of their jobs and their service to the country, should be entitled to full income and benefits for life even if their jobs are eliminated,’” although he later gave in to pressure to reduce his demand to four years of support.[72] After environmentalists complained that the word “superfund” “had too many negative connotations,” the proposal’s name was changed to “[j]ust [t]ransition.”[73]

In the 1970s and through his death in the early 2000s, Mazzocchi and his associates were involved in creating “powerful labor-environmental alliances” that pursued the just transition campaign with the hope of addressing “the jobs-versus-environment conundrum.”[74] He was “the first union president to negotiate partnerships with Greenpeace and the environmental justice communities.”[75] He also developed educational programs for workers on the environment.[76] Mazzocchi’s advocacy thus forms the basis of the modern iteration of the labor-driven “just transition” concept. This foundation shapes the term’s modern usage as the idea that workers and communities whose livelihoods will be lost because of an intentional shift away from hazardous activity deserve some sort of support through public policy.[77]

Meanwhile, the broader usage of “just transition” is of less certain origin. It appears to be the plain-language interpretation of the labor movement’s term of art, thereby calling for “justice” more generally, and not just for workers. In other words, it emphasizes the importance of not continuing to sacrifice the well-being of vulnerable groups for the sake of advantaging others, as has been the norm in the fossil-fuel-driven economy. Thus, the broad concept of a “just transition” may in fact be even more radical than the narrow one because the former calls for a grand restructuring of societal inequality.

This discussion focuses on the labor-driven usage of just transitions and argues that legal scholars should do the same for two main reasons, beyond the fact that it is confusing for scholars in different spheres to be using the same emergent term with different meanings, and in addition to the theoretical discussion below. First, the labor-related usage seems to predate the broad usage and to have gained more traction. Major international organizations have embraced the labor-related meaning. Just transitions for workers have been adopted as goals by the United Nations Environment Program, the International Labour Organization (“ILO”), and the World Health Organization.[78] In 2013, the ILO published a policy framework for a just transition, which focused specifically on workers, noting that “[s]ustainable development is only possible with the active engagement of the world of work.”[79]

In addition, the labor-related usage’s specificity makes it stand out. The broad call for justice shares similarities with other models used to call for equity in the face of climate change, including environmental justice, climate justice, and energy justice.[80] This overlap may suggest that the broad concept has less of a niche to fill than the narrow one, and more risk of redundancy. By contrast, the labor usage’s narrowness may give it more potency.[81] In other words, it is not clear what a broad call for a just transition adds to these powerful and better-known concepts of justice, which all relate directly to the low-carbon shift.

Scholarly commentary complicates the choice somewhat because the literature seems split between the two usages. The broad meaning appears in at least some social science and legal scholarship. In a 2012 book entitled Just Transitions, two sustainability scholars defined a just transition as one “that addresses the widening inequalities between the approximately one billion people who live on or below the poverty line and the billion or so who are responsible for over 80 percent of consumption expenditure.”[82] Environmental justice scholar Caroline Farrell has characterized a just transition as one that avoids “the problems with the fossil fuel economy . . . [and aims] to create a truly just economy,” or as a “transition to an economy that does not create disparate environmental impacts.”[83]

Sociologists, political scientists, and several legal scholars who have explored the labor-related meaning provide a solid foundation from which to continue examining it.[84] They have also begun filling in the contours of what, exactly, this usage of “just transitions” means. Rural sociologist Linda Lobao interprets a just transition as one that “mov[es coal] communities toward economic sectors that offer a better future.”[85] Interdisciplinary scholars Evans and Phelan define it more broadly as “a political campaign to ensure that the costs of environmental change [towards sustainability] will be shared fairly. Failure to create a just transition means that the cost of moves to sustainability will devolve wholly onto workers in targeted industries and their communities.[86]

In the legal sphere, David Doorey’s definition emphasizes work somewhat more. He explains the concept as “a policy platform that advocates legal and policy responses and planning that recognizes the need for economies to transition to lower carbon economic activity, while at the same time respects the need to promote decent work and a fair distribution of the risks and rewards associated with this transition.”[87] Climate law scholar J. Mijin Cha describes a just transition as “protecting workers who are impacted by climate protection policy,” including by re-training workers and providing them with education funds.[88] Ramo and Behles emphasize the need to recognize communities’ economic dependency on high-emissions activity as those communities transition away from that activity, suggesting, like Labao, that a just transition “help[s] revitalize . . . fossil-fuel dependent communities.”[89]

Calls for just transitions appear to arise the most in union advocacy, which again lends weight to the choice of the labor-driven definition. The International Trade Union Confederation has described a just transition as a “tool the trade union movement shares with the international community, aimed at smoothing the shift towards a more sustainable society and providing hope for the capacity of a ‘green economy’ to sustain decent jobs and livelihoods for all.”[90] Generally, just transitions advocates “highlight the need to engage affected workers and their representative trade unions in institutionalised formal consultations with relevant stakeholders including governments, employers and communities at national, regional and sectoral levels.”[91]

Despite the appearance of “justice” in the name of just transitions, few legal commentators have delved more deeply into the legitimacy, significance, or traits of the idea of a just transition. The next Part reviews Doorey’s article, further characterizes the labor-driven just transition concept, and explores what principles may or may not support the concept.

II.  Can a Law of Just Transitions Be Justified?

This Part asks whether incorporating the just transition principle into law is a worthwhile endeavor, theoretically and practically. Exploring three potential justifications for doing so—one based on environmental theory, one based on the experiences of coal communities, and one based on strategic considerations—the discussion reveals that pursuing just transitions is not merely a nice thing to do. Rather, this discussion supports the conclusion that the concept not only fits neatly within the sustainable development framework—an internationally accepted framework for reconciling competing interests in environmental decisionmaking—but that it in fact injects a long-overlooked, much-needed consideration of economic equity.[92] This Part argues further that coal communities are particularly worthy of attention because of their history of combined exploitation and dependence. This Part’s third argument relies on interest-group theory to propose that the pursuit of just transitions is desirable because it could unite environmental and labor groups around the goal of a potentially more attainable and more equitable climate policy than prior efforts have secured.

David Doorey’s article is the first piece of legal scholarship to explore the worthiness and potential contours of a body of Just Transitions Law (“JTL”). He notes that labor law scholars have “mostly ignored” the effects that climate change will have on labor markets, while environmental law scholars have generally disregarded labor relationships.[93] Because neither legal field seems adequately equipped to handle climate change, he considers whether a new field is needed that combines the strengths of each.[94]

Doorey suggests that areas of common ground between labor and environmental scholarship might be ripe for doctrinal synthesis, such as the fact that both are in the business of “impos[ing] a countervailing power on unbridled economic activity.”[95] Yet he also notes that “jobs versus environment” tensions and other conflicting interests have tended to keep the fields apart.[96] Without coming to a firm conclusion as to whether JTL is worthwhile as a new legal field, Doorey does conclude that a just transition strategy is critical in the face of climate change, and that “[t]o implement a just transition strategy, governments need to design policies that cross existing government ministerial portfolios and legal regimes.”[97]

Doorey explores three potential forms for a body of law that marries aspects of labor and environment, including: 1) “[a] [l]aw of [e]conomic [s]ubordination and [r]esistance” that combines environmental justice’s and labor law’s overlapping recognition of power relations and embrace of collective, bottom-up resistance;[98] 2) a law of “[h]uman [c]apital or [c]apacities,” which would assess the fairness of rules, both environmental and labor-related, based upon whether they further human capabilities and freedom; and 3) an explicitly-named body of “Just Transitions Law,” (“JTL”), which would draw upon existing just transitions policy strategies, such as the ILO’s, aimed at joint consideration of environmental and labor goals, including pursuing cross-sectoral collaboration, incentivizing sustainable industries, and offsetting impacts to workers affected by environmental policies.[99]

For his third proposal, the explicit body of JTL, Doorey provides three “normative claims (NC) drawn from climate science, environmental law, environmental justice, and labour law.”[100] They include:

Firstly, climate change is a pressing global problem that market forces alone will not adequately address. Therefore, states should respond through public policy and law (NC1). Secondly, public policy should encourage a transition towards greener, lower carbon economies (NC2). Thirdly, there will be social and economic costs and benefits associated with climate change, and with the transitional policies aimed at responding to it, and those costs and benefits will also not be equitably distributed by market forces alone. Therefore, governments should seek to minimize the economic and social harms associated with the desired transition to a greener economy, and attempt, through law and policy, to distribute those harms and any resulting benefits in an equitable manner (NC3).[101]

This discussion begins with Doorey’s third proposal and adopts his normative claims for reference. While his first two proposals have great appeal, his third one seems to capture the already-existing evolution of this area of law.

However, like with the broadly-defined just transition described above, one might ask what this set of normative claims adds to the concept of climate justice. A centerpiece of the evolving theory of climate justice is public policy geared toward equitable sharing of the burdens and benefits of climate change through transparent consultation with diverse stakeholders.[102] Climate justice also espouses recognition of the fact that some communities are more vulnerable to the effects of climate change than others, and are more likely to be excluded from benefits.[103]

In order to capture the potency that more specific concepts may yield, to avoid duplicative efforts, and to recognize the labor movement’s role in formulating this theory of justice, I would add a fourth normative claim to Doorey’s third proposal, whether explicitly or implicitly, which is justified in more depth below: the needs of the workers and communities that have developed dependency relationships with high-carbon industries, often with substantial past and present socioeconomic costs, should specifically factor into calculating the equitable distribution of harms and benefits in the transition to a decarbonized economy. This consideration is not proposed as a competitor to environmental justice, climate justice, or any other framework concerned with vulnerability. It is, rather, a call for the specific recognition of work and existing economic dependencies in the decarbonization process, which have often gone overlooked.

This discussion does not take up the question of whether JTL should be an entirely new area of law. Like Doorey’s, it is intended as an “early contribution” to this emerging field.[104] The discussion therefore explores instead whether the just transition principle is worthwhile, and how it could be incorporated into law—which is perhaps also a worthwhile consideration as an alternative to establishing a new legal field.

A.  An Environmental Theory of Just Transitions

The discussion in this Section argues that the labor-driven just transition concept has a natural and important place within current prominent distributive environmental decisionmaking frameworks. In other words, this discussion seeks to legitimize the concept and situate it in relevant literature. The discussion shows that the idea is neither foreign nor frivolous in relation to environmental theory. But further, I argue that it adds a point of consideration that other frameworks have tended to overlook, suggesting all the more that it is a worthwhile idea.

The just transition concept, understood in the context of climate change, is a call for distributive justice in (or after) environmental decisionmaking.[105] In order to understand or define it, then, it is important to assess it in relation to existing models for environmental distributive justice. Sustainable development and environmental justice are two of the most prominent of these models.[106] Each model strayed from traditional environmentalism, which is largely focused on pro-conservation, anti-pollution measures, in order to try to establish a framework that takes more socioeconomic realities into account, including the need for equitable distribution of benefits and burdens.[107]

Environmental injustice was originally known as environmental racism, calling attention to the fact that communities of color bear a disproportionate burden of environmental hazards.[108] Sustainable development, meanwhile, is a forward-looking decisionmaking paradigm that seeks to harmonize conservation priorities with economic considerations as well as social equity.[109] While environmental justice adds a civil rights component to environmentalism, sustainable development aims to mitigate standard development by incorporating historically overlooked priorities into development decisions.[110]

The just transition concept exhibits a significant parallel with environmental justice in that both ideas were born as social movements in the late twentieth century in response to the environmental movement.[111] Environmental justice calls for racial equity (and other forms of non-discrimination), while just transitions calls for labor equity. The movements are thus not dissimilar in that each advocates a distributive component on top of traditional environmentalism’s conservation priorities. Another parallel is that each is a broad, equitable principle that is at times embodied in laws in different ways. Yet the movements and legal schemes associated with each concept have rarely interacted, in part because of conflicting priorities and cultural backgrounds.[112]

Sustainable development, as compared to environmental justice, has perhaps more direct applicability to the question of work. The sustainable development approach aims to “capture[] the interrelationship between the environment, the economy, and human well-being in the effort to meet ‘the needs of the present without compromising the ability of future generations to meet their own needs.’”[113] In other words, it is “a decisionmaking framework to foster human well-being by ensuring that societies achieve development and environment goals at the same time.”[114] Sustainable development directly aims to undermine the fossil fuel economy. It thus, in turn, creates the need for a “just transition,” in that it is fundamentally premised on a shift to renewable energy sources.[115] Yet it also may provide tools for ensuring a just transition because of its concern for economic and equity-related priorities.

While sustainable development as a theory faces many criticisms, it is “not simply an academic or policy idea; it is the internationally accepted framework for maintaining and improving human quality of life.”[116] For instance, based on the overall aim of sustainable development, international frameworks have adopted as goals both poverty eradication and addressing “[t]he deep fault line that divides human society between the rich and the poor and the ever-increasing gap between the developed and developing worlds . . . .”[117] Sustainable development’s actual implementation takes on many forms, as the approach “needs to be realized in the particular economic, natural, and other settings of each specific country,”[118] as well as each specific state or city. “The key action principle of sustainable development is integrated decisionmaking. Essentially, decisionmakers must consider and advance environmental protection at the same time as they consider and advance their economic and social development goals.”[119] This contrasts with conventional development, where environmental concerns historically arose only as afterthoughts.[120]

Sustainable development decisionmaking is often represented as a triangle. Its three points are the economy, the environment, and equity or social justice.[121] The points are a simplified representation of the three values or priorities that sustainable development seeks to reconcile.[122] The standard sustainable development triangle is represented in Figure 1.


Figure 1
.  Sustainable Development Framework

 

The triangle represents an accessible conceptualization of the harmony that the decisionmaking paradigm seeks to achieve. In turn, these three values are embodied in law and policy in varied ways. For example, a traditional building code, reworked through the lens of sustainable development values, could transform into a “green” building code, prioritizing materials with minimal environmental impacts and low-carbon energy sources. The “equity” prong might dictate that new housing developments, as an example, should not only be green, but also affordable.

Environmental justice and sustainable development may seem like they occupy different spheres of environmental theory, but Uma Outka has observed that they have the potential for synergy. She notes a risk of conflict between the two models as the broader sustainable development agenda might prove insensitive to environmental justice concerns.[123] For instance, at the project level, sustainable development and environmental justice can face tensions, such as if the siting of wind farms (comporting with sustainable development’s driving concern for carbon reduction) harms indigenous cultural resources (violating environmental justice’s concern for communities’ autonomous decisionmaking and the non-discrimination principle).[124] Yet Outka argues that environmental justice in fact refines sustainable development by adding the particular environmental justice conception of equity.[125] She concludes that for sustainable development to be consistent with environmental justice, the significant differences among renewable energy sources require more recognition and concrete definition, so that each pathway’s potential for inequity can be better understood and addressed.[126]

 Outka’s articulation of this relationship can thus perhaps be represented by Figure 2 below, which highlights environmental justice as an aspect of the sustainable development framework at the nexus of the environment and equity points of the triangle. In other words, environmental justice becomes another value that must be harmonized with other values in environmental decisionmaking, including the three Es. As a principle of environmental equity, environmental justice aligns with sustainable development at the nexus of sustainable development’s environment and equity prongs.


Figure 2
.  Sustainable Development with Environmental Justice Refinement

 

Figure 2 is not meant to suggest that environmental justice is the only refinement to sustainable development, or the only point of interest on the environment-equity leg. However, in a decisionmaking framework that is intended to manage complex scenarios, understanding these relationships can help inform the characteristics of normative paradigms. Environmental justice is a call for environmental equity, and it has a natural locus in the sustainable development paradigm.

When viewed through the framework of sustainable development, just transitions no longer seems like such a foreign concept to environmental law. Primarily, environmental decisionmakers already have a framework for considering questions of economic equity as they relate to environmental decisionmaking. Just transitions, with its concern for avoiding or mitigating inequitable impacts to livelihoods in environmental decisions, is ultimately a doctrine of economic equity. Thus, a natural place for just transitions is running parallel to environmental justice and in the analogous position along the economic and equity side of the triangle, as shown in Figure 3.


Figure 3
.  Sustainable Development Framework with Environmental Justice and Just Transitions

 

This visualization is powerful because it suggests that, like environmental justice, a just transition is simply a refinement to a framework upon which decisionmakers already rely. While it might also be said to have already existed along the economy-equity side, it has largely gone unrecognized. Just as environmental justice is a principle of environmental equity that must be harmonized with other values, the just transition is a principle of economic equity that should also factor into the calculus—and it appears to have a natural place within that calculus.

Another reason this visualization is powerful is that it builds upon increasingly vocal calls for environmental justice to inform the transition to a low-carbon society.[127] These calls, in fact, circle back on the broad meaning of the just transition—the idea that the decarbonization process must be done fairly in general.[128] One may be concerned that these paradigms might all conflict with each other in the transition, or pose difficult zero-sum choices. The visualization in Figure 3 shows that these principles are complementary, and in fact, bring environmental decisionmaking toward a more holistic picture of societal needs.[129]

This visualization may also help reconcile some of the tensions between sustainable development theory and resilience theory. Resilience theory has emerged as a counter-framework to sustainable development.[130] Resilience theorists’ criticisms of sustainable development are that sustainable development assumes stationary, controllable circumstances; potentially sanctions current patterns of harmful development and an ethic of “green consumerism;” and fails to account for complexity, or the interrelatedness of complex social-ecological systems.[131] This latter point is particularly concerning to resilience theorists in the age of climate change, which will involve more drastic changes in ecological and social regimes than previously seen.[132] Resilience theorists instead advocate decisionmaking paradigms that are iterative, or ongoing, rather than traditional planning processes; that involve “principled flexibility;[133] and that anticipate constant change in social-ecological systems.[134] Adaptive management and adaptive governance have been considered potential vehicles for pursuing resilience governance, although scholars agree that a gap remains between theory and practice.[135]

Although the rift may be large, perhaps the addition of environmental justice and just transitions to the sustainable development framework brings sustainable development a modest inch closer to resilience thinking. The more points of interest that are added to the sustainable development framework, the more sustainable development would seem to wield potential for decisionmaking that accommodates social-ecological systems. Figure 4 illustrates that the framework above can in fact represent a continuum of social, economic, and natural concerns.[136] While there are infinite points of interest on the continuum, environmental justice and just transitions show points of particular concern based on society’s historical and potential inequities. If one recognizes that the sustainable development paradigm could have infinite points, the next natural inference must be an acceptance of uncertainty because infinite interacting aspects of social-ecological systems could never be stationary.


Figure 4
.  Making Sustainable Development Work for Social-Ecological Systems

 

In any case, the frameworks above show how the just transition concept has a natural place with several prominent environmental theories of today. But it can also follow the path of environmental justice and sustainable development in that it may at times be a principle warranting contemplation, rather than all or part of a framework in and of itself. Both environmental justice and sustainable development are “normative conceptual framework[s]” that are in turn embodied in law in various ways, sometimes simply as policy goals.[137] Just transitions can join their ranks as such a principle as well, offering an additional equitable priority, or a more concrete framework for decisionmaking.

In general, environmental law scholars have increasingly recognized the need to account for the jobs question, rather than to dismiss it.[138] As Richard Lazarus articulates, “there has been at best only an ad hoc accounting of how the benefits of environmental protection are spread among groups of persons.”[139] Environmental law scholars have recently contemplated how to overcome the perception and reality of “zero-sum” environmentalism, in which some segments of society must lose, or think they are losing, in pursuit of environmental progress.[140] This realization has come about at the same time as the recognition that environmental law is overall inadequate in the face of climate change.[141] The placement of just transitions into the framework above helps address both these concerns. It provides a way to think about contemplating livelihoods in environmental decisionmaking, as well as making decisionmaking align better with social-ecological systems.

B.  Fossil Fuel-Dependent Communities: An Exemplary Case Study for Just Transitions

The discussion in this Section examines what, exactly, is meant by “fossil fuel-dependent communities” and why they have prompted so much interest in just transitions in the climate change era. Many communities that depend on high-carbon industries have a unique history and relationship to work, and many have borne profound costs associated with energy production for over a century.[142] Yet the rest of society has alternately encouraged, acquiesced in, or benefited from this hazardous, economically depleting way of life.[143] Based on these troubling circumstances, this Section argues that the labor-driven just transition concept is legitimate because it is fair to these specific communities. A critical point is to understand that fossil fuel-dependent communities were not born in a vacuum. They were created. This discussion uses Appalachia as an example, but its story is relevant to comparable scenarios throughout the country.[144]

As early as the 1700s, companies played a central role in developing isolated Appalachian mono-economies, or monopsonies, where workers and communities became hostage to desperate dependency relationships.[145] The dependence stemmed in part from a rush of speculators in the 1800s seeking to acquire Appalachian land.[146] Locals, mostly subsistence farmers, did not know the worth of the minerals under their land and sold property interests for well under market value.[147] “Others who refused to sell their land became victims of legal traps, such as being jailed and then offered bond in exchange for their land.”[148]

Appalachia evolved into what some scholars call an “internal colony” or a “sacrifice zone,” which was “created to provide cheap resources to fuel the rest of the country.”[149] Companies dominated land ownership and isolated communities from penetration by other industries.[150] Through isolating people and dispossessing them of land, coal companies sought to turn local residents “into a docile workforce” that lived and breathed extractive work, residing in company towns and coal camps and paid in “scrip” instead of money.[151] While company towns are no longer the norm, the effects of these relationships are still felt in Appalachia today. Yet this was all in the name of “the greater good,”[152] with fossil fuel communities serving as the nation’s cheap energy powerhouse.[153]

Serving as the nation’s energy powerhouse has been costly. For decades, coal miners have lost their lives in and because of the mines.[154] Some of these deaths were in major disasters that caught the public’s attention, but most of them were a regular procession of daily accidents and health harms.[155] These hazards are not a phenomenon of history, either. “Between 1996 and 2005, nearly 10,000 miners died of black lung disease.”[156] As of this writing, black lung rates have in fact been rising.[157]  Yet the costs have not been limited to miners themselves. Residents living near mountaintop removal sites suffer high rates of disease and morbidity.[158] In addition to compromised health and safety, residents of fossil fuel communities have seen the destruction of irreplaceable cultural and ecological resources, as well as entrenched poverty and limited economic alternatives.[159]

Yet throughout the evolution of this exploitative dynamic, these relationships were encouraged and actively supported by the rest of the country through law and policy, evolving with the knowledge and acquiescence of the larger political body despite intermittent recognition of Appalachian problems. When coal miners sought to improve their conditions in the early twentieth century, federal actors intervened on behalf of companies.[160] In Hitchman Coal & Coke Co. v. Mitchell, the Supreme Court sanctioned mine operators’ power to contract with workers to prevent unionization.[161] In the 1921 Battle of Blair Mountain, the United States Army intervened to stop an uprising of miners, after which the Army left West Virginia to resolve the conflict internally, much to the detriment of the miners.[162] Black lung, a “chronicle of a preventable disease that was not prevented,” was ignored by state and federal public health authorities for most of the twentieth century “[d]espite the fact that physicians working among coal miners in the nineteenth century recognized and called attention to . . . [this] public health disaster.”[163] These egregious conditions notwithstanding, throughout the twentieth century, tax incentives and subsidies to the fossil fuel industry became a part of law.[164] As of 2017, the federal government continued to support fossil fuel production with $14.7 billion in subsidies, and state governments provided a total of $5.8 billion in incentives.[165]

Meanwhile, coal communities’ suffering was not unknown. Congress made a show of helping Appalachian residents with measures such as the Surface Mining Control and Reclamation Act (SMCRA). Yet SMCRA “has fallen far short of its potential;[166] indeed, with provisions providing for oversight by states known to be dominated by industry,[167] it could hardly be deemed an earnest effort to remedy Appalachian suffering. Similarly, the Black Lung Benefits Act of 1973 nominally addressed black lung, only to help a mere 7.6% of claimants in “a system that miners, unable to attract attorneys and financially incapable of matching the coal companies’ development of medical evidence, wholeheartedly despise[d] as unjust.”[168]

U.S. society thus has a decades-long tradition of propping up the fossil fuel industry and acquiescing in its creation of exploitative mono-economies. Viewed in this light, workers’ and communities’ anticipation or hope that support might continue for their sole economic lifeline seems less unreasonable than if one views that anticipation standing alone in the context of today’s changed markets, or viewed through the lens of communities with more resources or alternative options.[169] The argument that fossil fuels are harmful and that people simply have to find other jobs overlooks a longstanding history of exploitation and isolation, an abusive tradition from which the majority has benefited. A swift, unmitigated shift away from these industries stands to exacerbate the injustices that fossil fuel communities have already experienced. The transition has, in fact, already begun, and fossil fuel communities have not fared well.[170] Coal country has already lost a substantial portion of employment opportunities, and with those lost jobs have come lost tax resources, businesses, population, and spirit.[171]

One might argue that this is the nature of economic developments: markets change and workers and communities who bear the losses of those transitions must adapt, evolve, and potentially relocate. Yet attempts to distinguish between the public and private spheres in this context ring hollow. First, fossil fuel workers and communities have been engaged in what should be characterized as quasi-public activity.[172] While their contributions to the nation’s energy supply were through direct relationships with private companies, those companies were empowered by the public. The workers’ and communities’ labor and losses fueled a public electricity grid and provided fundamental public benefits for which they bore immeasurable externalized costs.

Second, one would be hard-pressed to disentangle the diverse public and private factors that converge to shape discrete sectors, especially in the energy context.[173] Many have pointed to the cheapness of natural gas as a driving force undermining the coal industry in order to suggest that coal’s decline is a private phenomenon not warranting mitigation.[174] However, Congress’s decision to impose minimal regulations on the natural gas industry was an intentional public policy development that shaped the status quo in foreseeable ways.[175]

These circumstances illustrate that, if nothing else, principles of fairness and equity weigh in favor of a just transition for these communities. Yet these principles also implicate some of the basic premises of our legal system. Communities’ expectations and reliance have been encouraged, even coerced, through law and policy. While formal legal avenues have been of little help to them—to demand, for instance, the delayed closure of a plant, collective compensation for environmental degradation to the region, or meaningful assistance with the black lung pandemic—the ethical impetus to help these communities transcends a mere nicety.

Several lines of scholarship have insisted upon the materiality of expectations at the community level. Joseph Sax was concerned with community reliance and formal property law’s silence on communities.[176] He argued “that the law offered no opportunity even to raise a question about the non-economic losses incurred when an established community is destroyed . . . for ‘just compensation’ includes only the value of the economic interests taken.”[177] He noted that:

there is a widespread sense that community is important, and a willingness exists to protect community interests; yet there is no principle or doctrine to which to turn in those cases where, for whatever reasons, the people affected are unable to generate the political support necessary to induce an act of grace.[178]

Sax argued that “[t]he idea of justice at the root of private property protections calls for identification of those expectations which the legal system ought to recognize,” including at the community level.[179]

The concern for community reliance evokes the related concern that frustrated expectations can lead to social instability and political upheaval.[180] For instance, Sax argued that the public trust doctrine was not merely a state’s obligation to conserve natural resources, as many understand it, but is also a means of marrying customs with formal law in order to respect common expectations and ward off social unrest.[181]

This line of thinking seems to suggest that where formal law fails to recognize the meaningful nature of coal communities’ reliance upon their way of life, the lens of first principles illuminates the way of life as meaningful and worth respecting. The reasons for undermining that way of life seem meaningful too. Fossil fuel communities have already been sacrificed for the sake of collective progress through their energy production activities. They stand to be sacrificed anew if their majoritarian-encouraged dependency relationships are ignored in the transition to clean energy, as state and federal policy drivers continue to curtail or undermine these communities’ economic activities in the name of collective progress.[182]

While the majority’s willingness to destroy coal communities’ dependency relationships is not a “takings,” it nonetheless raises the prospect of a discrete minority being sacrificed for “the greater good”—an approach to progress that legal ethicists have considered at best morally questionable.[183] Indeed, when federal legislators passed provisions of the Trade Act of 1974 to offset displacement caused by reduced restrictions on trade,[184] one decisionmaker reasoned, “much as the doctrine of eminent domain requires compensation when private property is taken for public use,” increased fair trade required compensation to displaced workers.[185] “Otherwise the costs of a federal policy [of free trade] that conferred benefits on the nation as a whole would be imposed on a minority of American workers.”[186]

It might be suggested that Appalachia and other carbon-dependent communities are not unique in their situation. Workers in the United States are often displaced and left vulnerable for a variety of reasons including changes in technology, new trade regimes, other policy developments, or the absence of legal protections.[187] This comparison is worthwhile. The story of Appalachia, while unique in some respects, shares many analogies, as with tenants and sharecroppers who were displaced by the mechanization of the cotton harvest, plant employees who lost manufacturing jobs when businesses moved overseas, and aerospace workers who were displaced during the 1990s with the end of the cold war, to name some examples.[188] The question becomes one of drawing lines. Where takings analyses stop, economic transitions begin. We ask people to bear the costs of the latter, not the former, and by not recognizing property interests in work,[189] we disfavor the property-less in decisions as to who receives compensation.[190]

This line-drawing may make sense. Otherwise, it could become cost-prohibitive to pass new laws. Yet certain factors weigh in favor of contemplating either more effective transitional policies or more robust baseline protections for workers and communities. First, as technology continues to evolve and render more work obsolete, the future will be replete with ongoing displacement.[191] As more and more people and professions are displaced, it seems unrealistic to assume that the supply of work will match the demand for it. Second, the egregious ramifications of the transition away from coal indicate that asking those workers and communities to bear the losses, adapt, and relocate has simply not worked for a substantial segment of those communities. While such a proposed allocation of losses may make sense in theory, in practice, the result has been poverty, deaths of despair, and regional stagnation.[192]

To be clear, none of this discussion is intended to suggest that deep decarbonization should not be pursued as swiftly and effectively as possible. The question of livelihoods should not hold the broader community hostage to the dire fate associated with a failure to reduce carbon emissions adequately.[193] This is also not a call for some form of reparations, especially considering other communities, such as indigenous populations and the descendants of slaves, whose under-acknowledged exploitation also fueled national wealth in even more dire ways. The argument is rather that fossil fuel communities have already borne loss after loss to the benefit of others. To ask them to bear yet another disproportionate loss in the clean-energy transition on behalf of the rest of society would be to effectuate yet another distributive injustice. In other words, these communities should not be forgotten in the decarbonization calculus. They deserve a just transition.

C.  A Political Economy Theory of Just Transitions

This Section explores a pragmatic and strategic argument in favor of embracing the just transition concept. In short, the United States is in urgent need of environmental and climate policy reform at the federal, state, and local levels.[194] Reform is often unachievable, however, because of entrenched political obstacles.[195] This Section argues that the pursuit of law and policy informed by just transitions principles may be more achievable than more traditional modes of seeking environmental reform.

Most scholars now agree that environmental reform had a zenith of sorts, and that the zenith has passed.[196] The late 1960s and early 1970s saw the passage of the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation, and Liability Act, and the Resource Conservation and Recovery Act.[197] Still today, these major federal statutes make up the foundation of the environmental legal apparatus. The reforms largely came out of a national social movement.[198] Reacting to works such as Rachel Carson’s Silent Spring[199] and the incident of the Cuyahoga River catching fire,[200] the public realized that their welfare in part depended upon some measure of environmental protection.[201]

Sporadic successes have been achieved since the peak of environmental reform. As recently as 1993, Daniel Farber observed how environmentalism’s successes undermined the idea that interest groups could warp governmental policy through lobbying.[202] He explained:

[A]ir pollution legislation benefits millions of people by providing them with clean air; it also imposes heavy costs on concentrated groups of firms. The theory predicts that the firms will organize much more effectively than the individuals, and will thereby block the legislation. We would also expect to find little regulation of other forms of pollution. Similarly, we would also expect firms to block legislation limiting their access to public lands. Thus, the two basic predictions are that environmental groups will not organize effectively and that environmental statutes will not be passed.[203]

Yet Farber concluded that “the reality is quite different.”[204] “Environmental groups manage to organize quite effectively. . . . . Nor, obviously, is there any dearth of federal environmental legislation.”[205] He thus argued that “the political system manages to overcome the inherent advantages of special interests.”[206]

A more recent article by the same author recognizes a largely different status quo, however. In his 2017 article, The Conservative as Environmentalist, Farber recognizes that interest groups do indeed now stand in the way of environmental reform.[207] He suggests that conservatives’ shift away from moderate environmental sympathies over the past several decades can be explained by the “emergence of a coalition of disaffected westerners and business interests (particularly in the fossil-fuel industry) supported by an interlocking network of foundations, donors, and conservative-policy advocates.”[208]

A movement does exist today that is not all that different from the environmental movement of the 1960s and 70s.[209] Much of the American public is deeply concerned about climate change.[210] The movements for climate reform and related principles, such as climate justice and energy justice, use activism, litigation, and lobbying to pursue much-needed changes.[211] Many successes have been achieved.[212] Most commentators concede, however, that progress to date has simply been inadequate to ward off the disastrous effects of climate change.[213]

Anti-environmental forces today seem to have become more powerful than in prior eras.[214] The fossil fuel industry manages to undermine the environmental movement even at the grassroots level.[215] Pat McGinley describes, for example, the so-called “War on Coal” campaign, a massive, industry-financed public relations effort “buttressed by think-tank studies” that has successfully fueled public antipathy toward environmental regulations.[216] According to sociologists Bell and York, despite its waning contributions to the economy and employment, the fossil fuel industry manages to “gain[] compliance from substantial segments of the public” by “actively construct[ing] ideology that furthers its interests.”[217]

As the fossil fuel industry and conservative politicians have joined forces, labor and workers’ groups have often sided with them.[218] According to sociologist Brian Obach, “workers are not typically the lead opponents of environmental measures.”[219] Rather, industry executives recruit workers with the threat of layoffs or total shutdowns of operations. In addition, as “a threat to corporate profits” is not particularly concerning to the public, workers also become the more sympathetic faces of environmental opposition.[220]

Commentators have observed the largely untapped potential of collaboration between environmental and labor groups. The longstanding “work-environment” rift often puzzles scholars.[221] While jobs-versus-environment tensions serve to divide the two camps, other areas seem like they should be unifying—for instance, workplace safety, shared concerns about basic human needs, and as Doorey observes, the fact that both fields serve as checks on what would otherwise be “unbridled” corporate activity.[222]

One explanation for the rift is environmentalism’s association with the middle class and upper middle class. In its early days, the environmental movement was spurred in large part based on a philosophy embracing a veneration for nature.[223] As one activist articulates,

environmental heroes like John Muir, Teddy Roosevelt, and Aldo Leopold—and the romanticizing of wilderness through art, poetry, essays, and music—created a catalyst for men to see communing with nature as a way of defining their manhood. Exploration, solitude, and game hunting became the foundation for saving and preserving nature. But for whom was nature being saved?[224]

As the activist suggests, this philosophy arguably disregards the needs of society’s less privileged ranks, for instance, by failing to prioritize issues such as immediate access to clean drinking water, or being overly dismissive of livelihoods that depend on natural resources.[225] Pruitt and Sobczynski have argued, for example, that poor, white rural residents may be seen as “trash[ing] pristine nature by their very presence.”[226]

Yet, in the instances when labor and environmental groups have combined their efforts, these efforts have proven quite potent. Many attribute the passage of the Clean Air Act and the Clean Water Act to a coalition between workers and environmental organizations.[227] A prior article, Alienation and Reconciliation in Social-Ecological Systems, examined the fruitfulness of collaborative partnerships between ranchers and bird conservationists on public lands.[228]

Compared with the fossil fuel industry, then, the modern environmental movement has two problems: (1) a power problem and (2) a branding problem. Pursuing more aggressive, concerted appeals to labor interests could help address both of these problems.

The power problem is evidenced in the modern environmental movement’s inability to penetrate the thick web of interest groups that benefit from impeding climate reform and other environmental measures.[229] The political process is indeed “dominated by the rent-seeking activities of specialinterest groups.”[230] Naturally, coalitions and alliances stand to fare better than interest groups that work alone. While outreach to the fossil fuel industry may involve mere tilting at windmills given the industry’s track record,[231] labor and environments’ overlapping interests may have more potential to give climate advocates more allies and leverage.

But further, joining forces with workers’ advocates could also help the environmental movement win more hearts and minds. As an example of why the branding of environmental reform matters, many conservatives said in one public opinion poll that they opposed the Obama administration’s Clean Power Plan because they thought it would cost people jobs.[232] If the environmental movement addressed the jobs concern directly and in coordination with labor advocates—which they could do by lobbying for reform through the lens of the just transition—they could proactively address one of the arguments against environmental reform.

A potential concern in addressing work and labor more directly in environmental advocacy is that such efforts could result in sustaining livelihoods in hazardous industries and delaying much-needed environmental action. However, as discussed below, it is not necessarily contemplated that just transitions law and policy must entail actually sustaining hazardous industries; the more important principle is instead attempting to offset or mitigate some of the losses to livelihoods and communities as those industries’ activities are curtailed. Further, even if some compromises were to be made, it is worth considering whether the movement risks letting the perfect be the enemy of the good, and whether compromise outcomes may still be preferable to substantively preferable outcomes indefinitely delayed by political obstacles.[233]

III.  Just Transitions as Law: Filling in the Contours

This Part asks what are perhaps the most challenging questions surrounding the prospect of embracing just transitions in law and policy: What, exactly, does a just transition look like? Who deserves a just transition? What are the avenues for achieving it?

A helpful starting point is the fact that the pursuit of just transitions is not entirely alien to United States law and policy. This Part therefore starts in Section III.A with a brief summary and critique of four of the most prominent instances when federal institutions have authorized transitional policy to address worker and community displacement: (1) the Trade Act of 1974 providing assistance to manufacturing workers displaced by reduced restrictions on trade; (2) the President’s Northwest Forest Plan providing assistance to timber communities displaced by reductions in timbering on public lands; (3) the Tobacco Transition Payment Program assisting tobacco farmers displaced by public litigation against tobacco companies in the 1990s; and (4) the Obama administration’s Partnerships for Opportunity and Workforce and Economic Revitalization (POWER) Initiative assisting coalfield communities in the face of coal’s decline.

Interestingly, only two of the programs—the Forest Plan and POWER—have an explicit environmental component. This suggests that in practice, the understanding of just transitions has not been simply as a corollary to environmental progress. Rather, the consistent conditions among these scenarios are (1) a dependency relationship between a community and an industry that is (2) undermined by some public action, or perhaps in the case of coal, public inaction. Section III.B therefore also explores other, non-environmental scenarios where just transitions may be warranted, such as the example of New York City taxi drivers being displaced by ride-sharing services, or of longstanding community residents facing displacement by gentrification. Section III.B also revisits the argument that the line between economic and legal transitions is often blurrier than some might suggest, indicating that a scenario should not necessarily require a clear act of direct public complicity in order to trigger a just transition.

Section III.C discusses instances of locally-driven approaches to just transitions and posits that these examples offer important insights alongside the federal programs, particularly since the federal programs have, as a whole, not been considered particularly successful (while the effects of the POWER Initiative remain to be seen as of this writing). Local land use planning processes and similar mechanisms help account for the complex, interconnecting factors that shape mono-economies’ dependency relationships. They thus may have benefits to offer as an alternative or complement to the standard practice of using federal agencies to implement transitional policy.

Finally, Section III.D offers additional thoughts as to how and when just transitions should be pursued and who should pay for them. Yet this discussion again raises the question of whether transitional policy is the answer for worker and community vulnerability in the face of climate change or in other contexts, or whether more robust baseline protections may be the simpler, more efficient approach. This latter approach may also be the fairer, more inclusive one, in that transitional policy directs resources to workers who are losing “good jobs,” while other workers, particularly disproportionate numbers of women and people of color in the service industry, have benefited inequitably from such jobs in the first place.

A.  Federal Transitional Policies

1.  The Trade Act of 1974

The Trade Act of 1962 established the Trade Adjustment Assistance Program (TAA), while the Trade Act of 1974 gave birth to the modern program still operational today.[234] The program has become a quid pro quo component of modern trade policy. That is, in order to open more trade avenues, more trade assistance for injured domestic workers is often a necessary political compensatory measure.[235]

Crafted in the name of fairness, the program’s goal is to provide aid to workers who lose their jobs, hours of work, or wages because of increases in imports.[236] Congress was “of the view that fairness demanded some mechanism whereby the national public, which realizes an overall gain through trade readjustments, can compensate the particular . . . workers who suffer a loss . . . .[237] Returning to the idea that certain forms of displacement are ethically similar to takings, even if not cognizable as such in law, a federal court observed that TAA was pursued in as “much as the doctrine of eminent domain requires compensation when private property is taken for public use. Otherwise the costs of a federal policy [of free trade] that conferred benefits on the nation as a whole would be imposed on a minority of American workers . . . .[238]

Individuals eligible under the program may file a petition to the U.S. Department of Labor within one year of losing work.[239] Once certified, workers are then eligible to apply for TAA program benefits, which are administered through state agencies.[240] The benefits include “weekly cash benefits, job retraining, and allowances for job searches or relocation.”[241] “According to [2011] White House statistics, the average worker receiving benefits is a 46 year-old male with a high school education who is the primary breadwinner for his family and has worked for at least ten years at a factory that is closing.”[242]

Since the program’s inception, however, studies have shown that trade adjustment benefits have simply not gone far enough to compensate displaced workers for their losses. In one survey of displaced shoe workers in the 1970s, researchers concluded that

even if benefits were granted to a larger number of workers, each individual would be compensated for only a very small portion of his actual loss. The actual payments have been characterized by organized labor as band-aid treatment, because the subsequent wage loss as well as the many nonmonetary losses from displacement are not directly addressed.[243]

 More recently, economist Lori Kletzer found that almost forty percent of displaced workers did not find new jobs within one to two years after a job loss resulting from increased competition.[244] Another economist described trade assistance programs as “a collection of ad hoc, out-of-date, and inadequate programs that provide too little assistance too late to those in need.”[245] Legal scholars—who tend to treat TAA as a component of international trade law—have also critiqued trade adjustment assistance programs. Some deem TAA “a grave failure,” for reasons including “failures at the administrative and state levels, to Federal incompetence, to lack of resources and outreach for displaced workers,” as well as the inadequacy of judicial review available for workers unfairly denied assistance.[246] Its flaws notwithstanding, many agree that the program is preferable to not offering assistance at all and that reforms may stand to improve it.[247]

2.  The President’s Northwest Forest Plan

The President’s Northwest Forest Plan (NWFP) was formed in the aftermath of a 1992 decision in which the U.S. District Court for the Western District of Washington imposed an injunction prohibiting over 66,000 acres of timber from being harvested on Washington public lands because of dangers the harvesting posed to the northern spotted owl.[248] The Ninth Circuit Court of Appeals upheld this and a series of related decisions.[249] The Clinton administration then developed the NWFP, aimed toward enhancing conservation in the region. In 1994, the Forest Service and the Bureau of Land Management adopted the NWFP.[250]

The circumstances surrounding the NWFP’s enactment were famously contentious.[251] This scenario is at times considered a classic case study of “jobs versus environment.” Timber harvesters were outraged based on the perception that the habitat of a single species should wield such an impact on their livelihoods. Predictions of “economic devastation” followed the court decisions, with fears of “a new ‘Appalachia in the Northwest.’”[252] Environmentalists, meanwhile, saw the decisions as a necessary conservation win.

The economic concerns were not fictional. According to one commentator, “[n]o economic analysis [could] ignore the suffering of some rural communities, which [bore] the brunt of the economic pain associated with reduced federally subsidized timber supplies.”[253] When the injunction issued, it threw “between 60,000 and 100,000 people out of work.”[254] The NWFP sought to address some of this pain:

[It] extend[ed] assistance to workers and communities, payments to counties to compensate for reduced income, removal of tax incentives for the export of raw logs, and assistance to encourage growth and investment of small businesses and secondary manufacturing. Similarly, the Economic Adjustment Initiative . . . provided over $550 million to aid communities and individuals affected by reduced timber harvests.[255]

The NWFP also illustrates the causal complexity of factors that influence regional decline. Because of automation, “many jobs in the federally subsidized timber industry were on their way out long before the owl was listed as threatened under the Endangered Species Act.”[256] Generally, “rural areas dependent on the federal land-based timber industry” were not faring as well as other regions as of the 1990s.[257] Nonetheless, federal actors saw fit to intervene in this scenario involving mixed technological, economic, and legal factors contributing to the decline.[258]

The NWFP “never truly satisfied the warring factions, the timber industry and the environmentalists.”[259] However, it was considered an achievement for the Clinton administration.[260] Much analysis of the NWFP’s implementation has focused on its ecological successes. Yet, in all, “the NWFP has been more successful in stopping actions thought to be harmful to conservation . . . than it has been in promoting active restoration and adaptive management and in implementing economic and social policies set out under the plan.”[261]

The NWFP provided for “payments to timber-dependent counties suffering from cutbacks” due to the law’s implementation in 2000.[262] Since the NWFP’s implementation, counties formerly dependent on timber harvests for tax revenues have received millions of dollars.[263] Today, many of these counties are considered to be “in crisis” because of curtailments in direct federal subsidies.[264] The NWFP was criticized as failing to “provide long-term economic growth and security” for former timber counties.[265]

3.  The Tobacco Transition Payment Program

The tobacco industry has several unique quirks, but the parallels between the tobacco industry and the fossil fuel industry are notable. Both industries have invested aggressively in science-denial and public relations initiatives, both have rendered entire communities dependent upon them, and both have seen major shifts in public awareness contribute to their decline.[266] In addition to increased anti-tobacco sentiment and knowledge of health risks among the public, a mass tort action against tobacco companies in the 1990s brought them to the brink of extinction—which perhaps signifies a parallel to ongoing climate-related litigation against fossil fuel companies.[267]

Because of the economic hardships associated with decreased tobacco demand and government pushback against the tobacco industry, in the late 1990s, a settlement between states and large tobacco companies provided for billions of dollars of economic assistance to be paid to tobacco farmers.[268] The ten-year Tobacco Transition Payment Program (TTPP) was created to “ease tobacco farmers’ worries” and give them “time to diversify their crop to include other commodities separate from tobacco, or to allow [them] . . . to cease planting tobacco altogether.”[269] The TTPP also terminated a federal price-fixing program that had supported tobacco farmers since the 1930s.[270]

The TTPP is often referred to as a “buy-out” program.[271]  However, the term is somewhat misleading because farmers were not necessarily paid to stop growing tobacco.[272] Tobacco producers received government assistance by signing up for the TTPP through the U.S. Department of Agriculture Commodity Credit Corporation, which “provide[d] payments to tobacco quota holders who voluntarily enter[ed] into appropriate contracts with the government”[273]—including for the cessation of tobacco production.[274] The TTPP provided eligible producers with ten equal annual payments “designed to transition tobacco producers into a free market for their produce.”[275]

 The program’s effects were mixed and may be the subject of debate. The number of tobacco farmers was reduced dramatically just after deregulation was implemented.[276] Each participating farmer received on average a total of approximately $17,000 over the course of the program, while 75% of payments went to the top ten percent of farms.[277] Some have suggested that these payments offered important “injections of cash” for struggling rural communities.[278] On the other hand, the program may have had the effect of shackling some farmers to their crops involuntarily, as many were “unable to break free of the cycle of debt” associated with restructured relationships.[279] Some farmers, in response to the program, actually expanded their production of tobacco.[280]

 The TTPP model may have some lessons to offer just transitions law and policy. The fact that the TTPP helped transition workers and communities away from a production activity that had been publicly subsidized for decades, with minimal public attention or controversy, seems like a success. At the very least, the TTPP recognized that the political majority was complicit in fostering farmers’ dependency on the hazardous activity through national legislative intervention since the 1930s, and complicit in undermining that dependency relationship.

On the other hand, the TTPP model’s slow-sunsetting approach may stand in direct tension with the urgency associated with decarbonization. It also seemed to rely somewhat on tobacco farmers’ capacity for autonomous decisionmaking over their own production activities, which may not apply to many other scenarios or address regional economic dependencies with necessary robustness.

4.  The POWER Initiative

In 2016, the Obama administration announced a nearly forty million dollar program for twenty economic and workforce development projects to assist communities affected by changes in the coal and power industry.[281] The POWER Initiative was a joint effort involving ten federal agencies with the goal of either creating or retaining several thousand jobs, in addition to broader economic development, such as economic diversification, attracting new sources of investment, and providing workforce services and skills training. Through the POWER Initiative, the Appalachian Regional Commission (ARC) and other agencies have received over $100 million in appropriations to assist displaced coal workers.[282]

For instance, the ARC alone has received $50 million from Congress since 2016 in order to:

target federal resources to help communities and regions that have been affected by job losses in coal mining, coal power plant operations, and coal-related supply chain industries due to the changing economics of America’s energy production. To date, ARC has invested $94 million in projects serving 250 coal impacted counties. These projects are expected to create or retain 8,800 jobs, train 25,400 workers or students, and leverage an additional $210 million to the Region.[283]              

ARC receives applications for funding from local governments, states, other political subdivisions, non-profit organizations, and institutions of higher education.[284] As of this writing, little commentary has assessed the program’s outcomes. The proposed POWER Plus Plan, meanwhile, focused on more direct assistance to workers; yet it and similar proposals have failed to make their way through Congress.[285]

B.  Synthesizing Federal Transitional Policies

Several themes emerge from the programs above. These themes illuminate the conditions that have been considered appropriate for triggering intervention in pursuit of a just transition. These programs’ strengths and weaknesses in design and implementation can also inform future efforts.

The first theme is that policymakers have implemented transitional policy when there is foreseeable, widespread displacement to workers as the result of some form of public action. Embedded in the foreseeable displacement is the existence of some kind of dependency relationship or longstanding regional mono-economy. This theme may explain why transitional support beyond unemployment benefits is not specifically provided when a sector like Blockbuster goes out of business: unlike with each of the sectors above, there are no company towns or regions where substantial portions of the population have been employed at Blockbuster for decades.

Critically, though, the programs do not require some sort of showing that a loss is the proximate result of an intentional public act. In fact, the Trade Act of 1974 specifically undid such a requirement imposed by the 1962 Act. The 1962 Act required that increased imports were the “major cause” of beneficiaries’ unemployment.[286] Yet it became clear shortly thereafter that most workers simply would not be able to meet such a burden.[287] One reason for the absence of a causality requirement is that economic and legal transitions in the United States are fundamentally entangled. Further, the absence of regulations may affect transitions in similar ways as the creation of regulations. As discussed above, commentators often point to the cheapness of natural gas as the “real” reason for the coal industry’s decline; yet Congress could easily have chosen to regulate natural gas more stringently or otherwise intervene into energy markets.

One weakness, at least with the NWFP and TAA, is that neither is considered to have achieved successful economic mitigation in the face of the loss being addressed. One reason for this may be that directing large aid packages to benefits such as relocation assistance will inevitably be a “band-aid” approach if those packages do not address the root cause of workers’ and communities’ vulnerability. The root cause is the development of the dependency relationship or mono-economy in the first place. In this sense, it is possible that federal actors—unless they create a New Deal-style form of transitional employment themselves—may be too detached from regional realities to meaningfully reshape a region. Similarly, the very nature of these programs may reflect a “too little, too late” approach to addressing longstanding histories of regional under-investment. The TTPP may have been more successful in part because many tobacco farmers were near retirement anyway, few depended solely on tobacco-farming income, and tobacco farmers may have been better able to exercise control over their own economic activities as compared to laid-off manufacturing or timber workers.[288]

The second problem with these programs is that as jobs like timbering and mining decline, no comparably lucrative, low-skill jobs are, in fact, available as alternatives for displaced workers. The three main traditional rural livelihoods—natural resource extraction, manufacturing, and farming—have declined dramatically.[289] The sectors that have taken their place are lower-paying positions in the service industry.[290] These positions lack the security, culture, and regional influence of the traditional livelihoods. Transitional policy geared toward moving a worker from a traditional livelihood to a modern one will almost inevitably be moving that worker a step down in the world of work. In turn, the region may be fated to suffer, as each individual experiences a loss in wages and security, effectuating ripple effects on local tax coffers.

The POWER Initiative does align with this Article’s theoretical discussion of how a just transition should be defined. The program’s focus on diverse forms of regional stakeholders and initiatives may make it better poised to succeed than programs focused more heavily on one approach, such as worker retraining or providing direct subsidies to local governments. Yet it is not clear that POWER is adequate to address the likely-intensified losses anticipated to be associated with deep decarbonization.

In any case, these programs indicate that circumstances triggering just transitions are not limited to what is arguably the perfect case study of the coalfield community. The case of the New York City taxi drivers illustrates yet another scenario where workers formed a longstanding dependency relationship with one industry; their industry performed a quasi-public function; and the public’s failure to act left the workers vulnerable to an abrupt collapse of their industry, leaving them without meaningful alternatives. As with manufacturing or mining jobs, taxi drivers, once part of a lucrative, regulated community, were suddenly in competition with options that were cheaper, faster, and less secure in the form of app-directed ride-sharing services.[291] Many drivers had invested their life savings in coveted taxi medallions, the value of which dropped dramatically due to the rise of Uber and Lyft. Six driver suicides over the course of six months in 2018 brought the City’s attention to this community’s struggle.[292] As of this writing, “New York’s city council is poised to approve a one-year cap on new licenses for Uber . . . and other ride-sharing vehicles as part of a sweeping package of regulations intended to reduce traffic and halt the downward slide in drivers’ pay.”[293]

Just transitions considerations also seem relevant to communities displaced by gentrification. In those instances, the community has developed a dependency relationship on an existing way of life. This way of life could have relied, in fact, on a history of under-investment, the absence of industry, or a mix of industries that are not necessarily lucrative. When more lucrative industries arrive to take advantage of that history of under-investment—bringing with them wealthier residents and higher home and goods prices—political inaction in the face of the communities’ vulnerability to displacement may be an analogous version of an unjust transition.[294]

The next Section looks at alternatives, or potential complements, to federal aid packages in transitional programs. It posits that locally-driven transitions may stand to more meaningfully untangle the diverse issues at play in a mono-economy or dependency relationship. This more intimate process could in turn wield more benefits in shaping regional economic fates.

C.  Locally-Driven Transitions

Alan Ramo and Deborah Behles examined the experience of Navajo and Hopi communities with the Mohave Generating Station along the Nevada-Arizona border in the late 1990s and early 2000s.[295] Their case study provides an illustration of a scenario in which local actors addressed the impending cessation of hazardous industrial activity that a community also depended upon economically.

The U.S. Department of the Interior decided in the early nineteenth century that the Mohave Station would receive its coal and water from nearby Hopi and Navajo reservations.[296] This decision commenced a longstanding exploitative relationship that gave Native groups little control over their coal and water resources.[297] For years, both Hopi and Navajo tribes advocated to set aside the original decree, protesting highly undervalued royalties they received for use of their coal and water.[298] Yet the communities also depended on the royalties, as well as the fact that about 250 Navajo were employed at Mohave’s mine.[299]

In 1998, two environmental groups sued Mohave’s owners, alleging violations of Clean Air Act emissions limits, compliance orders, and reporting requirements; simultaneously, the U.S. Environmental Protection Agency concluded that the plant posed a risk to visibility in the Grand Canyon.[300] Thus began the transition toward the closure of the Mohave Plant, which risked leaving the native communities in even worse circumstances than before, despite the closure’s likely environmental benefits.

The Mohave plant was closed in 2006.[301] It was not closed because of environmental hazards, but because it was no longer cost-effective—which again raises the question of untangling the causal factors that trigger the need for a just transition. The communities were “devastated by Mohave’s operation,” but also devastated by its closure.[302]

Issues concerning the plant arose in another proceeding around the same time, however, where Mohave’s former owner, Southern California Edison, was involved in a rate case with the California Public Utilities Commission (CPUC).[303] Local groups formed an organization called the “Just Transition Coalition” in order to intervene in the proceeding. The coalition was an alliance of environmental and grassroots Native American interests including the Indigenous Environmental Network, Black Mesa Trust, Black Mesa Water coalition, To’ Nizhoni Ani, Grand Canyon Trust, and the Sierra Club.”[304] The coalition intervened “to demand that the CPUC allocate funds from the sale of Acid Rain SO2 allowances, which were an unneeded windfall if Mohave remained closed, to help transition the Hopi and Navajo communities to cleaner energy alternatives.”[305] The group emphasized that a transition that invested in the communities “was equitable due to Mohave’s operation and closure’s devastating economic and social impacts and decades of . . . subsidized cheap coal power.”[306] The CPUC then ordered Mohave’s former owner to set aside acid rain allowances to be disbursed in the future.[307]

The process of transitioning the communities away from their dependency relationship with the plant involved “years of mediation, workshops, and litigation,” which resulted in the Hopi and Navajo agreeing with the Just Transition Coalition that revenues should be used to incentivize renewable energy generation.[308] The CPUC, relying on its authority to “exercise equitable jurisdiction as an incident to its express duties” to regulate utilities in its jurisdiction, as well as California’s Renewable Portfolio Standard, decided “to disburse the allowance revenues to incentivize renewable generation that benefited Hopi and Navajo communities.”[309]

While the procedural evolution of this case study may appear to be a unique or idiosyncratic approach to a just transition, it offers lessons for pursuing just transitions elsewhere. Ramo and Behles argued that this scenario “presents a roadmap for other states to consider creative solutions to help communities transition away from fossil-fuel generation.”[310] As of this writing, many commentators seem to view the Mohave transition as a success story.[311]

The Mohave process in fact mirrors several procedural models that can be embodied in law and policy in different ways. First, it resembles new governance. According to new governance theory, diverse stakeholders must be involved in decisionmaking, where traditional networks and hierarchies are emphasized less, and the exchange of information and pursuit of win-win solutions are emphasized more.[312] More traditionally, though, this process resembles land use planning processes, which also involve bringing stakeholders together to pursue collaborative decisionmaking.[313] Administrative law and policy can provide for mechanisms that facilitate communities’ ability to pursue these processes.

Diverse local and state jurisdictions in the United States and internationally are in the process of approaching transitions in different ways. In 2008, the State of Kentucky passed a tax incentive to attract new employers to the region.[314] The struggling coal town of Hazard, Kentucky, has developed a former surface mine site into a research and testing facility for drone companies, while also offering new skills courses through the local community college.[315] The Canadian province of Alberta has earmarked $40 million to help approximately 2,000 workers, who are “losing their jobs as the province transitions away from thermal coal mines and coal-fired power plants over the next decade,” by providing “tuition vouchers, retraining programs, and on-site transitioning advice.”[316] These varying approaches indicate that the ideal model for pursuing a just transition may be context-specific. At least, as much of the global community seeks to transition to low-carbon energy emissions in the coming years, more success stories and replicable models should emerge.

The Mohave study suggests that certain conditions may be conducive to a more transformative transition than an approach focused more narrowly on a measure such as worker retraining. These conditions include equal bargaining power among stakeholders, stakeholders with adequate resources, and a procedural mechanism to pursue a long-term decisionmaking or dispute resolution process. An effort toward transition that is more transformative also must involve some iterative decisionmaking—the “messiness” often associated with successful stakeholder collaboration—rather than single instances of legislative reform. Appropriate venues could be state, local, or federal administrative agencies, local governments, and courts.

The Mohave study also shows how a just transitions policy can, and often should, be pursued in tandem with remedies for a history of environmental injustice. Many communities that depend upon high-carbon industries have also been harmed by them; many communities harmed by high-carbon industries have not benefited economically at all. Yet the choice of remedy does not pose an “either/or” choice between remedying environmental injustice or remedying just transitions. A holistic, democratic process can account for both past harms and future risks.

D.  Additional Considerations for Pursuing Just Transitions

A pressing question in the pursuit of just transitions policy is, who pays for just transitions? More specifically, why should the public pay and not the employers who have left these regions and workers vulnerable?

The discussion in this Article is primarily concerned with public options for facilitating collective transitions. It is presumed that employers will often not be in a position to facilitate just transitions themselves. First—consistent with the above-mentioned concerns about interest groups—accountability for fossil fuel companies has been elusive.[317] Congress has virtually declined to regulate the natural gas industry, for example.[318] Second, many employers have become insolvent, as evidenced by the spate of coal companies that have filed for bankruptcy in recent years.[319]

Nonetheless, future research should address the prospect of employer involvement in just transitions law and policy, especially where employers have knowingly pursued hazardous industrial activity to society’s detriment. In addition to tobacco companies’ involvement in funding the TTPP program described in Section III.A.3, a starting point for this consideration would be the federal Worker Adjustment and Retraining Notification Act of 1988 (the WARN Act).

The WARN Act “was enacted in 1988 in response to the rash of plant closings and layoffs that had occurred in the immediately preceding years.”[320] It sought “to enable workers, their families, and local community leaders sufficient time to prepare for mass layoffs or plant closures.”[321] It “obligates employers to provide at least 60-days notice to employees and local government officials of a covered plant closure or mass layoff.”[322] The Act covers employers who plan to lay off fifty or more employees during any thirty-day period, excluding part-time employees.

The WARN Act has been heavily criticized. Not only does it do little for workers and communities beyond providing a strikingly brief notice period before entire communities may be upended, but it also was deemed “imprecise, vague, difficult to interpret, and . . . may be very difficult to apply sensibly to particular fact situations.”[323] But the idea could be helpful. Perhaps a modernized WARN Act of just transitions law and policy would require six to twelve months’ notice and options for assisting workers to retrain and relocate, for example.

Finally, perhaps the real concern underlying the justice or injustice of transitions is not about transitions at all. Measures such as guaranteed employment or universal basic income, for example, would preclude the need to manufacture new regional or sectoral economies in anticipation of the ebb and flow of industries. A more robust baseline of worker and community support would make the vulnerability associated with transitions less dire and help preclude difficult decisions as to who should win and lose in the distribution of benefits and burdens.

Conclusion

In the context of climate change, legal scholars should embrace the just transition as an equitable principle of easing the burden decarbonization poses to workers and communities who depend on carbon-heavy industries. Embracing this definition will be clarifying, will allow legal scholarship to engage with other fields and institutions that already recognize this definition, and will give the labor movement its due for originating the term. In turn, the concept finds support in important principles relevant to the environmental condition today, such as the need to account for complex social-ecological systems, to address jobs-versus-environment tensions, and to better consider economic equity. In short, if scholars and policymakers embrace the just transition concept, it stands to serve principles of economic equity, it might help make climate reform more achievable through coalition-building, and it is poised to bring environmental law more in line with the needs of the climate era.

Yet the just transition concept bears relevance to diverse scenarios where workers and communities face large-scale displacement from the longstanding industries on which they have relied. The moral impetus to help in the face of displacement may be the strongest where a public initiative is the clear cause of the displacement. This scenario is the most analogous to the state’s use of eminent domain, where the “taking” of something is compensated because a discrete group is not asked to bear the costs of an initiative pursued for the greater good. While one might suggest that workers and communities should bear the costs of such displacement as the natural price of regulation, U.S. transitional policy illustrates prominent instances where Congress was compelled to intervene.

The cause of displacement is often unclear, however. Our economic and legal evolutions tend to be intertwined. Thus, transitional policy may still be warranted where the cause of the displacement is less clear than the obvious, and relatively rare, “job-killing” law. Further, even if purely private forces caused large-scale displacement, considerations of fairness, compassion, and equity suggest it is the wrong choice to simply leave workers in the lurch where they lack other alternatives, or where their work contributed a public or quasi-public function—especially if, as Mazzocchi articulated and as is the case with fossil fuel workers, that work was particularly hazardous. This calculus does yield inherent problems with line-drawing. As an alternative, measures such as universal basic income or other provisions of a more robust social safety net could preclude the need to pick winners and losers in these scenarios.

Given federal agencies’ track record of failing to sustainably untangle regional dependency relationships, to adequately offset workers’ and communities’ losses, or to nurture forward-looking economic diversification for regions and sectors in decline, it may be time to question whether federal agencies are indeed the most appropriate forum for large-scale transitional policy. It is possible that the largely-untested POWER Initiative uses novel substantive approaches that may not repeat the mistakes of past policies. Processes driven by state and local institutions and stakeholders may allow for a more involved, context-specific approach that can help better address the challenges associated with historical mono-economies. Additional research can help illuminate the best mechanisms for achieving just transitions in practice, especially as the clean-energy transition gains momentum. Perhaps most importantly, when environmental decisions are made, just transitions can and should be among values decisionmakers seek to harmonize.

 


[*] *.. Assistant Professor of Law, University of South Carolina School of Law. I thank Lauren Aronson, Derek Black, Josh Eagle, Katherine Garvey, Joy Radice, Ed Richards, Kathryn Sabbeth, Emily Suski, Gavin Wright, and participants at the 2018 Texas A&M University School of Law’s Property Roundtable and the 2018 Just Transitions Workshop at the University of South Carolina School of Law for their thoughtful feedback on this project.

 [1]. Cf. Ann Eisenberg, Civil Society Versus Transnational Corporations in International Energy Development: Is International Law Keeping Up?, in China and Good Governance of Markets in Light of Economic Development 27 (Paolo Davide Farah ed., Routledge Pub., forthcoming 2019) (on file with author) (arguing that civil liberties may be sacrificed in the name of clean-energy development projects).

 [2]. While this Article refers to “low-carbon” policy goals, these goals are assumed to also contemplate other greenhouse gas emissions with similar effects relating to climate change. The discussion focuses on carbon both for the sake of succinctness and because of carbon’s prominence among the greenhouse gases as a driver of climate change.

 [3]. See Ngram Viewer: Just Transition, Google Books, https://books.google.com/ngrams
/graph?content=just+transition&year_start=1800&year_end=2017&corpus=15&smoothing=3&share=&direct_url=t1%3B%2Cjust%20transition%3B%2Cc0 (last visited Jan. 25, 2019) (searching for the frequency of the use of the term “just transition”).

 [4]. Cf. Dimitris Stevis & Romain Felli, Green Transitions, Just Transitions? Broadening and Deepening Justice, 3 Kurswechsel 35, 35 (2016) (Ger.) (“In short, there are varieties of Just Transition, reflecting the politics of its various advocates.”).

 [5]. See infra Section I.A.

 [6]. See Peter Newell & Dustin Mulvaney, The Political Economy of the ‘Just Transition’, 179 Geographical J. 132, 132–33 (2013) (discussing inequality and fossil fuel usage).

 [7]. See Mark Swilling & Eve Annecke, Just Transitions: Explorations of Sustainability in an Unfair World, 50–52 (2012); Victor B. Flatt & Heather Payne, Not One Without the Other: The Challenge of Integrating U.S. Environment, Energy, Climate, and Economic Policy, 44 Envtl. L. 1079, 1085 (2014) (discussing financial harms climate change has already posed to world economies and vulnerable populations). As an example, some scholarship has raised concerns about increased reliance on biofuels as a renewable energy source because of their potential to harm vulnerable populations—which would illustrate an unjust transition to renewables according to this definition. See, e.g., Nadia B. Ahmad, Blood Biofuels, 27 Duke Envtl. L. & Pol’y Forum 265, 282–94 (2017) (discussing impacts on small farmers and poor consumers in developing countries); Carmen G. Gonzalez, The Environmental Justice Implications of Biofuels, 20 UCLA J. Int’l L. & Foreign Aff. 229, 251–60 (2016) (discussing impacts on taxpayers, small farmers, and poor consumers in developing countries); Uma Outka, Environmental Justice Issues in Sustainable Development: Environmental Justice in the Renewable Energy Transition, 19 J. Envtl. & Sustainability L. 60, 77–85 (2012) (discussing impacts on Native American tribes and African American communities).

 [8]. See infra Section I.A.

 [9]. See David Doorey, Just Transitions Law: Putting Labour Law to Work on Climate Change, 30 J. Envtl. L. & Prac. 201, 206–07 (2017). In light of climate change,

energy and resource-intensive sectors are likely to stagnate or contract . . . new pressures will be brought to bear on unemployment, adjustment, and training strategies . . . . There will be winners and losers in domestic and international labour markets . . . . The idea of “just transition” to a greener, lower carbon economy has its roots in the global labour movement . . . . Just transition refers to a policy platform that advocates legal and policy responses and planning that recognizes the needs for economies to transition to lower carbon economic activity, while at the same time respects the need to promote decent work and a fair distribution of the risks and rewards associated with this transition.

Id.; Newell & Mulvaney, supra note 6, at 133–34.

 [10]. Josua Mata, What is ‘Just Transition’?, New Internationalist, Sept. 2016, at 21.

 [11]. See Shalanda Baker et al., Beyond Zero-Sum Environmentalism, 47 Envtl. L. Rep. 10328, 10330–32, 10340–43 (2017).

 [12]. Todd S. Aagaard, Environmental Law’s Heartland and Frontiers, 32 Pace Envtl. L. Rev. 511, 511–12 (2015) (“Environmental law is currently—and has been for some time—in a phase that is simultaneously reassuring and worrisome. As a society, we have been generally well served by the forty-five years of modern federal environmental law since 1970. . . . The unfortunate flip side of stability, at least in this case, has been a marked degree of ossification.”); David W. Case, The Lost Generation: Environmental Regulatory Reform in the Era of Congressional Abdication, 25 Duke Envtl. L. & Pol’y Forum 49, 89 (2014) (“[T]he prospects that Congress will enact any such positive reform-minded environmental legislation in the foreseeable future appear nonexistent.”); J.B. Ruhl, Climate Change Adaptation and the Structural Transformation of Environmental Law, 40 Envtl. L. 363, 407 (2010). But see Dave Owen, Little Streams and Legal Transformations, 2017 Utah L. Rev. 1, 5–6 (2017) (arguing that environmental protections have expanded and become more sophisticated and that overly pessimistic narratives discount environmental law’s accomplishments).

 [13]. See Todd S. Aagaard, Environmental Law Outside the Canon, 89 Ind. L.J. 1239, 1281–91 (2014) (calling for rethinking of environmental law as dominated and characterized by canon of major federal statutes enacted in 1970s, and proposing approaches that could work in antagonistic political climate, integrate with non-environmental laws, and better approach climate change); Todd S. Aagaard, Using Non-Environmental Law to Accomplish Environmental Objectives, 30 J. Land Use & Envtl. L. 35, 35 (2014); Daniel C. Esty, Red Lights to Green Lights: From 20th Century Environmental Regulation to 21st Century Sustainability, 47 Envtl. L. 1, 5 (2017).

 [14]. See Aagaard, Environmental Law’s Heartland and Frontiers, supra note 12, at 512–13.

 [15]. See Blake Hudson, Relative Administrability, Conservatives, and Environmental Regulatory Reform, 68 Fla. L. Rev. 1661, 1661 (2016) (arguing that geographic-delineation policies at state and local level offers environmental reform plan that would be palatable to conservatives); Dave Owen, Mapping, Modeling, and the Fragmentation of Environmental Law, 2013 Utah L. Rev. 219, 224–25 (2013) (arguing for applying quantitative spatial analysis to environmental law); Jedediah Purdy, American Natures: The Shape of Conflict in Environmental Law, 36 Harv. Envtl. L. Rev. 169, 169 (2012) (“Legal scholarship is in a bad position to make sense of [climate change] because the field has concentrated on making sound policy recommendations to an idealized lawmaker, neglecting the deeply held and sharply clashing values that drive, or block, environmental lawmaking.”); Rachael E. Salcido, Rationing Environmental Law in a Time of Climate Change, 46 Loy. U. Chi. L.J. 617, 621 (2015) (arguing that “rationing” environmental law, in other words, selectively applying environmental law to renewable energy because of climate change, is not ideal, but is nonetheless worthwhile “based on the reality of political failures, market forces, and horrifying consequences of unchecked fossil fuel dependence”); Michael P. Vandenbergh, Reconceptualizing the Future of Environmental Law: The Role of Private Climate Governance, 32 Pace Envtl. L. Rev. 382, 383 (2015) (arguing for “opportunity to buy time with private governance”).

 [16]. Cf. Doorey, supra note 9, at 206–07.

 [17]. Cf. Ruhl, supra note 12, at 407.

 [18]. Cf. Mark Sagoff, The Principles of Federal Pollution Control Law, 71 Minn. L. Rev. 19, 82–83 (1986) (criticizing environmentalism as separating ends of environmental policy from means necessary to attain the ends). So-called “blue-green alliances”—instances of environmental groups and labor groups joining forces to advocate for joint environmental and work-related platforms—demonstrate the potency of measures that bridge the historical rift between labor and environmental concerns. Ann M. Eisenberg, Alienation and Reconciliation in Social-Ecological Systems, 47 Envtl. L. 127, 145 (2017). Notable examples exist of environmentalists acknowledging labor issues, and vice versa. In 1973, Sierra Club President Mike McCloskey called for “the government ‘to indemnify workers who are displaced in true cases of plant closures for environmental reasons.’” He argued, “[w]orkers should not be made to bear the brunt of any nation’s commitment to a decent environment for all. Society should assume this burden and aid them in every way possible.” Les Leopold, The Man who Hated Work and Loved Labor 309 (2007). Today, the Sierra Club and other environmental organizations have partnered with large labor unions in a “blue-green alliance” to advocate for environmental reform alongside policies that “create and maintain quality jobs.” Members, Blue Green Alliance, https://www.bluegreenalliance.org/about/members (last visited Jan. 25, 2019).

 [19]. Cf. Scott D. Campbell, Sustainable Development and Social Justice: Conflicting Urgencies and the Search for Common Ground in Urban and Regional Planning, 1 Mich. J. of Sustainability 75, 75 (2013) (noting that “middle-class environmental interests typically trump the interests of the poor and marginalized, too often leading to an exclusionary sustainability of privilege rather than a sustainability of inclusion”); Eisenberg, supra note 18, at 127.

 [20]. Leopold, supra note 18, at 417.

 [21]. See discussion infra Section I.A.

 [22]. See Randall S. Abate, Public Nuisance Suits for the Climate Justice Movement: The Right Thing and the Right Time, 85 Wash. L. Rev. 197, 199 (2010) (“Climate justice embraces a human rights approach to advocating for rights and remedies for climate change . . . climate justice focuses on the rights of those disproportionately affected by the impacts of climate change.”); Shalanda H. Baker, Mexican Energy Reform, Climate Change, and Energy Justice in Indigenous Communities, 56 Nat. Resources J. 369, 379 (2016) (though not yet a cohesive field of study, energy justice provides overall framework to view related areas of climate justice, environmental justice, and energy democracy); see also Flatt & Payne, supra note 7, at 1081 (noting that “[e]nergy poverty” recognizes inextricable linkage between energy and “economics of the human condition.”).

 [23]. Cf. Geoff Evans & Liam Phelan, Transition to a Post-Carbon Society: Linking Environmental Justice and Just Transition Discourses, 99 Energy Pol’y 329, 333 (2016).

 [24]. Both unclean hands and estoppel are longstanding doctrines of equity that attempt to inject principles of fair play into parties’ dealings with one another. The unclean hands doctrine prevents parties from profiting from their own wrongdoing, while the estoppel doctrine prevents parties from taking inconsistent positions. See T. Leigh Anenson & Gideon Mark, Inequitable Conduct in Retrospective: Understanding Unclean Hands in Patent Remedies, 62 Am. U. L. Rev. 1441, 1450 (2013). Of course, it is not contemplated that fossil fuel workers could raise such claims in court successfully. Rather, the ideas underlying calls for just transitions seem to invoke similar principles: society should not profit substantially from its hazardous industries only to abandon the workers in those industries, and nor should it encourage fossil fuel development only to abruptly take the opposite stance. For a discussion of a takings analogy, see infra Section II.B.

 [25]. See discussion infra Section III.B for brief treatments of displacement resulting from taxi drivers competing with ride-sharing services and displacement resulting from gentrification. A forthcoming article, Distributive Justice and Rural America, further explores the just transitions concept as a principle of distributive economic justice. See generally Ann M. Eisenberg, Distributive Justice and Rural America (unpublished manuscript) (on file with author).

 [26]. See generally Doorey, supra note 9.

 [27]. See Richard J. Lazarus, Pursuing “Environmental Justice”: The Distributional Effects of Environmental Protection, 87 Nw. U. L. Rev. 787, 829 (1993).

 [28]. See Outka, supra note 7, at 62–63 (“[S]ustainable development . . . means more than ‘greener’ economic development. Instead, it captures the interrelationship between the environment, the economy, and human well-being in the effort to meet ‘the needs of the present without compromising the ability of future generations to meet their own needs.’”).

 [29]. Dylan Brown, Mining Union Faces ‘Life-and-Death’ Test, E&E News (Apr. 11, 2017), https://www.eenews.net/stories/1060052929.

 [30]. See infra Section II.B; see also Naomi Seiler et al., Legal and Ethical Considerations in Government Compensation Plans: A Case Study of Smallpox Immunization, 1 Ind. Health L. Rev. 3, 14 (2004) (noting that the question of whether government should compensate someone raises the question of whether government actor caused harm in question; noting, too, that government can act either way out of compassion rather than obligation, and that causation by a non-government actor also raises question of whether government failed to protect from harm).

 [31]. Cf. Holly Doremus, Takings and Transitions, 19 J. Land Use & Envtl. L. 1, 4–5 (2003) (“Focusing more directly on law as a dynamic phenomenon, on the benefits and costs of transitions, and on other factors that may encourage or impede transitions might bring some coherence to [the] famously incoherent area of [takings] law.”); Louis Kaplow, An Economic Analysis of Legal Transitions, 99 Harv. L. Rev. 509, 534 (1986) (“[N]one of the distinctions they offer for treating government and market risks differently withstands scrutiny.”).

 [32]. See, e.g., Mark Joseph Stern, A New Lochner Era, Slate (June 29, 2018), https://slate.com
/news-and-politics/2018/06/the-lochner-era-is-set-for-a-comeback-at-the-supreme-court.html.

 [33]. Swilling & Annecke, supra note 7; Caroline Farrell, A Just Transition: Lessons Learned from the Environmental Justice Movement, 45 Duke F.L. & Soc. Change 45, 45 (2012) (“As we transition away from a fossil fuel economy, we should . . . plan the transition not only to change the way we use fuel, but to create a truly just economy.”).

 [34]. Doorey, supra note 9, at 7.

 [35]. See, e.g., Outka, supra note 7, at 68 (listing harmful health and environmental effects of fossil fuel production and consumption).

 [36]. Cf. Evans & Phelan, supra note 23.

 [37]. See Wiwa v. Royal Dutch Petroleum Co., 226 F.3d 88 (2d Cir. 2000), cert. denied, 532 U.S. 941 (2001); see also Uma Outka, Fairness in the Low-Carbon Shift: Learning from Environmental Justice, 82 Brook. L. Rev. 789, 792 (2017) (explaining that the U.S. petroleum industry has caused devastating human rights abuses in Africa and South America).

 [38]. Debbie Elliot, 5 Years After BP Oil Spill, Effects Linger and Recovery Is Slow, Nat’l Pub. Radio (Apr. 20, 2015), http://www.npr.org/2015/04/20/400374744/5-years-after-bp-oil-spill-effects-linger-and-recovery-is-slow.

 [39]. E.g., Luis E. Cuervo, OPEC from Myth to Reality, 30 Hous. J. Int’l L. 433, 494 (2008).

 [40]. Shannon Elizabeth Bell & Richard York, Community Economic Identity: The Coal Industry and Ideology Construction in West Virginia, 75 Rural Soc. 111, 139 (2010); Jeanne Marie Zokovitch Paben, Green Power & Environmental Justice—Does Green Discriminate?, 46 Tex. Tech L. Rev. 1067, 1108 (2014).

 [41]. See Outka, supra note 7, at 790 (explaining that the energy sector’s reliance on fossil fuels, primarily coal, makes it the primary source of greenhouse gas emissions in the United States, a country which has contributed more to climate change than any other country); Salcido, supra note 15, at 618–19 (listing effects of climate change already occurring, such as more severe, frequent storms).

 [42]. Evans & Phelan, supra note 23, at 330 (describing social movement for “post-carbon society,” which ranges from grassroots, “bottom-up surveillance” and demands for more democratic and decentralized energy sources, to major U.S. banks that have moved away from ever-riskier coal investments).

 [43]. See, e.g., Tom Murray, China Is Going All in on Clean Energy as the U.S. Waffles. How Is that Making America Great Again?, Forbes (Jan. 6, 2017), https://www.forbes.com/sites
/edfenergyexchange/2017/01/06/china-is-going-all-in-on-clean-energy-as-the-u-s-waffles-how-is-that-making-america-great-again/2/#769f3bac340f.

 [44]. Michael Greshko et al., A Running List of How President Trump Is Changing the Environmental Policy, Nat’l Geographic (Oct. 19, 2018), http://news.nationalgeographic.com/2017
/03/how-trump-is-changing-science-environment.

 [45]. Devashree Saha & Mark Muro, Growth, Carbon, and Trump: State Progress and Drift on Economic Growth and Emissions ‘Decoupling’, Brookings (Dec. 8, 2016), https://www.brookings.edu
/research/growth-carbon-and-trump-state-progress-and-drift-on-economic-growth-and-emissions-decoupling.

 [46]. Camila Domonoske, Mayors, Companies Vow to Act on Climate, Even as U.S. Leaves Paris Accord, Nat’l Pub. Radio (June 5, 2017), http://www.npr.org/sections/thetwo-way/2017/06/05
/531603731/mayors-companies-vow-to-act-on-climate-even-as-u-s-leaves-paris-accord.

 [47]. Outka, supra note 7, at 793; Murray, supra note 43.

 [48]. Nigel Topping, The Irreversible Rise of the Clean Economy in 2017, GreenBiz (Feb. 7, 2017), https://www.greenbiz.com/article/irreversible-rise-clean-economy-2017.

 [49]. Id.

 [50]. Outka, supra note 7, at 77–85; Stevis & Felli, supra note 4, at 43 (“Like the grey economy before it, this Green Transition can be as exploitative of people and nature as the grey economy was, if there is no countervailing power and vision.”).

 [51]. Lakshman Guruswamy, Energy Justice and Sustainable Development, 21 Colo. J. Int’l Envtl. L. & Pol’y 231, 271 (2010).

 [52]. Alex Geisinger, Uncovering the Myth of a Jobs/Nature Trade-Off, 51 Syracuse L. Rev. 115 passim (2001); Carey Catherine Whitehead, Wielding a Finely Crafted Legal Scalpel: Why Courts Did Not Cause the Decline of the Pacific Northwest Timber Industry, 38 Envtl. L. 979, 981 (2008) (describing the “classic” jobs-versus-environment “story”).

 [53]. See, e.g., Garrett Ballengee & Michael Reed, Clean Power Plan: All Pain, No Gain for West Virginia, The Hill (Aug. 3, 2016), http://thehill.com/blogs/pundits-blog/energy-environment/289694-clean-power-plan-all-pain-no-gain-for-west-virginia.

 [54]. See, e.g., Geisinger, supra note 52.

 [55]. E.g., id. See generally Lois J. Schiffer & Jeremy D. Heep, Forests, Wetlands and the Superfund: Three Examples of Environmental Protection Promoting Jobs, 22 J. Corp. L. 571 (1997) (describing as a “myth” that conflict exists between protection of environment and protection of jobs).

 [56]. See, e.g., Isaac Shapiro & John Irons, Econ. Policy Inst., Briefing Paper #305  Regulation, Employment, and the Economy: Fears of Job Loss Are Overblown 12 (2011) (“Regulations can have broad economic benefits that may not be apparent at first blush. Clean air regulations, for instance, significantly improve the health of workers and children, resulting in lower health care costs and more productive workers.”); Jan G. Laitos & Thomas A. Carr, The Transformation on Public Lands, 26 Ecology L.Q. 140, 174 (1999) (noting benefits to communities of shifts away from extractive industries); Schiffer & Heep, supra note 55.

 [57]. Cf. Fran Ansley, Standing Rusty and Rolling Empty: Law, Poverty, and America’s Eroding Industrial Base, 81 Geo. L.J. 1757, 1763 (1993) (noting that plant closures of 1980s and 90s were “both quantitatively and qualitatively different” than regular layoffs and socioeconomic transitions in the number, size, and frequency of closings, as well as “disturbing patterns in the types of jobs lost and the types of jobs gained”).

 [58]. See Robert Pollin & Brian Callaci, A Just Transition for U.S. Fossil Fuel Industry Workers, 27 Am. Prospect 88, 89 (2016).

 [59]. Id.

 [60]. Maanvi Singh, Gassy Cows Are Warming the Planet and They’re Here To Stay, Nat’l Pub. Radio: The Salt (Apr. 12, 2014), https://www.npr.org/sections/thesalt/2014/04/11/301794415/gassy-cows-are-warming-the-planet-and-theyre-here-to-stay (methane from livestock accounted for 39% of agricultural greenhouse gas emissions in 2011).

 [61]. Pollin & Callaci, supra note 58, at 89.

 [62]. See generally, e.g., Int’l Civil Aviation Org., Environmental Report 2010: Aviation and Climate Change (2010) (reporting that aviation accounts for around 2% of total CO2 emissions); Lisa J. Hanle et al., CO2 Emissions Profile of the U.S. Cement Industry (2004) (noting that cement production is a substantial CO2 emitter); U.S. Envtl. Prot. Agency,  Fast Fact: U.S. Transportation Sector Greenhouse Gas Emissions 1990–2015, at 1 (2017) (noting that transportation accounted for 27% of U.S. greenhouse gas emissions in 2015).

 [63]. Pollin & Callaci, supra note 58, at 89.

 [64]. Geisinger, supra note 52.

 [65]. Pollin & Callaci, supra note 58, at 88.

 [66]. Doorey, supra note 9, at 221 (“[N]ew regulations limiting emissions or requiring ‘green’ production equipment or techniques can affect production systems in ways that impact working conditions, cause layoffs, or create downward pressure on labour costs.”); Alana Semuels, Do Regulations Really Kill Jobs?, Atlantic (Jan. 19, 2017), https://www.theatlantic.com/business
/archive/2017/01/regulations-jobs/513563 (“Regulations that seek to make air and water cleaner can also cause concentrated job losses in certain industries and locations.”); see also Lands Council v. McNair, 494 F.3d 771, 779 (9th Cir. 2007) (finding that an injunction of timber harvest would force timber companies to lay off some or all of their workers); Schiffer & Heep, supra note 55, at 582.

No economic analysis can ignore the suffering of some rural communities, which bear the brunt of the economic pain associated with reduced federally subsidized timber supplies. In addition to lost jobs and the associated closure of local businesses, county governments are receiving lower U.S. Treasury payments resulting from timber sales at the same time the county’s social services are most in demand.

Id. (footnotes omitted).

 [67]. Cf. Hari M. Osofsky, The Geography of Justice Wormholes: Dilemmas from Property and Criminal Law, 53 Vill. L. Rev. 117, 122 (2008).

 [68]. Jia Lynn Yang, Does Government Regulation Really Kill Jobs? Economists Say Overall Effect: Minimal., Wash. Post (Nov. 13, 2011), https://www.washingtonpost.com/business/economy
/does-government-regulation-really-kill-jobs-economists-say-overall-effect-minimal/2011/10/19
/gIQALRF5IN_story.html?noredirect=on&utm_term=.f23e96256dfa.

 [69]. Doorey, supra note 9, at 203; Newell & Mulvaney, supra note 6; Evans & Phelan, supra note 23, at 333; Stevis & Felli, supra note 4, at 35.

 [70]. Leopold, supra note 18, at 417.

 [71]. Id.

 [72]. Id. at 416.

 [73]. Id. at 417.

 [74]. Id. at 468.

 [75]. Id.

 [76]. Id.

 [77]. But see Caleb Goods, A Just Transition to a Green Economy: Evaluating the Response of Australian Unions, 39 Austl. Bull. of Lab. 13, 15 (2013) (“A just transition clearly seeks to resolve the divisive jobs versus environment problem; however, actual union commitments to what a just transition response constitutes can be assessed as variable and unclear.”).

 [78]. Evans & Phelan, supra note 23, at 333.

 [79]. Int’l Labour Org., Guidelines for a Just Transition Towards Environmentally Sustainable Economies and Societies for All 3–4, 13 (2015) (advising governments to include implementing workers’ skills training and engaging workers and their representatives in the means to achieve low-carbon policies while creating and protecting employment).

 [80]. Farrell, supra note 33, at 45 (discussing environmental justice); Shelley Welton, Clean Electrification, 88 U. Colo. L. Rev. 571, 573 (2017) (discussing “clean energy justice,” or the idea that “the suite of policies boosting green jobs also creates a new genre of environmental justice challenges,” and other inequitable effects of clean energy policies); see Ruhl, supra note 13, at 407 (noting “climate justice” refers to the fact that climate change impacts will be felt unevenly throughout the world; the capacity to adapt to climate change is also unevenly distributed).

 [81]. See infra Section III.C; cf. Frederico Cheever & John C. Dernbach, Sustainable Development and Its Discontents, 4 Transnat’l Envtl. L. 247, 282 (2015) (rejecting criticisms of “sustainable development” as too vague to be useful).

 [82]. Swilling & Annecke, supra note 7, at xiii.

 [83]. Farrell, supra note 33, at 45, 49.

 [84]. Linda Lobao et al., Poverty, Place, and Coal Employment Across Appalachia and the United States in a New Economic Era, 81 Rural Soc. 343, 343 (2016); Judson Abraham, Just Transitions for the Miners: Labor Environmentalism in the Ruhr and Appalachian Coalfields, 39 New Pol. Sci. 218, 218 (2017); Alan Ramo & Deborah Behles, Transitioning a Community Away from Fossil-Fuel Generation to a Green Economy: An Approach Using State Utility Commission Authority, 15 Minn. J. L., Sci. & Tech. 505, 507 (2014) (“A significant barrier to transitioning to clean energy sources is the local economic dependency fostered by a fossil fuel economy.”).

 [85]. Lobao et al., supra note 84, at 377.

 [86]. Evans & Phelan, supra note 23, at 331 (alterations in original) (internal quotation omitted).

 [87]. Doorey, supra note 9, at 207.

 [88]. J. Mijin Cha, Labor Leading Climate: A Policy Platform to Address Rising Inequality and Rising Sea Levels in New York State, 34 Pace Envtl. L. Rev. 423, 446 (2017).

 [89]. Ramo & Behles, supra note 84, at 508.

 [90]. Evans & Phelan, supra note 23, at 333.

 [91]. Id. Australia and Canada have also embraced the narrow just transitions meaning. The Canadian Labour Council defines just transitions “as a political campaign to ‘ensure that the costs of environmental change [towards sustainability] will be shared fairly. Failure to create a just transition means that the cost of moves to sustainability will devolve wholly onto workers in targeted industries and their communities.’” Id. at 331.

 [92]. Should Equity Be a Goal of Economic Policy?, Int’l Monetary Fund (Jan. 1998), https://www.imf.org/external/pubs/ft/issues/issues16 (discussing economic equity as a principle that economic resources, such as income, wealth, and land ownership, should be distributed fairly).

 [93]. Doorey, supra note 9, at 201.

 [94]. Id.

 [95]. Id.

 [96]. Id. at 214.

 [97]. Id. at 238.

 [98]. Id. at 225 (“Also like labour law, environmental justice has roots in a bottom-up resistance movement critical of a dominant legal system that benefits economically and politically powerful, privileged segments of society. [Environmental justice] is a natural ally to labour law in a re-imagined legal field organized around . . . subordination and resistance.”).

 [99]. Id.

 [100]. Id. at 234.

 [101]. Id.

 [102]. Principles of Climate Justice, Mary Robinson Found.,  https://www.mrfcj.org/principles-of-climate-justice (last visited Feb. 1, 2019).

 [103]. Maxine Burkett, Just Solutions to Climate Change: A Climate Justice Proposal for a Domestic Clean Development Mechanism, 56 Buff. L. Rev. 169, 196 (2008); Ruhl, supra note 12, at 408.

 [104]. Doorey, supra note 9.

 [105]. See generally John Rawls, A Theory of Justice (1971).

 [106]. Alice Kaswan, Distributive Justice and the Environment, 81 N.C. L. Rev. 1031 passim (2003). See generally Guruswamy, supra note 51.

 [107]. Outka, supra note 7, at 64–65.

 [108]. Id.

 [109]. See generally Guruswamy, supra note 51.

 [110]. Outka, supra note 7, at 64.

 [111]. Evans & Phelan, supra note 23, at 333.

 [112]. Id. at 331.

[W]hile there is potential synergy between environmental justice and just transitions campaigns, a harmonious resolution of the two concepts is not guaranteed if the interests and aspirations within the community are poorly negotiated between the parties involved. A melding of environmental justice campaign goals on the one hand and labour movement goals on the other, is particularly challenged by the continuing hegemony of the ‘jobs versus environment’ discourse.

Id.

 [113]. Outka, supra note 7, at 62–63.

 [114]. John C. Dernbach, Creating Legal Pathways to a Zero Carbon Future, 46 Envtl. Law Rep. 10780, 10782 (2016).

 [115]. Outka, supra note 7, at 72–74.

 [116]. Dernbach, supra note 114, at 10782 (footnote omitted); see also Campbell, supra note 19, at 75.

[D]espite the perhaps inevitable criticisms of immeasurability and vagueness, sustainability has endured as a central principle in urban planning because its oppositional engagement with social justice and economic development continually reinvigorates sustainability planning, keeps the term relevant and inclusive, and grants the task of urban planning greater urgency.

Campbell, supra note 19, at 75.

 [117]. Rep. of the World Summit on Sustainable Dev., U.N. Doc A/CONF.199/20, at 2 (2002).

 [118]. Outka, supra note 7, at 64.

 [119]. Dernbach, supra note 114, at 33 (footnotes omitted).

 [120]. Id.

 [121]. See, e.g., Campbell, supra note 19, at 83; Edward H. Ziegler, American Cities and Sustainable Development in the Age of Global Terrorism: Some Thoughts on Fortress America and the Potential for Defensive Dispersal II, 30 Wm. & Mary Envtl. L. & Pol’y Rev. 95, 110 (2005) (“[S]ocial equity, and particularly intergenerational equity, along with resource conservation and environmental protection, are central concepts in sustainable development philosophy.”).

 [122]. These values are also referred to as “the three Es (Economy, Environment, and Equity)[.] [S]ustainable development is often defined as an endeavor that strives to maintain equilibrium between these domains.” Catherine L. Ross et al., Measuring Regional Transportation Sustainability: An Exploration, 43 Urb. Law. 67, 69 (2010).

 [123]. Outka, supra note 7, at 66; see also Campbell, supra note 19, at 76 (“The sustainability and social justice movements may be coming closer together, yet much still divides them into two separate conversations that frequently overhear each other without easily merging.”).

 [124]. Outka, supra note 7, at 85.

 [125]. Id. at 63; see also Campbell, supra note 19, at 77 (suggesting that environmental justice is an “important subset of the larger field of urban sustainability”).

 [126]. Outka, supra note 7, at 91.

 [127]. Id. at 122.

 [128]. Farrell, supra note 33, at 45.

 [129]. Cf. id. at 51. Farrell uses the broad just transitions meaning, but she also concludes that holistic decisionmaking is necessary going forward.

 [130]. Eisenberg, Alienation and Reconciliation, supra note 18.

 [131]. Melinda Harm Benson & Robin Kundis Craig, The End of Sustainability, 27 Soc’y & Nat. Res. 777, 779–80 (2014).

 [132]. Id.

 [133]. Robin Kundis Craig, “Stationarity Is Dead”—Long Live Transformation: Five Principles for Climate Change Adaptation Law, 34 Harv. Envtl. L. Rev. 9, 63–64 (2010).

 [134]. Robin Kundis Craig & J.B. Ruhl, Designing Administrative Law for Adaptive Management, 67 Vand. L. Rev. 1 (2014); Flatt & Payne, supra note 7 at 1081.

 [135]. Benson & Craig, supra note 131.

 [136]. The President’s Northwest Forest Plan, discussed below as an example of just transitions policy that aided communities hurt by the decline in the timber industry, lends weight to the potential of the just transitions concept to help bring sustainable development goals more in line with resilience theory, although the Plan itself is considered a mixed success. Susan Charnley, formerly of the U.S. Department of Agriculture, said of the Plan:

From a social perspective, the Northwest Forest Plan as a model for broad-scale ecosystem management is perhaps most valuable in its attempt to link the biophysical and socioeconomic goals of forest management by creating high-quality jobs for residents of forest communities in restoration, research, monitoring, and other forest stewardship activities that protect the environment.

Susan Charnley, The Northwest Forest Plan as a Model for Broad-Scale Ecosystem Management: A Social Perspective, 20 Conservation Biology 330, 338 (2006).

 [137]. See Cheever & Dernbach, supra note 81, at 251.

 [138]. Flatt & Payne, supra note 7, at 1079.

 [139]. Lazarus, supra note 27, at 787.

 [140]. Baker et al., supra note 11.

 [141]. Craig & Ruhl, supra note 134.

 [142]. Bell & York, supra note 40.

 [143]. Anne Marie Lofaso, What We Owe Our Coal Miners, 5 Harv. L. & Pol’y Rev. 87, 87 (2011).

 [144]. See, e.g., discussion infra Section IV.C about Native American community in mixed environmental justice/economic dependency relationship with coal-fired power plant.

 [145]. Ann M. Eisenberg, Beyond Science and Hysteria: Reality and Perceptions of Environmental Justice Concerns Surrounding Marcellus and Utica Shale Gas Development, 77 U. Pitt. L. Rev. 183, 199 (2015); see also Bell & York, supra note 40, at 119.

 [146]. Bell & York, supra note 40, at 119.

 [147]. Id.

 [148]. Id.

 [149]. Id.

 [150]. Id.

 [151]. Id. at 120.

 [152]. Lofaso, supra note 143, at 88.

 [153]. Bell & York, supra note 40, at 11920.

 [154]. Lofaso, supra note 143, at 89.

 [155]. Id.

 [156]. Id.

 [157]. David J. Blackley et al., Continued Increase in Prevalence of Coal Workers’ Pneumoconiosis in the United States, 1970-2017, 108 Am. J. of Pub. Health 1220, 1221 (2018).

 [158]. Appalachian Voices, The Human Cost of Mountaintop Removal Coal Mining: Mapping the Science Behind Health and Economic Woes of Central Appalachia 1 (2012).

 [159]. See generally Chad Montrie, To Save the Land and the People: A History of Opposition to Surface Coal Mining in Appalachia (2003).

 [160]. Lofaso, supra note 143, at 94–95.

 [161]. Hitchman Coal & Coke Co. v. Mitchell, 245 U.S. 229, 250–52 (1917).

 [162]. Evan Andrews, The Battle of Blair Mountain, History (Aug. 25, 2016), http://www.history.com/news/americas-largest-labor-uprising-the-battle-of-blair-mountain.

 [163]. Brian C. Murchison, Due Process, Black Lung, and the Shaping of Administrative Justice, 54 Admin. L. Rev. 1025, 1026 (2002).

 [164]. Mona L. Hymel, Environmental Tax Policy in the United States: A “Bit” of History, 3 Ariz. J. Envtl. L. & Pol’y 157, 162 (2013).

 [165]. Janet Redman, Oil Change Int’l, Dirty Energy Dominance: Dependent on Denial: How the U.S. Fossil Fuel Industry Depends on Subsidies and Climate Denial 5 (2017).

 [166]. Mason Adams, A 40-Year-Old Federal Law Literally Changed the Appalachian Landscape, W.Va. Pub. Broadcasting (Aug. 5, 2017), http://wvpublic.org/post/40-year-old-federal-law-literally-changed-appalachian-landscape#stream/0.

 [167]. See Robert E. Beck, The Current Effort in Congress to Amend the Surface Mining Control and Reclamation Act of 1977 (SMCRA), 8 Fordham Envtl. L.J. 607, 617–18 (1997).

 [168]. Murchison, supra note 163, at 1027.

 [169]. Cf. Bailey H. Kuklin, The Plausibility of Legally Protecting Reasonable Expectations, 32 Val. U. L. Rev. 19, 19 (1997) (“[E]xpectations, particularly reasonable expectations, are at the heart of many legal doctrines. Contract, property and tort claims are often justified on the grounds that they protect reasonable expectations.”).

 [170]. See, e.g., Chris McGreal, America’s Poorest White Town: Abandoned by Coal, Swallowed by Drugs, Guardian (Nov. 12, 2015), https://www.theguardian.com/us-news/2015/nov/12/beattyville-kentucky-and-americas-poorest-towns.

 [171]. See Annalyn Censky, Coal ‘Ghost Towns’ Loom in West Virginia, CNN Money (May 26, 2011), http://money.cnn.com/2011/05/26/news/economy/west_virginia/index.htm.

 [172]. See Patrick McGinley, Collateral Damage: Turning a Blind Eye to Environmental and Social Injustice in the Coalfields, 19 J. Envtl. & Sustainability L. 305, 425 (2013) (noting that coal country’s sacrifice “ha[s] helped power and build a nation”).

 [173]. Kaplow, supra note 31, at 534 (“[M]ost commentators . . . defend mitigation of government risks, but not of market risks. Yet none of the distinctions they offer for treating government and market risks differently withstands scrutiny . . . . [T]here is little to distinguish losses arising from government and market risk.”).

 [174]. Trevor Houser et al., Columbia Ctr. on Global Energy Policy, Can Coal Make a Comeback? passim (2017), https://energypolicy.columbia.edu/sites/default/files/Center_on_Global
_Energy_Policy_Can_Coal_Make_Comeback_April_2017.pdf; Matt Egan, What Killed Coal? Technology and Cheaper Alternatives, CNN (Aug. 21, 2018), https://money.cnn.com/2018/08/21
/investing/coal-power-trump-epa/index.html; Andrew Sorensen, Natural Gas and Wind Energy Killed Coal, Not ‘War on Coal’, CU Boulder Today (May 7, 2018), https://www.colorado.edu/today/2018
/05/07/natural-gas-and-wind-energy-killed-coal-not-war-coal.

 [175]. Eisenberg, Beyond Science and Hysteria, supra note 145, at 207 (discussing exemptions for hydraulic fracturing in federal environmental statutes); see also Michael Pappas, A Right to be Regulated?, 24 Geo. Mason L. Rev. 99, 118–20 (2016) (arguing that regulatory changes may destroy the value of previously regulated utilities); cf. Christopher Serkin, Passive Takings: The State’s Affirmative Duty to Protect Property, 113 Mich. L. Rev. 345, 372–74 (2014) (“The harm resulting from inaction can be just as damaging as the harm resulting from overt action.”).

     [176].      Joseph L. Sax, Do Communities Have Rights—The National Parks as a Laboratory of New Ideas, 45 U. Pitt. L. Rev. 499, 499 (1983).

 [177]. Id.

 [178]. Id. at 500.

 [179]. Joseph Sax, Liberating the Public Trust Doctrine from Its Historical Shackles, 14 U.C. Davis L. Rev. 185, 187 (1980) (emphasis added).

 [180]. See id. at 186–88.

 [181]. Id.

 [182]. Cf. Legal Pathways to Deep Decarbonization in the United States (Michael B. Gerrard & John C. Dernbach eds. 2018); Chris Bataille et al., The Need for National Deep Decarbonization Pathways for Effective Climate Policy, 16 Climate Pol’y 1 (2016).

 [183]. See Frank Michelman, Property, Utility, and Fairness: Comments on the Ethical Foundations of “Just Compensation” Law, 80 Harv. L. Rev. 1180–81 (1967).

     [184].    Erin Fleaher Rogers, Agricultural Trade Adjustment Assistance: Food for Thought on the First Decade of the Newest Trade Adjustment Assistance Program, 23 Fed. Cir. B.J. 561, 562 (2014).

 [185]. Int’l Union v. Marshall, 584 F.2d 390, 395 (D.C. Cir. 1978).

 [186]. Id.

 [187]. See, e.g., Malcolm Bale & John Mutti, Income Losses, Compensation, and International Trade, 13 J. Hum. Resources 278, 283–84 (1978); Joseph Singer, The Reliance Interest in Property, 40 Stanford L. Rev. 3 (1988); Seth Mydans, Displaced Aerospace Workers Face Grim Future in California Economy, N.Y. Times (May 3, 1995), https://www.nytimes.com/1995/05/03/us/displaced-aerospace-workers-face-grim-future-in-california-economy.html. See generally Does Regulation Kill Jobs? (Cary Coglianese et al., eds. 2015).

 [188]. See Bale & Mutti, supra note 187; Singer, supra note 187; Mydans, supra note 187.

 [189]. Philip Levine, Towards a Property Right in Employment, 22 Buff. L. Rev. 1081 (1973); Robert Meltz, Takings Law Today: A Primer for the Perplexed, 34 Ecology L.Q. 307, 321 (2007). Takings jurisprudence does not recognize as property “the mere ability to conduct a business, as something separate from the business’ assets” or “permits and licenses if nontransferable and revocable.”  Meltz, Takings Law Today, supra, at 321. In a 1933 opinion in Lynch v. United States, the Court held that valid contracts could be property for takings purposes.  Lynch v. United States, 292 U.S. 571, 571 (1933). In 1995, however, the U.S. Court of Appeals for the Seventh Circuit observed that the Court effectively overruled Lynch in 1986 “to the extent that [Lynch] flatly holds that contracts are property that the government may not take without compensation . . . [an] analysis [that] does not resemble the takings jurisprudence of today.” Pro-Eco, Inc. v. Bd. of Comm’rs of Jay Cty., Ind., 57 F.3d 505, 510 n.2 (7th Cir. 1995) (discussing Connolly v. Pension Benefit Guarantee Corp., 475 U.S. 211 (1986)).

 [190]. Doremus, supra note 31, at 3 (“Regulatory takings claims are fundamentally conflicts over legal transitions. They arise when the rules change, those changes are costly (in economic or other terms), and the people bearing the costs believe that they are being unfairly singled out.”).

 [191]. James Manyika et al., Jobs Lost, Jobs Gained: What the Future of Work Will Mean for Jobs, Skills, and Wages, McKinsey Global Inst. (Nov. 2017), https://www.mckinsey.com/featured-insights/future-of-work/jobs-lost-jobs-gained-what-the-future-of-work-will-mean-for-jobs-skills-and-wages; James Doubek, Automation Could Displace 800 Million Workers Worldwide by 2030, Study Says, Nat’l Pub. Radio (Nov. 30, 2017), https://www.npr.org/sections/alltechconsidered/2017/11/30
/567408644/automation-could-displace-800-million-workers-worldwide-by-2030-study-says.

 [192]. See, e.g., Maggie Fox, Death Maps Show Where Despair Is Killing Americans, NBC (Mar. 13, 2018), https://www.nbcnews.com/health/health-news/death-maps-show-where-despair-killing-americans-n856231; Alec MacGillis, The Original Underclass, Atlantic (Sept. 2016), https://www.theatlantic.com/magazine/archive/2016/09/the-original-underclass/492731.

 [193]. Cf. Intergovernmental Panel on Climate Change, Summary for Policymakers of IPCC Special Report on Global Warming of 1.5C Approved by Governments (2018), https://www.ipcc.ch/pdf/session48/pr_181008_P48_spm_en.pdf.

 [194]. Ruhl, supra note 12, at 392.

 [195]. See Todd S. Aagaard, Environmental Law Outside the Canon, 89 Ind. L.J. 1239, 1241 (2014).

 [196]. Id. at 1240.

 [197]. Id. at 1251–54.

 [198]. Zygmunt J.B. Plater, From the Beginning, a Fundamental Shift of Paradigms: A Theory and Short History of Environmental Law, 27 Loy. L.A. L. Rev. 981, 1002 (1994).

 [199]. See generally Rachel Carson, Silent Spring (1962).

 [200]. Jonathon Adler, The Fable of the Burning River, 45 Years Later, Wash. Post (June 22, 2014), https://wapo.st/1lgHyz8?tid=ss_tw&utm_term=.e1b92a32a102.

 [201]. Plater, supra note 198 passim.

 [202]. See Daniel A. Farber, Politics and Procedure in Environmental Law, 8 J.L. Econ. & Org. 59, 60 (1992).

 [203]. Id.

 [204]. Id

 [205]. Id.

 [206]. Id. at 61.

 [207]. Daniel A. Farber, The Conservative as Environmentalist: From Goldwater and the Early Reagan to the 21st Century, 59 Ariz. L. Rev. 1005, 1007 (2017).

 [208]. Id.

 [209]. See generally Jonathan Mingle, Fighting for the Future, 5 Environment@Harvard 1 (2013).

 [210]. Lydia Saad, Global Warming Concern at Three-Decade High in U.S., Gallup (Mar. 14, 2017), http://news.gallup.com/poll/206030/global-warming-concern-three-decade-high.aspx; Robinson Meyer, What Americans Really Think About Climate Change, Atlantic (Apr. 22, 2017), https://www.theatlantic.com/science/archive/2017/04/climate-polling-burnout/523881.

 [211]. Sebastien Malo & Sophie Hares, On the Boil: Five Climate Lawsuits to Watch in 2018, Reuters (Dec. 27, 2017), https://www.reuters.com/article/us-global-climatechange-lawsuit-factbox
/onthe-boil-five-climate-lawsuits-to-watch-in-2018-idUSKBN1EM0J7.

 [212]. For example, California achieved its 2020 target for reduced greenhouse gas emissions four years early, see Cal. Air Resources Board, California Greenhouse Gas Emissions for 2000 to 2016 (2008), https://www.arb.ca.gov/cc/inventory/pubs/reports/2000_2016/ghg_inventory_trends_00-16.pdf, plaintiffs seeking more stringent regulations have succeeded in litigation based on the Clean Air Act, the Endangered Species Act, and the California Environmental Quality Act, see Sabrina McCormick et al., Strategies In and Outcomes of Climate Change Litigation in the United States, 8 Nature Climate Change 829 (2018), and major cities have committed to aggressive greenhouse gas reductions as well as the goal of limiting global warming to one-and-a-half degrees Celsius, Milman et al., The Fight Against Climate Change: Four Cities Leading the Way in the Trump Era, Guardian (June 12, 2017), https://www.theguardian.com/cities/2017/jun/12/climate-change-trump-new-york-city-san-francisco-houston-miami.

 [213]. Ruhl, supra note 12, at 411–12.

 [214]. Andrew Rowell, Green Backlash: Global Subversion of the Environmental Movement (1996).

 [215]. Eisenberg, Beyond Science and Hysteria, supra note 145, at 200; Eisenberg, Alienation and Reconciliation, supra note 18, at 154.

 [216]. McGinley, supra note 1702, at 316.

 [217]. Bell & York, supra note 40, at 139.

 [218]. Brian Obach, Labor and the Environmental Movement: The Question for Common Ground (2004).

 [219]. Id. at 9.

 [220]. Id. at 11.

 [221]. Eisenberg, Alienation and Reconciliation, supra note 18, at 140–47.

 [222]. Id.; Doorey, supra note 9, at 221.

 [223]. Jenna Hanson, The Modern Environmental Movement’s Big Failure, Pac. Standard (Apr. 17, 2015), https://psmag.com/environment/the-modern-environmental-movements-big-failure. But see Montrie, supra note 159 (discussing the untold history of popular opposition to environmental degradation).

 [224]. Hanson, supra note 223.

 [225]. Id.

 [226]. Lisa R. Pruitt & Linda T. Sobczynski, Protecting People, Protecting Places: What Environmental Litigation Conceals and Reveals About Rurality, 47 J. Rural Stud. 326, 326 (2016).

 [227]. Eisenberg, Alienation and Reconciliation, supra note 18, at 145.

 [228]. Id.

[229].     Farber, Politics and Procedure, supra note 202, at 60.

 [230]. Id.

 [231]. Cf. Kathy Mulvey et al., Union of Concerned Scientists, The Climate Accountability Scorecard: Ranking Major Fossil Fuel Companies on Climate Deception, Disclosure, and Action (2016), https://www.ucsusa.org/sites/default/files/attach/2016/10/climate-accountability-scorecard-full-report.pdf.

 [232].  Eisenberg, Alienation and Reconciliation, supra note 18, at 173.

 [233].  See generally Hari Osofsky & Jacqueline Peel, Energy Partisanship, 65 Emory L.J. 695 (2016) (discussing how environmental reform may be possible by tempering partisanship).

 [234]. Trade Act of 1974, 19 U.S.C. § 2101 (2012); 20 C.F.R. § 617.2 (2018).

 [235]. See, e.g., Trade Adjustment Assistance for Workers, Emp. & Training Admin., https://doleta.gov/tradeact (last visited Feb. 5, 2019).

 [236]. 19 U.S.C.. § 2251(a) (2012); Rogers, supra note 184 (“While the program initially provided aid only to workers, businesses, and communities, it was expanded in 2002 to cover farmers and fishermen through the Agricultural Trade Adjustment Assistance program.”); see also Stephen Kim Park, Bridging the Global Governance Gap: Reforming the Law of Trade Adjustment, 43 Geo. J. Int’l L. 797, 817–39 (2012) (discussing rationales for trade adjustment assistance).

 [237]. Int’l Union, UAW v. Marshall, 584 F.2d 390, 395 (D.C. Cir. 1978).

 [238]. Id.

 [239]. 19 U.S.C. § 2271 (2012); Petition Filing Frequently Asked Questions (FAQ), U.S. Dep’t of Labor (Aug. 31, 2018), https://doleta.gov/tradeact/petitioners/FAQ_Answers.cfm#G4.

 [240]. Investing in Trade-Affected Workers, U.S. Dep’t of Labor (Aug. 31, 2018), https://doleta.gov/tradeact/petitioners/petitionprocess.cfm; see also Benjamin Collins, Cong. Res. Serv.  Trade Adjustment Assistance for Workers and the TAA Reauthorization Act of 2015 (2018), https://fas.org/sgp/crs/misc/R44153.pdf (“Individual benefits are funded by the federal government and administered by state agencies through their workforce systems and unemployment insurance systems.”).

 [241]. Rogers, supra note 184, at 568.

 [242]. Id. at 568–69.

 [243]. Malcolm Bale & John Mutti, Income Losses, Compensation, and International Trade, 13 J. Hum. Resources 278, 283–84 (1978).

 [244]. See Lori G. Kletzer, Job Loss from Imports: Measuring the Costs 78 (2001).

 [245]. Designing a National Strategy for Responding to Economic Dislocation: Hearing Before the Subcomm. on Investigations and Oversight of the H. Comm. on Science and Technology, 110th Cong. 1 (2008) (testimony of Howard Rosen, Executive Director, Trade Adjustment Assistance Coalition).

 [246]. Shana Fried, Note, Strengthening the Role of the U.S. Court of International Trade in Helping Trade-Affected Workers, 58 Rutgers L. Rev. 747, 748 (2006); see also Steven T. O’Hara, Worker Adjustment Assistance: The Failure & The Future, 5 Nw. J. Int’l. L. & Bus. 394, 395              –96 (1983).

 [247]. See Fran Ansley, Standing Rusty and Rolling Empty: Law, Poverty, and America’s Eroding Industrial Base, 81 Geo. L.J. 1757, 1881 (1993); see also Park, supra note 236 passim; Fried, supra note 246 passim.

 [248]. Seattle Audubon Soc’y v. Mosley, 798 F. Supp. 1484, 1490 (W.D. Wash. 1992) (stating that endangering the northern spotted owl violated the National Forest Management Act, 16 U.S.C. § 1600).

 [249]. See, e.g., Portland Audubon Soc’y v. Lujan, 795 F. Supp. 1489, 1510 (D. Or. 1992), aff’d sub nom. Portland Audubon Soc’y v. Babbitt, 998 F.2d 705 (9th Cir. 1993).

 [250]. See Am. Forest Res. Council v. Shea, 172 F. Supp. 2d 24,  (D.D.C. 2001); Michael C. Blumm & Tim Wigington, The Oregon & California Railroad Grant Land’s Sordid Past, Contentious Present, and Uncertain Future: A Century of Conflict, 40 B.C. Envtl. Aff. L. Rev. 1, 4–5 (2013); Robert B. Keiter, Toward a National Conservation Network Act: Transforming Landscape Conservation on the Public Lands into Law, 42 Harv. Envtl. L. Rev. 62, 122 (2018).

 [251]. See, e.g., Seattle Audubon Soc’y v. Lyons, 871 F. Supp. 1291, 1307 (W.D. Wash. 1994) (rejecting a challenge to the scope of the federal government’s discretion in adopting the legislation); Kristin Carden, Bridging the Divide: The Role of Science in Species Conservation Law, 30 Harv. Envtl. L. Rev. 165, 245­–48 (2006).

 [252]. Schiffer & Heep, supra note 55, at 577.

 [253]. Id. at 582.

 [254]. Paul Koberstein, Will the Northwest Forest Plan Come Undone?, High Country News (Apr. 7, 2015), https://www.hcn.org/articles/will-the-northwest-forest-plan-come-undone.

 [255]. Schiffer & Heep, supra note 55, at 582. Charnley, supra note 136, at 286–87 (noting that the program met with mixed successes but suggesting that certain changes could have made it more successful); Michelle W. Anderson, The Western, Rural Rustbelt: Learning from Local Fiscal Crisis in Oregon, 50 Willamette L. Rev. 465, 503 (2014) (noting that NWFP’s job development programs, focused on common phenomenon of overlap between areas with economic hardship and areas with at-risk species, indicate that economic development should be cornerstone of environmental activism).

 [256]. Schiffer & Heep, supra note 55, at 577.

 [257]. Id. at 582.

 [258]. Carey Catherine Whitehead, Wielding a Finely Crafted Legal Scalpel: Why Courts Did Not Cause the Decline of the Pacific Northwest Timber Industry, 38 Envtl. L. 979, 1012 (2008) (discussing intermingled factors contributing to decline of regional timber industry, and economists’ struggle to separate effects of injunctions and general recession on regional timber industry).

 [259]. Koberstein, supra note 254.

 [260]. Id.

 [261]. Jack Ward Thomas et al., The Northwest Forest Plan: Origins, Components, Implementation Experience, and Suggestions for Change, 20 Conservation Biology 277, 283 (2006); see also Ted Helvoigt et al., Employment Transitions in Oregon’s Wood Products Sector During the 1990s, 101 J. Forestry 42, 42–46 (2003)              .

 [262]. Michael C. Blumm & Tim Wigington, The Past as Prologue to the Present Managing the Oregon and California Forest Lands, Or. St. B. Bull., July 2013, at 24, 25.

 [263]. Id. at 27.

 [264]. Anderson, supra note 255, at 470.

 [265]. Blumm & Wiginton, supra note 262, at 29.

 [266]. Craig P. Raysor, From the Sword to the Pen: A History and Current Analysis of U.S. Tobacco Marketing Regulations, 13 Drake J. Agric. L. 497, 512, 525 (2008) (noting inter alia problem of non-diversification of tobacco farms in early twentieth century).

 [267]. See id. See generally Juliana v. United States, 339 F. Supp. 3d 1062 (D. Or. 2018).

 [268]. 7 C.F.R. § 1463.1 (2018); Ryan D. Dreveskracht, Forfeiting Federalism: The Faustian Pact with Big Tobacco, 18 Rich. J.L. & Pub. Int. 291, 308 (2015).

 [269]. Dreveskracht, supra note 268, at 308; see also Tobacco Transition Payment Program: Examination Treatment of Assets Related to the Tobacco Transition Payment Program, Fed. Deposit Ins. Corp. (Aug. 3, 2005), https://www.fdic.gov/news/news/financial/2005/fil7305.html.

 [270]. Tobacco Transition Payment Program, supra note 269; see also Fair and Equitable Tobacco Reform Act of 2004, Pub. L. No. 108-357, 118 Stat. 1521 (codified at 7 U.S.C. § 518 (2012)); Joseph C. Robert, The Story of Tobacco in America 210 (1949).

 [271]. See, e.g., Tobacco Transition Payment Program, U.S. Dep’t of Agric., https://www.fsa.usda.gov/FSA/webapp?area=home&subject=toba&topic=landing (last updated Jan. 30, 2013).

 [272]. See generally Helen Pushkarskaya & Maria I Marshall, Lump Sum Versus Annuity: Choices of Kentucky Farmers During the Tobacco Buyout Program, 41 J. Agric. and Applied Econ. 613, 614 (2009).

 [273]. 5 West’s Fed. Admin. Prac. Income Support Programs—Tobacco § 5510, Westlaw (database updated July 2018) [hereinafter Income Support Programs—Tobacco].

 [274]. 7 U.S.C. § 518b (2012).

 [275]. Income Support Programs—Tobacco, supra note 273.

 [276]. Nathan Bomey, Thousands of Farmers Stopped Growing Tobacco After Deregulation Payouts, USA Today (Sept. 2, 2015), https://www.usatoday.com/story/money/2015/09/02/thousands-farmers-stopped-growing-tobacco-after-deregulation-payouts/32115163.

 [277]. Id.

 [278]. Id.

 [279]. Dreveskracht, supra note 268, at 312.

 [280]. Blake Brown, The End of the Tobacco Transition Payment Program, N.C. St. Univ. (Nov. 14, 2013), https://tobacco.ces.ncsu.edu/wp-content/uploads/2013/11/The-End-of-the-Tobacco-Transition-Payment-Program.pdf?fwd=no.

 [281]. Press Release, Office of the Press Sec’y, Fact Sheet: Administration Announces New Economic and Workforce Development Resources for Coal Communities Through POWER Initiative (Aug. 24, 2016), https://obamawhitehouse.archives.gov/the-press-office/2016/08/24/fact-sheet-administration-announces-new-economic-and-workforce.

 [282]. POWER Initiative, Appalachian Regional. Commission (last visited Feb. 5, 2019), https://www.arc.gov/funding/power.asp; ARC Seeks Funds for Coal-Impacted Communities, Fayette Trib. (Feb. 5, 2018), http://www.fayettetribune.com/news/arc-seeks-funds-for-coal-impacted-communities/article_cbae624e-09dc-11e8-896a-1f98f0f3a842.html.

 [283]. Appalachian Reg’l. Comm’n, FY 2019 Performance Budget Justification 5 (2018), https://www.arc.gov/images/newsroom/publications/fy2019budget/FY2019PerformanceBudgetFeb2018.pdf.

 [284]. POWER Initiative, supra note 282; see also Appalachian Reg’l Comm’n, POWER Awards, October 2018, https://www.arc.gov/images/grantsandfunding/POWER2018
/ARCEconDiversificationAwardsSummaries10-11-2018.pdf.

 [285]. Richard L. Revesz, Regulation and Distribution, 93 N.Y.U. L. Rev. 1489, 155055 (2018) (discussing both failed and implemented congressional and executive efforts to assist coal communities and workers, including the POWER Initiative (implemented), POWER Plus (failed), the Abandoned Mine Land Economic Revitalization (“AMLER”) Program (failed), and the Revitalizing the Economy of Coal Communities by Leveraging Local Activities and Investing More (“RECLAIM”) Act (failed)).

 [286]. Malcom Bale & John Mutti, Income Losses, Compensation, and International Trade, 13 J. Hum. Resources 278, 280 (1978).

 [287]. Id.

 [288]. Brown, supra note 280.

 [289]. See Council of Econ. Advisers, Strengthening the Rural Economy—The Current State of Rural America, White House: President Barack Obama (Apr. 27, 2010), https://obamawhitehouse
.archives.gov/administration/eop/cea/factsheets-reports/strengthening-the-rural-economy/the-current-state-of-rural-america.

 [290]. See U.S. Dep’t of Labor, Current Employment Statistics Survey: 100 Years of Employment, Hours, and Earnings, Bureau Lab. Stat. (Aug. 2016), https://doi.org/10.21916/mlr.2016.38.

 [291]. See Reihan Salam, Taxi-Driver Suicides Are a Warning, Atlantic (June 5, 2018), https://www.theatlantic.com/politics/archive/2018/06/taxi-driver-suicides-are-a-warning/561926.

 [292]. Phil McCausland, Sixth New York City Cab Driver Dies of Suicide After Struggling Financially, NBC News (June 16, 2018), https://www.nbcnews.com/news/us-news/sixth-new-york-city-cab-driver-dies-suicide-after-struggling-n883886; Nikita Stewart & Luis Ferré-Sadurní, Another Taxi Driver in Debt Takes His Life. That’s 5 in 5 Months., N.Y. Times (May 27, 2018), https://www.nytimes.com/2018/05/27/nyregion/taxi-driver-suicide-nyc.html.

 [293]. Henry Goldman, Hyperdrive: NYC Is Set to Impose a Cap on Uber, Bloomberg (Aug. 6, 2018), https://www.bloomberg.com/news/articles/2018-08-06/nyc-set-to-impose-cap-on-uber-as-ride-hail-vehicles-clog-streets.

 [294]. See Just Transition: A Framework for Change, Climate Just. Alliance, https://climatejusticealliance.org/just-transition (Last visited Feb. 6, 2019) (listing gentrification as scenario warranting just transition considerations).

 [295]. See Ramo & Behles, supra note 84, at 509.

 [296]. Id. at 509–10.

 [297]. Id. at 510.

 [298]. Id. at 512–13.

 [299]. Id. at 515.

 [300]. Id. at 513.

 [301]. Id. at 517.

 [302]. Id. at 520.

 [303]. Id.

 [304]. Id.

 [305]. Id. at 519.

 [306]. Id. at 521.

 [307]. Id. at 525–26.

 [308]. See id. at 522.

 [309]. Id. at 523–25.

 [310]. Id. at 526.

 [311]. See, e.g., J. Mijin Cha, Labor Leading on Climate: A Policy Platform to Addressing Rising Inequality and Rising Sea Levels in New York State, 34 Pace Envtl. L. Rev. 423, 447 (2017) (citing Mohave example as positive outcome).

 [312]. Eisenberg, Alienation and Reconciliation, supra note 18, at 138.

 [313]. Id.

 [314]. See generally Ky. Ctr. for Econ. Dev., Just the Facts: Kentucky Business Investment Program (2018), http://thinkkentucky.com/kyedc/pdfs/KBIFactSheet.pdf?57.

 [315]. Parija Kavilanz, How This Kentucky Coal Town Is Trying to Bring its Economy Back to Life, CNN (Nov. 8, 2017), https://money.cnn.com/2017/11/08/news/economy/hazard-kentucky-coal-jobs
/index.html.

 [316]. Slav Kornik, Alberta Puts Up $40M to Help Workers Transition During Coal-Power Phase-Out, Global News (Nov. 10, 2017), https://globalnews.ca/news/3855043/alberta-puts-up-40m-to-help-workers-transition-during-coal-power-phase-out; see also A Just Transition: The Way Forward for Coal Communities, Energy Transition (Feb. 20, 2017), https://energytransition.org/2017/02/a-just-transition-the-way-forward-for-coal-communities (discussing transitions for coal communities in Germany).

 [317]. See Joshua Macey & Jackson Salovaara, Bankruptcy as Bailout: Coal, Chapter 11, and the Erosion of Federal Law, 71 Stan. L. Rev. 137 passim (2019); see also Eisenberg, Beyond Science and Hysteria, supra note 145, at 207.

 [318]. See Macey & Salovaara, supra note 317 passim.

 [319]. See, e.g., Katy Stech Ferek, Coal Company Armstrong Energy Files for Chapter 11 Bankruptcy Protection, Wall St. J. (Nov. 1, 2017), https://www.wsj.com/articles/coal-company-armstrong-energy-files-for-chapter-11-bankruptcy-protection-1509548753.

 [320]. Ethan Lipsig & Keith R. Fentonmiller, A WARN Act Road Map, 11 Lab. Law. 273, 273 (1996).

 [321]. Nicole C. Snyder & Scott E. Randolph, Understanding the Federal WARN Act and Its Impact on the Sale of A Business, 52 Advocate 29, 29 (2009).

 [322]. Id.

 [323]. Lipsig & Fentonmiller, supra note 320, at 273.

An Examination of the Right to Try Act of 2017 and Industry’s Potential Path Moving Forward – Note by Sylvia Zaich

From Volume 92, Number 2 (January 2019)
DOWNLOAD PDF


 

An Examination of the Right to Try Act of 2017 and Industry’s potential Path Moving Forward

Sylvia Zaich[*]

TABLE OF CONTENTS

INTRODUCTION

I. A Brief History of the FDA and the current
Drug development process

A. The Origins of the FDA’s Regulatory Framework

B. The Drug Development Process

II. ChalLenges to the regulatory framework and
an overview of the Expanded access program

A. Prior Pre-Approval Access Challenges

1. 1970s: Laetrile, the FDCA, and Rutherford v. United States

2. 1980s–1990s: The Reagan Administration and the
HIV/AIDS Epidemic

3. 2000s: Pre-Approval Access, a Proposal, and Abigail Alliance v. Von Eschenbach

B. The Expanded Access Program

1. How a Physician Requests Expanded Access for
Individual Patient Use

2. How Companies Evaluate an Individual Patient Request

3. How the FDA Evaluates an Individual Patient Request

III. THE RIGHT-TO-TRY MOVEMENT

A. The Movement’s Rationale for Right to Try and
Success at the State Level

1. The Right-to-Try Movement’s Rationale

2. The Movement’s Success at the State Level

B. The FDA’s Response

1. Clarifying the FDA’s Use of Clinical Outcomes

2. Demystifying Manufacturers’ Eligibility Criteria

3. Increasing Awareness of Expanded Access

4. Streamlining the Individual Patient Request Process70

C. The Push for a Federal Right to Try

IV. the Right to Try Act of 2017

A. The Law

1. Who is Eligible?

2. When Would an Investigational Drug Qualify?

3. What are the Reporting Obligations?

4. When Can the FDA Use Clinical Outcomes?

B. Industry’s Potential Path Moving Forward

1. Even with the Right to Try Act, Most Companies Will
Continue to Use Expanded Access

2. Charting Industry’s Path Forward

CONCLUSION

Appendix

 

INTRODUCTION

In 2013, a petition started to circulate the Internet, urging the CEO of BioMarin Pharmaceutical to provide its investigational drug BMN-673 to then forty-five-year-old attorney Andrea Sloan, who was undergoing treatment for late stage ovarian cancer.[1] With standard treatments no longer an option, her physicians proposed trying BMN-673, one of a new class of cancer drugs called PARP inhibitors developed by BioMarin. The advanced nature of Sloan’s cancer disqualified her from enrolling in a clinical trial, so instead she and her physicians sought access to BMN-673 through the U.S. Food & Drug Administration’s (“FDA”) expanded access program, which allows pre-approval use of drugs outside of the clinical trial setting.[2]

The FDA confirmed Sloan was a candidate for expanded access use, but that confirmation did not guarantee use. That decision was left to the discretion of the company. BioMarin declined to provide BMN-673 because the drug was still in early phase of development: “It would be unethical and reckless to provide [BMN-673 to] end-stage refractory ovarian cancer patients outside a clinical trial.”[3] This decision sparked the Change.org petition that ultimately secured more than 230,000 signatures.[4] Even with this overwhelming public support, BioMarin maintained its position. A different company, which was developing a similar drug, eventually provided Sloan with access on the condition that it remain unidentified. Sloan started the treatment, but her cancer had progressed, and she died shortly thereafter.[5]

Sloan’s expanded access experience is not unique. A number of patients, with the support of their friends and families, launched similar online campaigns, seeking access to investigational medicines after becoming frustrated with companies’ unwillingness to accommodate expanded access requests for investigational drugs.[6] Some were successful; others were not. These campaigns, including Sloan’s, increased public awareness and dialogue regarding terminally ill patients’ ability to access investigational medicine and helped spark a national legislative movement promoting such individuals’ “right to try.”[7]

In 2015, Texas was the twenty-first state to adopt righttotry legislation.[8] The Texas bill was named in Andrea Sloan’s memory. These laws, despite often having bipartisan support, have been divisive, with supporters claiming that the right to try offers “real hope,[9] and critics maintaining that the right to try is merely political theatrics and ultimately will do more harm than good for individual patients.[10] Forty-one states have adopted righttotry laws since the movement first launched in 2014.[11] That success sparked a push for a federal righttotry law.

President Donald J. Trump voiced his support for such legislation in his 2018 State of the Union address: “People who are terminally ill should not have to go from country to country to seek a cure—I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”[12] That endorsement was the final nudge Congress needed. On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right to Try Act”).[13]

This Note proceeds in four parts. Part I briefly looks back at the FDA’s history and the impact of two significant drug crises in establishing the agency’s current framework before explaining the current drug development process. Part II recounts previous challenges to this regulatory framework, which ultimately led to the development of the current expanded access program. Part II also examines the current expanded access program and, more specifically, the evaluation criteria applied by three of its key decisionmakers: the treating physician; the manufacturer; and the FDA.

Part III traces the beginnings of the right to try movement, examining the rationale for the laws and exploring how social media and increased direct-to-consumer advertising of approved drugs possibly created an opening for widespread support of these laws. Part III also explores why the FDA’s efforts to address criticisms of the expanded access program were unable to dissuade enactment of the Right to Try Act. Part IV provides an overview of the Right to Try Act and how the Act differs from expanded access. Part IV further explores why, in general, mainstream industry likely will not adopt the righttotry pathway, before arguing that pharmaceutical and biotechnology companies should avoid maintaining their current positions regarding pre-approval access, and instead address some of the criticisms raised during the right-totry movement by (1) revising their existing expanded access policies and (2) improving clinical trial access.

I.  A Brief History of the FDA and the current Drug development process

To better understand the rationale for the FDA’s regulatory framework and the role it has “effectively balanc[ing] the interests of those patient populations who would benefit from having greater access to investigational drugs, with the broader interests of society in having safe and effective new therapies approved for marketing and widely available,”[14] Part I of this Note reviews how the FDA’s authority developed in response to two significant drug safety crises and provides a primer on the current drug development process.

A.  The Origins of the FDA’s Regulatory Framework

The origins of the FDA can be traced back to the 1800s, but two drug safety crises prompted the development of the agency’s current regulatory framework. The deaths of more than one hundred people from an untested drug formulation led to the enactment of the Federal Food, Drug, and Cosmetic Act of 1938 (“FDCA”), which required manufacturers to show “that any new drug was safe before it could be marketed.”[15] The initial effectiveness of the FDCA was limited. If the agency did not respond to a new drug application[16] within sixty days, the drug was automatically approved for public consumption.[17] The FDCA also did not require standardized drug testing.[18] This remained the regulatory environment—despite efforts by some to address these shortcomings—until the second drug safety crisis of the twentieth century.

In 1960, the manufacturer of the thenpopular sedative thalidomide submitted a marketing application for the drug in the United States.[19] The FDA refused to grant approval over concerns about inadequate and deficient safety data.[20] The manufacturer had distributed “more than two and a half million tablets . . . to approximately 20,000 patients” in the United States for clinical testing, but few, if any, of these individuals were actually monitored after receiving the drug.[21] The drug was eventually linked to an “epidemic of congenital malformations.”[22] The global thalidomide crisis motivated politicians to reconsider legislation that would have “tightened restrictions surrounding the surveillance and approval process for drugs.”[23]

Two years later, in 1962, Congress passed the Kefauver-Harris Amendment “to assure the safety, effectiveness, and reliability of drugs.[24] This amendment eliminated the FDCA’s de facto approval loophole and extended the review period to 180 days.[25] Even more significant, the Kefauver-Harris Amendment “laid the groundwork for the [current multi-phased] system of clinical trials”[26] by requiring a manufacturer to submit “substantial evidence” of an investigational drug’s safety and efficacy with its marketing application.[27]

B.  The Drug Development Process

A manufacturer or other protocol sponsor,[28] before conducting a clinical trial, must first submit an investigational new drug (“IND”) application.[29] The IND provides an overview of the biopharmaceutical company’s general investigational plan and clinical trial protocols for the drug.[30] The plan must provide:

(a) [t]he rationale for the drug or research study;

(b) the indication(s) to be studied;

(c) the general approach to be followed in evaluating the drug;

(d) the kinds of clinical trials to be conducted in the first year . . . ;

(e) the estimated number of patients . . . ; and

(f) any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug or related drugs.[31]

The IND gives the FDA the information it needs to assess the safety of the proposed phase I trials and the “scientific quality of [the proposed phase II and III trials] and the likelihood that the [trials] will yield data capable of meeting statutory standards for marketing approval.”[32]

In phase I, a manufacturer assesses the drug’s safety and determines the appropriate dosage for subsequent trials.[33] The participants are typically healthy volunteers but depending on the condition may be patient volunteers.[34] The enrollment size of these trials is small. A single phase I trial might enroll anywhere between twenty to eighty volunteers.[35] The Biotechnology Innovation Organization (“BIO”) estimates that approximately 60% of drugs advance from phase I to phase II clinical trials.[36]

In phase II, the investigational drug is tested in patient volunteers who have the disease or condition.[37] This commonly involves a randomized clinical trial in which patients are randomly assigned either the investigational drug or some other treatment—“either an inactive substance (placebo), or a different drug that is usually considered the standard of care for the disease”—without knowing which treatment they are receiving.[38] The manufacturer then compares the effectiveness of the investigational drug to the effectiveness of the alternative treatment.[39] Phase II clinical trials are also required to assess the drug’s “common short-term side effects and risks.”[40] In general, this is the stage of development with the lowest success rate”—almost 70% of drugs fail to move beyond phase II.[41]

The pre-approval development process culminates with phase III clinical trials,[42] which are intended to produce “statistically significant data about the safety, efficacy and overall benefit-risk relationship of the investigational medicine.”[43] This data is an integral component of the new drug application a manufacturer submits to the FDA.[44] To obtain statistically significant data, these studies often require a substantial number of volunteers—sometimes upwards of 5,000 volunteers depending on the disease or condition.[45]

The recruitment process throughout clinical development can take several years and be very expensive, with manufacturers often struggling to fully enroll their clinical trials.[46] The low accrual rates can be the result of strict inclusion and exclusion criteria.[47] Still, manufacturers can be resistant to making the criteria less restrictive and more inclusive,[48] perhaps because lessstandardized patients might make it harder to parse through data, extend the length or size of a clinical trial, increase the risk of adverse events potentially impacting a drug’s safety profile and potentially its approval, and make clinical development more expensive.[49]

The estimated time from discovery to FDA approval of a drug is now at least ten years. The cost of development is estimated between $10 million and $2.6 billion, with the higher estimate factoring in costs associated with investigational drugs that never advance beyond clinical development.[50] These costs are then passed on to patients, with some cancer therapies costing upwards of $375,000.[51] “The U.S. spent nearly $88 billion treating cancer in 2014, with patients paying nearly $4 billion out-of-pocket.”[52] All of that spending, however, does not necessarily translate into positive outcomes for every patient.[53]

II.  ChalLenges to the regulatory framework and an overview of the Expanded access program

A.  Prior Pre-Approval Access Challenges

The tension—highlighted most recently by the right-to-try movement—between ensuring patients have access to potentially groundbreaking medicines as soon as possible and ensuring that these therapies are both safe and effective is not nascent. There have been three significant pre-approval access challengesstarting with Rutherford v. United States in 1975to the FDA’s regulatory framework since the enactment of the Kefauver-Harris Amendment.

1.  1970s: Laetrile, the FDCA, and Rutherford v. United States

In 1975, a few individuals with terminal cancer filed a lawsuit seeking to enjoin the FDA from obstructing the interstate shipment and sale of the alternative treatment laetrile because it was not approved by the FDA.[54] The district court ordered the FDA to allow patients pre-approval access.[55] On appeal, the U.S. Court of Appeals for the Tenth Circuit referred the issue to the FDA,[56] which found laetrile was a new drug within the meaning of the FDCA and could be barred from interstate sale until the necessary safety and efficacy data was submitted for FDA review and received FDA approval.[57] The district court vacated that decision on statutory and constitutional grounds,[58] and the FDA appealed.[59] The Tenth Circuit—rather than relying on the district court’s reasoning—held instead that the FDCA’s “‘safety’ and ‘effectiveness’ terms” did not apply to individuals with terminal cancer diagnoses.[60]

The case was eventually heard by the Supreme Court, which decided in favor of the agency’s FDCA interpretation.[61] The Court held the FDCA made “no special provision for drugs used to treat terminally ill patients” based on the statute’s plain language.[62] The Court also explained that it could not imply a statutory exception because the “legislative history and consistent administrative interpretation” of the FDCA did not support one.[63]

2.  1980s–1990s: The Reagan Administration and the HIV/AIDS Epidemic

 After President Ronald Reagan’s election in 1980, his administration ushered in widespread deregulation efforts across all areas of government.[64] Those efforts included (1) amending the FDCA, which the administration viewed as unnecessarily delaying drug approvals, and (2) establishing a defined program for terminally patients seeking access to investigational drugs for treatment rather than research purposes.[65] The FDA, in response to the administration’s latter concern, proposed codifying the agency’s existing informal pre-approval access procedures.[66] Those efforts became even more urgent with the HIV/AIDS epidemic though the agency’s efforts and the administration’s initial concern regarding pre-approval access were not aimed directly at aiding individuals with HIV/AIDS.[67]

 The FDA promulgated several significant changes not only to improve patient access outside of the clinical trial setting to drugs still in clinical development, but also to reduce the length of time between discovery and final FDA approval. The latter issue being one in which the interests of activists and manufacturers aligned, as both advocated for changes to the regulatory framework.[68] First, the FDA amended its regulations in 1987 to allow widespread access to an investigational drug outside of the clinical trial setting through a “treatment protocol.”[69] The agency continued to apply an informal standard for individual requests until the Food & Drug Administration Modernization Act of 1997 codified the expanded access program, which specifically addressed the need for a formal individual patient request process.[70] Second, the FDA created the Accelerated Approval pathway[71] and introduced a striated review framework[72] to speed up the availability of promising new drugs intended for the treatment of serious diseases or conditions. Subsequent congressional action in 1997 and 2012 armed the FDA with two additional means to further reduce the time from initial development of a drug to its approval.[73]

3.  2000s: Pre-Approval Access, a Proposal, and Abigail Alliance v. Von Eschenbach

There was not another significant challenge to the drug development and approval process until an organization, seeking to improve terminally ill patients’ abilities to obtain investigational drugs, proposed a “three-tiered approval system.”[74] The first approval tier would have allowed limited marketing of investigational drugs following completion of phase I trials.[75] The organizationthe Abigail Alliance for Better Access to Developmental Drugs (the Abigail Alliance”)[76]claimed terminally ill patients with no other treatment options faced a “different risk-benefit tradeoff” and should have the option to try investigational drugs.[77] The FDA rejected this proposal, explaining that this approach “would upset the appropriate balance” by “giving almost total weight to the goal of early availability and giving little recognition to the importance of marketing drugs with reasonable knowledge . . . of their likely clinical benefit and their toxicity.”[78]

The Abigail Alliance, agency rejection in hand, filed an action against the FDA.[79] The organization sought to block the agency’s policy prohibiting the pre-approval sale of drugs to individuals with terminal conditions.[80] The Abigail Alliance argued that the FDA’s policy “violate[d] terminally ill patients’ constitutional privacy and liberty rights, as well as their due process rights to life.”[81] The district court found these claims legally unpersuasive.[82] But a United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) panel, in a 2–1 split, agreed with the group, holding that the due process clause protected the right of terminally ill patients to decide whether to use investigational drugs that the FDA had determined were safe enough for additional clinical trials after reviewing results from phase I clinical trials.[83] The panel directed the district court to determine whether the FDA’s policy was narrowly tailored to serve a compelling governmental interest.[84]

The FDA’s request for an en banc hearing was granted before a lower court could apply strict scrutiny.[85] The court en banc flatly rejected the panel’s decision.[86] The court expressed “serious doubt” about the constitutional validity of the Abigail Alliance’s articulated right: a “fundamental right of access for the terminally ill to experimental drugs.”[87] To establish its articulated right, the Abigail Alliance needed to illustrate a tradition of accessibility to drugs that were not proven to be safe or effective.[88] The en banc court found that “FDA regulation of post-phase I drugs [was] entirely consistent with [the United States’] historical tradition of prohibiting the sale of unsafe drugs.”[89] The en banc court also disputed the group’s effectiveness argument, noting the existence of “at least some drug regulation prior to [the Kefauver-Harris Amendment] address[ing] efficacy.”[90] The en banc court also dismissed the Abigail Alliance’s argument that the right to self-preservationbased on the common law doctrine of necessity, the tort of intentional interference with rescue, and the right to self-defensecreated a constitutionally protected right in this context.[91] The court concluded that the Abigail Alliance’s articulated right was not fundamental.[92] The court held that “the FDA’s policy of limiting access to investigational drugs [was] rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects.”[93]

Two years after the D.C. Circuit’s decision in Abigail Alliance, the FDA finally issued revised expanded access regulation clarifying the process by which an individual patient could request expanded access.[94] The current expanded access program is discussed in greater detail below.

B.  The Expanded Access Program

The expanded access program, as discussed, was designed to address concern that some individuals may not have an opportunity to try a promising therapy given the sometimes ten-year path to formal regulatory approval. The expanded access program allows some patients with serious or immediately life-threatening diseases to use an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.”[95] The program is available for individual patient use, intermediate-size patient use, and widespread patient use.[96] In addition to the patient, there are three other important decisionmakers. Section II.B.1 describes how a physician would initiate an expanded access request for an individual patient. Sections II.B.2 and II.B.3 then discuss the criteria used by biopharmaceutical companies and the FDA to determine eligibility in the individualpatient setting.

1.  How a Physician Requests Expanded Access for Individual Patient Use

Prior to initiating an expanded access request for a patient, the requesting physician must first conclude that “the probable risk to the person from the investigational drug is not greater than the probable risk from the disease or condition.”[97]

After this determination is made, the physician must then seek a letter of authorization (“LOA”) from the manufacturer.[98] The request must be made by a physician. The LOA allows the FDA to refer to the requested investigational drug’s IND file instead of requiring the requesting physician to obtain confidential information regarding the drug’s pharmacology, toxicology, chemistry, or manufacturing process.[99] As evidenced by Andrea Sloan’s unsuccessful request, this has been the greatest source of frustration for patients seeking expanded access use. Aside from Pfizer, most companies do not disclose how many requests they receive or grant each year.[100] This step of the process can also be lengthy as current FDA regulation does not impose a time restraint.[101] So even if a company acknowledges receipt of a request within twotothree business days,[102] the company is not required to expediently review that request, which often involves multiple parties within a company.[103]

If the company agrees to grant use and provides a LOA, the requesting physician would then submit an application form to the FDA. The FDA asks the physician to provide an overview of the patient’s clinical history, the rationale for the expanded access request, and the proposed treatment plan.[104] The FDA has up to thirty days to review the application and provide feedback.[105] A 2017 U.S. Government Accountability Office (“GAO”) report found that the FDA’s median response time was no more than nineteen days for non-emergency situations.[106]

While the FDA reviews the application, the physician must also obtain approval from his or her institution’s or hospital’s institutional review board (“IRB”).[107] The requesting physician can also request a waiver from the FDA, which would allow the expanded access request to be reviewed by either the IRB chair or another designated member.[108] The physician must also discuss the expanded access requirements with the patient and secure the patient’s informed consent to treatment.[109]

2.  How Companies Evaluate an Individual Patient Request

The expanded access regulation does not prescribe the criteria a manufacturer should use when determining whether to grant an expanded access request.[110] Industry groups Pharmaceutical Research and Manufacturers of America (“PhRMA”) and BIO, however, have each separately published guiding principles for the groups’ respective members that closely mirror the evaluation criteria used by the FDA.[111] PhRMA recommends that manufacturers consider five factors: (1) whether the individual has exhausted all available treatment options for a serious or life-threatening illness; (2) whether “[t]he investigational drug [is] under active clinical development”; (3) whether “[t]he patient is ineligible for, or otherwise unable to participate in, clinical trials”; (4) whether [t]he potential benefit to the patient [outweighs the] potential risk”; and (5) whether approving the request would interfere with the “successful completion of the clinical trial process.”[112]

A survey of twenty biopharmaceutical companies’ eligibility criteria[113] illustrates that most large companies offering expanded access have adopted criteria modeled off either PhRMA or BIO’s guidelines, with only slight variations.[114] In general, companies include criteria limiting expanded access to patients with serious or life-threatening conditions. The extent to which a patient must have tried standard treatment options and must not have other treatment options available varies. A few companies require the patient to have tried standard treatments unsuccessfully and to not have other treatment options available. Other companies just require that the patient does not have other treatment options available. The real difference in this language, however, might be just semantics.

Of the companies surveyed, one also factored in a patient’s ability to regularly travel to a treating site for observation and follow-up while receiving the investigational drug when deciding whether to grant an expanded access request.[115] Likewise, manufacturers will not consider an expanded access request unless the drug is in active development (that is, the company cannot have discontinued the program), but some companies choose to define this criterion more narrowly than BIO or PhRMA.[116] Take for examples, Merck, Amgen, and Allergan, which will not grant requests for a specific drug unless the company is actively developing the drug in the proposed intended use.[117] The criteria used by Merck and a few other companies also requires that the company have plans to submit a marketing application.[118]

Given concerns about expanded access impacting clinical trial enrollment, companies are hesitant to grant an expanded access request unless the individual is unable to participate in a clinical trial. This criterion is generally left vague, but some companies provide specific factors that they will or will not consider.[119] For example, under Genentech’s criteria, an individual who lives too far away from a clinical trial center would not be considered ineligible for a clinical trial and therefore would not qualify for expanded access based on this factor alone.[120] In contrast, Pfizer and Teva Pharmaceutical would consider geographic limitations as a factor affecting a patient’s ability to participate in a clinical trial.[121]

All of the companies surveyed included a criterion requiring the potential benefits of the drug to outweigh the potential combined risks of the treatment and the disease to the individual patient.[122] To make this risk-benefit assessment, PhRMA explains, there should be sufficiently robust preliminary safety and efficacy data, including dosing information, to determine that the preliminary benefit-risk balance is positive for the specific indication for which the request is made.”[123] While some companies keep this criterion vague to allow for greater discretion, a few companies’ criteria specifically mentions a dosing requirement.[124] Although most companies’ criteria did not distinguish between children and adults, one company’s guidelines specifically require sufficient pediatric data to determine the appropriate dosage before it will grant expanded access use for a child.[125]

Like the other criteria, almost all of the companies surveyed had some language in their expanded access guidelines addressing the clinical trial process and, more specifically, the need to ensure that pre-approval access use did not interfere with the clinical trial process.[126] A few companies specifically consider whether they have adequate drug supply for both their clinical trials and expanded access when making the determination.[127] While not specifically addressed, this criterion likely also considers the extent to which expanded access use might impact other aspects of clinical development, such as the FDA’s use of adverse events occurring during expanded access use, when reviewing an investigational drug’s marketing application.[128] A few companies also build in additional discretion by allowing their medical teams to establish additional criteria in light of a given drug’s current development and available data.[129]

As discussed, however, most companies do not disclose how many expanded access requests they receive or, of those, how many they grant.[130] This lack of disclosure makes it difficult for physicians, patients, or even the FDA to hypothesize how companies apply their criteria when reviewing an expanded access request. Two companies have made this type of information publicly available, but through different channels and with different levels of information. Pfizer, for example, discloses its overall expanded access approval rate on its website, but it does not explain the rationale for the small percentage of denials. By contrast, as part of a case study in the Journal of the American Medical Association (“JAMA”), Janssen released limited expanded access data regarding one investigational drug for a distinct period of time. That study reported the most common reason the company denied a request was an unfavorable risk-benefit profile.[131]

3.  How the FDA Evaluates an Individual Patient Request

The FDA, as mentioned, must review all expanded access requests. When reviewing an expanded access requestwhether for individual patient use, intermediate-size patient use, or widespread patient usethe FDA examines three threshold criteria: (1) patient eligibility; (2) risk-benefit analysis; and (3) impact on clinical trials.

a.  Patient Eligibility

The patient or group of patients must have a “serious or immediately life-threatening disease or condition,” in which “no comparable or satisfactory alternative therapy” is available.[132] An “immediately life-threatening disease” is defined as a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.”[133] A “serious disease” is defined as one “associated with morbidity that has substantial impact on day-to-day functioning.”[134] The FDA has previously authorized expanded access use for serious diseases like amyotrophic lateral sclerosis (“ALS”), narcolepsy, and Alzheimer’s disease.[135] In guidance from the FDA, the agency further clarifies its standard for a serious disease explaining: “short-lived and self-limiting morbidity will usually not be sufficient to qualify a condition as serious, but the morbidity need not be irreversible, provided it is persistent or recurrent.”[136] The FDA interprets no comparable or satisfactory therapy to “mean that there exists no other available therapy to treat the patient’s condition or that the patient has tried available therapies and failed to respond adequately or is intolerant to them.”[137]

b.  Risk-Benefit Analysis

The second requirement is that the “potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease.[138] This criterion acknowledges “the need for the risks and benefits of drugs to be well characterized” before the FDA will grant an expanded access request for an individual or group of patients.[139] This criterion is not intended to establish a uniform minimum approval threshold; that determination is dependent on the expanded access category and the seriousness of the disease.[140]

c.  Impact on Clinical Trials

The availability of expanded access also hinges on the FDA’s determination that “providing the investigational drug . . . will not interfere with . . . clinical investigations that could support marketing approval.[141] While it is understandable that many patients would prefer to secure an investigational drug outside of the confines of a clinical trial, especially given their randomized nature, expanded access use cannot “compromise enrollment in the trials” that would ultimately support a marketing application.[142] This criterion attempts to address concerns that expanded access would reduce individuals’ willingness to participate in clinical trials, especially given evidence that approximately 3% of adults with cancer enroll in clinical trials.[143]

* * *

The three expanded access categories each have additional category-specific criteria that the FDA must consider before granting a request (Table 1).With an individual patient expanded access request, the FDA must also conclude that “the patient cannot obtain the drug under another IND or protocol.”[144] This means that the patient is either ineligible to enroll in ongoing clinical trials based on eligibility criteria or unable to enroll for some other reason.[145]

The FDA approves most expanded access requests.[146] Between 2012 and 2015, the agency approved approximately 99% of the more than 5,000 single-patient expanded access requests it received.[147] The FDA does not just rubber-stamp these requests. The FDA made “meaningful changes in approximately 10 percent of these cases to enhance patient safety” such as adjusting dosage, increasing safety oversight, and strengthening informed consent.[148] FDA Commissioner Scott Gottlieb explained:

[t]he changes are based on the scientific and medical expertise of our staff, and informed by confidential information provided to FDA by product sponsors during the course of development. This information is often unavailable to the treating physician—and the larger medical community—and becomes available only after a drug is approved.[149]

The real question is how many expanded access requests never reach the FDA because the manufacturer declines to provide a letter of authorization.[150]

III.  THE RIGHTTOTRY MOVEMENT

In 2014, the Goldwater Institute, a conservative and libertarian public policy think tank, launched a new initiative based on patients’ right to “some choice over their own destinies.”[151] The think tank’s initial goal was to pass state laws giving terminally ill patients the right to obtain access to investigational drugs that have completed phase I clinical trials without interference from the FDA.[152] This goal was later expanded to secure the enactment of a federal law under the same premise.

Section III.A outlines and assesses the movement’s rationale for proposing a new pre-approval access pathway before briefly discussing the movement’s success at the state level. Section III.B examines the FDA’s attempts to address the movement’s claims and why those attempts by the agency were insufficient. Section III.C discusses the efforts by Senator Ron Johnson (R-Wis.) to secure enactment of federal right to try legislation.

A.  The Movement’s Rationale for Right to Try and Success at the State Level

1.  The RighttoTry Movement’s Rationale

The arguments for right to try can be distilled to three main claims: (1) the expanded access program is “so riddled with bureaucracy and delay that a patient’s chances of obtaining potentially lifesaving treatment in time are practically negligible”;[153] (2) the FDA is irreparably broken because it prevents individuals from using “potentially lifesaving medicines and treatments until those treatments receive final approval”;[154] and (3) patients with life-threatening diseases should be allowed to try an investigational drug that has already passed the FDA’s basic safety testing in phase I trials and remains within the FDA’s approval process because they are “safe.”[155]

a.  The Expanded Access Program Is Overly Bureaucratic and Slow

The Goldwater Institute specifically claimed that the expanded access program burdens people’s right to try because: (1) the FDA has “unfettered authority to deny a terminal patient access . . . for a variety of reasons, including nonmedical reasons”; (2) the application is overly burdensome and complicated for requesting physicians; and (3) the IRB review requirement prolongs and prevents access for patients undergoing treatment at non-academic centers outside of major metropolitan areas.[156]

There are two problems with the first part of this claim. First, this claim completely ignores the GAO report findings, which suggest a contrary proposition.[157] Second, this claim fails to acknowledge that sign-off from the FDA is only the last step in the process.[158] Take Andrea Sloan’s story as an example. The FDA acknowledged Sloan was an appropriate candidate for expanded access, but BioMarin would not provide BMN-673.[159] While the FDA approves nearly all of the expanded access requests it receives, the perception is that the bigger obstacle is manufacturer cooperation.[160] Most companies do not publicly disclose the number of requests received or promote the number of times the company has approved an individual patient’s request.[161] Of the company policies surveyed in Section II.B.2,[162] only Pfizer publicized information on its website about the number of requests it received and how many were approved by the company.[163] The lack of collective disclosure by manufacturers––and the inability of the FDA to require manufacturers to provide this information––leaves the public and politicians with a myopic view of the expanded access program.

The FDA has since introduced Form FDA 3926 (“Individual Patient Expanded Access – Investigational New Drug Application”) and modified the IRB review requirement addressing the second and third part of this claim, which are both discussed in greater detail in Section III.B. These changes could improve accessibility to the expanded access program over time.

 b.  The FDA Regulatory Framework Is Broken

The Goldwater Institute argued that the current regulatory framework is broken because it can take years before the FDA approves a drug. Yet instead of offering a solution to address the clinical trial process (for example, lobbying for legislation to support the use of different clinical trial designs,[164] or to incentivize companies to reconsider their rationale for certain inclusion and exclusion criteria that could provide data that more accurately reflects real-world patients[165])––which could potentially improve access to investigational drugs more broadly––the organization decided the easier path was pre-approval access legislation that cut-out the FDA. This strategy was shortsighted and arguably based on the Goldwater Institute’s overarching goal of limiting the FDA’s oversight of drugs for all patients and not just those drugs designed for the treatment of immediately life-threatening diseases.[166]

The claim that the framework is “broken” also focuses on speed to the detriment of safety and efficacy. The need for adequate safety and effectiveness data can prolong the drug approval process,[167] however, even with these requirements, the FDA is consistently faster at approving investigational drugs than other regulatory authorities. For example,

[a]mong the 289 unique novel therapeutic agents [approved between 2001 and 2010], 190 were approved in both the United States and Europe (either by the EMA or through the mutual recognition process), of which 121 (63.7%) were first approved in the United States; similarly, 154 were approved in both the United States and Canada, of which 132 (85.7%) were first approved in the United States.[168]

The speed with which a drug is approved, however, should not be the only priority—safety and efficacy are still important concerns. Some argue the agency is now underemphasizing these two criteria in its aim to ensure patients can access novel drugs more quickly.[169] A JAMA study found that “nearly a third of [drugs] approved [by the FDA] from 2001 through 2010 had major safety issues years after they were widely available to patients.”[170] A patient with a life-threatening disease or condition may understandably be frustrated by the lengthy development timeline, especially when a drug is touted as a potential “breakthrough” early on in its development cycle. However, pre-approval access without FDA oversight does not directly fix this lag between development and approval; it could make it worse for everyone if patients attempt to seek pre-approval access instead of enrolling in clinical trials.[171]

 c.  Patients Should Be Allowed to Use Investigational Drugs that Have Completed Phase I Clinical Testing

Finally, the Goldwater Institute’s claim that patients should be able to try investigational drugs because completion of phase I testing renders them safe fails to acknowledge that most investigational drugs are not approved by the FDA. The “overall likelihood of [FDA] approval . . . from Phase I for all developmental candidates [between 2006 and 2015] was 9.6%.”[172] The successful completion of a phase I clinical trial also does not guarantee a drug’s safety, and in general, investigational drugs have the lowest successful transition rates at phase II.[173] Take the example of fialuridine. In 1993, five individuals enrolled in a phase II clinical trial studying the use of fialuridine in hepatitis B died, despite an earlier phase I clinical trial in which 25% of a twenty-four-patient trial were cured after receiving fialuridine for twenty-eight days.[174] This example might seem extreme, but it still illustrates the risks associated with equating successful completion of a phase I trial with a broad endorsement of safety. As discussed, an approved drug’s safety profile is also not fully understood until sometimes years after it is approved. The potential harm of an investigational drug, even to someone “facing imminent death,” still needs to be considered before allowing an individual with a serious or life-threatening disease to use the investigational drug merely on the basis of completion of phase I testing.[175]

In conclusion, the movement’s rationales for these laws were misplaced and ill-guided. There is no doubt, however, that despite these claims, the Goldwater Institute was successful in securing the support necessary to pass both state and federal legislation.

2.  The Movement’s Success at the State Level

Post-Abigail Alliance, efforts were made to enact legislation to amend the expanded access program. While these federal bills failed to make it beyond congressional committee,[176] the state righttotry bills, from the outset, gained more support. There are several possible reasons for this increased support. First, information regarding investigational drugs, especially data from medical meetings, has become more accessible with the Internet and social media.[177] This increased accessibility is good, but it also can lead to increased interest in investigational drugs—especially when a drug is deemed “revolutionary” by the medical community, even with limited safety and efficacy data.[178] Timothy Turnham, the former executive director at the Melanoma Research Foundation, explains: “There is a disconnect between what researchers think is statistically significant and what is really significant for patients . . . . Patients hear ‘progress,’ and they think that means they’re going to be cured.”[179]

Second, there has been an increase in direct-to-consumer advertising of approved specialty drugs for the treatment of conditions such as cancer and autoimmune disorders by pharmaceutical companies[180] and of specific practices areas such as oncology and organ transplantation by cancer hospitals.[181] The United States is one of only a small number of countries which allows drug company advertising to not only mention an approved drug and its intended use, but also claims about its safety and efficacy.[182] These advertisements—though meant to be scientifically accurate—can also sometimes have misleading effects on people’s perceptions of their individual health outcomes.[183] If patients’ perceptions are skewed when they see a television advertisement claiming an FDA-approved drug will give them “a chance to live longer,” it is reasonable to think that patients’ perceptions could be equally skewed about investigational drugs given that investigational drugs are often touted as “revolutionary” at medical meetings by the manufacturers, tweeted as “ground-breaking” by physicians, and reported as “life-saving” by media, as compared to the currently available treatment option.

Third, with social media, individual patients like Andrea Sloan have a more accessible, widely-used platform by which to raise awareness of their struggle to obtain these investigational drugs through expanded access.[184] In the past, publicized efforts to pressure manufacturers for expanded access were generally a coordinated effort led by advocacy groups, aimed at obtaining an investigational drug for more widespread use.[185] Individual patients were often left to phone calls and letter writing with slim chance of successfully obtaining an experimental treatment without a connection.[186] This changed with social media. The news media found these campaigns and latched onto Sloan’s and other patients’ stories with headlines like “Company Denies Drug to Dying Child” and “Merck Expands Cancer Drug Access but too Late for Denver Dad,” which only amplified the public’s frustration with expanded access.[187] The social media campaigns and media attention, in turn, increased pressure on politicians to fix the system and allow individuals access to investigational drugs.[188]

The Goldwater Institute initially targeted more conservative states like Colorado, Arizona, and Texas,[189] but the movement also gained traction and success in more liberal states like California and Oregon.[190] The state bills also often had little political opposition and were supported by members on both sides of the aisle.[191] In total, forty states adopted righttotry laws prior to the enactment of the federal Right to Try Act. With Alaska’s enactment of its own righttotry law in July 2018, that total is now forty-one states.[192]

The goal of these state-level righttotry laws, as discussed, is to enable terminally ill patients to bypass the FDA expanded access program and request pre-approval use directly from manufacturers, but there are variations in these laws’ provisions regarding, among other things, cost recovery,[193] insurance coverage,[194] and informed consent.[195] The extent to which those variations now matter given the enactment of the Right to Try Act of 2017 is still not fully clear, but as discussed below, at least some are likely still applicable.

B.  The FDA’s Response

In response to the righttotry advocates’ criticisms, the FDA further clarified and modified aspects of the expanded access program to address its perceived shortcomings. The FDA also stepped up efforts to increase awareness and understanding of the expanded access program.

1.  Clarifying the FDA’s Use of Clinical Outcomes

A major issue for manufacturerswhich face external pressure from investors, physicians, and patient groups to bring new drugs to marketconcerns the potential impact an adverse event during expanded access use could have on an investigational drug’s development and subsequent agency review.[196] This concern was likely overstated, particularly given that “clinical safety data from expanded access treatment” has only been considered in a “small number of cases” when determining an approved drug’s label,[197] and that such a criterion has never been used to deny approval.[198] Still, the potential for an adverse event was often cited as an obstacle for patients seeking expanded access use.[199]

The FDA attempted to address these concerns, even if arguably overstated, by clarifying its policy. The treating physician needs to report only “suspected [serious or unexpected] adverse reactions . . . if there is evidence to suggest a causal relationship between the drug and the adverse event.”[200] The agency also noted that given the nature of expanded access use (in other words, an investigational drug administered outside of a controlled clinical trial to a terminally ill patient with multiple comorbidities), it would be difficult to often establish the necessary causal relationship.[201]

This modification, however, did not address the other major concern raised by manufacturers: the lack of a readily available supply of the drug sought for expanded access.[202] The FDA cannot directly tackle this issue, but it could affect the drug supply indirectly through clinical trial policies promoting diversity and inclusion.[203] This, in turn, could help some patients, who are willing to participate in a clinical trial but are instead driven to seek expanded access due to their failure to satisfy clinical eligibility requirements given age or certain comorbidities.[204]

2.  Demystifying Manufacturers’ Eligibility Criteria

A long-standing frustration for patients and their physicians was biopharmaceutical companies’ lack of transparency regarding how they evaluated expanded access requests. Before the enactment of the 21st Century Cures Act (“Cures Act”), manufacturers were not required to disclose their evaluation processes.[205] A few biopharmaceutical companies released their criteria after either coming under pressure from patients’ social media campaigns, which requested expanded access, or observing the impact that such campaigns had on other, similar companies.[206] Generally, however, this information was not easily available to patients or physicians.[207]

The Cures Act now requires manufacturers to disclose how they evaluate and respond to individual patient requests for access to investigational drugs.[208] The following information must be included on a manufacturer’s website: (1) contact information; (2) expanded access request procedures; (3) individual patient eligibility criteria; (4) anticipated response time; and (5) a link or other reference to information about the clinical trials of the drug for which expanded access is sought, available on ClinicalTrials.gov.[209]

Three primary issues have impacted the Cures Act’s effectiveness. First, not all companies are in compliance with its provisions.[210] The Cures Act does not contain an enforcement mechanism to give the FDA the ability to penalize companies that do not publish policies. Second, the Cures Act does not require participation in expanded access—just that a company post its policies. Though most companies have guidelines similar to the ones previously detailed in Section II.B.2, a company is still allowed under the Cures Act to have a policy against providing expanded access, so long as that policy is available on the company’s website.[211] And even if a company’s criteria mirrors that of PhRMA’s criteria, they are still subject to interpretation by that company’s employees. This could make it difficult to determine whether a physician’s request on behalf of a patient will be approved. Third, the Cures Act does not ensure timely response—just that a company post an anticipated response time. In general, that time frame represents the estimated time to an acknowledgment rather than an estimated time to a decision.[212] The FDA seems posed to address this final issue but has not announced definite plans to institute a timing requirement.[213]

3.  Increasing Awareness of Expanded Access

The FDA has also attempted to dispel many of the misconceptions regarding expanded access and clarify the application process for physicians and patients, especially those outside of major academic medical centers. The Reagan-Udall Foundation for the FDA, for example, created the Expanded Access Navigator.[214] This website provides an overview of the application process from both a physician and patient perspective. The physician-specific section includes contact information for independent IRB committees should a physician’s institution not have its own IRB committee,[215] and a manufacturer directory listing companies’ expanded access criteria and their anticipated response time. 

4.  Streamlining the Individual Patient Request Process

a.  Form FDA 3926

Prior to the release of Form FDA 3926, a physician could spend up to one hundred hours in his or her attempt to secure expanded access use for a single patient.[216] Although a significant portion of that estimate likely included time spent negotiating with the manufacturer to obtain a LOA and coordinating with the IRB, physicians complained the application, comprised of Form FDA 1571 (“Investigational New Drug Application”) and Form FDA 1572 (“Statement of the Investigator”),[217] was unnecessarily complex and took upwards of eight hours to complete.[218]

In 2016 the FDA rolled out a streamlined application, Form FDA 3926, to ease the application process.[219] This change was meant not only to reduce the burden on physicians already familiar with requesting expanded access, but also, more importantly, to encourage doctors less familiar with the regulatory process who may have been previously dissuaded from submitting an expanded access request for their patients because of the forms’ complexities.[220] Form FDA 3926 only requires the physician to provide: (1) the patient’s initials; (2) the date of submission; (3) the type of submission; (4) clinical information; (5) treatment information; (6) a LOA; (7) the physician’s qualification statement; and (8) the physician’s name, address, and contact information.[221] The new two-page form takes forty-five minutes to complete—a time savings of more than 90%.[222] The total application process is now estimated to take thirty hours with this new estimate likely factoring in the FDA’s simplified IRB requirement.[223]

b.  IRB Review

In October 2017, the FDA announced another change to the single-patient expanded access process. A requesting physician can now seek approval from a specifically assigned IRB or the IRB chairperson, rather than waiting for a full IRB review (in other words, a committee meeting where “a majority of the members are present”).[224] This change was intended to reduce the time between when the patient and treating physician determine an investigational drug might be appropriate and when the treating physician’s IRB approves that request, as well as to remove another potential hurdle for physicians outside of major academic centers.[225]

This modification attempts to strike the appropriate balance between oversight and timeliness as it recognizes the continued need for independent confirmatory review, while also acknowledging that full IRB review may be unnecessary in the individual patient expanded access setting, given that it could cause undue delays and potentially deter some community-based physicians from using the expanded access pathway. Yet this change also has at least one limitation and two potential drawbacks. With respect to the limitation, it is difficult to know whether hospitals will adopt this modification as it is permissive not mandatory. At least a few major centers appear to be utilizing it, though further research is necessary to determine the full extent of its adoption.[226] To facilitate more widespread adoption, the FDA or the Reagan-Udall Foundation should work with those institutions effectively utilizing the less-stringent IRB review process to develop recommended criteria that other institutions could utilize.

With respect to potential concerns, first, the modification to the IRB requirement potentially reduces the amount of independent oversight. The average IRB is composed of fourteen members, so before the change, an average of seven members would need to be present to constitute a full IRB review.[227] This change places that decision in the hands of one chairperson or another designated member; this type of reduced oversight is typically reserved for research that poses “minimal risk” to the individual.[228] Second, the FDA did not establish specific eligibility criteria for this waiver. Instead, the FDA has said such a waiver is appropriate for individual patient expanded access INDs when the physician obtains concurrence by the IRB chairperson or another designated IRB member before treatment use begins.”[229] This standard again places that decision in the hands of one person; the same person who also decides whether expanded access treatment is appropriate. To address these concerns, the FDA should closely monitor incoming expanded access requests to determine if reducing the number of IRB reviewers increases the number of denied FDA requests based on patients not meeting the eligibility criteria. As an initial step, the FDA could refer institutions incorrectly utilizing the waiver to other hospitals that are correctly applying the waiver criteria, and if that appears to not resolve this potential problem, the FDA should consider changing its policy to require at least two or three IRB members or one designated IRB member and a consulting physician specializing in the patient’s disease or condition.[230]

* * *

There were arguably three reasons that these modifications did not quell the righttotry movement and those ultimately pushing for a federal law. First, the legislation—both at the state and federal level—was not aimed at improving pre-approval access for patients, but was instead meant “to weaken” the FDA.[231] Congress did not even wait to assess the impact of the modifications before voting on the Right to Try Act, even though it had authorized the agency to release a report assessing the impact of some of these modifications in 2017.[232] That report, published after the enactment of the Right to Try Act, suggests that all of the key stakeholders, patients, physicians, manufacturers, and payers, have a positive perception of the program and the FDA’s role in pre-approval access decisions.[233] The efforts to reduce some of the administrative burdens associated with expanded access appear to be well-received.[234] In 2017 (the first full year Form FDA 3926 was available and the year the Expanded Access Navigator was launched), there were 1,151 single-patient expanded access requests, which was a 12% increase from 2016 (1,025 requests).[235] Moreover, Congress did not thoroughly assess the effectiveness of the state righttotry laws before moving forward with the federal law.

Second, the slow implementation of the FDA’s modifications likely further validated for some the righttotry advocates’ argument that the FDA is too rigid and unresponsive. For example, the modifications to the application process were introduced more than two years after the righttotry movement started.[236]

Third, the modifications, aside from the clarification regarding use of clinical outcomes, also did not address the other weakness of the expanded access program—uneven manufacturer participation.[237] The movement’s supporters argued a federal righttotry law would improve manufacturer participation in pre-approval access.[238]

C.  The Push for a Federal Right to Try

Capitalizing on the success at the state level, proponents pushed for federal legislation,[239] even though (1) there was little evidence to suggest that existing state laws had a real impact on patients’ ability to secure pre-approval access,[240] and (2) the effects of the FDA’s modifications to the expanded access program were not fully evaluated.

The first proposed bill never made it out of committee,[241] but in 2016 Senator Ron Johnson (R-Wis.) started strategically laying the groundwork. As Chair of the U.S. Senate Committee on Homeland Security and Governmental Affairs, he convened a hearing to discuss how Congress could reform the regulatory framework to provide “more patients a chance to save their lives.”[242] He introduced a righttotry bill later that year,[243] but this bill was blocked by Senate Minority Leader Harry Reid (D-Nev.) who objected over the bill’s lack of bipartisan support and nonexistent review through a formal hearing process.[244] In January 2017, Senator Johnson reintroduced a federal righttotry billthe Trickett Wendler Right to Try Act of 2017 (“S. 204”).[245] On August 3, 2017, the Senate passed the bill with no opposition, thus moving the debate over right to try to the U.S. House of Representatives.[246]

The fate of S. 204 remained in limbo for several months after an October hearing before the House Committee on Energy and Commerce.[247] The momentum shifted in favor of the righttotry movement, however, after President Trump singled out the proposed righttotry law in his 2018 State of the Union address.[248] This mention was enough to reenergize efforts in the House. In March 2018, the House Committee on Energy and Commerce introduced H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, a narrower righttotry bill incorporating feedback from the FDA.[249] H.R. 5247 failed an initial vote on March 13, but a week later, on March 21, 2018, the bill passed by a vote of 267–149, mostly along partisan lines.[250]

H.R. 5247 never reached the Senate floor.[251] With the Senate at a standstill, the House renewed discussions over S. 204.[252] In spite of ongoing criticism from industry, patient groups, and physicians,[253] on May 22, 2018, the House passed S. 204 by a vote of 250–169, again on partisan lines.[254] On May 31, 2018, President Trump signed the Right to Try Act and declared the law a victory for patients.[255]

IV.  the Right to Try Act of 2017

A.  The Law

The Right to Try Act creates “national standards and rules by which investigational drugs may be provided to terminally ill patients.”[256] The federal law—like its predecessor state laws—is permissive and not mandatory. A manufacturer is not required and cannot be compelled to provide access to an investigational drug after receiving a righttotry request pursuant to the federal Right to Try Act.[257]

1.  Who is Eligible?

First, a patient may pursue a right-to-try request if they have a “life-threatening disease or condition.”[258] Senator Johnson chose this disease threshold, rather than the “immediately life-threatening disease” standard previously used in the expanded access program “because [he thought that the immediately life-threating disease definition] would exclude patients with Duchenne muscular dystrophy, an illness [he] explicitly intended to be covered.”[259] Second, the patient must have “exhausted approved treatment options” and be “unable to participate in a clinical trial involving the eligible investigational drug.”[260] A physician—but not necessarily the requesting physician—must certify the patient cannot participate in a clinical trial.[261] The physician who certifies that a patient is unable to participate in the clinical trial must be in “good standing” and cannot receive compensation from the manufacturer in direct response to the certification.[262] Third, the patient must provide “written informed consent”––a term that is undefined under the law, rather than using the existing federal regulation defining informed consent.[263]

2.  When Would an Investigational Drug Qualify?

To qualify for right to try, an investigational drug must satisfy four requirements. First, it must have completed a phase I clinical trial.[264] The Act does not specify whether the investigational drug must have completed a phase I clinical trial in the requested indication. The Act also does not preclude requests for investigational drugs that have only been tested in healthy volunteers. Second, the drug must not be approved for any other use.[265] Third, the manufacturer must either (1) have already filed a marketing application for the investigational drug with the FDA, or (2) be investigating the drug in a clinical trial that is “intended to form the primary basis of a claim of effectiveness in support of approval” and is the subject of an active IND.[266] This language is broad because, as Senator Johnson explains, the Act was not intended to enable the FDA to exclude any clinical trial as a basis for precluding access to treatments under right to try.”[267] Fourth, the drug must be in active development (that is, not discontinued) and not subject to a clinical hold.[268]

An investigational drug that meets these requirements is then exempt from certain statutory and regulatory requirements[269] as long as the providing company also complies with sections 312.6 (labeling of investigational new drugs), 312.7 (promoting investigational drugs), and 312.8 (charging for investigational new drugs) of the Code of Federal Regulations.[270]

3.  What are the Reporting Obligations?

a.  Companies              ’ Reporting Obligations

The Right to Try Act requires a company to file a yearly report of right-to-try use with Health and Human Services (“HHS”). This yearly report to HHS must include “the number of doses supplied, the number of patients treated, [and] the uses for which the drug was made available”; the manufacturer must also report “any known serious adverse events.”[271]

b.  FDA’s Reporting Obligations

The Right to Try Act also requires the publication of a yearly report summarizing right-to-try use on the FDA’s website. This yearly report must disclose how often the FDA determines a clinical outcome to be critical to deciding safety, how often a manufacturer asks the FDA to consider such outcomes, and how often the FDA does not consider clinical outcomes when reviewing the investigational drugs marketing application.[272]

4.  When Can the FDA Use Clinical Outcomes?

The Right to Try Act bars the FDA from considering a “clinical outcome” related to a patient’s use of an investigational drug “to delay or adversely affect the review or approval” of that drug––except in two situations.[273] The FDA is allowed to use a clinical outcome if it is (1) critical to the assessment of the investigational drug’s safety, and (2) the company that provided the investigational drug can also ask for a clinical outcome to be considered.[274] The Act does not define “critical.”

* * *

 

B.  Industry’s Potential Path Moving Forward

 This Section proceeds as follows. Section IV.B.1 explains why regardless of future FDA guidance, most companies are unlikely to adopt a two-pathway approach or even a single-pathway approach using just right to try, favoring continued use of the expanded access program instead. Section IV.B.2 argues that the status quo, however, is insufficient and that companies need to address some of the criticisms raised during the right-to-try movement by (1) revising their existing expanded access policies, and (2) improving clinical trial access.

1.  Even with the Right to Try Act, Most Companies Will Continue to Use Expanded Access

All along, right-to-try advocates have contended that the Right to Try Act’s provisions limiting liability and limiting the FDA’s use of outcome data would incentivize manufacturers to utilize this new pre-approval pathway.[275] Yet, as this Note explains below, these two provisions are not enough for most companies to utilize the Right to Try Act.[276]

Lack of Support from Key Stakeholders. The Right to Try Act lacks support from industry, advocacy groups, physician organizations, and the FDA. Companies, including Janssen and Bristol-Myers Squibb, have already stated that right-to-try requests will be funneled through the expanded access pathway.[277] Janssen announced prior to the enactment of the federal Right to Try Act that it would not “evaluate right-to-try requests because [the state] laws don’t allow for FDA input, which is ‘critical for ensuring patient safety.’”[278] Patient advocacy groups and physician organizations have not significantly changed their position on the Right to Try Act since its adoption.[279] The FDA has also since voiced its continued preference for use of the expanded access program in November 2018,[280] and announced in December 2018 a new program, “Project Facilitate,” which aims to further alleviate the criticisms of the expanded access program. Project Facilitate will establish a department within the FDA that (1) will field calls from physicians requesting expanded access on behalf of a patient and patients seeking single-patient expanded access for themselves; (2) complete Form FDA 3926, and if necessary forward the completed form to a patient’s treating physician for sign-off if the initial request was made by the patient; (3) forward the request to an IRB; and (4) ultimately submit the request to the company developing the requested drug, which must make a determination “within a specified time period . . . yet [to be] determined” by the FDA.[281] With industry generally reticent to act without agency guidance,[282] the November 2018 announcement and the forthcoming Project Facilitate arguably send strong signals to keep using the expanded access program.

Insufficient Incentives. The Right to Try Act’s provisions limiting a company’s liability and limiting the FDA’s use of outcome data are insufficient incentives. First, the Right to Try Act does limit a company’s potential liability but does not protect a manufacturer against any and all liability claims. As attorney James M. Beck notes, the Act still allows claims of reckless or willful misconduct, gross negligence, or intentional tort.[283] The Right to Try Act also does not foreclose claims under state or federal product liability, tort, consumer protection, or warranty law.[284] A company would also be trading more liability protection for less FDA input when it is not clear further liability protection is even necessary. As others have pointed out, there are no examples of patients suing manufacturers of investigational drugs for “treatment-related harm[s]” stemming from expanded-access use.[285] Therefore, companies––at least within the context of expanded access––should have minimal concern over potential tort claims.

Second, although the Right to Try Act limits the FDA’s use of outcome data to when it is “critical” to determining safety, in practice the FDA rarely uses expanded access data when reviewing an investigational drug unless there is evidence to suggest a causal relationship.[286] Even though the FDA’s use of outcomes is often a concern for manufacturers, the FDA has assured companies it rarely uses expanded access data, so it is unclear how the Right to Try Act’s provision further limits the FDA’s use. Furthermore, as the Act does not define “critical,” without some guidance from the FDA it is unclear whether this is the same standard as used in expanded access, a more relaxed standard, or a heightened standard given that the FDA is not involved in reviewing the righttotry request and determining proper usage, such as dosage. Finally, even if the FDA is limited in its ability to assess reported events, manufacturers may still be concerned about whether any adverse events associated with righttotry use would impact regulatory approval in other countries.[287]

Third, the Right to Try Act does not contain a significant financial incentive for industry. The Act requires companies to comply with the existing regulation, which limits cost recovery to direct costs, except under specific circumstances.[288] A two-pathway approach would require companies to allocate additional money, personnel, and drug supply to another program that is outside the drug development process. With the cost of developing a new drug estimated to be around $2.6 billion,[289] it seems unlikely that manufacturers would be willing to expend any additional resources to only recoup direct costs.[290] A publicly traded company, like Pfizer or Janssen, might have the necessary financial resources and employees but will still answer to shareholders and still have concerns about maintaining adequate supply of the drug for its clinical trials.[291] A small, private company under pressure from investors is likely to have even less motivation to redirect limited resources to a two-pathway pre-approval program, or even a single-pathway program without some financial upside.[292] Take, for example, BrainStorm Therapeutics, which announced plans to offer its therapy through right to try and would have charged patients seeking the right to try its drug potentially $300,000. The company’s nowretracted plan likely did not comply with federal regulation given that it was positioned as a “semicommercial enterprise with modest profits.”[293]

Unanswered Implementation Questions. The Right to Try Act is meant to be a parallel pathway to expanded access and not a replacement, but it would be difficult for a company to implement a pre-approval access program in which both of these programs co-exist. The Right to Try Act does not provide companies considering utilizing right to try as a parallel pathway guidance to the threshold issue: when it should use right to try and when it should use expanded access. The FDA is working to develop guidance,[294] but for now it has said that companies are in the best position to make that determination.[295] While this Note identifies two potential options, each is not without their own drawbacks and complexities. A company could (1) use right to try when an investigational drug will be used by a single patient and use expanded access when an investigational drug will be used by a larger patient population, or (2) use right to try under certain pre-defined circumstances (for example, pediatric patients or patients with exceptional safety risks) and use expanded access in all other circumstances.

 The first option—use of right to try in the single-patient setting—would be administratively easier. A company would not need to develop new policies delineating between the two pathways for individual patients. That said, this approach does have potential challenges. First, individuals with certain types of serious diseases would not qualify for the righttotry pathway, therefore limiting their pre-approval access options until the drug has sufficient evidence to support expanded access for intermediate-size or widespread treatment.[296] Take, for example, the conditions narcolepsy or rheumatoid arthritis, which the FDA has said would independently qualify as a serious disease; these conditions would not be considered lifethreatening because both are considered chronic diseases and are alone not fatal.[297] Therefore, adoption of this approach would likely be dependent on a company’s investigational drug pipeline. A company with a single drug in development might be less concerned about this issue, but a company with a large disease pipeline that targets multiple different disease areas might be.

Second, it is not clear what the patient limit should be for right to try (that is, at what point should a company stop providing pre-approval access through right to try and transition over to expanded access for intermediatesize and widespread treatment). The Right to Try Act does not provide any guidance. A company should not be able to provide five, ten, or fifteen patients at a single hospital with an investigational drug through the right to try pathway. That starts looking more like an intermediate-size expanded access protocol[298] and arguably should have FDA oversight. Without specific right-to-try guidance, a manufacturer would need to rely on expanded access guidance as a benchmark for when a company should transition from the righttotry pathway to intermediate-size or widespread use through expanded access, but even then the existing FDA guidance does not address other concerns regarding the potential applicability of the Right to Try Act’s provisions limiting liability and use of outcome data once a certain patient threshold is crossed.

The second option—use of right to try under certain pre-defined settings—would be administratively more complicated, given that it would require companies to determine those pre-defined circumstances and ensure that the criteria for those standards is clear and easy to apply. That said, some companies might consider this approach in order to allow some patients who might otherwise not be eligible for expanded access to receive the drug through right to try, given the Act’s provisions limiting liability and use of outcome data. Two such settings that a company might reasonably consider are (1) patients who have exceptional safety risks[299] and (2) patients who are children.[300] The former group is frequently ineligible for a clinical trial and likely to be denied expanded access use because of manufacturers’ concerns about potential liability or adverse events impacting clinical development.[301] The latter group—often the face of the righttotry movement[302]is also frequently ineligible for industry-sponsored clinical trials and may be denied expanded access use because of manufacturers’ concerns about inadequate clinical data to determine an adequate dosage in the pediatric setting, potential liability, or adverse events impacting clinical development.[303]

This second approach is also not without its drawbacks. First, the pre-defined settings would need to be unambiguous. Though pediatric patients can be more clearly defined by age, the term “exceptional safety risks” is not susceptible to one definition, so companies allowing pre-approval access in this setting would need to establish a specific standard and make sure it is clearly communicated internally and externally. Second, with pediatric patients[304] and patients who are terminally ill,[305] there are also ethical considerations requiring companies to adopt more rigorous informed consent requirements and procedures. Take pediatric patients, for example, cases in which “[p]arents or other surrogates technically provide ‘informed permission’ for diagnosis and treatment, with the assent of the child whenever appropriate.”[306] Third, companies would also still need to refer back to the state righttotry laws to ensure their pre-defined settings are compliant. Oregon, for example, limits the right to try pathway to individuals who are at least eighteen years old.[307] This could increase the complexities of implementation. Fourth, the drawbacks relating to the first option likely would also impact the second option.

The practical complexities of operating a two-pathway approach, stemming from presently unanswered legal questions regarding the Right to Try Act and concerns that might arise from utilizing Right to Try in specific patient settings, make companies unlikely to use right to try even if the FDA provides guidance.

State Right-to-Try Laws. The applicability of state righttotry laws is also still uncertain.[308] While the Right to Try Act creates a national standard,[309] it does not explicitly preempt these state laws.[310] Senator Ron Johnson has previously stated that the Right to Try Act was meant to be the “federal counterpart” to the state righttotry laws.[311] With forty-one statelevel righttotry laws, implementation and compliance would be complicated. A company would likely need to comply with at least some of the provisions of the state righttotry laws in addition to the Right to Try Act’s provisions.

Take, for example, the California state statute’s criteria for patient eligibility, which requires a person to have: (1) “an immediately life-threatening disease or condition”; (2) “considered all other treatment options currently approved”; (3) “not been accepted to participate in the nearest clinical trial to his or her home . . . within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial”; (4) “received a recommendation from his or her primary physician and a consulting physician”; (5) “given written informed consent”; (6) documentation . . . attesting that the patient has met the requirements . . . .[312]

The first requirement limiting patient eligibility is narrower than the Right to Try Act.[313] The second requirement is arguably broader, because it would allow a patient to rely on the pathway after considering, but not exhausting, all treatment options. The first part of the third requirement could possibly supplement the Right to Try Act’s clinical trial requirement if it was interpreted as requiring proof of non-acceptance, but it is likely more accurately interpreted as allowing a patient to make a request within one week of not receiving a response, which is broader than the Right to Try Act. The second part of that requirement is clearly broader, however, than the federal law, as the Right to Try Act requires a physician to certify that a patient cannot participate in a clinical trial, and not just that it would be unreasonable for a patient to participate in a clinical trial; the California law uses a different standard. The fourth requirement supplements the Right to Try Act because it requires confirmation from a second physician.[314] The fifth requirement also supplements the federal law because, whereas the federal law leaves “informed consent” undefined, California defines “informed consent” in another part of the statute.[315] The sixth requirement mirrors the federal law.[316]

Although a company could theoretically challenge state right to try laws as preempted by the federal provision, this is not an issue that an individual company, or companies collectively, are likely to challenge, particularly given the high costs of litigation and limited financial incentive of success on the merits.[317] This issue could also impact patient’s actual interest[318] and healthcare providers’ willingness to offer such treatments.[319]

External Regulatory Challenges. The adoption of the Right to Try Act by industry seems less likely given that companies already face “challenges particularly related to . . . managing divergent requirements and guidance from ex-US health authorities” when implementing expanded access.[320] The potential effect of righttotry use on product development or regulatory review in other countries is unclear. And, if companies are already overly tasked from other countries’ requirements, they are not going to add another pathway to that mix.

Confidential Information. A final reason the Right to Try Act will not gain industry support is that, as practitioners James Valentine and David Clissold explain, some of the Right to Try Act’s drug eligibility requirements may require companies to “disclose details of their development program that might otherwise be confidential, commercial information.”[321] This potential disclosure requirement is not an issue with expanded access because the FDA has access to this proprietary information  through the drug’s IND file and can utilize it when evaluating an expanded access request and making recommendations regarding use and dosage.[322] With the FDA’s ability to review proprietary drug information, the expanded access program offers two benefits over the righttotry pathway—(1) it limits a company’s potential need to disclose confidential commercial development information and (2) it ensures patients who may not be undergoing treatment from a physician also acting as a clinical trial investigator can still request access to an investigational drug.[323]

These reasons make adoption of a two-pathway approach or abandonment of expanded access in favor of right to try unlikely. However, maintaining the status quo is not feasible––nor is it appropriate. Companies have already started receiving calls from patients seeking the right to try with some of those calls even escalating to threats when people are referred back to the expanded access program.[324] This could further escalate to widespread social media campaigns and media coverage if companies do not explicitly address right to try within their existing pre-approval access policies. With the public’s negative perception of the pharmaceutical industry,[325] companies need to address at least some of the criticisms raised during the righttotry debate that were not rectified through adoption of the Right to Try Act.

2.  Charting Industry’s Path Forward

a.  Companies Should Revise Existing Expanded Access Guidelines

RighttoTry Position Statement. Companies should update both their expanded access guidelines to include language that clearly addresses the Right to Try Act and their plans to only offer pre-approval access through expanded access. Some companies have already done this. Take, for example, the statement Bristol-Myers Squibb features prominently on the section of its website addressing pre-approval access:

We believe our current approach to early patient access . . . is consistent with the objectives of the Right to Try Act. Requests for early patient access to Bristol-Myers Squibb investigational medicines should continue to be made through the treating physician and by visiting Bristol-Myers Squibb Early Patient Access Requests Portal.[326]

To avoid potential criticisms from righttotry advocates and patients, companies need to take additional steps outlined below.

Company Pre-Approval Access Reporting. Companies should publish annual reports on their websites regarding their expanded access programs. Although companies are granting expanded access requests,[327] this information is often not publicly available. The reports should include detailed information, such as the number of requests received (and of those the number of requests approved), the most common reasons for a denial (for example, ability to enroll in a clinical trial or insufficient clinical data to support the requested use), and the number of patients referred to clinical trials (and of those, the number that chose to enroll).[328] If companies are unwilling to publish this data on their own websites, then an alternative approach would be for BIO and PhRMA to commission a report summarizing this data. If the report is published by BIO and PhRMA, companies might be more comfortable providing additional data, such as the number of requests received by investigational drug (or class of drug) and the number of requests received by disease (or category of disease). Either approach—self-reporting or industry-wide reporting—could increase transparency regarding the gap between the number of requests received by companies and the number of requests received by the FDA.

Patient Eligibility—Clinical Trial Ineligibility. Companies need to better explain what factors render a patient unable to participate in clinical trials beyond just not qualifying. The only factor sometimes listed is geographic limitations, and companies sometimes list this as only an example of a factor that will generally not support expanded access use. This creates two distinct problems. First, without additional information, physicians and patients are left guessing what other factors render a patient unable to participate in a clinical trial. This could discourage a physician from submitting an otherwise valid request. Second, the FDA will consider geographic limitations when reviewing a request even when the company does not, making the agency’s guidance at odds with some companies’ policies. This is confusing. For those companies generally unwilling to consider geographic limitations as a factor impacting a patient’s ability to participate, companies could add additional criteria such as transportation and financial limitations. The FDA has identified both as common obstacles to clinical trial enrollment.[329]

Patient Eligibility—Pediatrics.[330] Companies often either do not address pediatric expanded access use[331] or will not consider pediatric expanded access use without sufficient pediatric data.[332] The former approach is short-sighted from a public relations perspective, especially with the enactment of the Right to Try Act and its focus on pediatric access. In 2014, Bristol-Myers Squibb cited lack of pediatric data when asked about a specific patient’s denial by CNBC, but even four years after that media firestorm, the company still does not address pediatric expanded access use in its published guidelines.[333] A physician might recommend expanded access for a child only to learn after submitting a request that the company will not provide pre-approval access without sufficient pediatric data. Thus, companies should strive to increase transparency. The latter approach also needs to be reconsidered. With so many pediatric patients currently being treated using FDA-approved drugs that only underwent clinical testing in adults,[334] the justification that pediatric data is needed can be difficult to reconcile, especially given how few industry-sponsored pediatric trials there are.[335] There is also evidence, at least with oncology drugs, that “[d]rug exposure in adolescents (age 12 to 18 years) and adults is similar, supporting the enrollment of adolescents in adult trials that involve the same disease and/or therapeutic target.”[336] Therefore, companies with explicit pediatric expanded access criteria should reconsider whether it would be appropriate to loosen or eliminate this requirement for adolescents.

Qualifying Drugs. A manufacturer’s determination of when an investigational drug has sufficient data can sometimes differ from that of the treating physician and patient.[337] Companies should consider publishing a list of drugs (updated on a regular basis) for which they will consider expanded access requests. This is a practice already adopted by some companies.[338]

External Review Committee. Companies should consider adopting Janssen’s approach of utilizing an outside review board in collaboration with its internal decisionmakers.[339] Janssen piloted the New York University program, Compassionate Use Advisory Committee (“CompAC”), in 2015 with one investigational drug.[340] Janssen has since rolled out the program to other disease areas.[341] The CompAC approach is as follows: (1) the treating physician submits expanded access request to Janssen; (2) company physicians and medical personnel review requests to determine whether any are medically inappropriate or eligible for clinical trials and expanded-access programs; (3) CompAC reviews the other requests providing an “independent recommendation” to Janssen; (4) the treating physician can appeal a CompAC decision.[342] An independent review committee could reduce public misconceptions that companies’ default response to an expanded access request is “no,” especially given media’s widespread coverage of those denials. Likewise, the committee may be helpful when evaluating cases involving pediatric patients or patients with exceptional safety risks. The built-in appeal process could reduce the public appeals initiated through social media. Furthermore, just as there are independent IRBs available for physicians whose institutions do not have internal committees,[343] smaller companies with limited financial and personnel resources to devote to expanded access requests could consider partnering with other companies to develop an independent, external review committee to aid in assessing expanded access requests.

Cost-Recovery Policy. Companies need to adopt more transparent cost recovery guidelines even if their policies mandate not charging patients because of concerns that doing so could impact a “higher sale price” [344] in the future or because insurance will not reimburse even direct costs.[345] A few companies do post cost-recovery policies,[346] but of the companies surveyed in this Note, none had this information available. The rising cost of healthcare in the United States is on the public’s mind; it was the top issue in the 2018 mid-term elections.[347] Furthermore, HHS recently announced “a proposed rule to require pharma to include list prices in direct-to-consumer ads” for approved drugs.[348] This increasing scrutiny makes it even more important for companies to publish clear cost-recovery policies for their expanded access programs.

Expanded Access Navigator. Companies should submit a Navigator Directory listing when they initiate a phase II or phase III study for an investigational drug. Companies’ websites should also refer physicians and patients to the Expanded Access Navigator. Neither of these recommendations are currently required by the Cures Act.

b.  Companies Need to Improve Access to Clinical Trials

 Companies will often cite concern about maintaining adequate supply of an investigational drug for their clinical trials as a factor in their expanded access criteria. This is arguably a genuine concern given that a manufacturer will develop only enough supply for its clinical trials, but not more until it receives FDA approval.[349] At the same time, however, companies often struggle to fully enroll their clinical trials.[350] Trials often have strict inclusion and exclusion criteria, which can affect some patient populations more so than others.[351] Furthermore, clinical trials are often conducted in regions with large academic institutions and major medical centers,[352] which can limit certain patients’ ability to participate and negatively affect some patient populations disproportionately from others.[353]

 Inclusion and Exclusion Criteria. As discussed in Section II.B, companies generally prefer standardized study groups, but companies should reconsider eligibility criteria because “[b]roadening the eligibility criteria for clinical trials [would] provide the opportunity for more people to participate in research studies,” and “it [would] make the trial results more reflective of the people that will ultimately use the drug.”[354] While specific to oncology, the American Society of Clinical Oncology (“ASCO”) and Friends of Cancer Research, identified five common exclusion factors (brain metastases, age, HIV infection, organ dysfunction, and prior or concurrent cancer diagnoses) and proposed recommended clinical trial protocols that would facilitate inclusion of patients with these factors in clinical trials.[355] Their recommendations address both early-phase trial design (for example, proposing study groups limited to “specific patient population” to “inform the decision as to whether and how to include (or not) the patient population in later phase trials”) and later-phase trials (for example, “expand[ing] eligibility criteria to include a specific patient population,” but “restricting primary analysis to defined patient population”).[356] A JAMA Oncology study, published in January 2019, estimates that at least “6,317 additional patients would be allowed to join trials each year” if these recommendations were adopted.[357] Companies should work with the FDA, ASCO, and Friends of Cancer Research to determine how to incorporate these recommendations into their existing clinical trials, not only to ease patient access to the clinical trial process, but also to ensure clinical trial data reflects real-world patients.

 Diversity in Clinical Trials. Some companies have initiatives aimed at improving diversity in participation,[358] but others are more resistive.[359] With most clinical trial participants white, more companies need to adopt measures addressing diversity in clinical trials that go beyond just patient education. In 2015, the FDA approved a drug for the treatment of multiple myeloma, a blood cancer that disproportionately affects blacks, “yet of the 722 participants [enrolled in its phase III study] only 13—or 1.8 percent—were black.”[360] Efforts to improve potential pre-approval access through the clinical trial process need to address this underrepresentation of minorities. Companies, rather than resisting those efforts, should work with the FDA, patient groups, and professional organizations to develop legislation that would incentivize widespread participation. For example, companies could propose legislation, modeled off of state laws encouraging diversity and inclusion in certain industries,[361] that would give tax credits and clinical trial grants to companies[362]utilizing the FDA’s various expedited approval pathwaysthat submit diversity proposals detailing how they plan to ensure clinical trial enrollment is representative of a disease’s U.S. incidence rates by race, age, and gender even if specific risk factors don’t require it and then meet certain minimum thresholds based on those incidence rates.[363]

CONCLUSION

The Right to Try Act passed with great fanfare and proclamations of hope by President Trump and others. Yet industry—as a whole—is unlikely to adopt this parallel pathway.[364] This will likely further increase frustration and confusion amongst the public regarding pre-approval access,[365] especially since the Right to Try Act was marketed as a “right to try” when in reality it is simply a “right to ask”—a right the public has had all along through the expanded access program.[366] With this added risk, companies should and need to move beyond the status quo, adopting measures aimed at increasing transparency and awareness of their expanded access programs and pursuing initiatives aimed at improving access to clinical trials.

This proposal is not without its limitations. First, it relies on companies choosing to adopt these changes. Companies already do not fully comply the Cures Act expanded access requirements. These proposed changes may be more broadly implemented if BIO and PhRMA revise their existing expanded access guidelines to incorporate some of these proposals as many companies now model their guidelines off of the either BIO or PhRMA’s guidelines. Another option is for Congress to amend the Cures Act to not only to give the FDA power to assess civil monetary penalties when a company fails to comply with the Cures Act expanded access requirements, but also to further require companies to submit an annual summary of their expanded access programs to the FDA, thereby extending the Right to Try Act’s reporting requirement to the expanded access program. These amendments will not, however, have any weight unless the FDA has enforcement capability.[367] Any civil money penalties collected for non-compliance could be used to support “Project Facilitate” and other expanded access awareness initiatives such as the Expanded Access Navigator, FDA-sponsored webinars, or targeted educational programming in regions underutilizing expanded access.

Second, changes aimed at increasing manufacturer transparency and clarifying companies’ existing policies admittedly do not directly improve manufacturer participation. That said, increased manufacturer transparency may reveal greater manufacturer participation than one would anticipate based on the media’s coverage of companies denying expanded access requests. Furthermore, clarification of companies’ existing policies may ease physicians’ and patients’ overall frustration with the expanded access program and encourage more widespread utilization of the program.

Third, the second part of this proposal relies on companies to adopt clinical trial measures that improve overall access through diversity and inclusion initiatives and less-restrictive eligibility criteria or to advocate for legislation that would help facilitate these efforts. With some companies potentially resistive due to ongoing concerns that increased diversity or less-restrictive eligibility criteria could delay drug development or cost millions of dollars, it may be difficult to secure wide-scale adoption without Congressional action aimed at not only improving patient access to investigational drugs through the clinical trial process, but also ensuring that clinical trials produce the data necessary to allow the FDA “to separate the relative handful of discoveries which prove to be true advances in therapy from a legion of false leads and unverifiable clinical impressions,”[368] and also to “maximize generalizability of results” to patients in the real world.[369]

 

 

Appendix

 


[*] *. Executive Senior Editor, Southern California Law Review, Volume 92; J.D. Candidate 2019, University of Southern California Gould School of Law; B.S., Journalism and Political Science 2011, Northwestern University, Medill School of Journalism. I would like to thank Professor Michael H. Shapiro for encouraging me to pursue this topic, which first sparked my interest in 2013. His feedback and insights on early drafts was invaluable. Special appreciation and thanks to my parents, Jon and Anna, for their love and support even after reviewing multiple drafts; to my friends and classmates, and in particular Aly, for allowing me to talk through my ideas on numerous occasions; and to my niece and nephew for their superb editing skills! I would also like to thank the Volume 92 editors of the Southern California Law Review for their careful editing and invaluable feedback, especially Nick Thomas, Jay Simmons, and Chris Phillips. Lastly, I would like to report working for Weber Shandwick where I represented biopharmaceutical and medical device clients (2011–2014) and working for Adaptive Biotechnologies (2014–2016).

 [1]. BioMarin Pharmaceutical: Give Andrea Sloan (@andi_sloan) Access to the Cancer Drug That Could Save Her Life, Change.org, [hereinafter Change.org] https://www.change.org
/p/biomarin-pharmaceutical-give-andrea-sloan-andi-sloan-access-to-the-cancer-drug-that-could-save-her-life (last visited Feb. 6, 2019).

 [2]. William Hudson, In Cancer Drug Battle, Both Sides Appeal to Ethics, CNN (Sept. 28, 2013, 5:38 PM), http://www.cnn.com/2013/09/28/health/compassionate-drug-use. Expanded access is sometimes also referred to as either “compassionate use” or “pre-approval access.”

 [3]. Id. At the time of Sloan’s request, BioMarin had only completed a phase I trial in thirty-nine patients. Johann Sebastian De Bono et al., First-in-Human Trial of Novel Oral PARP Inhibitor BMN 673 in Patients with Solid Tumors, Am. Soc’y Clinical Oncology (June 3, 2013), https://meetinglibrary.asco.org/record/83852/abstract.

 [4]. Change.org, supra note 1; Andrea Ball, Austin Woman Dies After Battle for Access to Experimental Cancer Drug, Austin Am.-Statesman (Jan. 3, 2014), https://www.statesman.com
/NEWS/20140103/Austin-woman-dies-after-battle-for-access-to-experimental-cancer-drug (noting her “Facebook page—Andi’s Army—ha[d] more than 15,000 followers”).

 [5]. Meg Tirrell, When Unapproved Drugs Are the Only Hope, CNBC (Aug. 5, 2014), https://www.cnbc.com/2014/08/05/a-case-for-compassionate-use-when-unapproved-drugs-are-the-only-hope.html.

 [6]. See, e.g., Elizabeth Cohen, Company Denies Drug to Dying Child, CNN (Mar. 11, 2014, 2:57 PM), http://www.cnn.com/2014/03/10/health/cohen-josh; accord Tirrell, supra note 5; Amanda Woerner, Dying 25-Year-Old Fights for Compassionate Use Access to Cancer Treatment, Fox News (Mar. 26, 2014), http://www.foxnews.com/health/2014/03/26/dying-25-year-old-fights-for-compassionate-use-access-to-cancer-treatment. With the enactment of the federal Right to Try Act, some patients and their families are once again turning to social media to request access to investigational drugs through right to try. See Sumathi Reddy, The ‘Right to Try’ Law Says Yes, the Drug Company Says No, Wall St. J. (June 6, 2018, 5:56 PM), https://www.wsj.com/articles/family-battling-a-rare-disease-sees-roadblocks-despite-right-to-try-law-1528293923 (discussing how—after a company declined to provide an investigational drug because an expanded access program was not yet available—given the limited clinical data in only a small number of patients, the parents of a toddler—both of whom were doctors—launched a Change.org petition in June 2018 that collected more than 100,000 signatures in just two weeks).

 [7]. Erin Mershon, ‘Right-to-Try’ Law Intended to Weaken the FDA, Measure’s Sponsor Says in Blunt Remarks, Stat News (May 31, 2018), https://www.statnews.com/2018/05/31/right-to-try-ron-johnson.

 [8]. Tex. Health & Safety Code Ann. § 489 (West 2015); Eric Janez, Andrea Sloan Bill Signed into Law, KXAN (June 12, 2015), http://kxan.com/2015/06/12/andrea-sloan-bill-signed-into-law.

 [9]. Kenneth Artz, U.S. House Approves Federal Right to Try Bill, Heartland Inst. (Apr. 25, 2018), https://www.heartland.org/news-opinion/news/u-s-house-approves-federal-right-to-try-bill (quoting Rep. Andy Biggs (R-Ariz.)); see also Christina Sandefur, Safeguarding the Right to Try, 49 Ariz. St. L.J. 513, 521 (2017) (arguing right-to-try laws are a “major change” from expanded access). See generally Christina Corieri, Goldwater Inst., Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of Their Treatment (2014), https://goldwaterinstitute.org/wp-content/uploads/cms_page_media/2015/1/29/Right%20To%20Try.pdf (proposing the right-to-try legislation).

 [10]. Ron Leuty, The Right to Try: Terminally Ill Patients Say Trying Experimental Drugs Offers Hope. But Is It Just False Hope?, S.F. Bus. Times (June 8, 2017, 5:15 PM), https://www.bizjournals.com/sanfrancisco/news/2017/06/08/biotech-2017-right-to-try-laws-biomarin-fda-ca.html. See generally Rebecca Dresser, The “Right to Try” Investigational Drugs: Science and Stories in the Access Debate, 93 Tex. L. Rev. 1631 (2015) (examining the right to try movement and the role of patient stories in the debate); Lisa Kearns & Alison Bateman-House, Who Stands to Benefit? Right to Try Law Provisions and Implications, 51 Therapeutic Innovation & Reg. Sci. 170 (2017) (arguing the laws are not pro-patient); Rebecca Dresser, “Right to Try” Laws: The Gap Between Experts and Advocates, 45 Hastings Ctr. Report, May-June 2015, at 9–10 [hereinafter Dresser, The Gap] (proposing ways to shift public debate regarding right to try in favor of existing programs).

 [11]. Press Release, Goldwater Inst., Alaska Becomes 41st State to Enact Right to Try Legislation (July 13, 2018), http://righttotry.org/alaska-becomes-41st-state-to-enact-right-to-try-legislation (Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, and Wyoming).

 [12]. Donald J. Trump, President of the United States, State of the Union Address (Jan. 30, 2018), https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-state-union-address. Vice President Mike Pence, who signed into law the Indiana Right to Try Act, is also a public proponent of right-to-try legislation. E.g., Vice President Mike Pence (@vp), Twitter (Aug. 3, 2017, 12:21 PM), https://twitter.com/vp/status/893190193829875713 (“Right to Try is about giving terminally ill patients hope & a chance. Proud of @POTUS’ & @SenRonJohnson’s work to help pass it in Senate.”); Vice President Mike Pence (@vp), Twitter (Mar. 13, 2018, 2:12 PM) [hereinafter Vice President Mike Pence, March 13 Tweet], https://twitter.com/vp/status/973668021028950017 (“Always great to see Jordan McLinn & his mother Laura McLinn, 2 great Hoosiers who have been fierce advocates for the Right to Try legislation the House will consider today. This bipartisan bill is about restoring hope to patients w/ terminal illnesses & it’s the right thing to do.”).

 [13]. Press Release, White House, President Donald J. Trump to Sign Right to Try Legislation Fulfilling the Promise He Made to Expand Healthcare Options for Terminal Americans (May 30, 2018) [hereinafter White House Press Release], https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-sign-right-try-legislation-fulfilling-promise-made-expand-healthcare-options-terminal-americans.

 [14]. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,160, 75,160 (Dec. 14, 2006) (to be codified at 21 C.F.R. pt. 312).

 [15]. Ctr. for Drug Evaluation & Research, U.S. Food & Drug Admin., The History of Drug Regulation in the United States 2, 7 (2006), https://www.fda.gov/downloads/AboutFDA
/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/UCM114468.pdf; Michelle Meadows, Promoting Safe and Effective Drugs for 100 Years, U.S. Food & Drug Admin. Jan.–Feb. 2006, https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/FOrgsHistory/CDER
/UCM586463.pdf. The marketing application had to include information regarding “all clinical investigations . . . the drug’s components and composition, methods of manufacture including facilities and controls, and copies of both the packaging and labeling of the new drug.” Suzanne White Junod, U.S. Food & Drug Admin., FDA and Clinical Drug Trials: A Short History 6 (2008), https://www.fda.gov/downloads/AboutFDA/History/ProductRegulation/UCM593494.pdf.

 [16]. A new drug application “is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials . . . become part of the NDA.” New Drug Application (NDA), U.S. Food & Drug Admin., https://www.fda.gov/drugs/developmentapprovalprocess
/howdrugsaredevelopedandapproved/approvalapplications/newdrugapplicationnda/default.htm (last updated Mar. 29, 2016).

 [17]. Federal Food, Drug and Cosmetic Act, Pub. L. No. 75-717, § 505(c), 52 Stat. 1040, 1052 (1938).

 [18]. Junod, supra note 15, at 6–7. The randomized, controlled trial is now considered to be the “gold standard” of clinical research. See generally Laura Bothwell et al., Assessing the Gold Standard—Lessons from the History of RCTs, 374 New Eng. J. Med. 2175 (2016) (describing how randomized, controlled trials rose to prominence and transformed medical research).

 [19]. The drug’s sales equaled those of aspirin. Bara Fintel et al., The Thalidomide Tragedy: Lessons for Drug Safety and Regulation, Helix (July 28, 2009), https://helix.northwestern.edu/article
/thalidomide-tragedy-lessons-drug-safety-and-regulation.

 [20]. Id.

 [21]. Id.

 [22]. Tom Brody, Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines 783 (2nd ed. 2016). More than 8,000 babies were born missing limbs, blind, or intellectually disabled as a result of the drug. Id.

 [23]. Fintel et al., supra note 19.

 [24]. Kefauver-Harris Amendment, Pub. L. No. 87-781, 76 Stat. 780 (1962).

 [25]. Id. § 104(c), 76 Stat. at 784.

 [26]. Jeremy A. Green & Scott H. Podolsky, Reform, Regulation, and Pharmaceuticals—The Kefauver-Harris Amendments at 50, 367 New Eng. J. Med. 1481, 1481 (2012). See also infra Section II.A for further discussion of the clinical trial process.

 [27]. Kefauver-Harris Amendment §§ 102(d), 103(b), 76 Stat. at 780–81, 783. To meet this requirement, a manufacturer needs to conduct “adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience.” Id. at § 102(d), 76 Stat. at 780–81.

 [28]. A sponsor can be an individual physician or researcher, company, or institution that is responsible for the initiation, management, and possibly funding of the clinical trial. Int’l Council for Harmonisation of Tech. Requirements for Pharm. for Human Use (ICH), Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance 7 (2016) [hereinafter E6 Good Clinical Practice].

 [29]. 21 C.F.R. § 312.20 (2018) (listing IND requirements). The FDA defines “[a]n Investigational New Drug Application [(‘IND’) as] a request for authorization . . . to administer an investigational drug or biological product to humans.” Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER), U.S. Food & Drug Admin., https://www.fda.gov/biologicsbloodvaccines
/developmentapprovalprocess/investigationalnewdrugindordeviceexemptionideprocess/default.htm (last updated Jan. 19, 2018). A company must secure an IND prior to shipping a drug interstate or administering any investigational drug not the subject of an approved marketing application. Id.

 [30]. 21 § 312.23(a)(3)(iv). A clinical trial protocol describes “the objective(s), design, methodology, statistical considerations, and organization of a trial . . . [and] usually gives the background and rationale for the trial.” E6 Good Clinical Practice, supra note 28, at 6.

 [31]. 21 C.F.R. § 312.23(a)(3)(iv).

 [32]. Id. § 312.22(a). The number of clinical trials necessary during each phase of clinical development can vary depending on the disease and availability of current treatments. It is estimated about seventy trials are needed during clinical development. Rick Ng, Drugs: From Discovery to Approval 140 (2005).

 [33]. Biotech. Innovation Org., Clinical Development Success Rates 2006–2015, at 13 (2016) [hereinafter Clinical Development Success Rates 2006–2015], https://www.bio.org/sites/d
efault/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,
%20Biomedtracker,%20Amplion%202016.pdf; see also 21 C.F.R. § 312.21 (describing the three phases of clinical development); Brody, supra note 22, at 321 (noting phase I trials for cancer therapies are designed to identify the “minimal dose that can cause significant toxicity” given the assumption that “the most appropriate dose” is just below the “dose that produces unacceptable toxicity”).

 [34]. 21 C.F.R. § 312.21(a).

 [35]. U.S. Food & Drug Admin., 22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results 2 (2017) [hereinafter 22 Case Studies], https://www.fda.gov/downloads
/AboutFDA/ReportsManualsForms/Reports/UCM535780.pdf; Pharma. Research & Mfrs. of Am., Biopharmaceutical Research & Development: The Process Behind New Medicines 13 (2015) [hereinafter Biopharmaceutical Research & Development], http://phrma-docs.phrma.org/sites
/default/files/pdf/rd_brochure_022307.pdf.

 [36]. Clinical Development Success Rates 2006–2015, supra note 33, at 10.

 [37]. Biopharmaceutical Research & Development, supra note 35, at 13.

 [38]. Id.

 [39]. See id.

 [40]. 21 C.F.R. § 312.21(b) (2018).

 [41]. Clinical Development Success Rates 2006–2015, supra note 33, at 7.

 [42]. A company will sometimes conduct phase IV studies post-approval. Biopharmaceutical Research & Development, supra note 35, at 16.

 [43]. Id. at 13.

  [44]. 21 C.F.R.  § 314.50 (describing the requirements for submitting a new drug marketing application); id. § 601.2 (describing the requirements for submitting a biologics license application). The new drug application must “tell the drug’s whole story” so that the FDA can decide

[1] [w]hether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks[;] [2] [w]hether the drug’s proposed labeling (package insert) is appropriate, and what it should contain[;] [3] [w]hether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.

New Drug Application (NDA), supra note 16.

 [45]. Biopharmaceutical Research & Development, supra note 35, at 13.

 [46]. See Benjamin Carlisle et al., Unsuccessful Trial Accrual and Human Subjects Protections: An Empirical Analysis of Recently Closed Trials, 12 Clinical Trials 77, 81 (2015) (“19% of trials registered as newly closed in 2011 either terminated due to failed accrual or completed with less than 85% of their expected [enrollment.]”); Aylin Sertkaya et al., Key Cost Drivers of Pharmaceutical Clinical Trials in the United States, 13 Clinical Trials 117, 117 (2016) (finding the three main causes of high clinical trial expenses were clinical procedures, administrative staff, and site monitoring); Gina Kolata, A Cancer Conundrum: Too Many Drug Trials, Too Few Patients, N.Y. Times (Aug. 12, 2017), https://nyti.ms/2vsMRXf. There are even companies that manufacturers hire to increase volunteer enrollment. See, e.g., Putting Our Focus to Work, Praxis, https://www.gopraxis.com/experience (last visited Feb. 8, 2019) (providing various case studies of successful clinical trial enrollment campaigns).

 [47]. ASCO and Friends of Cancer Research Release Comprehensive Recommendations to Broaden Eligibility Criteria for Cancer Clinical Trials, Am. Soc’y of Clinical Oncology (Oct. 2, 2017) [hereinafter ASCO and Friends], https://www.asco.org/advocacy-policy/asco-in-action/asco-and-friends-cancer-research-release-comprehensive (noting factors, including age, comorbidities––such as heart disease, liver dysfunction, or kidney disease––advanced stage of disease, prior history of cancer, and HIV/AIDS).

 [48]. Id.

 [49]. Edward Kim et al., Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement, 35 J. Clinical Oncology 3737, 3742 (2017). See generally Susan Jin et al., Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015, 35 J. Clinical Oncology 3745 (2017) (discussing the problems with eligibility criteria and finding that current criteria is too narrow in cancer clinical trials).

 [50]. Biopharmaceutical Research & Development, supra note 35, at 1 (“The overall probability of clinical success . . . is estimated to be less than 12%.”); see also Clinical Development Success Rates 2006–2015, supra note 33, at 7 (“[O]nly 9.6% of drug development programs successfully make it to market.”); Joseph A. DiMasi, Henry G. Grabowski & Ronald W. Hansen, Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs, 47 J. Health Econ. 20, 20 (2016); Matthew Herper, The Cost of Developing Drugs Is Insane. That Paper that Says Otherwise Is Insanely Bad, Forbes (Oct. 16, 2017, 10:58 AM), https://www.forbes.com/sites/matthewherper
/2017/10/16/the-cost-of-developing-drugs-is-insane-a-paper-that-argued-otherwise-was-insanely-bad.

 [51]. Michelle Cortez, The ‘Right to Try’ Could Cost Dying Patients a Fortune, Bloomberg (June 20, 2018, 10:44 AM) [hereinafter Cortez, Cost Dying Patients], https://www.bloomberg.com
/news/articles/2018-06-20/the-price-to-try-a-drug-could-be-300-000-for-dying-patients.

 [52]. Liz Szabo, Widespread Hype Gives False Hope to Many Cancer Patients, Kaiser Health News (Apr. 27, 2017), https://khn.org/news/widespread-hype-gives-false-hope-to-many-cancer-patients.

 [53]. See id.

 [54]. United States v. Rutherford, 442 U.S. 544, 548 (1979). Laetrile, derived from apricot pits, had been touted as an anti-cancer drug despite limited clinical studies examining its safety and efficacy. Barron H. Lerner, McQueen’s Legacy of Laetrile, N.Y. Times (Nov. 15, 2005), http://www.nytimes.com/2005/11/15/health/mcqueens-legacy-of-laetrile.

 [55]. Rutherford, 442 U.S. at 548 (citing Rutherford v. United States, 399 F. Supp. 1208, 1215 (W.D. Okla. 1975)).

 [56]. Id. at 549 (citing Rutherford v. United States, 542 F.2d 1137 (10th Cir. 1976)).

 [57]. Rutherford v. United States, 438 F. Supp. 1287, 1289 (W.D. Okla. 1977). A new drug is one “not generally recognized, among experts . . . as safe and effective for use under conditions prescribed, recommended, or suggested in the labeling.” 21 U.S.C. § 321(p)(1) (2018).

  In addition to determining that laetrile was a new drug, the FDA also concluded that the Kefauver-Harris Amendment’s grandfather clause did not apply. Rutherford, 438 F. Supp. at 1289. The grandfather clause exempted drugs from the effectiveness requirement if they were on the day prior to enactment of the Kefauver-Harris Amendments (1) “commercially used or sold in the United States,” (2) not a new drug under section 201(p) of the 1938-version of the FDCA, and (3) not “covered by an effective application” under section 505 of the 1938-version of the FDCA. See Kefauver-Harris Amendment § 107(4).

 [58]. Rutherford, 438 F. Supp. at 1294, 1300–01 (finding FDCA’s grandfather clause exempted laetrile from any pre-market approval requirement and that regardless of the statutory interpretation the right to “use a nontoxic substance” was encompassed within one’s “constitutional right of privacy”).

 [59]. Rutherford v. United States, 582 F.2d 1234, 1235 (10th Cir. 1978).

 [60]. Id. at 1236. The court was not persuaded by the FDA’s argument that a non-effective drug used in the treatment of a life-threatening disease was also not safe. Id. at 1236–37. The court also expressly declined to address the lower court’s constitutional findings. Id. at 1237.

  In another case involving laetrile, a physician and several other co-defendants appealed misdemeanor convictions “for conspiracy to sell and prescribe an unapproved drug laetrile”—a violation of California Health and Safety Code section 1707.1—as unconstitutional. The California Supreme Court held, however, that “a right of access to drugs not recognized by the government as effective” was not a fundamental right recognized by the California or U.S. Constitutions. People v. Privitera, 591 P.2d 919, 925 (Cal. 1979).

 [61]. United States v. Rutherford, 442 U.S. 544, 551 (1979).

 [62]. Id. (explaining how FDCA section 505 requires FDA approval of a new drug unless the drug qualifies for grandfather clause exemption or is being administered through a clinical trial).

 [63]. Id. at 552.

 [64]. The deregulation efforts of the Trump administration, which include the Right to Try Act, arguably closely mirror, if not surpass, the deregulation efforts of the Reagan administration. See Paul Bedard, Trump Ahead of Reagan’s Record in Cutting Regulations, Wash. Examiner (Oct. 3, 2017, 7:16 AM), https://www.washingtonexaminer.com/trump-ahead-of-reagans-record-in-cutting-regulations.

 [65]. Lewis A. Grossman, AIDS Activists, FDA Regulation, and the Amendment of America’s Drug Constitution, 42 Am. J.L. & Med. 687, 700–01 (2016).

 [66]. Id. at 699–700 (citing Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations, 48 Fed. Reg. 26,720, 26,742 (June 9, 1983) (codified at 2 C.F.R. pt. 312)).

 [67]. Id. at 701–02, 706.

 [68]. Id. at 694, 704–07 (“AIDS activism was the first mass movement for freedom of therapeutic choice within orthodox scientific medicine.”); see also Rebecca Dresser, When Science Offers Salvation: Patient Advocacy and Research Ethics 48–49, 52–55 (2001) (citing individual autonomy, the anticipated hastened development of improved treatments as a result of more clinical involvement, and justice by way of non-exclusionary participation as reasons to change the regulatory framework).

 [69]. A protocol sponsor could request that an investigational drug be made available for widespread use if the drug was intended for the treatment of a “serious or immediately life-threatening disease” for which there was “no comparable or satisfactory alternative drug or other therapy available.” 21 C.F.R. 312.34 (1987). The FDA also required the manufacturer to be actively investigating the drug in a “controlled clinical trial” or to have completed testing, and “actively pursuing marketing approval” of the therapy with “due diligence.” Id. A sponsor requesting access for a “substantial population” of patients with a serious disease would likely need to submit data from phase III trials. Id.

 [70]. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,148 (proposed Dec. 14, 2006) (to be codified at 21 C.F.R. pt. 312); Grossman, supra note 65, at 735. The current individual patient expanded access program is separately discussed in Section II.B.

 [71]. The Accelerated Approval pathway enables a drug for the treatment of a serious condition to be approved based on a “surrogate endpoint.” U.S. Food & Drug Admin., Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics 1–7 (2014) [hereinafter Expedited Programs for Serious Conditions], https://www.fda.gov/downloads/Drugs
/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Although a surrogate endpoint is not always indicative of the viability of a treatment, it “may be used instead of stronger indicators, such as longer survival or improved quality of life, because the results of the trial can be measured sooner.” Surrogate Endpoint, Nat’l Cancer Inst., https://www.cancer.gov/publications
/dictionaries/cancer-terms?cdrid=729831 (last visited Feb. 8, 2019). The FDA has approved more than 100 new drug applications submitted through the accelerated approval pathway since its introduction in 1992. See U.S. Food & Drug Admin., CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint (2018), https://www.fda.gov/downloads/Drugs
/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM404466.pdf.

 [72]. With the striated review framework, an investigational drug will either receive “Priority” or “Standard Review.” The FDA will grant an investigational drug Priority Review when it “treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.” See Expedited Programs for Serious Conditions, supra note 71, at 24. The designation requires the FDA to review a marketing application within six months of receiving the submission rather than the standard ten-month review. Id. at 8.

 [73]. In the last twenty years, the FDA has introduced two other approaches to address concerns regarding the lengthy approval process—Fast Track and Breakthrough Therapy. See Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 112, 111 Stat. 2296, 2309–10 (1997); Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, § 902, 126 Stat. 993-1132 (2012). For more background regarding these two expedited designations, see Expedited Programs for Serious Conditions, supra note 71, at 9–15.

 [74]. Karyn Hede, Patient Group Seeks Overhaul of FDA Clinical Trial System in Court, 98 J. Nat’l Cancer Inst. 1268, 1268 (2006); see also Citizen Petition of the Abigail Alliance and the Washington Legal Foundation to the Food and Drug Administration, U.S. Dept. of Health and Human Services, In re Tier 1 Initial Approval Program to Expedite the Availability of Lifesaving Drugs (June 11, 2003) [hereinafter Abigail Alliance Citizen Petition].

 [75]. Abigail Alliance Citizen Petition, supra note 74, at 5.

 [76]. The Abigail Alliance for Better Access to Developmental Drugs (the “Abigail Alliance”) was founded in November 2001 following the death of twenty-one-year-old Abigail Burroughs from squamous cell carcinoma of the head and neck. About, Abigail All. for Better Access to Dev. Drugs, https://www.abigail-alliance.org/p/about.html (last visited Feb. 8, 2017). Burroughs’s story is similar to that of Andrea Sloan’s. After traditional chemotherapy and radiation failed, Burroughs attempted to enroll in multiple clinical trials but did not meet the eligibility requirements. While she was ultimately able to enroll in a clinical trial, her cancer had progressed, and she died shortly thereafter. Peter Hart, Abigail Alliance Case Discussed: Balancing Study Drugs, Safety, Univ. Pitt. Times (Feb. 19, 2009), http://www.utimes.pitt.edu/?p=8605; Peter D. Jacobson & Wendy E. Parmet, A New Era of Unapproved Drugs: The Case of Abigail Alliance v. Von Eschenbach, 297 JAMA 205, 205 (2007). The investigational drug that Burroughs sought, cetuximab, was at the time only being studied in patients with colorectal cancer. Id. In 2011—ten years after Burroughs’s death—cetuximab was approved by the FDA for the treatment of patients with late-stage head and neck cancer. Ben Leach, Cetuximab Approved by FDA for Patients with Late-Stage Head and Neck Cancer, OncLive (Nov. 7, 2011), http://www.onclive.com/web-exclusives/cetuximab-approved-by-fda-for-patients-with-late-stage-head

-and-neck-cancer.

 [77]. Abigail Alliance Citizen Petition, supra note 74, at 9.

 [78]. Abigail All. for Better Access to Dev. Drugs v. McClellan, 2004 U.S. Dist. LEXIS 29594 at *4, *20–21 (D.D.C. 2004) (citing Letter from Peter J. Pitts, Associate Commissioner for External Relations, Department of Health and Human Services, to Frank Burroughs, President Abigail Alliance for Better Access to Developmental Drugs (Apr. 25, 2003)).

 [79]. Id. at *5.

 [80]. Id.

 [81]. Id. The Abigail Alliance reasoned that if companies were allowed to profit from sales of investigational drugs to terminally ill patients, they would be more apt to provide terminally ill patients access under compassionate use. Id.

 [82]. Id. at *25–36. The court concluded that no recognized fundamental right was involved because the “plaintiffs have stated the holdings of Glucksberg, Cruzan, and Griswold too broadly in their attempt to apply the privacy and liberty rights to the instant case,” and that there was no authority supporting “the proposition that the due process right to life extends to requiring affirmative access by terminally ill patients to investigational drugs.” Id. at *31–32. Therefore, the FDA policy was rationally related to a legitimate state interest. Id.

 [83]. Abigail All. for Better Access to Dev. Drugs v. Von Eschenbach, 445 F.3d 470, 486 (D.C. Cir. 2006). Of note, the court distinguished this action from Rutherford v. United States by emphasizing that in this action, terminally ill patients were seeking investigational drugs that had successfully completed phase I trials. Id. at 486.

 [84]. Id.

 [85]. See Abigail All. for Better Access to Dev. Drugs v. Von Eschenbach, 469 F.3d 129, 132 (D.C. Cir. 2006).

 [86]. Abigail All. for Better Access to Dev. Drugs v. Von Eschenbach, 495 F.3d 695, 711–12, 714 (D.C. Cir. 2007). Only the author of the panel’s majority opinion dissented. Id.

 [87]. Id. at 703. The en banc court noted that the Alliance’s “claimed right depends on a regulatory determination that the drug is safe for testing, prompting an obvious question: How can a constitutional right be defined by an administrative regulation that is subject to change?” Id. at 702 n.6.

 [88]. Id. at 702–03.

 [89]. Id. at 703 n.7, 704–06 (discussing the long history of drug regulation in England, the adoption of drug-dispensing legislation by the Virginia colony, and enactment of various other legislation regulating unsafe drugs in Louisiana, Alabama and Georgia).

 [90]. Id. at 706–07 (explaining that if lack of government interference was sufficient, “it would be easy to employ such a premise to support sweeping claims of fundamental rights”). The court posited that a more “plausible explanation for the limited efficacy regulation” was the fact that “[t]he history of the effectiveness requirement in drug regulation is inextricably linked to the advent of the randomized, controlled clinical trial as the cornerstone of medical research . . ., [which] would not become widely recognized until the twentieth century.” Id. at 706 n.12 (quoting Jennifer Kulynych, Will FDA Relinquish the “Gold Standard” for New Drug Approval? Redefining “Substantial Evidence” in the FDA Modernization Act of 1997, 54 Food & Drug L.J. 127, 131 (1999)).

 [91]. See id. at 707–10.

 [92]. Id. at 713.

 [93]. Id. The en banc court further substantiated its reasoning with previous Supreme Court decisions upholding the FDCA and prior circuit court decisions rejecting “arguments that the Constitution provides an affirmative right of access to particular medical treatments reasonably prohibited by the Government.” Id. at 710–13 (citing Gonzales v. Raich, 545 U.S. 1, 28 (2005); United States v. Rutherford, 442 U.S. 544, 552 (1979)); see also id. at 711 n.18 (citing Mitchell v. Clayton, 995 F.2d 772, 775 (7th Cir. 1993); N.Y. State Ophthalmological Soc’y v. Bowen, 854 F.2d 1379, 1389 (D.C. Cir. 1988); Carnohan v. United States, 616 F.2d 1120, 1122 (9th Cir. 1980); Rutherford v. United States, 616 F.2d 455, 457 (10th Cir. 1980)).

 [94]. Expanded Access to Investigational Drugs for Treatment Use, 74 Fed. Reg. 40,900, 40,942–45 (Aug. 13, 2009) (codified at 21 C.F.R. pts. 312, 316). While the Abigail Alliance case made its way through the judicial system in 2006, the FDA announced proposed rules to clarify the individual patient expanded access program. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,148 (proposed Dec. 14, 2006) (to be codified at 21 C.F.R. pt. 312).

 [95]. Expanded Access, U.S. Food & Drug Admin., https://www.fda.gov/NewsEvents
/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm (last updated Nov. 8, 2018).

 [96]. Expanded Access Categories for Drugs (Including Biologics), U.S. Food & Drug Admin., https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm431774.htm (last updated Jan. 4, 2018).

 [97]. 21 C.F.R. § 312.310(a)(1) (2018); Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,153 (Dec. 14, 2006) (codified at 21 C.F.R. pt. 312).

The evidence needed to make this determination for expanded access for an individual patient will vary. For a patient with an immediately life-threatening condition, the evidentiary burden could be very low—little if any clinical evidence to suggest a potential benefit or possibly only animal data to support safety of the use. For a patient with a serious, but not immediately life-threatening, condition who could expect to enjoy a reasonable quality of life for an extended time without any treatment, the evidentiary burden would be higher.

Id. § 312.310(a)(1).

 [98]. Expanded Access: Information for Physicians, U.S. Food & Drug Admin. [hereinafter Information for Physicians], https://www.fda.gov/NewsEvents/PublicHealthFocus
/ExpandedAccessCompassionateUse/ucm429624.htm (last updated Dec. 17, 2018).

 [99]. IND Applications for Clinical Treatment: Contents and Format, U.S. Food & Drug Admin., https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm363005.htm (last updated Dec. 23, 2015). The criteria used by a manufacturer to determine whether to provide a letter of authorization (“LOA”) is covered in Section II.B.2.

 [100]. Compassionate Use and Expanded Access, Pfizer [hereinafter Pfizer Policy], https://www.pfizer.com/purpose/medicine-access/compassionate-use (last visited Feb. 8, 2019) (“In 2017, the PfizerCAReS portal received 4,818 requests from 59 countries, of which 98% were approved.”); see also Criteria for Consideration of Access, Genentech [hereinafter Genentech Policy], https://www.gene.com/patients/investigational-medicines/criteria (last visited Feb. 8, 2019). See generally U.S. Gov’t Accountability Office, GAO-17-564, Investigational New Drugs: FDA Has Taken Steps to Improve the Expanded Access Program but Should Further Clarify how Adverse Events Data Are Used 16 (2017) [hereinafter GAO-17-564, Investigational New Drugs], https://www.gao.gov/assets/690/685729.pdf (discussing findings of an FDA survey of nine manufacturers, in which manufacturers reported receiving between thirty-nine and 800 individual patient expanded access requests).

 [101]. Steve Usdin, FDA to Facilitate Access to Unapproved Drugs, BioCentury (Dec. 14, 2018, 5:34 PM), https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-get-expanded-access-unapproved-drugs.

 [102]. See generally Company Directory, Reagan-Udall Found., http://navigator.reaganudall.org
/company-directory
(last visited Feb. 8, 2019).

 [103]. See infra Appendix.

 [104]. Information for Physicians, supra note 98. An abbreviated form was introduced by the FDA in 2016 after complaints that the previous form, which was required for all expanded access categories, was overly complex and time consuming. See discussion infra Section III.B.

 [105]. 21 C.F.R. § 312.20(c) (2018). A patient may start treatment thirty days after the FDA’s receipt of the IND submission, or earlier if the FDA informs the treating physician that expanded access use can start. Id. § 312.20(c); FDA, Expanded Access: Information for Patients, https://www.fda.gov
/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20041768.htm (last updated Dec. 14, 2018). The criteria used by the FDA to determine whether to grant expanded access is covered in Section II.B.3.

 [106]. GAO-17-564, Investigational New Drugs, supra note 100, at 20.

 [107]. U.S. Food & Drug Admin., Individual Patient Expanded Access Applications: Form FDA 3926 Guidance for Industry 6 (2017), https://www.fda.gov/downloads/drugs
/guidancecomplianceregulatoryinformation/guidances/ucm432717.pdf. “An [institutional review board (“IRB”)] means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects. The primary purpose of IRB review is to assure that the rights and welfare of human subjects are protected.” Id. at 6 n.10.

 [108]. 21 C.F.R. § 312.10 (2018); see also Scott Gottlieb, Expanded Access: FDA Describes Efforts to Ease Application Process, FDA Voice (Oct. 3, 2017), https://www.fda.gov/NewsEvents/Newsroom
/FDAVoices/ucm612009.htm
.

 [109]. Information for Physicians, supra note 98.

 [110]. There is also no guidance on who within a biopharmaceutical company should make that decision. In general, most companies delegate decisionmaking authority to their medical or clinical team. See infra Appendix.

 [111]. See Pharm. Research and Mfrs. of Am., Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results 28–29 (2015) [hereinafter Principles on the Conduct of Clinical Trials], http://phrma-docs.phrma.org/sites/default/files/pdf/042009
_clinical_trial_principles_final_0.pdf; BIO Principles on Expanded Access to Investigational, Unapproved Medicines, Biotech. Innovation Org. [hereinafter BIO Principles on Expanded Access], https://www.bio.org/articles/bio-principles-expanded-access-investigational-unapproved-medicines (last visited Feb. 8, 2019); see also Bill Chin, Newly Implemented Expanded Access Principles Support Commitment to Patients, PhRMA: The Catalyst (June 3, 2015), https://catalyst.phrma.org/newly-implemented-expanded-access-principles-support-commitment-to-patients. The evaluation criteria of the FDA, respectively, are discussed in Section II.B.3.

 [112]. Principles on the Conduct of Clinical Trials, supra note 111, at 28–29.

 [113]. The Appendix surveys the expanded access criteria of the top twenty pharmaceutical companies by global sales. Top Pharma List: Top 25 Pharma Companies by Global Sales, PMLiVE, http://www.pmlive.com/top_pharma_list/global_revenues (last visited Feb. 8, 2019). For additional analysis of expanded access policies, see Emily Jung et al., Prevalence of Publicly Available Expanded Access Policies, 104 Clinical Pharm. & Therapeutics 1016 (2018).

 [114]. See infra Appendix. These policies were not widely available until the enactment of the 21st Century Cures Act (“Cures Act”). For a more in-depth discussion of the Cures Act, see supra Section III.B.

 [115]. See infra Appendix.

 [116]. Id. PhRMA and BIO do not define active clinical development. Principles on the Conduct of Clinical Trials, supra note 111, at 28; BIO Principles on Expanded Access, supra note 111.

 [117]. See infra Appendix.

 [118]. Id.

 [119]. Id. This aligns with PhRMA’s approach. Principles on the Conduct of Clinical Trials, supra note 111, at 28 (“Geographic limitations alone would generally not be considered a barrier to participation in clinical trials.”).

 [120]. Genentech Policy, supra note 100. This could have implications for some rural patients, who might have difficulties enrolling in a clinical trial given the distance and costs associated with travel. Rebecca A. English et al., Transforming Clinical Research in the United States: Challenges and Opportunities 24 (2010), https://www.ncbi.nlm.nih.gov/books/NBK50892/pdf
/Bookshelf_NBK50892.pdf.

 [121]. Pfizer Policy, supra note 100; see also Teva Pharm., Expanded Access Programs 2 (2015), https://www.tevapharm.com/files/policy.pdf.

 [122]. See infra Appendix.

 [123]. Principles on the Conduct of Clinical Trials, supra note 111, at 29; see also BIO Principles on Expanded Access, supra note 111 (discussing similar requirements).

 [124]. See, e.g., Position on Expanded Access to Investigational Medicines, Astellas [hereinafter Astellas Position], https://www.astellas.com/system/files/Position%20on%20Expanded%20Access
%20E%202017-04-11.pdf (last updated Apr. 2017).

 [125]. Allergan Pre-Approval Access Program, Allergan, https://www.allergan.com/research-and-development/pre-approval-access (last visited Feb. 8, 2019).

 [126]. See infra Appendix.

 [127]. See, e.g., Genentech Policy, supra note 100.

 [128]. See Principles on Conduct of Clinical Trials, supra note 111, at 29; BIO Principles on Expanded Access, supra note 111. See also infra Section III.B for a discussion regarding the FDA’s use of adverse events.

 [129].               See infra Appendix.

 [130]. See supra note 100 and accompanying text.

 [131]. Arthur L. Caplan & Amrit Ray, The Ethical Challenges of Compassionate Use, 315 JAMA 979, 980 (2016).

Between July 1 and December 31, 2015, Janssen received 160 preapproval access requests for daratumumab. Of these, company physicians determined that [forty-three] had a benefit-risk profile that was not favorable, [twenty-eight] requests had not exhausted all approved alternative therapies or were eligible for expanded-access programs or clinical trials, and [thirteen] were excluded for other reasons (eg, incomplete data for assessment).

Id.

 [132]. 21 C.F.R. § 312.305(a)(1) (2018).

 [133]. Id. § 312.300(b).

 [134]. Id.

 [135]. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,151 (proposed Dec. 14, 2006) (codified at 21 C.F.R. pt. 312). Additional examples of diseases and conditions that would fit in this category include seizures, rheumatoid arthritis, and chronic depression. Id.

 [136]. Id.

 [137].               Id.

 [138]. 21 C.F.R. § 312.305(a)(2).

 [139]. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. at 75,150.

 [140]. Id. at 75,151.

 [141]. 21 C.F.R. § 312.305(a)(3).

 [142]. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. at 75,151.

 [143]. Rebecca A. English et al., supra note 120, at 64.

 [144]. 21 C.F.R. § 312.310(a)(2).

 [145]. U.S. Food & Drug Admin., Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers: Guidance for Industry 12 (2017) [hereinafter Expanded Access: Guidance for Industry], https://www.fda.gov/downloads/drugs/guidances
/ucm351261.pdf.

 [146]. For additional discussion regarding why the FDA might deny a request for individual patient expanded access, see id. at 12.

 [147]. GAO-17-564, Investigational New Drugs, supra note 100, at 17 (reporting FDA received more than 5,000 single-patient expanded access requests during this period). The FDA also granted 245 requests from trial sponsors for expanded access in the intermediate-size and treatment protocol setting. Id. (stating that the FDA allowed 95.1% of intermediate-size requests and 100% of treatment protocol requests to proceed). The FDA does not specifically track the number of patients who are treated under intermediate-size or treatment protocol applications. In 2006, the FDA estimated that since the formal implementation of the expanded access program, this number was around 100,000 patients. Expanded Access to Investigational Drugs for Treatment Use, 71 Fed. Reg. 75,147, 75,148 (Dec. 14, 2006) (codified at 21 C.F.R. pt. 312).

 [148]. Examining Patient Access to Investigational Drugs: Hearing Before the H. Comm. on Energy and Commerce, 115th Cong. (2017) (statement of Scott Gottlieb, U.S. Food & Drug Admin. Comm’r), https://www.hhs.gov/about/agencies/asl/testimony/2017-10/examining-patient-access-to-investigational
-drugs.html.

 [149]. Id.

 [150]. See supra note 6 and accompanying text.

 [151]. Examining Patient Access to Investigational Drugs: Hearing Before the H. Comm. on Energy and Commerce, 115th Cong. 2 (2017) (statement of Rep. Andy Biggs (R-Ariz.)); see also Sandefur, supra note 9, at 528.

 [153]. Sandefur, supra note 9, at 519.

 [154]. Id. at 513.

 [155]. Id. at 529–30. The Goldwater Institute attempted to root this final argument in a constitutional right to access while distinguishing it from the prior failed attempts to challenge FDA regulatory oversight in Rutherford and Abigail Alliance. Sandefur, supra note 9, at 513, 519 (suggesting that in Abigail Alliance, patients wanted the “authority to access drugs that had not yet been approved for safe use by the FDA”). That claim, however, that terminally ill patients have a fundamental right to use non-FDA approved drugs that have successfully completed phase I testing is the very same fundamental right the Abigail Alliance unsuccessfully advocated for in Abigail Alliance v. Von Eschenbach. Abigail All. for Better Access to Dev. Drugs v. Von Eschenbach, 495 F.3d 695, 701 (D.C. Cir. 2007) (examining “whether terminally ill patients have a fundamental right to experimental drugs that . . . passed Phase I clinical testing”). For additional background regarding Rutherford and Abigail Alliance, see supra Section II.A.

 [156]. Corieri, supra note 9, at 11.

 [157]. See supra Section II.B.3.

 [158]. Id.

 [159]. See supra Introduction.

 [160]. Gail A. Van Norman, Expanding Patient Access to Investigational Drugs, 3 JACC: Basic Translational Sci. 280, 291 (2018); see also GAO-17-564, Investigational New Drugs, supra note 100, at 17; Hudson, supra note 2. But see U.S. Food & Drug Admin., Expanded Access Program Report 21 (2018) [hereinafter Expanded Access Program Report], https://www.fda.gov
/downloads/AboutFDA/ReportsManualsForms/Reports/UCM618903.pdf (noting that manufacturers with active expanded access programs approve 40% to 95% of expanded access requests).

 [161]. See supra Section II.B.2; infra Appendix.

 [162]. Top Pharma List: Top 25 Pharma Companies by Global Sales, supra note 113.

 [163]. Pfizer Policy, supra note 100.

 [164]. See Margot J. Fromer, Accelerating Pediatric Drug Development: Master Protocols May be a Way to Go, ASCO Post (Apr. 25, 2017), http://www.ascopost.com/issues/april-25-2017/accelerating-pediatric-drug-development-master-protocols-may-be-a-way-to-go (proposing a master protocol to aid pediatric research); Press Release, Memorial Sloan Kettering Cancer Ctr., FDA Announces First Approval of Targeted Therapy Based on Basket Study (Nov. 6, 2017), https://www.mskcc.org/trending-topics/fda-announces-first-approval-targeted-therapy-based-basket-study (discussing similar protocol used in the adult setting, which lead to FDA approval).

 [165]. Kim et al., supra note 49, at 3742.

 [166]. See generally Mark Flatten, Goldwater Inst., Studied to Death: FDA Overcaution Brings Deadly Consequences (2018), https://goldwaterinstitute.org/wp-content/uploads/2018/11
/Studied-to-Death-web.pdf
(proposing additional means to reduce FDA oversight through conditional approval, reciprocal review upon approval from a foreign regulatory authority, and off-label promotion of approved drugs).

 [167]. See supra Section I.B.

 [168]. Nicholas S. Downing et al., Regulatory Review of Novel Therapeutics—Comparison of Three Regulatory Agencies, 366 New Eng. J. Med. 2284, 2284 (2012). Of note, this study was conducted prior to the creation of the Breakthrough Therapy designation. See supra note 73 and accompanying text.

 [169]. Caroline Chen, FDA Repays Industry by Rushing Risky Drugs to Market, ProPublica (June 26, 2018, 5:00 AM), https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market. Of note, some HIV/AIDs activists now argue that their efforts during the 1980s and 1990s “opened a Pandora’s box.” Id.

 [170]. Sydney Lupkin, Nearly 1 in 3 Recent FDA Drug Approvals Followed by Major Safety Actions, Kaiser Health News (May 9, 2017), https://khn.org/news/1-in-3-recent-fda-drug-approvals-followed-by-major-safety-actions (“It took a median time period of 4.2 years after the drugs were approved for these safety concerns to come to light, and issues were more common among . . . drugs that were granted ‘accelerated approval’ and drugs that were approved near the regulatory deadline for approval.”).

 [171]. See How Will the Federal Right to Try Law Impact Drug Development?, Clinical Leader (June 27, 2018) [hereinafter Clinical Leader], https://www.clinicalleader.com/doc/how-will-the-federal-right-to-try-law-impact-drug-development-0001.

 [172]. Clinical Development Success Rates 2006–2015, supra note 33, at 3 (“Phase II clinical programs continue to experience the lowest success rate of the four development phases, with only 30.7% of developmental candidates advancing to Phase III.”); see also 22 Case Studies, supra note 35, at 1.

 [173]. See supra Section I.B.

 [174]. Larry Thompson, The Cure that Killed: FIAU Destroyed a Deadly Virus. Then It Began to Destroy Patients., Discover Mag. (Mar. 1, 1994), http://discovermagazine.com/1994/mar
/thecurethatkille345.

 [175]. Mark Flatten, Dead on Arrival: Federal “Compassionate Use” Leaves Little Hope for Dying Patients, RighttoTry (Feb. 24, 2016), http://righttotry.org/dead-on-arrival (“Those facing imminent death cannot access a drug while it is being tested, even if early results show that it works better than existing treatments, unless they are among the fortunate few who qualify for clinical trials. That amounts to a death sentence for most patients, even though their cure may have already been found.”); see also Thompson, supra note 174.

 [176]. H.R. 6288 (112th): Patient Choice Act of 2012, GovTrack, https://www.govtrack.us
/congress/bills/112/hr6288 (last visited Feb. 8, 2019) (proposing to allow “provisional approval” of drugs with Fast Track designation); S. 3045 (110th): ACCESS Act, https://www.govtrack.us
/congress/bills/110/s3046 (last visited Feb. 8, 2019) (proposing the creation of a “conditional approval system”).

 [177]. See Debate: Benefits, Harms of Social Media Sharing from Medical Conferences,  HemOnc Today (Sept. 13, 2017), https://www.healio.com/hematology-oncology/practice-management/news
/online/%7Bfa961a3a-28d2-4909-a186-dbad928ddd03%7D/debate-benefits-harms-of-social-media-sharing-from-medical-conferences (describing how non-attendees can follow along on Twitter or access abstracts and posts through conference databases); Forums, Myeloma Beacon, https://myelomabeacon.org/forum (last visited Feb. 8, 2019) (including example of patient forum discussing treatment options).

 [178]. See Sharon Begley, Beware the Hype: Top Scientists Cautious About Fighting Cancer with Immunotherapy, Stat News (Sept. 25, 2016), https://www.statnews.com/2016/09/25/cancer-immunotherapy-caution; Joy Victory, A Cancer Doctor Speaks Out: How Premature Hype About Experimental Drugs Fails Patients, HealthNewsReview (Apr. 10, 2018), https://www.healthnewsreview.org/2018/04/a-cancer-doctor-speaks-out-how-premature-hype-about-experimental-drugs-fails-patients.

 [179]. Szabo, supra note 52.

 [180]. Ned Pagliarulo, Viagra No More: The Changing Face of Drug Ads on TV, BioPharmaDive (Oct. 22, 2018), https://www.biopharmadive.com/news/drug-ads-tv-pharma-changing-face-dtc-advertising/539982; see also Kevin McCaffrey, Merck’s DTC Ad for Keytruda Hints at More Cancer Brands Turning to TV, MM&M (Feb. 12, 2017), https://www.mmm-online.com/home
/channel/commercial/mercks-dtc-ad-for-keytruda-hints-at-more-cancer-brands-turning-to-tv (“From June 2013 to February [2017], pharma companies spent an estimated $223 million on more than 42,000 airings for DTC ads . . . Before 2013, when the first Provenge DTC aired, it was unheard of for brands to use direct-to-consumer advertising for oncology drugs.”).

 [181]. Kathryn Doyle, Cancer Hospital Advertising Triples Since 2005, Reuters (July 11, 2016, 12:40 PM), https://www.reuters.com/article/us-health-cancer-ads-idUSKCN0ZR2D6.

 [182]. C. Lee Ventola, Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic?, 36 Pharmacy & Therapeutics 669, 669, 673–82 (2011).

 [183]. Stephanie M. Lee, Cancer Hospital Ads Deceive Patients About Their Chances of Survival, New Report Finds, BuzzFeed (Oct. 25, 2018, 4:01 PM), https://www.buzzfeednews.com/article
/stephaniemlee/cancer-treatment-center-misleading-ads; Szabo, supra note 52 (“A TV commercial for the Bristol-Myers Squibb drug Opdivo projects the words ‘a chance to live longer’ on the side of skyscrapers, as a captivated crowd looks on. In much smaller type, a footnote reveals that lung cancer patients taking Opdivo lived just 3.2 months longer than others.”).

 [184]. Tim K. Mackey & Virginia J. Schoenfeld, Going “Social” to Access Experimental and Potentially Life-Saving Treatment: An Assessment of the Policy and Online Patient Advocacy Environment for Expanded Access, 14 BioMed Cent. Med., no. 17, 2016, at 1–10; see also Alison Bateman-House et al., Findings on “Right to Try” Laws and Pre-Approval/Compassionate/Expanded Access to Investigational Medical Products, N.Y.U. Sch. Med. (July 1, 2016) [hereinafter Bateman-House, Findings], https://med.nyu.edu/pophealth/sites/default/files/pophealth/RTT%20Findings
%20FINAL%207_1.pdf (“The number of Change.org online petitions in support of individual requests has increased over the last several years.”).

 [185]. See, e.g., Laura Fraser, The Demonstration, Genentech (Sept. 2016), https://www.gene.com
/stories/the-demonstration.

 [186]. E.g., Darshak M. Sanghavi, The Pills of Last Resort, N.Y. Times Mag. (Oct. 31, 2013), https://www.nytimes.com/2013/11/03/magazine/how-dying-patients-get-access-to-experimental-drugs
.html.

 [187]. Cohen, supra note 6; Sydney Lupkin, Merck Expands Cancer Drug Access but too Late for Denver Dad, ABC News (Mar. 18, 2014), http://abcnews.go.com/Health/merck-expands-cancer-drug-access-late-denver-dad/story?id=22954543; Tirrell, supra note 5.

 [188]. See Dresser, The Gap, supra note 10, at 10 (“To lawmakers and the public hearing these stories, it would be cruel to vote against a right to try law.”); Paige Winfield Cunningham, The Health 202: How ‘Right to Try’ Caught Washington’s Eye, Wash. Post (Feb. 1, 2018), https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2018/02/01/the-health-202-how-right-to-try-caught-washington-s-eye/5a71fcc330fb041c3c7d755e (discussing how the right-to-try movement’s success is in part due to patients and their families reaching out to their representatives); Richard Halstead, BioMarin Denies ‘Compassionate Use’ of Experimental Drug, Considers Adding Cancer Patient to Clinical Trial, Marin Indep. J. (Jul. 19, 2018, 3:17 AM), https://www.marinij.com
/2013/09/06/biomarin-denies-compassionate-use-of-experimental-drug-considers-adding-cancer-patient-to-clinical-trial (discussing how Rep. Jared Huffman (D-San Rafael, Cal.) was involved in a case after receiving “a flood of calls to his office”).

 [189]. See Colo. Rev. Stat. § 25-45-101–108 (2014); Tex. Health & Safety Code Ann. § 489.001–.151 (West 2015); Ariz. Rev. Stat. Ann. § 36-1311–1314 (2014); see also Patti Parson, Colorado First State to Pass ‘Right to Try,’ or the ‘Dallas Buyers’ Club’ Law, PBS News Hour (May 19, 2014), https://www.pbs.org/newshour/health/colorado-first-state-pass-right-try-dallas-buyers-club-law.

 [190]. See Or. Rev. Stat. § 127 (2017); Cal. Health & Safety Code § 111548–111548.5 (West, Westlaw through 2018 Sess.).

 [191]. Some of the state laws were sponsored by politicians with personal connections. Brady Dennis & Ariana Eunjung Cha, “Right to Try” Laws Spur Debate Over Dying Patients’ Access to Experimental Drugs, Wash. Post (May 16, 2014), https://www.washingtonpost.com/national/health-science/right-to-try-laws-spur-debate-over-dying-patients-access-to-experimental-drugs/2014/05/16/820e08c8-dcfa-11e3-b745-87d39690c5c0_story.html (the Colorado law was co-sponsored by a Democrat whose brother benefited from a clinical trial); Michele Munz, Missouri’s “Right to Try” Law No Guarantee Patient Will Get Experimental Drugs, St. Louis Post-Dispatch (May 20, 2015), https://www.stltoday.com
/news/local/metro/missouri-s-right-to-try-law-no-guarantee-patientwill/article_05c07958-5217-5c3f-9f15-1a43c8a3e740.html (reporting the Missouri law was sponsored by a Republican lawmaker whose daughter died of cancer). Others, like California Assembly Majority Leader Ian Calderon, sponsored the right-to-try bill because it was “a logical companion to Death with Dignity.” Exploring a Right to Try for Terminally Ill Patients: Hearing Before the S. Comm. on Homeland Sec. & Gov’t Affairs, 114th Cong. 1–2 (2016) (statement of Ian C. Calderon, Majority Leader, Cal. State Assemb.), https://www.hsgac.senate.gov/imo/media/doc/Testimony-Calderon-2016-09-22.pdf. He explained before Congress:

I never saw the two issues as incompatible. I didn’t want to limit the options for those diagnosed with a terminal illness, to only death, albeit a more controlled one. I felt strongly that if we were going to pass Death with Dignity, and thus make it easier for terminally ill patients to die in California, that we should also make it easier for these terminally ill patients to fight to live, by giving them access to potentially life-saving drugs and treatments, that have been deemed safe, but not yet approved by the FDA.

Id. at 2–3.

 [192]. See supra note 11 (listing states that have adopted right-to-try laws).

 [193]. Compare Tex. Health & Safety Code Ann.  § 489.053(c) (West, Westlaw through 2017 Regular & First Called Sess.) (stating a company cannot charge a patient), with Ariz. Rev. Stat. Ann. § 36-1312(B)(2) (West, Westlaw through First Special & Second Regular 2018 Sess.) (stating a company can charge a patient “costs of or associated with the manufacture of the investigational drug”), and Cal. Health & Safety Code § 111548.2(b)(2) (West, Westlaw through 2018 Sess.) (same).

 [194]. E.g., Cal. Health & Safety Code § 111548.2(c)(2) (West, Westlaw through 2018 Sess.) (stating insurance providers are allowed to choose not to cover the cost of the therapy or costs related to that treatment); Or. Rev. Stat. § 127 (2017), https://www.oregonlegislature.gov/bills_laws/ors
/ors127.html (same); Colo. Rev. Stat. § 25-45-104(b)–(c) (2014) (stating insurance providers are also allowed to deny certain coverage for a period of up to six months after the commencement of treatment).

 [195]. Compare Cal. Health & Safety Code § 111548.1(h)(1)­(A)–(H), (h)(2) (stating a patient must be informed, among other things, of potential impact on hospice eligibility and at-home care), and Colo. Rev. Stat. § 25-45-103(4) (West, Westlaw through Second Regular 2018 Sess.) (same), with Ariz. Rev. Stat. Ann. § 36-1311(1)(d) (2014) (including no definition of informed consent).

 [196]. See Alexander Gaffney, Company’s Compassion Leads to Clinical Hold on Experimental Drug, Reg. Focus (Nov. 19, 2014), http://www.raps.org/Regulatory-Focus/News/2014/11/19/20780
/Companys-Compassion-Leads-to-Clinical-Hold-on-Experimental-Drug (noting the FDA stopped enrollment of an expanded access treatment protocol after a patient died).

 [197]. Expanded Access: Guidance for Industry, supra note 145, at 18. A drug label includes information “such as disease indications, target populations, drug–drug interactions, and [adverse drug reactions]. The label of a prescription drug is prepared by manufacturers and approved by the FDA and, thus, in its final form, reflects the collective input from regulators, drug manufacturers, and scientific experts.” Hong Fang et al., FDA Drug Labeling: Rich Resources to Facilitate Precision Medicine, Drug Safety, and Regulatory Science, 21 Drug Discovery Today 1566, 1566 (2016).

 [198]. Expanded Access: Guidance for Industry, supra note 145, at 18.

 [199]. GAO-17-564, Investigational New Drugs, supra note 100, at 17.  

 [200]. Gottlieb, supra note 108; see also U.S. Food & Drug Admin., Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies 29 (2012), https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf (providing criteria regarding what might qualify as an adverse event).

 [201]. Expanded Access: Guidance for Industry, supra note 145, at 18.

 [202]. Shannon Firth, FDA Head Expresses Doubt About ‘Right to Try’, MedPage Today (Oct. 4, 2017), https://www.medpagetoday.com/washington-watch/fdageneral/68310 (FDA Commissioner Scott Gottlieb stated, “I think that the biggest obstacle to providing drugs through expanded access is the supply constraints”). Adequate supply is often a factor when evaluating an expanded access request. See infra Appendix. This is a genuine concern because a manufacturer initially only develops sufficient supply for its trials. See Fraser, supra note 185 (“[Genentech] was already in the process of trying to dramatically ramp up its production of Herceptin, encountering roadblocks in machinery, engineering and chemistry along the way.”).

 [203]. U.S. Food & Drug Admin., Public Workshop: Evaluating Inclusion and Exclusion Criteria in Clinical Trials: Workshop Report 10 (2018) [hereinafter Public Workshop: Evaluating Inclusion and Exclusion Criteria], https://www.fda.gov/downloads
/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDARA/UCM613054.pdf.

 [204]. See Tirrell, supra note 5 (explaining that fifteen-year-old Nathalie Traller was unable to enroll in clinical trials—despite meeting all of the eligibility criteria—because of her age).

 [205]. Juliet Eilperin & Carolyn Y. Johnson, Obama, Paying Tribute to Biden and Bipartisanship, Signs 21st Century Cures Act Tuesday, Wash. Post: PowerPost (Dec. 13, 2016), https://wapo.st
/2gXhOsT.

 [206]. E.g., Hal Barron, A Scientific Application of Compassion, Genentech (May 15, 2013), https://www.gene.com/stories/a-scientific-application-of-compassion. But see Press Release, Cancer Survivor Andrea Sloan, Ovarian Cancer Survivor Andrea Sloan Seeks Compassionate Use Exemption from BioMarin to Save Her Life (Aug. 29, 2013, 2:28 PM), http://www.marketwired.com/press-release/ovarian-cancer-survivor-andrea-sloan-seeks-compassionate-use-exemption-from-biomarin-1825934.htm (“Despite best efforts to contact BioMarin, the company has not been cooperative, merely sighting their lack of a policy on the issue.”).

 [207]. Ed Silverman, 21st Century Cures Would Require Pharma to Post Policies on Experimental Drugs, Stat: PharmaLot (Nov. 28, 2016), https://www.statnews.com/pharmalot/2016/11/28/21st-century-experimental-drugs.

 [208]. See generally 21st Century Cures Act, 21 U.S.C. § 360bbb–0 (2018).

 [209]. Id. § 360bbb–0(c).

 [210]. Examining Patient Access to Investigational Drugs: Hearing Before the H. Comm. Energy and Commerce, 115th Cong. 4 (2017) (statement of the Alison Bateman-House, Assistant Professor, Division of Medical Ethics, Department of Population Health, N.Y.U. Langone Health) [hereinafter Bateman-House, Examining Patient Access] (explaining why an enforcement mechanism is necessary, given that there is “less than 100% compliance with the rule”). For additional discussion about compliance with respect to specific provisions in the Cures Act, see Jung et al., supra note 113.

 [211]. See Expanded Access/Right to Try Act, BrainStorm Cell Therapeutics, http://www.brainstorm-cell.com/patients-caregivers/expanded-accesscompassionate-use (last visited Feb. 8, 2019) (stating the company currently does not offer expanded access).

 [212]. Company Directory, supra note 102.

 [213]. Usdin, supra note 101.

 [214]. About the Expanded Access Navigator, Reagan-Udall Found., http://navigator.reaganudall.org/about (last visited Feb. 8, 2019) (“The Expanded Access Navigator, or EA Navigator, represents a unique partnership between the Reagan-Udall Foundation for the FDA, patient advocacy organizations, the pharmaceutical industry, and the federal government to provide clear, digestible information on single-patient EA.”).

 [215]. See id. The addition of this resource (that is, connecting community physicians with regional IRB committees) could be a relatively simple way of helping alleviate potential application disparities between patients who are primarily treated at academic centers where physicians are more aware of clinical trials and expanded access, and patients who are primarily treated by a community physician who might have less familiarity and access to these resources.

 [216]. Zachary Brennan, FDA Looks to Revitalize Compassionate Use Program with Simplified Form, Final Guidance, Reg. Focus (June 2, 2016) [hereinafter Brennan, Revitalize Compassionate Use], https://www.raps.org/news-articles/news-articles/2016/6/fda-looks-to-revitalize-compassionate-use-program-with-simplified-form,-final-guidance.

 [217]. U.S. Food & Drug Admin., Investigational New Drug Application (IND): Form FDA 1571 [hereinafter Form FDA 1571], https://www.fda.gov/downloads/AboutFDA
/ReportsManualsForms/Forms/UCM083533.pdf (last updated July 2018); U.S. Food & Drug Admin., Statement of Investigator: Form FDA 1572, https://www.fda.gov/downloads/AboutFDA
/ReportsManualsForms/Forms/UCM074728.pdf (last updated Feb. 2016).

 [218]. Expanded Access Program Report, supra note 160, at 5.

 [219]. Statement, U.S. Food & Drug Admin., Statement from FDA Commissioner Robert Califf, M.D. on the Release of the Final Individual Patient Expanded Access Form (Jun. 2, 2017) [hereinafter Statement from FDA Commissioner Califf], https://www.fda.gov/NewsEvents/Newsroom
/PressAnnouncements/ucm504579.htm.

 [220]. Brennan, Revitalize Compassionate Use, supra note 216.

 [221]. Id. Form FDA 1571 has twenty-six fields and requires seven attachments. Form FDA 1517, supra note 217. Form FDA 3926 has eight fields and requires one attachment. U.S. Food & Drug Admin., Instructions for Filling out Form FDA 3926—Individual Patient Expanded Access, Investigational New Drug Application (IND), https://www.fda.gov/downloads/AboutFDA
/ReportsManualsForms/Forms/UCM504574.pdf (last updated Apr. 2017).

 [222]. Id.; see also Expanded Access Program Report, supra note 160, at 5.

 [223]. Expanded Access Program Report, supra note 160, at 16.

 [224]. Gottlieb, supra note 108; Expanded Access: Guidance for Industry, supra note 145, at 6.

 [225]. Gottlieb, supra note 108; see also FDA Simplifies IRB Requirements for Individual Patient Expanded Access, Am. Soc’y Clinical Oncology (Oct. 3, 2017), https://www.asco.org/advocacy-policy/asco-in-action/fda-simplifies-irb-requirements-individual-patient-expanded-access. But see Kelly McBride Folkers & Alison Bateman-House, Will New FDA Regulation on IRB Review Speed Patient Access to Experimental Drugs?, Health Affairs Blog (Dec. 11, 2017), https://www.healthaffairs.org/do/10.1377/hblog20171205.384786/full (suggesting it is difficult to assess the actual impact of this change without “baseline data” regarding the role of IRB review in the expanded access process).

 [226]. E.g., Expanded Access to Unapproved Drugs, Biologics, or Devices and Right to Try Laws, U. Cal. Irvine: Off. Res., https://www.research.uci.edu/compliance/human-research-protections
/researchers/expanded-access-and-right-to-try.html (last visited Feb. 8, 2019); Investigational New Drugs and Biologics, U. Cal. S.F.: Off. Ethics & Compliance, https://irb.ucsf.edu/investigational-new-drugs-and-biologics (last updated Apr. 13, 2018).

 [227]. E.g., Joseph A. Catania et al., Survey of U.S. Human Research Protection Organizations: Workload and Membership, 3 J. Empirical Res. on Hum. Res. Ethics 57, 61–62 (2008); see also IRB—Human Participants Committee Membership, Cornell Univ. Off. Res. Integrity & Assurance, https://www.irb.cornell.edu/membership (noting the university’s IRB committee is generally made up of twelve to eighteen voting members) (last visited Feb. 8, 2019).

 [228]. See Levels of Review: Expediated Research, U. Cal. Irvine: Off. Res., https://www.research.uci.edu/compliance/human-research-protections/researchers/levels-of-review.html
#Expedited (last visited Feb. 19, 2018) (anonymous surveys and chart reviews).

 [229].  Expanded Access: Guidance for Industry, supra note 145, at 6.

 [230]. The idea of a “consulting physician” builds from a few of the state right-to-try laws, including California, which still require a second physician to review and concur with the treating physician’s opinion, but not an IRB to review and approve the treating physician’s opinion. E.g., Cal. Health & Safety Code § 111548.1(a), (b)(4), (b)(6) (West, Westlaw through 2018 Sess.).

 [231]. Mershon, supra note 7; Press Release, U.S. Senate Comm. on Homeland Sec. & Gov’t Affairs, Johnson to FDA: Agency Should Comply with Right to Try Law (May 31, 2018) [hereinafter Press Release, Johnson to FDA], https://www.hsgac.senate.gov/media/majority-media/johnson-to-fda-agency-should-comply-with-right-to-try-law (“This law intends to diminish the FDA’s power over people’s lives, not increase it. It is designed to work within existing FDA regulations, definitions, and approval processes. It is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations . . . .”); see also Alison Bateman-House & Christopher T. Robertson, Opinion, The Federal Right to Try Act of 2017—A Wrong Turn for Access to Investigational Drugs and the Path Forward, 178 JAMA Internal Med. 321, 321–22 (2018) (arguing that as-written the federal Right to Try Act was meant to undercut the FDA’s authority rather than to create a more effective pre-approval access pathway).

 [232]. FDA Reauthorization Act of 2017, Pub. L. 115–52, § 610(a)(2), 131 Stat. 1005, 1052 (2017).

 [233]. Expanded Access Program Report, supra note 160, at 13.

 [234]. Id. at 13–14.

 [235]. Expanded Access INDs and Protocols 2009–2017, U.S. Food & Drug Admin., https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm443572.htm (last updated Feb. 21, 2018). The number of requests between 2015 and 2016 increased 31% from 779 to 1,025. Id.

 [236]. See Statement from FDA Commissioner Califf, supra note 219.

 [237]. This is not just an expanded access problem. The right-to-try laws, both state and federal, do not compel manufacturer participation. See infra Section IV.A.

 [238]. Sammy Caiola, Federal Right to Try Proposal Could Make California Law More Effective, Capital Pub. Radio (Jan. 31, 2018), http://www.capradio.org/109381 (discussing the need for complementary federal legislation).

 [239]. See Right to Try Act of 2015, H.R. 3012, 114th Cong. (as reported by H. Judiciary Subcomm. on Crime, Terrorism, Homeland Sec. & Investigations, July 29, 2015); see also Caiola, supra note 238.

 [240]. Zachary Brennan, Who’s Actually Using ‘Right-to-Try’ Laws? A Texas Oncologist Explains His Experience, Reg. Aff. Blog (Aug. 4, 2017), https://www.raps.org/news-articles/news-articles/2017
/8/who-s-actually-using-right-to-try-laws-a-texas-oncologist-explains-his-experience (“The six patient testimonies provided to Focus by the libertarian Goldwater Institute . . . all focus on obtaining this same investigational cancer therapy outside of a clinical trial from the former director of therapeutic nuclear medicine at M.D. Anderson Cancer Center.”); David Kroll, Trump’s Call for #RightToTry Experimental Drug Access: A Nothingburger for Patients and Families, Forbes (Jan. 31, 2018, 12:51 PM), https://www.forbes.com/sites/davidkroll/2018/01/31/trumps-call-for-righttotry-experimental-drug-access-a-nothingburger-for-patients-and-families (citing National Right to Try Movement, Meet Dr. Ebrahim Delpassand, Facebook (Sept. 22, 2016), https://www.facebook.com/RightToTry/videos
/592616080918116; and Richard Pazdur, U.S. Food & Drug Admin., NDA Approval Letter, NDA-208700 for Luthathera 4–5 (Jan. 26, 2018), https://www.accessdata.fda.gov/drugsatfda_docs/appletter
/2018/208700Orig1s000ltr.pdf).

It’s disingenuous of #RightToTry advocates to use [Dr. Delpassand’s story] to justify non-FDA-reviewed patient access to drugs after Phase 1 preliminary safety studies, the very early stage of drug studies in humans. If you look specifically around 0:54 of the Right To Try video, Dr. Delpassand’s disappointment on behalf of his patients was due to the FDA’s denial of his broad expanded-use request—that is, after Phase 3 safety and efficacy trials were completed and under FDA review. If one looks at the NDA approval letter, the FDA still had at least another year of questions and concerns about the drug since the April 28, 2016, NDA submission.

Kroll, supra (emphasis in original); see also Munz, supra note 191 (discussing how one man with ALS moved back to Missouri after the state passed its right-to-try law thinking that he would be able to obtain an investigational drug through the pathway, but the company declined).

 [241]. H.R.3012—Right to Try Act of 2015, Congress.gov, https://www.congress.gov/bill/114th-congress/house-bill/3012/actions (last visited Feb. 11, 2018).

 [242]. Connecting Patients to New and Potential Life Saving Treatments: Hearing Before the S. Comm. on Homeland Sec. & Gov’t Affairs, 114th Cong. (2016) (statement of Sen. Ron Johnson, Chairman, S. Comm. on Homeland Sec. & Gov’t Affairs), https://www.hsgac.senate.gov/media/majority-media/chairman-ron-johnson-opening-statement-connecting-patients-to-new-and-potential-life-saving-treatments. Of note, no one from the FDA was present at the hearing, which included the president and CEO of the Goldwater Institute, two patients, the now former executive director of the Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson University, who also authored the book Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances, and the executive director of the non-profit organization Kids v. Cancer. Connecting Patients to New and Potential Life Saving Treatments, U.S. Senate Committee on Homeland Security & Gov’t Aff. (Jan. 25, 2016), https://www.hsgac.senate.gov/hearings/connecting-patients-to-new-and-potential-life-saving-treatments. See generally Joseph Gulfo, Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances (2014) (arguing the FDA is “horribly broken”).

  Senator Ron Johnson convened a second hearing in September 2016 that included testimony from one patient, the California Assembly Majority Leader Ian Calderon, U.S. Representative Jim Neely (R-Mo.), the former president and CEO of Neuralstem, Inc., the executive director of the non-profit organization the Isaac Foundation, and the FDA’s Associate Commissioner for Public Health Strategy and Analysis Peter Lurie. Exploring a Right to Try for Terminally Ill Patients, U.S. Senate Committee on Homeland Security & Gov’t Aff. (Sept. 22, 2016), https://www.hsgac.senate.gov/hearings/exploring-a-right-to-try-for-terminally-ill-patients.

 [243]. Press Release, U.S. Sen. Comm. on Homeland Sec. & Gov’t Affairs, Johnson Introduces Trickett Wendler Right to Try Act (May 10, 2016), https://www.hsgac.senate.gov/media/majority-media/johnson-introduces-trickett-wendler-right-to-try-act.

 [244]. Bill Glauber, Johnson’s Right-to-Try Bill Blocked, Milwaukee J. Sentinel (Sept. 28, 2016), https://www.jsonline.com/story/news/politics/2016/09/28/johnsons-right–try-bill-blocked
/91225922.

 [245]. Press Release, U.S. Sen. Comm. on Homeland Sec. & Gov’t Affairs, Chairman Johnson Introduces Bill to Help Terminally Ill Patients (Jan. 24, 2017), https://www.hsgac.senate.gov/media
/majority-media/chairman-johnson-introduces-bill-to-help-terminally-ill-patients.

 [246]. Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, S. 204, 115th Cong. (as passed by Senate, Aug. 3, 2017).             

 [247]. Examining Patient Access to Investigational Drugs: Hearing Before the H. Comm. on Energy & Commerce, 115th Cong. (2017), https://energycommerce.house.gov/hearings/examining-patient-access-investigational-drugs. This hearing included testimony from Rep. Andy Biggs (R-Ariz.), FDA Commissioner Scott Gottlieb, the Director for Health Care from the U.S. Government Accountability Office, New York University Assistant Professor and Bioethicist Alison Bateman-House, one patient, the Director of Healthcare Policy from the Goldwater Institute, the president and CEO from Cognition Therapeutics, and the chairperson of the non-profit organization Friends of Cancer Research. Id.

 [248]. Donald Trump, State of the Union Address, supra note 12.

 [249]. Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, H.R. 5247, 115th Cong. (as passed by House, Mar. 21, 2018). H.R. 5247 was narrower than S. 204 because it would have required a requesting patient to have an immediately life-threatening diseases and would have limited eligible drugs to those with an active IND application that were not subject to a clinical hold. Id. The bill would have also required the manufacturer to notify the FDA within seven days of granting a right-to-try request and to report adverse events. Id.

 [250]. See Actions Overview: H.R. 5247 — 115th Congress, Congress.gov, https://www.congress.gov/bill/115th-congress/house-bill/5247/actions (last visited Feb. 11, 2019).

 [251]. Id.

 [252]. Paige Winfield Cunningham, The Health 202: How Democrats Got a Version of ‘Right to Try’ They Like Even Less, Wash. Post: PowerPost (May 23, 2018), https://www.washingtonpost.com
/news/powerpost/1anada/the-health-202/2018/05/23/the-health-202-how-democrats-got-a-version-of-right-to-try-they-like-even-less.

 [253]. Rachel Roubein, House Eyes Changes for ‘Right to Try’ Bill, Hill (Feb. 8, 2018, 6:00 AM), http://thehill.com/policy/healthcare/372858-house-eyes-changes-for-right-to-try-bill (quoting Letter from the American Cancer Society Cancer Action Network et al., to U.S. Reps. Paul Ryan & Nancy Pelosi (Feb. 6, 2018), https://www.asco.org/sites/new-www.asco.org/files/content-files/February-2018-Right-to-Try-Coalition-Letter.pdf) (noting a group of almost forty patient advocacy groups and professional organizations sent a letter to House leaders that “warned the measure would ‘likely do more harm than good’”).

 [254]. See 21 U.S.C. § 360bbb-0a (2018); Actions Overview: S. 204 — 115th Congress, Congress.gov, https://www.congress.gov/bill/115th-congress/senate-bill/204/actions (last visited Feb. 11, 2019).

 [255]. White House Press Release, supra note 13.

 [256]. Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115–176, 132 Stat. 1372, 1372 (2018).

 [257]. See generally 21 U.S.C. § 360bbb-0a (2018) (noting no such liability exists under the law).

 [258]. Id. § 360bbb-0a(a)(1)(A). “Life-threatening” is defined to be “where the likelihood of death is high unless the course of the disease is interrupted” or where there is the potential for fatal outcomes. 21 C.F.R. § 312.81(a) (2018).

 [259]. Press Release, Johnson to FDA, supra note 231.

 [260]. 21 U.S.C. § 360bbb-0a(a)(1)(B) (2018).

 [261]. Id.

 [262]. Id. § 360bbb-0a(a)(1)(B)(i)–(ii). Of note, the Act does not limit other types of compensation (in other words, the certifying physician could theoretically have an equity interest in the drug company).

 [263]. Id. § 360bbb-0a(a)(1)(C). This may have been intentional given that the federal regulation does not allow informed consent to include “any exculpatory language through which the subject . . . is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release . . . the sponsor [that is, manufacturer], the institution, or its agents from liability for negligence.” 21 C.F.R. § 50.20 (2018); see also id. § 50.25 (describing the basic elements of informed consent); Id. § 312.305(c)(4) (cross-referencing 21 C.F.R. pt. 50 as the applicable informed consent standard for the expanded access program).

 [264]. 21 U.S.C. § 360bbb-0a(a)(2)(A). The Act uses the definition of phase I trial from section 312.21 of Title 21, Code of Federal Regulation. Id. § 360bbb-0a(a)(3); see also 21 C.F.R. § 312.21(a) (2018).

These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.

21 C.F.R. § 312.21(a).

 [265]. 21 U.S.C.S. § 360bbb-0a(a)(2)(B).

 [266]. Id. § 360bbb-0a(a)(2)(C).

 [267]. Press Release, Johnson to FDA, supra note 231.

 [268]. 21 U.S.C. § 360bbb-0a(a)(2)(D) (2018). “A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation.” 21 C.F.R. § 312.42(a).

 [269]. See 21 U.S.C. § 360bbb-0a(b) (2018) (citing 21 U.S.C. § 352(f) (stating directions for use and warnings on labels); id. § 353(b)(4) (misbranded drugs); id. § 355(a)(i) (necessity of effective approval of application; exemptions of drug research); 42 U.S.C. § 262(a) (biologics license); 312 C.F.R. § 50 (protection of human subjects); id. § 56 (IRBs)). Of note, the Act, however, does not exempt a company from all statutory and regulatory requirements pertaining to INDs. Holly Fernandez Lynch et al., Opinion, Promoting Patient Interests in Implementing the Federal Right to Try Act, 320 JAMA 869, 870 (2018) (noting ongoing reporting obligations).

 [270]. Id.

 [271]. Id. § 360bbb-0a(d)(1).

 [272]. Id. § 360bbb-0a(d)(2).

 [273]. Id. § 360bbb-0a(c)(1).

 [274]. Id. § 360bbb-0a(c)(1)(a)–(b). If the FDA decides it needs to use outcome data, it must give written notice to the company explaining why it was necessary for public health. Id. § 360bbb-0a(c)(2). This decision can only be made by “the director of the agency center that is charged with the premarket review of the eligible investigational drug.” Id.

 [275]. Sammy Caiola, Federal Right to Try Law Could Mean More Access—and Risk—for California Patients, Capital Pub. Radio (May 31, 2018), http://www.capradio.org/articles/2018/05/31/federal-right-to-try-law-could-mean-more-access-and-risk-for-california-patients. The Right to Try Act does not “modify or otherwise affect the right of any person to bring a private action under any State or Federal product liability, tort, consumer protection, or warranty law.” 21 U.S.C. § 360bbb-0a (2018) (Limitation of Liability).

 [276]. See Reddy, supra note 6; Arlene Weintraub, Biotech Executives Fret Over Hassles and Uncertainties of ‘Right to Try’, Forbes (Jun 13, 2018), https://www.forbes.com/sites/arleneweintraub/2018/06/13/biotech-executives-fret-over-hassles-and-uncertainties-of-right-to-try/#6df52d69bc78.

 [277]. See Janssen Policy: Evaluating and Responding to Pre-Approval Access Requests for Investigational Medicines, Janssen [hereinafter Janssen Policy], http://www.janssen.com/sites/wwwjanssencom/files/janssenpolicyevaluatingrespondingpreapprovalrequests022018.pdf; Pfizer’s Position on Federal Right to Try Legislation, Pfizer (May 2018), https://www.pfizer.com/files/research/PolicyPositionRighttoTryFederalLegislationMay2018.pdf; GlaxoSmithKline, U.S. Public Policy Position Paper: Right-to-Try Legislation, GlaxoSmithKline (Mar. 2015), https://us.gsk.com/media/1444389/ppright-to-trylegislation.pdf; Early Patient Access to Investigational Medicine, Bristol-Myers Squibb [hereinafter Bristol-Myers’ Position], https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine.html (last visited Feb. 11, 2019); see also Michelle Cortez, Dying Patients Face Reality Check on Right to Try, Bloomberg (June 8, 2018, 7:53 AM), https://www.bloomberg.com/news/articles/2018-06-08/dying-patients-seeking-drugs-face-reality-check-on-right-to-try (discussing how manufacturers do not plan to change their “current approach” even after the enactment of the Right to Try Act).

 [278]. Dan Diamond, Johnson & Johnson Won’t Consider Patients’ Right-to-Try Requests, POLITICO (Jan. 17, 2018, 10:00 AM), https://www.politico.com/newsletters/politico-pulse/2018/01/17/hhs-readying-new-rule-to-expand-conscience-protections-075342; see also Janssen Policy, supra note 277.

 [279]. See Thaddeus Mason Pope, Why Oncologists Should Decline to Participate in the Right to Try Act, ASCO Post (Aug. 10, 2018), http://www.ascopost.com/issues/august-10-2018/declining-to-participate-in-the-right-to-try-act (“Because the extra risks posed by the Right to Try Act are not offset by any countervailing benefit, it would be unethical for oncologists to use it to gain access to an experimental drug for their patients.”).

 [280]. See Statement, U.S. Food & Drug Admin., Statement from FDA Commissioner Scott Gottlieb, M.D., on New Efforts to Strengthen FDA’s Expanded Access Program (Nov. 8, 2018), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625397.htm.

 [281]. Usdin, supra note 101. The goal of this program is two-fold: (1) “to remove impediments that prevent physicians and patients from seeking access to investigational drugs and [(2)] to communicate FDA’s support for manufacturers providing access.” Id. The agency anticipates rolling out a pilot version for oncology requests in 2019. Id.

  This modification to the expanded access program goes well beyond the modifications discussed in Section III.B. The aptly named program creates a new tension within the expanded access program: the FDA is now not only a key decisionmaker, but also, as the program is aptly named, a facilitator, and possibly the key facilitator. This modification raises new questions that, although beyond the scope of this Note, are worth noting. First, to what extent will a patient-initiated request impair the treating physician’s decisionmaking responsibility? Will FDA staff consult with the requesting patient’s physician to ensure he or she weighed the risks associated with use of the investigational drug against the risks associated with the disease (and discussed those risks with the patient) prior to filling out Form FDA 3926 and sending to the physician for signature? Second, will an FDA-facilitated request ensure a fair and separate IRB review process? Will the FDA be responsible for costs associated with the IRB or will those costs continue to be covered by the patient? Third, how will the FDA ensure companies comply with a response deadline? Will the FDA’s to-be-determined manufacturer review period result in more companies denying requests to avoid simply missing that deadline?

 [282]. See, e.g., Rich Thomaselli, FDA’s Social-Media ‘Guidelines’ Befuddle Big Pharma, AdAge (Dec. 30, 2011), https://adage.com/article/digital/fda-s-social-media-guidelines-befuddle-big-pharma/231855 (suggesting the lack of FDA guidance regarding social media has restrained biopharmaceutical companies’ use of expanded access).

 [283]. James M. Beck, Federal Right to Try Legislation—Is It Any Better?, Drug & Device L. (Sept. 5, 2017), https://www.druganddevicelawblog.com/2017/09/federal-right-to-try-legislation-is-it-any-better.html.

That’s not much protection at all, given how readily the other side throws around such allegations, and how infrequently judges throw them out. In subsection 1, “Reckless/willful” is a standard for punitive damages, which routinely survive dismissal in [multidistrict litigation] and other actions around the country. “Gross negligence” is a standard even less than that—merely an aggravated form of negligence that doesn’t require any finding of intent at all. Intentional torts include fraud, which is currently included in just about any product liability complaint. Battery, which encompasses informed consent in many states, is also an intentional tort.

Id.

 [284]. Though some states’ right-to-try laws could preclude these types of claims. E.g., Cal. Health & Safety Code § 111548.5 (West, Westlaw through 2018 Sess.).

 [285]. Jonathan J. Darrow et al., Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs, 327 New Eng. J. Med. 279, 282 (2015) (“Litigation in this arena, however, has been limited to obtaining access rather than seeking redress of treatment-related harm.”); see also Lynch et al., supra note 269, at 870 (suggesting that FDA input and IRB oversight might be “an important indication of reasonableness” in a hypothetical expanded access-product liability case).

 [286]. See supra Section III.B.

 [287]. See, e.g., ClinRegs: Canada, Nat’l Inst. Health, https://clinregs.niaid.nih.gov/country
/1anada (last updated Feb. 8, 2018) (“During a clinical trial, the sponsor is required to inform [Health Canada] of any serious, unexpected [adverse drug reaction] that has occurred inside or outside Canada.”).

 [288]. 21 C.F.R. § 312.8 (2018) (charging for investigational drugs under an IND); U.S. Food & Drug Admin., Charging for Investigational Drug Under an IND—Questions and Answers: Guidance for Industry 6–7 (2016), https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm351264.pdf.

 [289]. See DiMasi et al., supra note 50, at 20; Herper, supra note 50.

 [290]. 21 U.S.C. § 360bbb-0a(b) (2018) (citing 21 C.F.R. § 312.8 (2018) (charging for investigational drugs under an IND)).

 [291]. See infra Appendix (listing companies citing adequate supply); see also Darrow et al., supra note 285, at 280–81 (describing the “administrative burden” for companies when preparing an intermediate-size patient expanded access protocol).

 [292]. Clinical Leader, supra note 171; see also Paige E. Finkelstein, Expanded Access to Investigational Drugs: What Physicians and the Public Need to Know About FDA and Corporate Processes, 17 Am. Med. Ass’n J. Ethics 1142, 1143–44 (2015). See generally Kenneth I. Moch, Ethical Crossroads: Expanded Access, Patient Advocacy, and the #SaveJosh Social Media Campaign, 1 MedAccess 1 (2017) (describing one company’s response to a targeted expanded access social media campaign).

 [293]. Cortez, Cost Dying Patients, supra note 51.

 [294]. Zachary Brennan, FDA Prepares to Implement ‘Right-to-Try’ Law, Reg. Focus (May 31, 2018), https://www.raps.org/news-and-articles/news-articles/2018/5/fda-prepares-to-implement-right-to-try-law (“[The FDA] is convening an internal group to assess how to effectively and efficiently implement the new law. [The FDA] will report on [their] implementation steps regularly.” (quoting an emailed statement from the FDA)).

 [295]. Id.(“[I]f [FDA staff] receive inquiries about the legislation from patients or physicians about a specific product, [they] refer them to the sponsor of the investigational drug . . . . If sponsors contact [FDA staff] regarding their obligations under this law, [the FDA] suggest[s] that [staff] refer them to the statute.” (quotation omitted)).

 [296]. See supra Table 1 (describing the additional criteria the FDA needs to determine whether intermediate-size or widespread expanded access use is appropriate).

 [297]. Jennifer Freeman, RA Life Expectancy: Can I Live a Long Life with Rheumatoid Arthritis?, Rheumatoid Arthritis Support Network (Sept. 17, 2018), https://www.rheumatoidarthritis.org/ra
/prognosis/life-expectancy (characterizing rheumatoid arthritis as a chronic, but progressive disease); Narcolepsy Fact Sheet, Nat’l Inst. of Neurological Disorders & Stroke, https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Narcolepsy-Fact-Sheet (describing narcolepsy as a chronic neurological condition) (last visited Feb. 11, 2019).

 [298]. The FDA has not established an exact numeric threshold that would trigger intermediate-size use, but explains that it will recommend when “it is generally most efficient to consolidate expanded access in a single intermediate-size patient population IND or protocol.” Expanded Access: Guidance for Industry, supra note 145, at 14. The FDA has also not established a threshold for when intermediate-size expanded access as opposed to widespread treatment expanded access should be used, instead considering two criteria: (1) “whether the drug is under development for marketing for the expanded access use,” and (2) “the size of the patient population.” Id. at 15.

 [299]. See, e.g., How We Operate: Compassionate Use, Shire, https://www.shire.com/who-we-are/how-we-operate/policies-and-positions/compassionate-use (last updated Apr. 2015) (excluding “patients with exceptional safety risks that have not been sufficiently studied” from expanded access use).

 [300]. See Florence T. Bourgeois et al., Pediatric Versus Adult Drug Trials for Conditions with High Pediatric Disease Burden, 130 Pediatrics 285, 286 (2012) (children often treated with drugs only approved for adult use); Tirrell, supra note 5 (companies declining to grant pediatric expanded access request due to insufficient pediatric data).

 [301]. Public Workshop: Evaluating Inclusion and Exclusion Criteria, supra note 203, at 3.

 [302]. See RighttoTry, http://righttotry.org (last visited Feb. 11, 2019); Vice President Mike Pence, March 13 Tweet, supra note 12.

 [303]. See Bourgeois et al., supra note 300, at 286; Tirrell, supra note 5; Public Workshop: Evaluating Inclusion and Exclusion Criteria, supra note 203, at 4–5.

 [304]. Pathama D. Joseph et al., Clinical Trials in Children, 79 British J. Clinical Pharmacology 357, 360–61 (2013) (describing complex nature of informed consent in the pediatric setting).

 [305]. A study published in the Journal of the American Medical Association (“JAMA”) found that not only do “cancer patients tend to overestimate their prognoses,” but that the overestimation impacts treatment decisions. Jane C. Weeks et al., Relationship Between Cancer Patients’ Predictions of Prognosis and Their Treatment Preferences, 279 JAMA 1709, 1712–13 (1998); see also Andrew S. Epstein et al., Discussions of Life Expectancy and Changes in Illness Understanding in Patients with Advanced Cancer, 34 J. Clinical Oncology 2398, 2398–2401 (2016) (“Results of this study demonstrate how poorly patients with advanced cancer understand their prognoses and how effective recent prognostic discussions are to improve illness understanding by patients.”).

 [306]. Am. Acad. Of Pediatrics, Informed Consent in Decision-Making in Pediatric Practice, 138 Pediatrics 2 (2018), http://pediatrics.aappublications.org/content/pediatrics/early/2016/07/21/peds.2016-1484.full.pdf.

 [308]. Kate Gallin Heffernan et al., Federal “Right to Try”: Don’t Disregard Your State Laws Just Yet! How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal “Right to Try”, Verrill Dana LLP (2018), http://www.verrilldana.com/federal-right-to-try-dont-disregard-your-state-laws-just-yet.

 [309]. Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115–176, 132 Stat. 1372, 1372 (2018).

 [310]. U.S. Const. art. VI, cl. 2 (“This Constitution, and the laws of the United States which shall be made in pursuance thereof . . . shall be the supreme law of the land.”); see also Phoebe Mounts et al., A Closer Look at New Federal ‘Right to Try’ Law, Law360 (June 1, 2018, 12:17 PM), https://www.morganlewis.com/-/media/files/news/2018/law360-a-closer-look-at-new-federal-right-to-try-law-01jun18.ashx; Heffernan et al., supra note 308 (suggesting enactment of the Right to Try Act revives the preemption issue because the Act is “less in conflict with its state counterparts” and “state laws could reasonably be found by a court to supplement and explicate the way in which this activity (the provision of investigational drugs outside of FDA’s purview) can occur in a given jurisdiction, rather than serving to frustrate Congress’ intent in making the ‘right to try’ pathway available”).

 [311]. Exploring a Right to Try for Terminally Ill Patients: Hearing Before the S. Comm. on Homeland Sec. & Gov’t Affairs, 114th Cong. 2 (2016) (statement of Sen. Ron Johnson). The Act also authorizes pre-approval access “in accordance with State law.” Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, Pub. L. No. 115–176, 132 Stat. 1372, 1372 (2018).

 [312]. Cal. Health & Safety Code § 111548.1(b)(1)–(6) (West, Westlaw through 2018 Sess.).

 [313]. Compare id. § 111548.1(d) (“‘Immediately life-threatening disease or condition’ means a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months.”), with 21 U.S.C. § 360bbb-0a(a)(1)(A) (2018) (requiring “life-threatening disease or condition”).

 [314]. See supra Section IV.A (describing Right to Try Act provisions).

 [315]. Cal. Health & Safety Code § 111548.1(h) (West, Westlaw through 2018 Sess.) (right to try informed consent requirements); id. § 24173(a)–(e) (general informed consent requirements).

 [316]. See supra Section IV.A (describing Right to Try Act provisions).

 [317]. See Press Release, Pharm. Research & Mfg. of Am. & Biotech. Innovation Org., PhRMA and BIO Initiate Litigation to Challenge Unconstitutional Provisions of Nevada’s SB 539 (Sept. 1, 2017), https://www.phrma.org/phrma-bio-release (initiating litigation over a Nevada law, which the groups argued “attempt[s] to set de facto price controls” on diabetes medicines).

 [318]. See supra notes 194–95 and accompanying text. 

 [319]. See Bateman-House, Findings, supra note 184.

[T]here is no guidance for physicians about which law to follow in cases of conflicts. For example, if a patient lives in South Dakota but seeks care in North Dakota, which state law ought to be observed? If a hospital is located in Arkansas but is part of a network based in Delaware, which state law ought to be observed? If the patient and doctor are in Tennessee but the experimental product they wish to try can be administered only in Texas, which state law ought to be observed?

Id.

 [320]. Expanded Access Program Report, supra note 160, at 3.

 [321]. James E. Valentine & David B. Clissold, Burden of “Right to Try” Implementation on Sponsors (for Now); Risk of Unexpected SAEs Negatively Impacting Development and Approval Still Remains, Hyman, Phelps & McNamara PC: FDA L. Blog (June 8, 2018), http://www.fdalawblog.net
/2018/06/burden-of-right-to-try-implementation-on-sponsors-for-now-risk-of-unexpected-saes-negatively-impacting-development-and-approval-still-remains.

 [322].  Expanded Access to Investigational Drugs for Treatment Use, 74 Fed. Reg. 40,900, 40,924 (Aug. 13, 2009) (codified at 21 C.F.R. pts. 312, 316).

 [323]. Cortez, Cost Dying Patients, supra note 51. BrainStorm planned to limit provider access to those physicians “who participated in the drug’s clinical trials,” and therefore would be experienced with the drug and, presumably, its appropriate dosage and potential side effects. Id. This plan might be one way to combat widespread disclosure, but it would arguably limit the availability of right to try to academic centers and other major hospitals where clinical trials are conducted as opposed to increasing access across the United States—the whole point of the Right to Try Act.

 [324]. Weintraub, supra note 276 (“The new law doesn’t require drug makers to comply with Right to Try requests, but that doesn’t make the burden of dealing with phone calls and e-mails from patients demanding access to experimental products any less burdensome.”).

 [325]. See Edelman, Edelman Trust Barometer—Healthcare: Global 26–27 (2018) (presenting an online survey in twenty-eight markets with 1,150 respondents per market); Laura Entis, Inside Pharma’s Trust Problem, MM&M (June 26, 2018), https://www.mmm-online.com/home
/channel/commercial/inside-pharmas-trust-problem (citing high drug prices, misconceptions that companies are withholding the cure for financial gain, and misleading direct-to-consumer advertising as reasons for this distrust).

 [326]. Bristol-Myers’ Position, supra note 277; see also Janssen Policy, supra note 277 (“We are committed to helping patients with serious illnesses and their families request access to our investigational medicines. We support these requests through our established review and evaluation processes, which includes independent review by the FDA.”).

 [327]. Expanded Access Program Report, supra note 160, at 21 (“40% to 95% [are] the manufacturer approval rates for [expanded access] requests.”).

 [328]. See Rep. Michael McCaul, Expanded Access to 21st Century Cures Act, https://mccaul.house.gov/sites/mccaul.house.gov/files/Expanding%20Access%20to%2021st%20Century%20Cures.pdf (last visited Feb. 11, 2019) (proposing the Cures Act include a provision requiring manufacturers to track and report requests for expanded access to the FDA).

 [329]. Public Workshop: Evaluating Inclusion and Exclusion Criteria, supra note 203, at 6; Caroline McNeil, Broadening the Evidence Base for Older Patients: FDA-ASCO Workshop Explores Emerging Strategies, ASCO Post (Dec. 25, 2017), http://www.ascopost.com/issues/december-25-2017/broadening-the-evidence-base-for-older-patients-fda-asco-workshop-explores-emerging-strategies (“50% of U.S. oncologists are concentrated in eight states.”). Some patients’ jobs might also limit their ability to travel to a clinical trial site on a regular basis while other patients’ insurance may not cover the portions of the clinical trial not paid for by the trial sponsor. See Caroline Chen & Riley Wong, Black Patients Miss Out on Promising Cancer Drugs, ProPublica (Sept. 19, 2018, 5:00 AM), https://www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs.

 [330]. See supra notes 6, 177 and accompanying text (discussing specific cases of companies denying pediatric patient expanded access requests).

 [331]. Tirrell, supra note 5; see infra Appendix.

 [332]. Allergan Pre-Approval Access Program, supra note 125.

 [333]. Tirrell, supra note 5; see infra Appendix.

 [334]. See Bourgeois et al., supra note 300.

 [335]. Id. at 287.

 [336]. Kim et al., supra note 49, at 3740.

 [337]. Reddy, supra note 6.

 [338]. Investigational Drugs Available, Bristol-Myers Squibb, https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine/investigational-drugs-available.html (last visited Feb. 11, 2019); Investigational Medicines for Compassionate Use Requests, Janssen, https://www.janssen.com/compassionate-use-pre-approval-access/investigational-medicines-for-compassionate-use-requests (last updated Feb. 11, 2019).

 [339]. Janssen Policy, supra note 277, at 361.

 [340]. CompAC: The Compassionate Use Advisory Committees, N.Y.U. Langone Health, https://med.nyu.edu/pophealth/divisions/medical-ethics/compassionate-use-advisory-committee (last visited Feb. 11, 2019) (describing the role of CompAC and the composition of the committee).

 [341]. Id.

 [342]. Caplan & Ray, supra note 131, at 979–80. This approach emphasizes fairness, attempting to ensure that requests are not granted to only those individuals who are social media savvy or well-connected. Id.

 [343]. About the Expanded Access Navigator, supra note 215 (providing a “roadmap” for IRBs).

 [344]. Alexander Gaffney, Regulatory Explainer: FDA’s Expanded Access (Compassionate Use) Program, Reg. Focus (Feb. 4, 2015), https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2014/2/regulatory-explainer-fda-s-expanded-access-(compassionate-use)-program.

 [345]. Letter from Marc B. Wilenzick, Pfizer Senior Counsel on behalf of Pfizer, Comment Letter on Proposed Rule Charging for Investigational Drugs 7 (Feb. 14, 2007), https://www.pfizer.com/sites
/default/files/research/research_clinical_trials/Charging_for_Investigational_Drugs.pdf.

 [346]. Jung et al., supra note 113, at 1018.

While the 21st Century Cures Act did not require manufacturers to include pricing information in their expanded access policies, seven addressed financial aspects of accessing investigational medicines. Five indicated that they provide investigational medicines to patients at no cost, and among these five, one also stated that the manufacturer may reimburse fees and expenses associated with the use of the drug for expanded access. The other two manufacturers described pricing as depending on insurance and other factors.

Id.

 [347]. Ashley Kirzinger et al., KFF Election Tracking Poll: Health Care in the 2018 Midterms, Kaiser Family Found. (Oct. 18, 2018), https://www.kff.org/health-reform/poll-finding/kff-election-tracking-poll-health-care-in-the-2018-midterms.

 [348]. Dan Diamond, Drug Prices in Ads Are Coming—If HHS Gets Its Way, Politico Pulse (Oct. 15, 2018, 10:00 AM), https://www.politico.com/newsletters/politico-pulse/2018/10/15/drug-prices-in-ads-are-coming-if-hhs-gets-its-way-373552. PhRMA has proposed its own plan in which “[a]ll TV ads that mention a medicine by name should direct patients to information about cost, ‘such as a company-developed website.’” Feds, Big Pharma Issue Competing Price Transparency Plans, Modern Healthcare (Oct. 20, 2018), https://www.modernhealthcare.com/article/20181020/NEWS
/181019859.

 [349]. See infra Appendix (adequate supply); Fraser, supra note 185 (“[Genentech] was already in the process of trying to dramatically ramp up its production of Herceptin, encountering roadblocks in machinery, engineering and chemistry along the way.”).

 [350]. See supra notes 4647 and accompanying text.

 [351]. Kim et al., supra note 49, at 3740 (studies often exclude pediatric patients); Chen & Wong, supra note 329 (noting criteria often excludes patients with more than chronic condition, which can disproportionately affect African Americans); Judith Graham, Seniors Miss out on Clinical Trials, Kaiser Health News (June 29, 2017), https://khn.org/news/seniors-miss-out-on-clinical-trials (“[O]nly 40 percent of patients participating in cancer clinical trials were 65 and older” despite “more than 60 percent of cancer patients [being] older adults.”).

 [352]. See Pharma. Research & Mfr. of Am., Biopharmaceutical Industry-Sponsored Clinical Trials: Impact on State Economies, at I (2015) (“The five states with the highest number of active clinical trial sites were California (3,111), Florida (2,571), Texas (2,799), New York (2,476), and Pennsylvania (1,972).”).

 [353]. See supra note 329 and accompanying text.

 [354]. ASCO and Friends, supra note 47; see also Bateman-House & Robinson, supra note 231, at 322 (proposing Congress should explore measures that would encourage greater potential access to investigational drugs through clinical research).

 [355]. Kim et al., supra note 49.

 [356]. Id. at 3742.

 [357]. Press Release, SWOG Cancer Research Network, Cancer Comorbidities Reduce Trial Enrollment (Jan. 10, 2019), https://www.swog.org/news-events/news/2019/01/10/cancer-comorbidities-reduce-trial-enrollment. The lead author of the JAMA Oncology study Joseph Unger explained,

[i]f you look at the numbers, they tell you that the ASCO/Friends/FDA guidelines were well focused, as they alone would account for more than half of the potential gains from updating eligibility criteria in trials. . . . This would have the short-term impact of helping patients by giving them access to new treatments and have a long-term impact on the discovery of new treatments, speeding the time it takes to run trials and get new treatments to the public.

Id.

 [358]. Compare Diversity in Lilly-Sponsored Clinical Trials in North America, Eli Lilly, https://www.lilly.com/diversity-in-lilly-sponsored-clinical-trials-in-north-america (“[E]very study conducted with more than 25 clinical trial sites must select at least two sites meeting Lilly’s diversity criteria.”) (last visited Feb. 11, 2019), with Advancing Inclusive Research, Genentech, https://www.gene.com/patients/advancing-inclusive-research (assessing its site selection process and developing new “inclusive research” standards) (last visited Feb. 11, 2019).

 [359]. Chen & Wong, supra note 329 (noting biotech firm CEO citing concerns that regulation aimed at improving diversity would delay development efforts).

 [360]. See id.

 [361]. Chreasea Dickerson, Incentives Watch: Illinois Diversity and Inclusion Tax Credit Initiatives, Bloomberg BNA: Salt Talk Blog (Sept. 12, 2017), https://www.bna.com/incentives-watch-illinois-b57982087723 (discussing state efforts to include diversity and inclusion provisions in film production tax credits). The adoption of diversity inclusion plans could require companies to reevaluate their inclusion and exclusion criteria.

 [362]. The FDA already gives tax credits, trial grants, and exemptions from the Prescription Drug User Fee Act to incentivize development of drugs for rare diseases. Designating an Orphan Drug Product: Drugs and Biological Products, U.S. Food & Drug Admin., https://www.fda.gov/forindustry
/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm (last updated July 26, 2018). For more information about the Prescription Drug User Fee Act, see Prescription Drug User Fee Amendments, U.S. Food & Drug Admin., https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee (last updated Feb. 8, 2019).

 [363]. See Chen & Wong, supra note 329.

 [364]. But see Michelle Cortez, Brain Cancer Patient Is First to Get Untested Treatment Under Trump-Backed Law, Bloomberg (Jan. 10, 2019, 6:16 AM), https://www.bloomberg.com/news/articles
/2019-01-10/brain-cancer-patient-gets-unproven-therapy-first-under-new-law (reporting that a European-based biotechnology company is “the first publicly known” company to provide an investigational drug through the Right to Try Act).

 [365]. E.g., Munz, supra note 191 (discussing a patient moving to a state with a right-to-try law, but who is unable to secure access); Weintraub, supra note 276 (noting that one relative’s calls seeking right to try for a family member escalated to threats).

 [366]. Rita Rubin, Experts Critical of America’s Right-to-Try Drug Laws, Lancet (Oct. 3, 2015), https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00393-1/fulltext.

 [367]. The FDA can currently assess civil monetary penalties against companies that fail to submit registration or clinical trial results to ClinicalTrials.gov. 42 U.S.C. § 282(j) (2018). Congress should also amend the Cures Act to give the agency a similar enforcement mechanism when a company fails to publish its expanded access guidelines and related cost recovery policies. Id.; see also Bateman-House, Examining Patient Access, supra note 210.

 [368]. Junod, supra note 15 (quoting William Thomas Beaver, who drafted the controlled clinical trial regulation promulgated after the enactment of the Kefauver–Harris Amendment). The adoption of diversity and inclusion plans would likely require companies to reevaluate their inclusion and exclusion criteria. See ASCO and Friends, supra note 47 (“Broadening the eligibility criteria for clinical trials will provide the opportunity for more people to participate in research studies. Not only will this improve access, it will make the trial results more reflective of the people that will ultimately use the drug.”).

 [369]. Kim et al., supra note 49, at 3737.

 

 [i]. Pfizer Policy, supra note 100; Pfizer’s Position on Preapproval Access to Investigational Drugs, Pfizer (May 2018), https://www.pfizer.com/files/research/Policy_paper_Preapproval_Access_to_Investigational_Drugs_May2018.pdf.

 [ii]. Managed Access Programs, Novartis, https://www.novartis.com/our-focus/healthcare-professionals/managed-access-programs (last visited Feb. 11, 2019).

 [iii]. Genentech Policy, supra note 100.

 [iv]. Compassionate Use of Sanofi Investigational Products, Sanofi, https://www.sanofi.com/en/science-and-innovation/clinical-trials-and-results/compassionate-use-expanded-access (last visited Feb. 11, 2019).

 [v]. Access to Investigational Medicines, Merck, https://www.merck.com/about/views-and-positions/access-to-medicines/home.html (last visited Feb. 11, 2019).

 [vi]. Janssen Policy, supra note 277.

 [vii]. GlaxoSmithKline, GSK Public Policy Positions: Compassionate Use 1–2 (2017), https://www.gsk.com/media/3368/compassionate-use.pdf.

 [viii]. Expanded Access: Individual Access to Investigational Medicines Intended to Treat Serious Diseases, Gilead, http://www.gilead.com/research/expanded-access (last visited Feb. 11, 2019).

 [ix]. Pre-Approval Access to Investigational Drugs Policy, AbbVie, https://www.abbvie.com/our-company/access-to-investigational-drugs-policy.html (last visited Feb. 11, 2019).

 [x]. Access to Investigational Medicines, Amgen, https://www.amgen.com/responsibility/access-to-medicine/access-to-investigational-medicines (last visited Feb. 11, 2019).

 [xii]. Early Patient Access to Investigational Medicine, Bristol-Myers Squibb, https://www.bms.com/healthcare-providers/early-patient-access-to-investigational-medicine.html (last visited Feb. 11, 2019).

 [xiii]. Teva Pharm., supra note 121, at 1–8.

 [xiv]. How to Request Access to Investigational Medicines, Bayer, http://pharma.bayer.com/en/commitment-responsibility/ethics-and-transparency/ethics-in-r-and-d/access-to-investigational-medicinal-products (last visited Feb. 11, 2019).

 [xv]. Expanded Access, Lilly, https://www.lilly.com/discovery/clinical-trials/expanded-access (last visited Feb. 11, 2019).

 [xvi]. Expanded Access, Novo Nordisk, http://www.novonordisk-us.com/whoweare/about-novo-nordisk/expanded-access.html (last visited Feb. 11, 2019).

 [xvii]. Allergan Pre-Approval Access Program, supra note 125.

 [xviii]. Expanded Access to Investigational Drugs, Takeda Oncology, http://www.takedaoncology.com/medicines/access-to-investigational-drugs (last visited Feb. 11, 2019).

 [xix]. Clinical Trials, Celgene, https://www.celgene.com/research-development/clinical-trials (last visited Feb. 11, 2019).

 [xx]. Astellas Position, supra note 124.

From Presentation to Presence: Immersive Virtual Environments and Unfair Prejudice in the Courtroom – Note by Khirin Bunker

From Volume 92, Number 2 (January 2019)
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FROM PRESENTATION TO PRESENCE: IMMERSIVE VIRTUAL ENVIRONMENTS AND UNFAIR PREJUDICE IN THE COURTROOM

What if you could transport your jury from a courtroom to the scene of a catastrophic event? . . . Imagine how much more empathy you would feel for the victim of a catastrophic collision if you were to experience the tragedy first-hand.[1]

Introduction

In the courtroom environment, oral presentations are becoming increasingly supplemented and replaced by advancing digital technologies that provide legal practitioners with effective demonstrative capabilities.[2] Improvements in the field of virtual reality (VR) are facilitating the creation of immersive environments in which a user’s senses and perceptions of the physical world can be completely replaced with virtual renderings.[3] As courts, lawyers, and experts continue to grapple with evidentiary questions of admissibility posed by evolving technologies in the field of computer-generated evidence (CGE),[4] issues posed by the introduction of immersive virtual environments (IVEs) into the courtroom have, until recently, remained a largely theoretical discussion.

Though the widespread use of IVEs at trial has not yet occurred, research into the practical applications of these VR technologies in the courtroom is ongoing,[5] with several studies having successfully integrated IVEs into mock scenarios. For example, in 2002, the Courtroom 21 Project (run by William & Mary Law School and the National Center for State Courts) hosted a lab trial in which a witness used an IVE.[6] The issue in the case was whether a patient’s death was the result of the design of a cholesterolremoving stent or a surgeon’s error in implanting it upside down.[7]

During the mock trial, a key defense witness who was present during the surgery donned a VR headset, which recreated the operating room, and then projected to the jury her view of the operation on a large screen as she reenacted her role in the surgery. The demonstration significantly reduced the credibility of the witness when it revealed that she could not possibly have seen the doctor’s hands or wrists.[8]

In another experiment, Swiss researchers successfully used an Oculus Rift headset and Unity 3D software to render an IVE that made it possible for a viewer to assess how close bullets came to severely injuring a victim during a shooting.[9] Using a laser scan of the crime scene, footage taken from an onlooking security camera, and the final position of the projectiles, researchers were able to reconstruct the scene of the shooting to enable viewers to review the bullet trajectories, visibility, speed, and distance.[10]

Similarly, the Bavarian State criminal office, which currently handles the prosecution of Nazi war criminals tied to the Holocaust, applied laser scanning technology to develop a VR model of the Auschwitz concentration camp.[11] The model was recently adapted into an IVE for future use at trial, allowing jurors to examine the camp from almost any point of view.[12]

As research continues and new applications of IVE technology have been investigated, the use of VR technology is becoming increasingly mainstream and costeffective,[13] making it more practical to use an IVE in the courtroom. As such, early adapters in civil practice have announced plans to use IVEs at trial,[14] while litigation support providers are beginning to advertise VR development services.[15] Rising use of laser imaging software and body cameras among law enforcement departments, with the capacity to be converted into an IVE format for use at trial,[16] also has significant potential to facilitate the rapid expansion of these technologies in criminal proceedings.

From the standpoint of a legal practitioner, the potential value in applications of IVE use at trial are numerous. As a form of evidence, IVEs have the potential to redefine the way in which litigators can recreate crime and accident scenes for the jury.[17] Rather than having a jury watch a video rendering or review images after-the-fact, an IVE could allow jury members to witness an event firsthand—from any specific moment, angle, or viewpoint.[18] As a demonstrative technology, an IVE can be easily adapted to depict eyewitness and expert testimony, explain highly technical concepts, or transport users into an interactive environment in any given scenario.[19]

While some commentators have welcomed the onset of IVEs into the courtroom as a natural progression and the next step in technological development of visual media,[20] others have argued that IVEs are fundamentally different from prior forms of evidence and warrant heightened caution due to potential prejudicial effects on juries.[21] This Note supports the latter position and, drawing on psychological research, ultimately argues for revisions to be made in the admission of IVEs as demonstrative evidence.

Part I of this Note defines and distinguishes IVEs from other forms of VR and CGE. Part II compares the treatment of substantive and demonstrative evidence under the Federal Rules of Evidence and discusses the relevant evidentiary rules for the use of an IVE as an illustrative aid. Part III outlines applicable psychological and cognitive research and potential prejudicial effects on juries stemming from the employment of IVEs in a trial setting under the current rules. Part IV examines several cases in which computer-generated animations were subjected to lower evidentiary standards and raises further concerns in applying the current rules to an IVE. Part V explains the need for revisions to the procedures for admitting an IVE as demonstrative evidence and concludes by recommending new procedures which should be implemented prior to the proliferation of IVEs in the courtroom.

I.  Distinguishing Immersive Virtual Environments

The term “virtual reality” is used in many contexts, and it is important to note the distinctions between VR technologies capable of facilitating IVEs, which are the subject of this Note, and other mediums for virtual environment (VE) interaction and display. Computergenerated VEs can be roughly grouped into three broad categories based on the level of user immersion:[22] non-immersive (desktop), semi-immersive, and immersive virtual environments.[23]


Non-immersive systems, which include Fish Tank and Desktop VR, are monitor-based VR systems where users engage with the VE through a basic desktop display using stereoscopic lenses or an inherent autostereoscopic feature.[24] These kinds of displays do not necessitate that the user wear a VR headset or glasses and typically do not surround the user visually.[25] Likewise, semi-immersive systems have similar technologies but use large screen monitors, large screen projector systems, or multiple television projection systems that increase the users field of view, thereby increasing the level of immersion.[26]

Separate from these categories are mixed-reality, or augmented reality (AR), technologies that combine physical and virtual objects and align them with the real-world environment.[27] AR environments create a local virtuality, which is mapped onto the physical environment around the user, rather than completely replacing the surrounding environment with a virtual one.[28]

An IVE, by contrast, “perceptually surrounds the user.”[29] This is accomplished with a combination of three-dimensional computer graphics, high-resolution stereoscopic projections, and motion tracking technologies that continually render virtual scenes to match the movements and viewpoint of the user.[30] Through the use of a head-mounted display (HMD),[31] sensory information from the physical world is replaced with the perception of a computergenerated, three-dimensional world in which the user is free to move and explore.[32] In the context of an IVE, VR can therefore be understood to mean “a computer-generated display that allows or compels the user (or users) to have a feeling of being present in an environment other than the one they are actually in and to interact with that environment.”[33]

The resulting sense of presence felt by the user is described as a function of an individual’s psychology,[34] representing the degree to which that user experiences a conscious presence in the virtual setting.[35] This effect on a user’s state of consciousness has been attributed to the unique vividness and interactivity of an IVE,[36] which distinguishes IVEs from prior forms of CGE.[37] This sense of consciousness created by an IVE also forms the basis for psychological concerns about leading to potential risks of unfair prejudice in using an IVE at trial.[38] However, prior to further discussion of the unique psychological issues raised by IVEs, it is important to understand how an IVE offered for use at trial would be evaluated under the current rules of evidence.

II.  Immersive Virtual Environments and the Federal Rules of Evidence

As previously noted, at trial, an IVE could be applied by courtroom attorneys for presentations to the jury that recreate crime and accident scenes, illustrate highly technical procedures, and demonstrate eyewitness or expert testimony. The most practical method of IVE application in the courtroom would be jurors donning individual HMDs during the course of, or simultaneous with, live testimony.

Though the use of IVEs in the courtroom remains largely unprecedented, the process for addressing the question of an IVE’s use at trial will likely be similar to that used for other forms of visual media.[39] At present, the Federal Rules of Evidence fail to make specific reference to any form of CGE, and therefore do not address the concept of an IVE.[40] Yet, in the absence of legislative revision, it is fair to assume that the admissibility of IVE evidence will be evaluated under existing basic evidentiary rules[41] as well as accompanying general principles which have developed among the courts for determining the admissibility of other forms of CGE.[42]

As a form of visual media, an IVE would need to be classified as either demonstrative—also called illustrative—or substantive evidence.[43] In the realm of CGE, courts have generally labeled 3D renderings as either computer animations (typically treated as demonstrative evidence) or computer simulations (typically treated as substantive evidence).[44] This classification is critical in determining the applicable foundational requirements, which vary due to the differing purposes for which the evidence is introduced.[45]

Substantive evidence is offered by the proponent “to help establish a fact in issue.”[46] Thus, a computer-generated simulation created through the application of scientific principles would be considered to have independent evidentiary value and therefore be evaluated as substantive evidence.[47] If treated similarly, an IVE used to reconstruct the moment of a car accident, created through software that was programmed to analyze and draw conclusions from pre-existing data (such as calculations, eyewitness testimony, and so forth) would be considered substantive evidence.[48]

One of the primary hurdles facing an IVE entered as substantive evidence at trial would be in laying the foundation for its admission.[49] Because of these foundational challenges, the primary method for introducing an IVE as substantive evidence at trial would likely be in a form accompanying expert testimony.[50] This introduction could be done in several ways: as “part of the basis for expert opinion testimony, an illustrative aid to expert testimony, or a stand-alone exhibit introduced through the testimony of an expert involved in creating the IVE.”[51] As substantive evidence, a testifying expert could draw conclusions about the accident based on the IVE simulation, and it might be admitted as an exhibit that would be made available to the jury for review in deliberations.[52] Yet, as such, both the expert who prepared the IVE and the underlying scientific principles and data used in its construction would be subject to validation.[53]

Demonstrative evidence, in contrast, is defined as “physical evidence that one can see and inspect . . . and that, while of probative value and [usually] offered to clarify testimony, does not play a direct part in the incident in question.”[54] Meaning that, in theory, demonstrative evidence itself serves merely to illustrate the verbal testimony of a witness and should not independently hold any probative value to the case.[55] As such, visual aids introduced as demonstrative evidence are not typically allowed into jury deliberations and are not relied on as the basis for expert opinion.[56] Because visual aids offered as demonstrative evidence are not formally admitted as exhibits, courts treat this kind of evidence more leniently than substantive evidence when evaluating its use at trial.[57] An IVE presented as an illustrative aid to expert testimony, rather than as a basis for expert testimony or an independent exhibit, would therefore not be subject to the same level of scrutiny as substantive evidence.[58]

Despite these standards being significantly lowered, an IVE offered as demonstrative evidence would still need to meet basic evidentiary standards of relevancy, fairness, and authentication.[59] However, it is important to note that the extent to which these requirements would be enforced is a question of judicial discretion and ultimately rests with the presiding trial judge.[60]

The initial inquiry into an IVE, regardless of whether it was offered for demonstrative purposes, would determine whether it was relevant under Federal Rules 401 and 402. Rule 401 would require that the IVE have a “tendency to make a fact more or less probable than it would be without the evidence” and be “of consequence in determining the action.”[61] After a preliminary determination of relevancy, and absent any restrictions in Rule 402,[62] a demonstrative IVE would also need to be authenticated using the guidelines of Rule 901.[63]

Rule 901(a) states that to “satisfy the requirement of authenticating or identifying an item of evidence, the proponent must produce evidence sufficient to support a finding that the item is what the proponent claims it is.”[64] With respect to computer-generated animations used as demonstrative evidence, the animation must “fairly and accurately reflect the underlying oral testimony . . . aid the jury’s understanding” and be authenticated by a witness.[65] Thus, an animation used solely to illustrate witness testimony requires only that the witness testify that it was an accurate representation of the testimony and,[66] in the case of an expert witness, that it would help the jury to understand the expert’s theory or opinion.[67] Using the current method for computergenerated animations, a witness with personal knowledge of the event in question or an expert who had been made aware of the circumstances surrounding the event could simply testify that the IVE was a fair and accurate portrayal of the expert’s testimony.[68]

Importantly, some commentators have posited that, as a newer technology, the foundational requirements imposed on an IVE could be higher than those required for existing forms of illustrative aid.[69] This might necessitate that the proponent of an IVE meet some or all of the more difficult foundational hurdlesbriefly mentioned aboveregarding the use of scientific evidence.[70] As with other questions of admissibility, however, this determination would be made by the trial judge and the imposition of additional requirements, more akin to substantive evidence, should not be taken as a certainty.[71] Though the underlying data in an IVE offered as demonstrative evidence would undoubtedly be challenged by an opposing party, similar challenges were made in the context of computergenerated animations and were rejected by the courts even during the earliest stages of that technology’s introduction into the legal system.[72]

Regardless of the outcome of future methods used for authentication and despite a finding of relevance using Rules 401 and 402, an IVE could still be excluded by the trial judge under the balancing test of Rule 403.[73] Rule 403 states that “[t]he court may exclude relevant evidence if its probative value is substantially outweighed by a danger of one or more of the following: unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.”[74] These broad standards set out by Rule 403 are a result of the high level of subjectivity required in making an admissibility determination, which essentially dictates a case-by-case analysis.[75] As such, decisions made by the trial judge pursuant to Rule 403 are largely exercises of discretion and are reviewed almost exclusively for abuse of discretion at the appellate level.[76] Although a trial judge might exclude an IVE for any of the above reasons listed under Rule 403, the distinct potential for unfair prejudice created by an IVE is the source of concern for much of the remaining discussion in this Note.

The Rule 403 advisory committee notes define unfair prejudice as “an undue tendency to suggest decision on an improper basis, commonly, though not necessarily, an emotional one.”[77] Broadly speaking, decisions to exclude a piece of evidence for unfair prejudice can be broken down into two primary categories: emotionalism and misuse of evidence.[78] Unfair prejudice caused by overreliance on emotion can be understood as evidence deemed to be “overly charged with appeal to this less rational side of human nature.”[79] Though the goal of Rule 403 is not to exclude all forms of evidence that elicit emotional response, the aim of the trial judge is to moderate the extent to which this response occurs. Aside from emotional concerns, unfair prejudice also results when evidence is misused by the jury after being deemed “admissible for one purpose (or against one party) but not another.”[80] The risk of misuse arises when there is a high likelihood “that the jury will mistakenly consider the evidence on a particular issue or against a particular party, even when properly instructed not to do so.”[81]

In either case, it is necessary for the judge to evaluate whether the probative value of the evidence is substantially outweighed by the risk of a juror’s reliance on an improper basis.[82] To do so, the judge must also take into consideration whether or not the risk can be remedied by issuing a limiting instruction.[83] In making determinations about admissibility, however, it is important for a judge to understand the unique psychological factors implicated by the use of an IVE. Without so doing, a judge may come to a decision which appears on the surface to be well-founded, but ultimately fails to consider the full extent of the risks posed by the use of an IVE. In the next Part, I will discuss several psychological and cognitive factors which should be measured when determining the admissibility of an IVE as demonstrative evidence.

III.  Potential Prejudicial Impacts of Immersive Virtual Environments on Jury Decisionmaking

A.  Designing Emotion in a Virtual Environment

As discussed in Part I, the element of presence in an IVE distinguishes this form of presentation from other forms of CGE. The concept of presence can be understood to manifest itself in a VE in three ways: via social presence, physical presence, and self presence. This Note is primarily concerned with the latter two.[84] Self presence has been defined as “a psychological state in which virtual (para-authentic or artificial) self/selves are experienced as the actual self in either sensory or nonsensory ways.”[85] Similarly, physical presence has been explained as “a psychological state in which virtual (para-authentic or artificial) physical objects are experienced as actual physical objects in either sensory or nonsensory ways.”[86] Reported experiences of both user self and physical presence in IVEs have led researchers to examine the ways in which IVEs influence user emotion, empathy, and embodiment, each of which will be addressed in turn below.

While research into the effects of IVEs on user emotion remains an active area for experimentation and debate,[87] initial studies have shown significant links between user presence in an IVE and stimulated emotion. One particular area of research has focused on the impact of emotional content in VEs and the relationship between user feelings of presence and actual user emotion.[88] The basic premise behind this type of research follows the logic that “if a dark and scary real-life environment elicits anxiety, so will a corresponding VE if the user experiences presence in it.”[89]

Following this theory, studies have been conducted involving mood induction procedures (MIPs), in which VEs have been intentionally designed to provoke specific emotional states.[90] For example, one such study presented participants with three different virtual park scenarios using an HMD with head tracking software and an accompanying joystick to facilitate movement.[91] The three park renderings shared the same virtual structure and objects (for example, trees, lamps, and so forth), but the developers manipulated the sound, music, shadows, lights, and textures with the purpose of inducing either anxiety or relaxation in users. The third park served as a neutral control that was not designed to induce any emotion.[92] Participants were assessed for emotional predisposition prior to the study, and they answered questionnaires regarding emotion and presence throughout the study.[93] The results showed significant variability in user happiness and sadness depending on which park the participant experienced.[94] The anxious park, which contained darker imagery and shadows, reduced user happiness and positive effects, while increasing feelings of sadness and anxiety.[95] In contrast, the relaxing park, which contained brighter imagery, increased user quietness and happiness, while reducing anger, sadness, anxiety, and negative effects.[96] The neutral park, however, did not elicit significant measurable changes.

Building on the same research, a more recent study exposed participants to different virtual park scenarios intentionally designed to elicit one of five specific affective states: joy; anger; boredom; anxiety; and sadness.[97] Effects on participants emotional reactions were measured through both physiological responses (monitoring electrodermal activity) and self-reporting. Based on these measures, researchers found they were able to induce the intended emotions in almost all cases and that they could elicit different emotional states by applying only slight changes to the lighting conditions or sounds in the VE.[98] Thus, these measures exhibit further support for the notion that VEs may be specifically designed to induce intended emotional states through various MIPs and alterations to the design elements in a virtual scenario.[99]

In addition to studies on inducing emotional states, others have examined the effects of IVEs on user empathy.[100] As previously noted, a core fundamental difference between traditional CGE and IVEs is in the form of presentation. Any time an image is rendered on a screen, there is a possibility that a viewer will interpret the image objectively because it appears without a human operator (who would be viewed as a subjective party).[101] Yet, in a traditional CGE display, the physical surroundings of the courtroom remain within the perspective of the viewer and the animation or simulation playing on the screen often retains a fixed camera viewpoint.[102] In contrast, through an IVE, the user can effectively take on the role of any specific actor or third-party observer in any given scenario.[103]

A recent study examining the influence of a user’s point of view on his or her assessment of vehicle speed and culpability in a computer animated car crash sequence demonstrates this effect.[104] Participants were presented with three separate animations of a two-car collision from different points of view: overhead (behind and above Car 1), internal (inside Car 1), and facing (looking directly at Car 1).[105] They were then asked to fill out a questionnaire which involved apportioning blame to either Car 1 or Car 2.[106] The study results demonstrated substantial differences in overall culpability assessments depending on the participant’s point of view, with participants apportioning 92% of the blame to Car 1 from the facing position, but only 43% from the overhead view and 34% from the internal view.[107] Though the study acknowledged limitations on ecological validity, the results were in line with Feigenson and Dunn’s hypothesis that small changes and manipulations to an observer’s point of view in a computer-generated animation may “have various legally significant effects.”[108]

In another study, participants were divided into 2 x 2 groups based on levels of immersion and user personality traits.[109] Participants then watched a documentary news series through VRcontent-based or flat-screen-based technologies, depending on the immersion group.[110] The study found that presence in the VE positively influenced both empathy and embodiment—meaning that users in a higher immersion setting were more likely to feel a sense of compassion for the subjects of the news story.[111] Importantly, the authors of the study urged that immersion in a VE should be recharacterized “as a cognitive dimension alongside consciousness, awareness, understanding, empathizing, embodying, and contextualizing” rather than as a strong stimulus for facilitating illusion.[112] In other words, instead of viewing IVE technology as an illustrative aid in storytelling, it should be viewed as a factor influencing user cognition in reasoning through a proposed narrative.[113]

Based on current findings in both areas of research and despite ongoing debate regarding specific limitations and interplay between these factors in a VE, the potential for an IVE to be purposefully designed to elicit user emotions and empathy appears to exist. While relying on emotion and empathy in our day-to-day decisionmaking can be an ecologically valid tool of assessment, in the courtrooman intentionally hermetically sealed universeit poses a distinct risk of unintended prejudicial effects. Murtha v. City of Hartford provides an example of how these potential effects might be implicated in the trial setting.[114] In 2006, Connecticut Police Officer Robert Murtha was acquitted on all charges relating to his shooting a suspect who was evading police in a stolen car.[115] During the pursuit, the car stalled in snow on the side of the road.[116] As Murtha left his cruiser and approached the car, the suspect attempted to reenter the road and speed off. Murtha fired multiple shots into the driver’s side window that injured the fleeing driver. Dashcam footage from another police cruiser positioned behind Murtha showed him chasing the vehicle and firing into the car as it sped off.[117]

At trial, Murtha argued that his use of deadly force was justified as an act of self-defense because, at the time, he believed that the car was headed towards him.[118] Murtha presented the jury with a hybrid of the dash cam footage and a computergenerated animation to illustrate his point of view.[119] As the driver begins to pull onto the road, the original video freezes and an interspliced animation rotates the field of view from the liveaction shot to a recreation of Murtha’s first-person perspective.[120] Comparing the original footage to the animation, there are some clear discrepancies: (1) the car re-enters the road at a sharper angle; (2) Murtha is placed partially within the path of the car and his gun is already drawn and extended; (3) as the car begins to drive off, Murtha moves slowly alongside the car while firing instead of running.[121] However, over the prosecutor’s objections as to the inaccuracy of the animation, the judge determined that the video was a fair and accurate depiction of Murtha’s recollection and issued a limiting instruction that the animation was not meant to depict a precise reenactment.[122]

In creating a computer-generated display, a designer’s decision to provide one viewpoint over another “can potentially alter which ‘character’ in an evidence presentation a viewer identifies with, or aligns themselves with.”[123] Through the animation in Murtha, the jury effectively took on the role of the officer in the shooting. Putting any discrepancies in the animation aside, placing the jurors in the shoes of the officer alone created the potential for unfair prejudice resulting from actorobserver bias. If the same animation in Murtha was presented in the form of an IVE, the additional factor of user presence would further complicate this potential. Based on the above studies, an IVE can be intentionally designed to elicit, or even unintentionally cause, a user to feel strong emotions, empathy, and overall self-alignment, which would significantly magnify the risk of unfair prejudice. Though these potential sources of prejudice may not ultimately have been grounds for reversal in Murtha,[124] they should be recognized as important factors when addressing the question of prejudicial effects in an IVE.

B.  Body Ownership Illusions

When an IVE user feels strongly about another person’s emotions or circumstances in a VE, this can translate into a cognitive feeling of embodiment.[125] Thus, in addition to increasing user emotion and empathy through presence, the virtual body experienced by the user can begin to feel like an analog of the user’s biological body generated through user cognition.[126] As a result, the user-tracking technologies used to facilitate an IVE uniquely involve the potential to produce body ownership illusions (“BOIs”).[127] BOIs are created when non-bodily objects (like a virtual projection or prosthetic limb) are experienced as part of the body through a perceived association with bodily sensations such as touch or movement.[128] The first experiment by Botvinick and Cohen introduced the concept of BOIs through a rubber hand illusion.[129] Participants in the original experiment had their hands concealed and a rubber hand with a similar posture was placed in front of them. An experimenter then stroked both the real and rubber hands simultaneously, causing the majority of participants to report feeling that the rubber hand was a part of their own body.[130] This phenomenon, termed the rubber hand illusion, was later shown to activate areas of the brain “associated with anxiety and interoceptive awareness” when “the fake limb is under threat and at a similar level as when the real hand is threatened.”[131] Thus, participants in one study reacted in anticipation of pain, empathic pain, and anxiety when experimenters occasionally threatened a rubber hand with a needle while participants were under the effects of a BOI.[132]

Subsequent experiments have also tested the extent to which certain multisensory factors are necessary to induce BOIs.[133] While the original experiment involved a visuotactile cue (where participants experienced a combination of visual stimulation and physical contact), further experiments have induced BOIs solely through visuomotor input.[134] Visuomotor stimulation involves participants performing active or passive movements while simultaneously seeing the artificial body (or body part) perform the same movements.[135] Most significantly, this phenomenon has been shown to occur in VEs.[136]

For example, in one study, experimenters outfitted participants with an HMD and a handtracking data glove and asked them to focus on the movement of a virtually projected right arm which moved synchronously with the actions of their real right arm, hand, and fingers.[137] The participants’ real right arm was located approximately twenty centimeters away from the virtual projection. Participants were then asked to use their left arm, which was not tracked or projected, to point to their right arm.[138] The participants largely tended to misidentify their real hand and instead identify the virtual hand, in some cases even after the virtual simulation had terminated.[139] The results were consistent with prior studies involving the rubber hand illusion and showed that the illusion of ownership could occur as a result of visuomotor synchrony in movements between the real and virtual hand.[140]

Additional studies of BOIs in VR have led to consistent findings that VEs can produce these effects when homogenous body parts are moved synchronously.[141] These studies have found BOIs resulting from the synchronous movement of virtual legs,[142] upper bodies,[143] and even full bodies.[144]

In an IVE, the occurrence of BOIs as a result of visuomotor stimulation has significant implications as a potential source of unfair prejudice. Beyond the concern that user emotion and empathy in an IVE might cause a juror to sympathize more with a party whose perspective he or she shares, BOIs introduce a separate issue: synchrony between a juror’s movements and those of an actor perceived in an IVE could cause the juror to temporarily feel as if he or she is that person. While some psychological studies have highlighted benefits of inducing BOIs through VR in the courtroom, for example in the potential for reducing racial biases,[145] the risk for unfair prejudice is also exceptionally high. From the standpoint of emotional prejudice, BOIs created through an IVE can both cause the viewer to feel anxious or threatened in a scenario[146] and ultimately to identify with the avatar.[147] For example, if the animation in Murtha were presented through an IVE (with jurors wearing an HMD and data gloves), the jurors could feel as if the car was coming towards their own bodies, eliciting fear or anxiety through an apprehension of contact. Moreover, this vivid and emotional experience could cause a juror to disregard conflicting pallid evidence in the case as to the car’s trajectory or the sequence of events and unduly rely on the IVE, despite its being used merely as a representation of the propounding party or witness’s theory of the case.

IV.  Problems with the Current Rules for Demonstrative Computer-Generated Evidence

A.  Case Studies

When subjecting jurors to an IVE, both presence and the phenomenon of BOIs create a unique potential for unfair prejudice. Even though IVEs are uniquely immersive and extremely vivid when introduced as demonstrative evidence, they could still remain subject to surprisingly low evidentiary standards. While the rules presented in Part II may at face value appear to be a significant burden for the proponent of an IVE, as stated previously, the characterization of an IVE as substantive or demonstrative and the broad discretion afforded to trial judges can significantly impact the extent to which the rules are used to allow the use of IVE at trial. The treatment of CGE in the following cases is illustrative of the more lenient approach applied in many jurisdictions when dealing with demonstrative evidence.[148]

In Commonwealth v. Serge, a defendant found guilty of first-degree murder for killing his wife appealed the State’s use of a computer-generated animation as demonstrative evidence.[149] The animationintroduced to illustrate the expert testimonies of a forensic pathologist and crime scene reconstructionistpurported to show the manner in which the defendant shot his wife.[150] Prior to admitting the animation, the trial court required that it be authenticated as both a fair and accurate depiction of the testimony and that any potentially inflammatory material be excluded.[151] The trial court also issued a lengthy jury instruction at trial cautioning that the animation was a demonstrative exhibit for the sole purpose of illustrating expert testimony and cautioned the jury not to “confuse art with reality.”[152] The defendant challenged the animation as unfairly prejudicial and improperly authenticated under Pennsylvania Rule of Evidence 901(a) given that the depictions were unsupported by the record or the accompanying expert opinions.[153] The Pennsylvania Supreme Court found both that the animation was a proper depiction of the witness testimony and that the limiting instruction and lack of dramatic elements in the animation were sufficient to eliminate any concerns over prejudice.[154] The court affirmed the admissibility of the animation and held that the animation properly satisfied the basic requirements of Pennsylvania Rules of Evidence 401, 402, 403, and 901.[155]

More recently, in a Utah case—State v. Pereaa defendant convicted of two counts of aggravated murder and two counts of attempted murder appealed his sentence, arguing, in part, that computer-generated animations, excluded by the district court, were sufficiently authenticated under Utah Rule of Evidence 901(a).[156] At trial, the defendant attempted to introduce two animations to visually represent the testimony of a crime scene reconstruction expert.[157] The expert testified that “although he did not personally create the animations, they ‘g[a]ve an indication of what [he] believe[d] may have happened,’” making it easier for the jury to understand his testimony.[158] The State objected for lack of foundation and on the grounds that the animations did not accurately represent the facts, because under the State’s theory there was only one shooter.[159] Reversing the ruling of the district court, the Utah Supreme Court held that despite a lack of knowledge about the creation of the animation on the part of the testifying expert, Rule 901 “does not require that the demonstrative evidence be uncontroversial, but only that it accurately represents what its proponent claims.”[160] The district court’s exclusion was an error because the crime scene reconstruction expert confirmed that the animations accurately represented his interpretation of the facts.

In both cases, the computer-generated animations were deemed relevant under Rules 401 and 402, properly authenticated under Rule 901, and passed the balancing test of Rule 403. However, in neither case were the proponents of the animations obligated to meet foundational requirements beyond an assertion that the animation “fairly and accurately” depicted the testimony of the witnesses—despite the fact that the animations were constructed solely using witness testimony about their memories of the event. Additionally, both courts found that the trial court’s issuance of limiting instructions to the jury was sufficient to combat any prejudicial effects. Under examination, the court’s analyses contain multiple flaws which would be further complicated if IVEs were at issue.

B.  Issues with the Court’s Analyses

First, in creating computer-generated representations of a witness’s testimony “[n]o matter how much evidence exists, there is never enough to fill in every detail necessary. . . . The expert (or the animator) must make assumptions to fill in the blanks.”[161] In Serge, like in Murtha, the animators took significant liberties in creating the animation.[162] By placing a knife next to the victim and dressing the defendant’s character in red plaid, the animators made decisions that were not necessarily supported by the physical evidence but were then authenticated by the accompanying witness’s memory or an expert’s theory as to what happened.[163]

Like an animation, the creation of an IVE inevitably involves choices by a designer regarding not only what is perceived, but also how it is perceived. Without proper safeguards or consideration, a party at trial could ostensibly introduce an IVE for demonstrative purposes which appeared to be sufficiently limited in emotional content to the eyes of the trial judge but was designed using MIPs to subtly influence jury attitudes towards a given scenario. For example, in arguing a self-defense claim, a party could ask designers of an IVE to select color palettes and illumination levels more likely to elicit fear and anxiety.[164] As explained in Part III, even subtle or indirect changes to factors such as lighting, point of view, level of interactivity, or synchrony of movement can have significant psychological implications for users of an IVE.[165] However, none of these factors are involved in the current analysis for demonstrative CGE in many jurisdictions.[166]

Second, it seems clear that in combatting highly vivid demonstrative evidence, “the opponent of the animation should be allowed [on cross-examination] to demonstrate to the jury that the . . . animation [is] based, at least partially, on assumptions and conjectures, and not on purely objective, scientific factual determinations.”[167] Yet, under the current standards for demonstrative CGE, many jurisdictions do not require the testifying witness to have personal knowledge regarding the creation of the animation.[168] In Perea, for example, the animation was admitted despite the accompanying witness possessing no information about the creation of the animation.[169] A similar decision by a trial judge to admit an IVE as demonstrative evidence, without an accompanying witness having knowledge about the decisions or assumptions made in creating the IVE, would likewise significantly disadvantage an opponent in combatting its highly vivid qualities through cross-examination.

Third, both courts relied heavily on jury instructions to moderate the potential prejudicial impacts of the animations on the jury.[170] Though the general rule is to assume that juries will abide by limiting instructions,[171] the Supreme Court has previously recognized that “there are some contexts in which the risk that the jury will not, or cannot, follow instructions is so great . . . that the practical and human limitations of the jury system cannot be ignored.”[172] Moreover, research in the field of social psychology has “repeatedly demonstrated that . . . limiting instructions are unsuccessful at controlling jurors’ cognitive processes.”[173] While this does not necessitate the presumption that all jury instructions are ineffective, it does call into question whether a jury subjected to the highly vivid and unique psychological effects of an IVE might have trouble following a judge’s directions as to the permissible and impermissible purposes for its use.

V.  Recommendations

In anticipation of the onset of IVEs in the courtroom, this Note proposes several changes to the current standards for admissibility, as well as judicial guidelines for best practice in moderating the prejudicial impacts of IVEs.

A.  Stricter Foundational Requirements

Though it would be impractical to develop a “one-size-fits-all” method in dealing with the numerous potential contexts and purposes for which an IVE might be offered as demonstrative evidence, uniformly increasing the foundational requirements for admitting demonstrative IVEs would help to combat some of the potential sources for prejudice.

In State v. Swinton, the Connecticut Supreme Court recognized the need for changes in the rules governing demonstrative evidence with regard to evolving computer technologies.[174] Addressing the binary distinction of the courts between computer animations and computer simulations, the court recognized that there are some kinds of evidence which do “not fall cleanly within either category.”[175] Though Swinton addressed the enhancement of photographs through Adobe Photoshop, the court’s discussion is particularly applicable in relation to an IVE.[176] The court found that “the difference between presenting evidence and creating evidence was blurred”[177] and endorsed a previously established general rule requiring that in all cases involving CGE there be “testimony by a person with some degree of computer expertise, who has sufficient knowledge to be examined and cross-examined about the functioning of the computer.”[178] In addition, the court went one step further in setting out factors with which the expert should be familiar and which could be weighed in determining the reliability of, and adherence to, procedural requirements.[179]

Adopting the court’s logic, this Note recommends that as a basic requirement, an expert who prepared the IVE should be present at the trial to testify regarding the expert’s qualifications and the underlying processes used to create the IVE. This would ensure that the opposing party has the opportunity to cross-examine the expert regarding the underlying data and assumptions used in its creation. In continued recognition of the differences between substantive and demonstrative evidence, this would not necessitate that the proponent satisfy all of the requirements for admitting scientific evidence under Rule 702 (and the Daubert or Frye tests).[180] However, this would at least afford the opposing party the opportunity to cross-examine someone with personal knowledge of the IVE technology and its creation.[181]

B.  Evaluating and Limiting Prejudicial Effects

While establishing an adequate foundation by requiring the presence of an informed expert works to combat some of the unfairness stemming from reliability and misuse of evidence under the current demonstrative standards, this alone is insufficient to curb the range of significant potentials for prejudice. In addition to raising the foundational requirements, there are several factors which should be considered by a judge in conducting the Rule 403 balancing test. In addressing the potential for juror’s unfair reliance on an IVE, consideration of the factors identified in Part IV—chiefly the role of presence and BOIs—should be a necessary predicate to admission. This would require judges to scrutinize not only the design factors in an IVE, but also the level of interactivity facilitated.

Interestingly, beyond mere consideration of such factors, it may also be possible for judges to take affirmative steps to impose limitations on an IVE which could help to mitigate juror overreliance. As this Note has repeatedly stated, the source of many of the potentials for prejudice created by IVEs is their unique vividness and interactivity, which produce feelings of presence and body ownership in the user.[182] Both psychologicalpresence research and BOI studies indicate that there may be ways to limit, reduce, or remove the feelings of presence and ownership in a VE.[183] Such phenomenon, termed as “breaks in presence” (BIPs),[184] occur when the user’s feelings of ownership or consciousness within the VE are disrupted by perceived virtual or real-world interferences.[185]

Under Rule 611(a), judges have broad authority to regulate the admission of demonstrative evidence.[186] As such, judges could potentially use BIPs to mitigate the prejudicial effects of an IVE. Multiple studies have concluded that BOIs occur in VEs only when the movements depicted are relatively synchronous.[187] Because of this, “[w]hen there is asynchrony the illusion does not occur.”[188] With this knowledge, a judge would have the option to instruct the proponent of an IVE to increase the latency (delay) between the movements of the juror and the avatar, thereby reducing the likelihood that a BOI would occur. In another study, examiners found that replacing a perceived limb with a virtual arrow indicator would similarly reduce the BOI phenomenon.[189] Thus, an alternative option might be to instruct the proponent to limit the realistic qualities of the avatar by replacing human features with indicators. Naturally, as further studies are completed and the concepts of presence and ownership in VEs become better understood, so too will the options available to judges in imposing limitations.

Conclusion

As was recognized by the drafters of the Federal Rules of Evidence, it is difficult to define bright line admissibility rules.[190] Despite these difficulties, it stands that the current treatment of demonstrative evidence in many jurisdictions does not properly accommodate IVEs. Though it may appear contrary to logic to think that an IVE could be treated like a chart or graph in the courtroom, under current standards this might very well become the case in some jurisdictions. This author agrees that “every new development is eligible for a first day in court;[191] however, we as a legal community should be cognizant of the differences between past and emerging technologies and of the potential prejudicial risks newer technologies may pose. It is inevitable that IVEs will continue to make their way into the courtroom, but they should not proceed unchecked. The proposed increase in authentication requirements, as well as the potential factors for judges in evaluating and moderating the use of IVEs in the courtroom, are but an initial step in integrating IVEs for courtroom use. Thus, it remains essential that further psychological and cognitive studies be conducted with regard to the use of IVEs in the courtroom.


[*] *.. Senior Submissions Editor, Southern California Law Review, Volume 92; J.D. Candidate 2019, University of Southern California Gould School of Law; B.A. 2015, University of California, Riverside. My sincere gratitude to Professor Dan Simon for his guidance and the editors of the Southern California Law Review for their excellent work.  I would also like to thank my parents, Pamela and Robert Bunker, for their unwavering support and encouragement.

 [1]. High Impact Bringing Virtual Reality to the Courtroom, High Impact, https://highimpact.com/news/High-Impact-to-Bring-Virtual-Reality-to-the-Courtroom (last visited Jan. 23, 2019).

 [2]. Damian Schofield, The Use of Computer Generated Imagery in Legal Proceedings, 13 Digital Evidence & Electronic Signature L. Rev. 3, 3 (2016). Some commentators have attributed the increase in use of computer-generated evidence (“CGE”) in the courtroom to three primary factors: (1) we have become a more visual society; (2) people retain much more of what they see than what they hear; and (3) technological advancements and decreasing costs are making this form of evidence more affordable for clients. See Mary C. Kelly & Jack N. Bernstein, Comment, Virtual Reality: The Reality of Getting It Admitted, 13 John Marshall J. Computer & Info. L. 145, 148–50 (1994).

 [3]. Carrie Leonetti & Jeremy Bailenson, High-Tech View: The Use of Immersive Virtual Environments in Jury Trials, 93 Marq. L. Rev. 1073, 1073 (2010).

 [4]. Compare Betsy S. Fielder, Are Your Eyes Deceiving You?: The Evidentiary Crisis Regarding the Admissibility of Computer Generated Evidence, 48 N.Y.L. Sch. L. Rev. 295 (2003) (discussing potential problems posed by the use of CGE), and Gareth Norris, Computer-Generated Exhibits, the Use and Abuse of Animations in Legal Proceedings, 40 Brief 10 (2011) (weighing the pros and cons of computer-generated animations in the courtroom), with Fred Galves, Where the Not-So-Wild Things Are: Computers in the Courtroom, the Federal Rules Of Evidence, and the Need for Institutional Reform and More Judicial Acceptance, 13 Harv. J.L. & Tech. 161 (2000) (arguing that computer-generated animations are akin to earlier forms of demonstrative media and should be introduced into the courtroom under existing standards).

 [5]. See, e.g., Juries ‘Could Enter Virtual Crime Scenes’ Following Research, BBC (May 24, 2016), http://www.bbc.com/news/uk-england-stoke-staffordshire-36363172 (reporting on a £140,000 European Commission grant to the Staffordshire University project for research and experiments on technology and techniques to transport jurors to virtual crime scenes).

 [6]. Fredric I. Lederer, The Courtroom 21 Project: Creating the Courtroom of the Twenty-First Century, 43 Judges’ J., Winter 2004, at 39, 42.

 [7]. Id.

 [8]. Id.

 [9]. Lars C. Ebert et al., The Forensic Holodeck: An Immersive Display for Forensic Crime Scene Reconstructions, 10 Forensic Sci. Med. Pathology 623, 62426 (2014).

 [10]. Id. A similar virtual reality (“VR”) reconstruction was developed in the United States by Emblematic Group in 2012 using audio files of 911 calls, witness testimony, and architectural drawings to re-create the events of the widely publicized Trayvon Martin shooting. Emblematic Group, One Dark Night-Emblematic Group VR, YouTube (May 9, 2015), https://www.youtube.com/watch?v
=1hW7WcwdnEg. It is also offered for download in the Google Play and Steam Store. See Mike McPhate, California Today: In Virtual Reality, Investigating the Trayvon Martin Case, NY Times (Feb. 24, 2017), https://nyti.ms/2mflo8f (interviewing one of the creators).

 [11]. See Marc Cieslak, Virtual Reality to Aid Auschwitz War Trials of Concentration Camp Guards, BBC (Nov. 20, 2016), http://www.bbc.com/news/technology-38026007.

 [12]. Although the immersive virtual environment (“IVE”) version has not yet been used at trial, the same 3-D model was previously utilized in the prosecution of wartime SS camp guard Reinhold Hanning to help assert his point of view from his post at a watchtower in the camp. Id.

 [13]. Basic VR headsets can be purchased for under $100 (for example, Google Cardboard and Samsung Gear VR), with more high-end headsets costing around $600 (for example, Oculus Rift and HTC Vive). See John Gaudiosi, Over 200 Million VR Headsets to Be Sold by 2020, Fortune (Jan. 21, 2016), http://fortune.com/2016/01/21/200-million-vr-headsets-2020; see also Stevi Rex, Global Virtual Reality Industry to Reach $7.2 Billion in Revenues in 2017, Greenlight Insights (Apr. 11, 2017), https://greenlightinsights.com/virtual-reality-industry-report-7b-2017 (forecasting global VR product sales to reach $7.2 billion by the end of 2017).

 [14]. See, e.g., Lamber Goodnow Legal Team Brings Virtual Reality Technology to the Courtroom, PR Newswire (Jan. 27, 2017), https://www.prnewswire.com/news-releases/lamber-goodnow-legal-team
-brings-virtual-reality-technology-to-the-courtroom-300397710.html (reporting on Arizona personal injury firm advertising use of VR in pending cases) (“In the old days, I’d use demonstrative exhibits, visual aids and witness statements in an attempt to ‘transport a jury to an accident scene.’ With virtual reality, not only can I transport jurors to the accident scene, I can put them in the car at impact.”).

 [15]. See, e.g., High Impact Bringing Virtual Reality to the Courtroom, supra note 1.

 [16]. See Nsikan Akpan, How Cops Used Virtual Reality to Recreate Tamir Rice, San Bernardino Shootings, PBS News Hour (Jan. 13, 2016, 5:00 PM), https://www.pbs.org/newshour/science/virtual-reality-tamir-rice-3d-laser-scans-shootings-san-bernardino (discussing law enforcement agencies use of laser scanners at crime scenes and current projects to convert these kinds of scans for use with VR headsets) (“That’s what I see coming. We’re going to be putting these goggles on juries and say look around and tell me what you see.”). For more on various types of 3-D laser scanning devices employed by law enforcement in the United States, including use with drone technologies, see Robert Galvin, Capture the Crime Scene, Officer (Jul. 19, 2017), https://www.officer.com/investigations/article
/12339566/3d-crime-scene-documentation-for-law-enforcement.

 [17]. See Jeremy N. Bailenson et al., Courtroom Applications of Virtual Environments, Immersive Virtual Environments, and Collaborative Virtual Environments, 28 Law & Pol’y 249, 255–58 (2006).

 [18]. Leonetti & Bailenson, supra note 3, at 1076.

 [19]. See Bailenson et al., supra note 17, at 258–60.

 [20]. Leonetti & Bailenson, supra note 3, at 1118.

 [21]. Caitlin O. Young, Note, Employing Virtual Reality Technology at Trial: New Issues Posed by Rapid Technological Advances and Their Effects on Jurors’ Search for “The Truth,93 Tex. L. Rev. 257, 258 (2014).

 [22]. For further explanation of the concept of immersion in virtual environments (“VEs”), see Mel Slater & Sylvia Wilbur, A Framework for Immersive Virtual Environments (FIVE): Speculations on the Role of Presence in Virtual Environments, 6 Presence 603, 604–05 (1997) (“Immersion is a description of a technology, and describes the extent to which the computer displays are capable of delivering an inclusive, extensive, surrounding and vivid illusion of reality to the senses of a human participant.” (emphasis in original)).

 [23]. Patrick Costello, Health and Safety Issues Associated with Virtual Reality – A Review of Current Literature 6–8 (1997), http://www.agocg.ac.uk/reports/virtual/37/37.pdf.

 [24]. See Frank Stenicke et al., Interscopic User Interface Concepts for Fish Tank Virtual Reality Systems, in 2007 IEEE Virtual Reality Conference 27, 27–28 (2007).

 [25]. George Robertson et al., Immersion in Desktop Virtual Reality, in Proceedings of the 10th Annual ACM Symposium on User Interface Software and Technology 11, 11 (1997); see also Stenicke et al., supra note 24, at 27. Modern-day desktop VR examples can be seen in video games, like the Call of Duty franchise, where users control their in-game avatars through a handheld controller or mouse/keyboard interface. These kinds of video games can be played from both first-person and third-person perspectives and computer-generated animations are rendered on a monitor (primarily via television and computer screens).

 [26]. Stenicke et al., supra note 24, at 27.

 [27]. See D.W.F. van Krevelen & R. Poelman, A Survey of Augmented Reality Technologies, Applications and Limitations, 9 Int’l J. Virtual Reality, no. 2, 2010, at 1, 1.

 [28]. Id. A popular example of this type of technology can be seen in Niantic’s Pokémon Go, which was released for mobile devices in July 2016. The game utilizes a user’s phone/tablet camera (which functions to depict their surrounding physical environment) and overlays virtual animations of monsters onto the camera image. Users can interact with the monsters through their touch-screen interface and the user’s real-world movements are tracked using their devices GPS services. See Pokémon Go, https://support.pokemongo.nianticlabs.com/hc/en-us (last visited Dec. 28, 2018).

 [29]. See Bailenson et al., supra note 17, at 251.

 [30]. Id. at 250–53, 259.

 [31]. An alternative configuration is a Cave Automatic Virtual Environment (“CAVE”) where the user moves in a room surrounded by rear-projection screens. The user, wearing stereoscopic glasses instead of a head-mounted display (“HMD”), is tracked through an electromagnetic device and updated visual images are reflected on the screens. See id. at 253.

 [32]. Id.

 [33]. Ralph Schroeder, Social Interaction in Virtual Environments: Key Issues, Common Themes,

and a Framework for Research, in The Social Life of Avatars 1, 2 (2002) (citation omitted).

 [34]. For a comprehensive overview of studies on user feelings of presence in IVEs, see generally James J. Cummings & Jeremy N. Bailenson, How Immersive Is Enough? A Meta-Analysis of the Effect of Immersive Technology on User Presence, 19 Media Psychol. 272 (2016) (analyzing meta data collected from eighty-three studies on immersive system technology and user experiences of presence).

 [35]. Id. at 274. Of the factors relating to the level of user presence, “results show that increased levels of user-tracking, the use of stereoscopic visuals, and wider fields of view of visual displays are significantly more impactful than improvements to most other immersive system features, including quality of visual and auditory content.” Id. at 272.

 [36]. Neal Feigenson, Too Real? The Future of Virtual Reality Evidence, 28 Law & Pol’y 271,

273 (2006). Vividness means the extent to which the display forms a “sensorially rich environment,” and interactivity results from the ability of the user to “influence the form or content of the mediated environment.” Id.

 [37]. See Young, supra note 21, at 261.

 [38]. See infra Part III.

 [39]. Leonetti & Bailenson, supra note 3, at 1077.

 [40]. See generally Fed. R. Evid.

 [41]. Feigenson, supra note 36, at 276.

 [42]. See generally Laura Wilkinson Smalley, Establishing Foundation to Admit Computer-Generated Evidence as Demonstrative or Substantive Evidence, 57 Am. Juris. Proof of Facts 3d 455 (Westlaw 2018) (providing an overview of the various legal foundations for CGE’s admission into evidence).

 [43]. Karen L. Campbell et al., Avatar in the Courtroom: Is 3D Technology Ready for Primetime?, 63 Fed’n Def. & Corp. Counsel Q. 295, 296 (2013).

 [44]. Id.

 [45]. Id. at 298.

 [46]. Substantive Evidence, Black’s Law Dictionary (10th ed. 2014).

 [47]. Kurtis A. Kemper, Admissibility of Computer–Generated Animation, 111 A.L.R. 5th 529, § 2 (2003).

 [48]. Id.

 [49]. Leonetti & Bailenson, supra note 3, at 1098–99 (“The impediments that a proponent of an IVE would face, under Rule 403, the best evidence rule, or Rule 901, are chiefly matters of foundation, i.e., the admissibility of an IVE turns on whether the proponent could establish its accuracy, reliability, and authenticity.”).

 [50]. Id. For example, a blood spatter analyst could use a recreation of the crime scene to explain her findings.

 [51]. Id. at 1099 (footnotes omitted). For a comprehensive view of potential courtroom and pre-trial IVE applications, see generally Bailenson et al., supra note 17.

 [52]. Leonetti & Bailenson, supra note 3, at 1099.

 [53]. Campbell et al., supra note 43, at 299. Thus, requiring a sufficient showing of:

(1) the qualifications of the expert who prepared the simulation and (2) the capability and reliability of the computer hardware and software used to create the simulation . . . [that] (3) the calculations and processing of data were done on the basis of principles meeting the standards for scientific evidence under Rule 702; (4) the data used to make the calculations were reliable, relevant, complete, and input properly; and (5) the process produced an accurate result.

Id.

 [54]. Demonstrative Evidence, Black’s Law Dictionary (10th ed. 2014).

 [55]. I. Neel Chatterjee, Admitting Computer Animations: More Caution and New Approach Are Needed, 62 Def. Couns. J. 36, 37 (1995).

 [56]. Smalley, supra note 42, § 8.

 [57]. Id.

 [58]. Despite the fact that an IVE would utilize computer programming to create the illustrative aid, the separate treatment of an IVE as demonstrative or substantive evidence would not depend on whether VR technology was employed to achieve the rendering. See Galves, supra note 4, at 228 (“Although demonstrative animations use programs in design, the substantive result they create is based on the witness’s testimony rather than numerical calculations and other underlying input data.”).

 [59]. Feigenson, supra note 36, at 276. Although demonstrative evidence is not technically “evidence” in the context of the Federal Rules, standards of relevance, fairness, and authentication are still enforced by courts in weighing the admissibility of demonstrative evidence through analogy. Id.

 [60]. See Fed. R. Evid. 611(a). “The court should exercise reasonable control over the mode and order of examining witnesses and presenting evidence so as to: (1) make those procedures effective for determining the truth; (2) avoid wasting time; and (3) protect witnesses from harassment or undue embarrassment.” Id.

 [61]. Fed. R. Evid. 401.

 [62]. See Fed. R. Evid. 402. “Relevant evidence is admissible unless any of the following provides otherwise: the United States Constitution; a federal statute; these rules; or other rules prescribed by the Supreme Court. Irrelevant evidence is not admissible.” Id.

 [63]. See Fed. R. Evid. 901(a).

 [64]. Id.

 [65]. Chatterjee, supra note 55, at 37.

 [66]. Smalley, supra note 42, § 9.

 [67]. See, e.g., Gosser v. Commonwealth, 31 S.W.3d 897, 903 (Ky. 2000) (“[B]ecause a computer-generated diagram, like any diagram, is merely illustrative of a witness’s testimony, its admission normally does not depend on testimony as to how the diagram was prepared, e.g., how the data was gathered or inputted into the computer.”), abrogated on other grounds by Elery v. Commonwealth, 368 S.W.3d 78 (Ky. 2012).

 [68]. See Fed. R. Evid. 901(b)(1). Significantly, this would include a re-creation of a scene or accident based on the personal knowledge of a sponsoring witness. See Leonetti & Bailenson, supra note 3, at 1098.

 [69]. See Feigenson, supra note 36, at 277.

 [70]. Campbell et al., supra note 43, at 299.

 [71]. Though, as argued in Part V, subjecting all IVE evidence to more substantive standards could have a moderating effect on some of the concerns raised in Part III.

 [72]. See, e.g., People v. McHugh, 476 N.Y.S.2d 721, 722–23 (Sup. Ct. 1984) (rejecting a motion for a pre-trial Frye hearing despite no prior instances of computer-generated animations being used at trial) (“While this appears to be the first time such a graphic computer presentation has been offered at a criminal trial, every new development is eligible for a first day in court.”); see also People v. Hood, 62 Cal. Rptr. 2d 137, 140 (Ct. App. 1997) (holding that the Kelly formulation for “new scientific procedures” does not apply to computer-generated animations when introduced as demonstrative evidence).

 [73]. See Fed. R. Evid. 403.

 [74]. Id.

 [75]. Christopher B. Mueller & Laird C. Kirkpatrick, Federal Evidence § 4:12 (4th  ed. 2013) (“Much depends on surrounding facts, circumstances, issues, the conduct of trial, and the evidence adduced already and expected as proceedings move forward.”).

 [76]. Id.

 [77]. Fed. R. Evid. 403, advisory committee’s notes to 1972 proposed rules.

 [78]. Mueller & Kirkpatrick, supra note 75, § 4:13.

 [79]. Id.

[E]vidence is unfairly prejudicial in the sense of being too emotional if it is best characterized as sensational or shocking; if it provokes anger, inflames passions, or if it arouses overwhelmingly sympathetic reactions; provokes hostility or revulsion; arouses punitive impulses; or appeals to emotion in ways that seem likely to overpower reason.

Id. (footnotes omitted).

 [80]. Id.

 [81]. Id.; see, e.g., United States v. Brown, 490 F.2d 758, 764 (D.C. Cir. 1973) (“Despite a limiting instruction to the effect that the evidence is to be considered solely on the issue of the declarant’s state of mind (the proper purpose), there is the ever-present danger that the jury will be unwilling or unable to so confine itself.”).

 [82]. Fed. R. Evid. 403, advisory committee’s notes to 1972 proposed rules.

 [83]. Id.

 [84]. See Kwan Min Lee, Presence, Explicated, 14 Comm. Theory 27, 42 (2004). Though important with respect to the study of co-presence and other social phenomenon experienced in an IVE, social presence falls outside the scope of this Note. Social presence pertains to the way in which virtually rendered social actors are experienced as actual social actors by a user and is an important concept in the understanding of feelings of co-presence between multiple users in a VE. For more on social presence, see id. at 45.

 [85]. Id. at 46.

 [86]. Id. at 44.

 [87]. Julia Diemer et al., The Impact of Perception and Presence on Emotional Reactions: A Review of Research in Virtual Reality, 6 Frontiers Psychol., Jan. 2015, at 1.

 [88]. See R.M. Baños et al., Immersion and Emotion: Their Impact on the Sense of Presence, 7 CyberPsychology & Behav. 734, 735 (2004); see also Rosa M. Baños et al., Presence and Emotions in Virtual Environments: The Influence of Stereoscopy, 11 CyberPsychology & Behav. 1, 2–3 (2008).

 [89]. Anna Felnhofer et al., Is Virtual Reality Emotionally Arousing? Investigating Five Emotion Inducing Virtual Park Scenarios, 48 Int’l J. Hum.-Computer Stud. 48, 49 (2015) (citation omitted).

 [90]. For a seminal text on psychological laboratory designs for mood induction procedures, see generally Maryanne Martin, On the Induction of Mood, 10 Clinical Psychol. R. 669 (1990).

 [91]. Giuseppe Riva et al., Affective Interactions Using Virtual Reality: The Link Between Presence and Emotions, 10 CyberPsychology & Behav. 45, 46–47 (2007).

 [92]. Id. at 46.

 [93]. Id. at 46–48.

 [94]. Id. at 47.

 [95]. Id. at 49.

 [96]. Id.

 [97]. See Felnhofer et al., supra note 89, at 50.

 [98]. Id. at 53.

 [99]. Id. at 54. Interestingly, in contrast to these findings, an experiment performed using a desktop VR system to attempt to assess whether a simulated level of illumination could impact the affective appraisal of users in a VE failed to yield any measurable results. See Alexander Toet et al., Is a Dark Virtual Environment Scary?, 12 CyberPsychology & Behav. 363, 363 (2009). This suggests that the lack of interactivity in a non-immersive environment means that these kinds of systems may not pose the same risks as an IVE in strongly influencing user emotion through design. See id.

 [100]. See generally, e.g., Donghee Shin, Empathy and Embodied Experience in Virtual Environment: To What Extent Can Virtual Reality Stimulate Empathy and Embodied Experience?, 78 Computers Hum. Behav. 64 (2017).

 [101]. Schofield, supra note 2, at 13.

 [102]. See id.

 [103]. Id.

 [104]. See Gareth Norris, The Influence of Angle of View on Perceptions of Culpability and Vehicle Speed for a Computer-Generated Animation of a Road Traffic Accident, 20 Psychiatry, Psychol. & L. 248, 252–53 (2013).

 [105]. Id. at 250.

 [106]. Id. at 251.

 [107]. Id.

 [108]. Id. at 252 (citation omitted).

 [109]. Shin, supra note 100, at 66.

 [110]. Id.

 [111]. Id. (“By experiencing a virtual version of the story location as a witness/participant, and by feeling the perspective of a character depicted in the story, users received specialized access to the sights and sounds (and even to the feelings and emotions) associated with the story.”).

 [112]. Id. at 71. Interestingly, the study also found that, despite higher levels of immersion, users with a lower empathy trait had lower levels of reported embodiment and empathy—suggesting that the disposition of certain users may have a correlation on their empathy within a virtual world. Id. at 69.

 [113]. Id. at 69 (“VR developers propose immersion but users process it.”).

 [114]. See State v. Murtha, CR03-0568598T (Conn. Super. Ct., JD Hartford, 2006); see also Neal Feigenson & Christina Spiesel, Law on Display: The Digital Transformation of Legal Persuasion and Judgment 92103 (2009) (discussing the case in detail).

 [115]. Feigenson & Spiesel, supra note 114, at 92.

 [116]. Id.

 [117]. Id.

 [118]. Id. at 92–93.

 [119]. Id. at 93–94.

 [120]. Id.; see also NYU Press, Law on Display – Murtha Video, Part One, YouTube (Sept. 23, 2009), https://youtu.be/kWMyBg6Zt-o (showing the original police footage); NYU Press, Law on Display – Murtha Video, Part 2, YouTube (Sept. 23, 2009), https://youtu.be/J0kd-vv9DeM (showing the edited footage with the animation used at trial).

 [121]. Feigenson & Spiesel, supra note 114, at 97.

 [122]. Id. at 9495.

 [123]. Schofield, supra note 2, at 13.

 [124]. Feigenson & Spiesel, supra note 114, at 251 n.113.

 [125]. See Konstantina Kilteni et al., The Sense of Embodiment in Virtual Reality, 21 Presence 373, 381–82 (2012).

 [126]. Id.

 [127]. Natalie Salmanowitz, Unconventional Methods for a Traditional Setting: The Use of Virtual Reality to Reduce Implicit Racial Bias in the Courtroom, 15 U.N.H. L. Rev. 117, 141 (2016) (“Instead of simply personifying an animated character in a digital game, immersive virtual environments can induce body ownership illusions, in which individuals temporarily feel as though another person’s body part is in fact their own.”).

 [128]. Konstantina Kilteni et al., Over My Fake Body: Body Ownership Illusions for Studying the Multisensory Basis of Own-Body Perception, Frontiers Hum. Neuroscience, Mar. 2015, at 1, 2.

 [129]. Matthew Botvinick & Jonathan Cohen, Rubber Hands ‘Feel’ Touch that Eyes See, 391 Nature 756, 756 (1998).

 [130]. Id.

 [131]. Kilteni et al., supra note 128, at 4.

 [132]. See generally H. Henrik Ehrsson et al., Threatening a Rubber Hand that You Feel Is Yours Elicits a Cortical Anxiety Response, 104 Proc. Nat’l Acad. Sci. U.S. 9828 (2007).

 [133]. See, e.g., Kilteni et al., supra note 128, at 3.

 [134]. Id. at 5, 8.

 [135]. Id. at 8.

 [136]. See id. at 11–12.

 [137]. Maria V. Sanchez-Vives et al., Virtual Hand Illusion Induced by Visuomotor Correlations, PLoS ONE, Apr. 2010, at 1, 3, https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone
.0010381&type=printable.

 [138]. Id.

 [139]. Id. at 5 (“[I]n spite of the fact that they saw the virtual hand move, did not feel their hand move, nor move it, they still blindly pointed towards the virtual hand when asked to point where they felt their hand to be.”).

 [140]. Id. at 2.

 [141]. See, e.g., Kilteni et al., supra note 128, at 9.

 [142]. See Elena Kokkinara & Mel Slater, Measuring the Effects Through Time of the Influence of Visuomotor and Visuotactile Synchronous Stimulation on a Virtual Body Ownership Illusion, 43 Perception 43, 56 (2014) (“The results provide evidence that congruent multisensory and sensorimotor feedback between the unseen real and the seen virtual legs can induce sensations that the seen legs are part of the actual body.”).

 [143]. See Konstantina Kilteni et al., Drumming in Immersive Virtual Reality: The Body Shapes the Way We Play, 19 IEEE Transactions on Visualization & Computer Graphics 597, 599, 603 (2013) (“Seeing a virtual body from first person perspective, and receiving spatiotemporally congruent multisensory and sensorimotor feedback with respect to the physical body entails an illusion of ownership over that virtual body.”).

 [144]. See Domna Banakou et al., Illusory Ownership of a Virtual Child Body Causes Overestimation of Object Sizes and Implicit Attitude Changes, 110 Proc. Nat’l Acad. Sci. 12846, 12849 (2013) (“[I]t is possible to generate a subjective illusion of ownership with respect to a virtual body that represents a child and a scaled-down adult of the same size when there is real-time synchronous movement between the real and virtual body.”); see also Tabitha C. Peck et al., Putting Yourself in the Skin of a Black Avatar Reduces Implicit Racial Bias, 22 Consciousness & Cognition 779, 786 (2013) (“IVR can be used to generate an illusion of body ownership through first person perspective of a virtual body that substitutes their own body. . . . [M]ultisensory feedback, such as visuomotor synchrony as used in our experiment, may heighten this illusion.”).

 [145]. See id. at 786 (finding that embodiment of light-skinned people in darker-skinned avatars can lead to comparative reductions in implicit racial bias).

 [146]. Ehrsson et al., supra note 132, at 9830.

 [147]. See Peck et al., supra note 144, at 786.

 [148]. While the following cases are taken from the Pennsylvania and Utah Supreme Courts respectively, the applicable rules of evidence are basically identical to the Federal Rules. See Pa. R. Evid. 403 cmt. (“Pa.R.E. 403 eliminates the word ‘substantially’ to conform the text of the rule more closely to Pennsylvania law.”); see also Pa. R. Evid. 901(a) cmt. (“Pa.R.E. 901(a) is identical to F.R.E. 901(a)”); Utah R. Evid. 901(a), 2011 advisory committee note (noting that the Utah rule is “the federal rule, verbatim.”); Utah R. Evid. 403, 2011 advisory committee note (same). For a general overview and survey of the treatment of computer animations at both the state and federal level, see generally Victoria Webster & Fred E. (Trey) Bourn III, The Use of Computer-Generated Animations and Simulations at Trial, 83 Def. Couns. J. 439 (2016).

 [149]. Commonwealth v. Serge, 896 A.2d 1170, 1176 (Pa. 2006).

 [150]. Id. at 1179–80.

 [151]. Id. at 1175.

 [152]. Id.

 [153]. Id. 1176.

 [154]. Id. at 1187. Notably, the animation was devoid of any “(1) sounds; (2) facial expressions; (3) evocative or even life-like movements; (4) transition between the scenes to suggest a story line or add a subconscious prejudicial effect; or (5) evidence of injury such as blood or other wounds.” Id. at 1183.

 [155]. Id. at 1187.

 [156]. State v. Perea, 322 P.3d 624, 635–36 (Utah 2013).

 [157]. Id. at 632.

 [158]. Id. at 635 (alterations in original).

 [159]. Id. at 635–637. Stating that

[t]he State objected and the district court refused to admit the animations, finding that “there [was] no foundation for the animation[s]” because Mr. Gaskill did not know “who created [them],” “the background of the people who created [them],” “how [they were] created,” or “what [the animators] relied upon in creating [them].”

Id.

 [160]. Id. at 637.

 [161]. David S. Santee, More than Words: Rethinking the Role of Modern Demonstrative Evidence, 52 Santa Clara L. Rev. 105, 135 (2012).

 [162]. See id. at 136.

 [163]. See id. at 136, 136 n.180, 140.

 [164]. In thinking about the effect of lighting, one cannot help but remember the first televised Nixon-Kennedy debate in which Richard Nixon refused makeup for the studio camera lighting, instead applying a cheap “coat of [drugstore] Lazy Shave to hide his five o’clock shadow.” Dan Gunderman, The Story of the First TV Presidential Debate Between Nixon and Kennedy—‘My God, They’ve Embalmed Him Before He Even Died’, N.Y. Daily News (Sept. 24, 2016, 4:25 AM), http://www.nydailynews.com/news
/politics/story-televised-debate-nixon-jfk-article-1.2803277. The interesting result being that most viewers who listened to the radio felt Nixon had prevailed, but those viewing the televised debate overwhelmingly found favor with Kennedy, who had subtly applied powder. See id.

 [165]. See supra Part III.

 [166]. See Webster & Bourn, supra note 148, at 441–42.

 [167]. John Selbak, Comment, Digital Litigation: The Prejudicial Effects of Computer-Generated Animation in the Courtroom, 9 High Tech. L.J. 337, 366 (1994).

 [168]. See Webster & Bourn, supra note 148, at 441–42.

 [169]. See State v. Perea, 322 P.3d 624, 635–36 (Utah 2013).

 [170]. As previously mentioned, federal courts are advised to rely on jury instructions to attempt to limit prejudice following the Advisory Committee Notes to Rule 403. Fed. R. Evid. 403, advisory committee’s notes to 1972 proposed rules. At the federal level, most jurisdictions rely on jury instructions which essentially include the following:

(1) an admonition that the jury is not to give the animation or simulation more weight just because it comes from a computer; (2) a statement clarifying that the exhibit is based on the supporting witness’s evaluation of the evidence; and, (3) in the case of an animation, a statement that the evidence is not meant to be an exact recreation of the event, but is, instead, a representation of the witness’s testimony.

Webster & Bourn, supra note 148, at 442.

 [171]. Bruton v. United States, 391 U.S. 123, 135 (1968) (“Unless we proceed on the basis that the jury will follow the court’s instructions where those instructions are clear and the circumstances are such that the jury can reasonably be expected to follow them, the jury system makes little sense.” (citation omitted)). But see Krulewitch v. United States, 336 U.S. 440, 453 (1949) (Jackson, J., concurring) (“The naive assumption that prejudicial effects can be overcome by instructions to the jury . . . all practicing lawyers know to be unmitigated fiction.”).

 [172]. Bruton, 391 U.S. at 135.

 [173]. Joel D. Lieberman & Jamie Arndt, Understanding the Limits of Limiting Instructions, 6 Psychol., Pub. Pol’y & L. 677, 686 (2000).

 [174]. See State v. Swinton, 847 A.2d 921, 945–46 (Conn. 2004).

 [175]. Id. at 937.

 [176]. Id. at 946.

 [177]. Id. at 938 (emphasis omitted).

 [178]. Id. at 942 (citation omitted).

 [179]. Id. at 942–43. These procedural factors included:

(1) the underlying information itself; (2) entering the information into the computer; (3) the computer hardware; (4) the computer software (the programs or instructions that tell the computer what to do); (5) the execution of the instructions, which transforms the information in some way—for example, by calculating numbers, sorting names, or storing information and retrieving it later; (6) the output (the information as produced by the computer in a useful form, such as a printout of tax return information, a transcript of a recorded conversation, or an animated graphics simulation); (7) the security system that is used to control access to the computer; and (8) user errors, which may arise at any stage.

Id. (citation omitted).

 [180]. See Fed. R. Evid. 702.

 [181]. Therefore, avoiding a situation like in Perea, where the witness cannot speak to the design of the accompanying computer-generated exhibit beyond asserting that it is a fair and accurate depiction of their testimony. See State v. Perea, 322 P.3d 624, 637 (Utah 2013).

 [182]. See Cummings & Bailenson, supra note 34, at 273.

 [183]. See Mel Slater & Anthony Steed, A Virtual Presence Counter, 9 Presence: Teleoperators & Virtual Environments 413, 426 (2000) (measuring the occurrence of user breaks in presence (“BIPs”) using an HMD); see also Sanchez-Vives et al., supra note 137, at 5; Kokkinara & Slater, supra note 142, at 56 finding that:

[T]he analysis of breaks suggest that asynchronous [visuotacticle] may be discounted when synchronous [visuomotor] cues are provided. . . . [W]e can predict a high or low estimated probability of the illusion solely from knowing which [visuomotor] group (synchronous or asynchronous) the person was in . . . asynchronous [visuotacticle] stimulation combined with asynchronous [visuomotor] stimulation is shown to be incompatible with the illusion.

Kokkinara & Slater, supra note 142, at 56.

 [184]. For a further explanation of BIPs, see generally Maria V. Sanchez-Vives & Mel Slater, From Presence to Consciousness Through Virtual Reality, 6 Nature Reviews Neuroscience 332 (2005).

 [185]. Take, for example, when a person is deeply engrossed in watching a movie:

Every so often . . . some real world event, or some event within the movie itself, will occur that will throw you out of this state of absorption and back to the real world of the theatre: someone nearby unwraps a sweet wrapper, someone coughs, some aspect of the storyline becomes especially ridiculous, and so on.

Slater & Steed, supra note 183, at 419.

 [186]. See Fed. R. Evid. 611(a), advisory committee’s notes to proposed rule (describing the broad powers of the judge to regulate demonstrative evidence).

 [187]. See, e.g., Sanchez-Vives et al., supra note 137, at 2.

 [188]. Id. at 3.

 [189]. See Ye Yuan & Anthony Steed, Is the Rubber Hand Illusion Induced by Immersive Virtual Reality?, in 2010 IEEE Virtual Reality Conference 95, 101 (2010) (“[T]he IVR arm ownership illusion appears to exist when the virtual arm roughly appears in shape and animation like the participant’s own arm, but not when there is a virtual arrow.”).

 [190]. See Mueller & Kirkpatrick, supra note 75.

 [191]. People v. McHugh, 476 N.Y.S.2d 721, 722 (Sup. Ct. 1984).

 

 

Justice or Just Us?: SFFA v. Harvard and Asian Americans in Affirmative Action – Note by Cynthia Chiu

From Volume 92, Number 2 (January 2019)
DOWNLOAD PDF


 

Justice or Just Us?:
SFFA v. Harvard and Asian Americans in Affirmative Action

Cynthia Chiu[*]

TABLE OF CONTENTS

INTRODUCTION

I. The Current Affirmative Action STANDARD

II. The Role of Asian Americans in
Affirmative Action

A. History of Asian Americans and Affirmative Action

B. A History of Discrimination Against Asian Americans

C. The Racial Bourgeoisie

III. STUDENTS FOR FAIR ADMISSIONS V. HARVARD

A. The Procedural History and Current Status of
SFFA v. Harvard

B. SFFA’s Arguments

1. Count I: Harvard Intentionally Discriminates Against
Asian Americans

2. Count II: Harvard Engages in Racial Balancing

3. Count III: Harvard Considers Race as More than Just
a “Plus Factor”

4. Count V: Harvard Has Failed to Show There Are
no Workable Race-Neutral Alternatives

D. Criticisms of SFFA’s Arguments

1. The Arguments in the Complaint Are Flawed

2. Logical Fallacies

IV. Asian Americans and Affirmative Action
in the Future

A. Diversity Re-Evaluated

B. Unity with Other Minorities

Conclusion

 

INTRODUCTION

Here is what I sometimes suspect my face signifies to other Americans: an invisible person, barely distinguishable from a mass of faces that resemble it. A conspicuous person standing apart from the crowd and yet devoid of any individuality. An icon of so much that the culture pretends to honor but that it in fact patronizes and exploits. Not just people “who are good at math” and play the violin, but a mass of stifled, repressed, abused, conformist quasi-robots who simply do not matter, socially or culturally.[1]

I can recall excitedly filling out my college applications in the fall of 2010. I can recall writing my application essay about my experience at a private, all-girls Catholic high school. I can recall being told to volunteer more and to join speech and debate. I can recall being told that playing four years of varsity tennis would make me appear more well-rounded. I can recall being told to not check the “Asian” box when the application asked for my ethnicity. At eighteen years old, this sounds like being told it is better to be anything besides exactly who you are. I can recall feeling that it was not enough to be the daughter of a first-generation immigrant from China and the granddaughter of Japanese American citizens interned during World War II.[2] The appropriate box for me was apparently “Other.”[3]

This revelation about my own experience was necessary to understand the frustration felt by the Asian American community regarding college admissions. While this frustration may be well-founded, the Asian American community is not unified on what the appropriate reaction to it should be. On one hand, the model minority myth[4] perpetuates a stereotype that portrays Asian Americans as successful. But on the other hand, Asian Americans feel wide-spread discrimination that goes unrecognized due to an image of them as achievers of the “American Dream.” This places Asian Americans in a precarious middle ground as a “racial bourgeoisie”[5]stuck between being viewed as “superior” but feeling inferior. Asian Americans should be cautioned, though, that serving in this racial middle ground runs the risk of “reinforc[ing] white supremacy if the middle deludes itself into thinking it can be just like white if it tries hard enough.”[6] Asian Americans have long been left out of the whiteblack affirmative action debate, and this opportunity to speak out should not be tarnished by being used as a tool to further white images at elite universities.

This Note examines the arguments made in Students for Fair Admissions v. Harvard College, which allege that Harvard’s consideration of race is a violation of Title VI of the Civil Rights Act of 1964 because it is not narrowly tailored to a compelling interest of diversity.[7] The complaint filed by Students for Fair Admissions (“SFFA”)[8] came off the back of Justice Alito’s comments in his dissent in Fisher v. University of Texas at Austin (Fisher II), which proposed the possibility that Asian Americans may face discrimination in admissions.[9] While this was an important inclusion of Asian Americans in the discussion, Justice Alito’s comments in Fisher II perpetuated the logical fallacy that Asian Americans[10] are losing admission spots to African Americans and Hispanic Americans due to affirmative action, and may have encouraged the initiation of SFFA’s action against Harvard College. However, while the frustration experienced by many in the Asian American community over what feels like racial ceilings on Asian American admissions at elite universities is valid, these ceilings are the result of negative action aimed against Asian Americans, not the result of affirmative action. Prohibiting universities from considering race as part of a holistic admissions process will not eliminate the negative action felt by Asian Americans.

SFFA’s use of Asian Americans to target affirmative action is a parallel to the double movement that occurred in the nineteenth century. While there was a movement toward inclusion based on increased egalitarianism among white males to reduce barriers based on wealth and property ownership, there was also a movement toward exclusion of African Americans, women, Native Americans, and non-white immigrants.[11] SFFA and the organization’s creator, Edward Blum, move to include Asian Americans as part of the group deemed worthy enough to “earn” spots at elite universities only to maintain the dominance needed to continue to exclude other groups. The status that is ascribed to different groups comes with a series of stereotypes and associations that the larger, dominant group naturalizes to determine whether the group is eligible for certain benefits, like admission to elite universities.[12] Asian Americans should be wary about their sudden inclusion in this larger group, when they had for so long been denied eligibility for status as citizens and still continue to be given the stereotype of “perpetual foreigner.”[13] Similar to the poor white males of the nineteenth century, the inclusion of Asian Americans could simply be used to maintain the dominance of wealthy white[14] males and to perpetuate a “white image” in elite universities.

Part I of this Note examines the current standard of affirmative action: that the only acceptable justification for race-conscious admissions policies is one of educational diversity. Part II discusses the role of Asian Americans in the affirmative action discussion, with an understanding that Asian Americans have been subject to unrecognized historical discrimination and treated as a “racial bourgeoisie”[15] due to perpetuation of the model minority myth. Part III describes the background and status of SFFA v. Harvard, analyzes the complaint’s arguments, including those made at trial, and criticizes the bases for the complaint. Part IV suggests that the future role of Asian Americans in the affirmative action discussion is one of increased political activeness and unity and argues for a change in the way elite universities value Asian American diversity when assessing applicants in a holistic process.

I.  The Current Affirmative Action STANDARD

All racial classifications are subject to strict scrutiny, even where the classification is non-invidious as it is for affirmative action. This requires the means to be narrowly tailored to a compelling government interest.[16] For affirmative action, Regents of the University of California v. Bakke established that diversity, through its educational benefits, is a compelling state interest under strict scrutiny analysis.[17] Diversity was originally conceived as simply racial diversity; however, Justice Powell’s majority opinion in Bakke advocates for a diversity that goes beyond race to include diversity of ideas, opinions, and backgrounds in order to improve the educational experience.[18] The Court explicitly bans the use of a quota system where race is used as a dispositive factor in admissions, but it permits race to be used as one of many factors in the diversity consideration.[19] There is a clear rejection of race being used as a permissible factor in admissions as a means to remedy past discrimination; instead, the Court focuses on the instrumental justification, which states that race can provide educational benefits by accepting candidates with diverse experiences. Justice Powell specifically cites to Harvard’s admissions policy, which uses race as one of many “plus factors, in a holistic consideration of an applicant, as a permissible example of a policy that would allow an institution to maintain freedom in its academic goals.[20]

Justice Powell’s opinion in Bakke created the blueprint for the Court in Grutter v. Bollinger to firmly establish that diversity is the only justification for race-conscious admissions policies that would satisfy strict scrutiny.[21] The Court continued to recognize that there were educational benefits[22] from diversity that could satisfy a compelling government interest.[23] Grutter determined that admissions policies seeking to obtain a “critical mass” of diverse students were not a violation of the prohibitions against racial balancing and proportional representation.[24] Critical mass does not refer to a specific quota or percentage, but refers to “meaningful numbers” sufficient to “encourage[] underrepresented minority students to participate in the classroom and not feel isolated.[25] The Court gives institutions of higher education deference in deciding whether they need diversity to pursue their educational mission.[26] Once the university determines diversity to be one of its educational goals, a race-conscious admissions policy is permissible only if race is used as merely a “plus factor in the context of a holistic process that involves individualized consideration.[27] Individualized consideration allows a university to balance academic selectivity with the need for diversity, without sacrificing academic excellence in attempts to achieve race-neutral alternatives.[28] Grutter established that “narrow tailoring . . . require[s] serious, good faith consideration of workable race-neutral alternatives that will achieve the diversity the university seeks.”[29] However, what this goodfaith consideration would require and whether the threshold of critical mass for a university would be given deference were not addressed until Fisher v. University of Texas (Fisher I).[30]

Fisher I established that universities must show that the means used to achieve their diversity interest are narrowly tailored, as the court will not simply defer to the university on this issue.[31] To satisfy the narrowly tailored requirement, a university must show its admissions policy is necessary to achieve the educational benefits of diversity and that no race-neutral alternative is workable.[32] The Court in Fisher I ordered the University of Texas at Austin to show that they had exhausted race-neutral alternatives and reviewed the findings in Fisher II.[33] In Fisher II, the Court determined that the University of Texas at Austin had to show that a critical mass had not already been achieved through its race-neutral Top Ten Percent Plan.[34] However, the University of Texas’s goals did not need to be a precise number because a critical mass of diversity is qualitative, not quantitative.[35] The Court ultimately gave deference to the university’s goodfaith efforts to achieve diversity and accepted the argument that the university had not achieved critical mass.[36] Although Fisher I seemed to be arguing that the Court would require proof that there were no workable race-neutral alternatives, the Court in Fisher II seemed to give deference to the university on whether the race-neutral alternatives were good enough, or “workable,” to achieve its diversity goals.[37] This leaves the state of affirmative action in a similar place to where it was in Grutter.

Grutter’s conception of diversity is the current model[38] under which affirmative action is able to fulfill the function of a compelling interest,[39] but this has several limitations. Grutter specifically connects the value of diversity to education,[40] while also inflating the idea of critical mass as something that can be both a quantitatively meaningful number and a means of addressing diversity’s qualitative benefits.[41] It pursues diversity for its instrumental value and rejects any remedial justification, leading to the conception of diversity as one of integration rather than an effort to provide equal opportunity.[42] It does not distinguish “exploitative” from “egalitarian” objectives, which creates an equal opportunity problem—one that will continue to exist so long as there are hindrances unique to minorities that prevent any given admission “spot” from being fungible.[43]

II.  The Role of Asian Americans in Affirmative Action

Asian Americans have a complicated history with affirmative action that has developed into a divided stance on the topic within the Asian American community.[44] Adding to this complexity is the difficulty in establishing whether the objective of affirmative action is to seek equality in outcomes for a racial group or equality in opportunity for individual applicants.[45] For Asian Americans, the way in which the purpose of affirmative action is conceived greatly impacts what “side” of the debate feels fair.[46] There is confusion among the Asian American community about what affirmative action actually entails, leading some to misplace blame for what may be “hidden quotas to keep down Asian admissions” on affirmative action policies.[47] The misunderstanding of affirmative action within the Asian American community may stem from several legitimate concerns, involving a combination of an unrecognized history of discrimination in the United States, the role of Asian Americans as a “racial bourgeoisie,”[48] the perpetuation of the model minority myth, negative action policies, and the stereotype of Asian Americans as a “reticent minority.”[49]

A.  History of Asian Americans and Affirmative Action

Affirmative action was first enacted in a federal program under President Lyndon B. Johnson’s Executive Order 11246 as an “affirmative step” in remedying a history of excluding minority workers, including Asian Americans, from employment in contracting firms that accepted federal funding.[50] In the educational context, affirmative action programs led to significant increases in enrollment for African Americans, Hispanic Americans, and Asian Americans.[51] However, following the decision in Bakke, the growth in enrollment for African Americans and Hispanic Americans stopped and retreats from affirmative action programs swept the country.[52]

The flexible, “holistic” review idealized by the Harvard Plan[53] led to admissions programs that considered race without using strict quotas; some Asian Americans believed that this created an admissions ceiling, as Asian American admissions rates reached a constant plateau.[54]

In the most recent affirmative action decision in Fisher II, a significant number of amicus briefs were filed in support of the University of Texas at Austin’s admissions policy and diversity goals, including some by several Asian American organizations.[55] However, the Asian American Legal Foundation and the Asian American Coalition for Education (claiming to represent 117 Asian American organizations) filed an amicus brief in support of Abigail Fisher, indicating an increasing divide within the Asian American community on the issue of affirmative action.[56]

B.  A History of Discrimination Against Asian Americans

There is a tendency for the historical discrimination against Asian Americans to go unrecognized due to a perpetuation of the model minority myth. The model minority myth paints Asian Americans as successful, particularly in an educational context, and as immigrants who have achieved the American dream. This conception of Asian Americans is problematic because it creates racial dissonance between Asian Americans and other minorities by implying that the barriers to success do not stem from systematic and structural oppression of some groups, but rather from individuals within a minority group failing to progress. The model minority myth is dangerous because it is used to underscore institutional racism while simultaneously de-emphasizing Asian American success.[57] In addition, Asian Americans are not a monolithic group, and many ethnicities within the Asian American community have different experiences and suffer inequality in income and corporate hierarchies in different ways.

For much of the nineteenth century, Asian Americans were subject to exclusionary immigration laws.[58] Naturalization rights were not granted to people of Asian ancestry until the mid-twentieth century[59]1943 for Chinese, 1946 for Asian Indians and Filipinos, and 1952 for all other Asians.[60] Even for those born in the United States, the Fourteenth Amendment did not allow citizenship for Asian Americans until 1898,[61] and this was challenged as recently as 1942.[62] Though not to the same extent as African Americans, Asian Americans were affected by segregation laws and anti-miscegenation laws as well.[63] In addition, the Alien Land Laws forbade Asians from owning land by prohibiting “aliens ineligible for citizenship” from owning property.[64] Asian Americans were also subjected to targeted discrimination by all levels of government, from San Francisco’s laundry licensing authority which allowed white laundries to stay open while closing Chinese laundries[65] to the federal governmentsanctioned internment of more than 120,000 people of Japanese descent during World War II.[66]

Even though the Supreme Court has, in some instances, struck down laws racially prejudicial against Asian Americans, societal prejudice remains a constant issue. In 1982, two white men in Detroit murdered Vincent Chin, a Chinese-American man, because they thought he was Japanese and were upset over American automakers losing business to the Japanese auto industry.[67] In 1992, the killer of Japanese student Yoshihiro Hattori was acquitted on the basis of “reasonable” self-defense arguments,[68] but the validity of the self-defense claims were based on the jury’s racial prejudice in determining what a reasonable threat was.[69] In some cities, such as Boston and Philadelphia, as recently as the 1990s, Asian Americans suffered the highest per capita hate crime rate of all racial minorities.[70] Today, Asian Americans continue to be the target of discrimination and hate crimes.[71] Racist actions and violence against Asian Americans have seen a disturbing increase recently.[72] These hate crimes tend to be perpetuated by stereotypes of Asian “foreignness”[73] and create fear within the Asian American community that stretches beyond the immediate victims.

C.  The Racial Bourgeoisie

University of Hawaii Law Professor Mari Matsuda writes of Asian Americans being a “racial bourgeoisie”:

If white, as it has been historically, is the top of the racial hierarchy in America, and black, historically, is the bottom, will yellow assume the place of the racial middle? The role of the racial middle is a critical one. It can reinforce white supremacy if the middle deludes itself into thinking it can be just like white if it tries hard enough. Conversely, the middle can dismantle white supremacy if it refuses to be the middle, if it refuses to buy into racial hierarchy, and if it refuses to abandon communities of black and brown people, choosing instead to forge alliances with them.[74]

As a racial bourgeoisie, Asian Americans could take on a significant role in the affirmative action discussion. The danger of a racial bourgeoisie is that it places Asian Americans as “middlem[e]n,” too different to be white but not different enough to be “true minorities.”[75] “Racial triangulation” of Asian Americans describes the view in American society that places Asians in a middle ground between whites and African Americans on a level of superiority but on the opposite end of the spectrum from both groups in a level of “foreignness.”[76] This conception of Asian Americans as “perpetual foreigners”[77] means that it is easy to discount them, which allows people to place blame on Asian Americans for acts attributable to actual foreigners.[78]

Part of what enables Asian Americans to be a racial bourgeoisie is the perpetuation of the model minority myth.[79] This conception of Asian Americans as a “model minority” not only unfairly criticizes other minorities, but it also is based on false premises that lead to the diminution of those Asian American individuals who achieve success in the face of great adversity.[80] The dangers of the model minority myth and the conception of Asian Americans as too different to be a true minority are that they create the assumption that Asian Americans cannot face discrimination. However, not only do Asian Americans continue to face racial violence,[81] but they also face negative action in admissions policies. While Asian Americans have benefited and continue to benefit from affirmative action,[82] the creation of ceilings on Asian Americans, particularly in university admissions policies, is a separate, unrelated issue that works to keep Asian Americans in a racial bourgeoisie.[83] No amount of success that is perceived to be enjoyed by Asian Americans through the stereotype of the model minority myth should be used to defend any use of negative action, and while Asian Americans may not merit affirmative action preferences, they should be subject to the same “neutral action” associated with white applicants. A misunderstanding of the distinction between negative action and affirmative action has led many in the Asian American community to use statistics that indicate Asian Americans require higher test scores to get into the same colleges as applicants of other races in order to oppose affirmative action.[84] While there may be legitimate concern over intentional caps against Asian Americans, it should not allow the Asian American community to be confused by the goals and outcomes of affirmative action. It should be the goal of the Asian American community to prevent our own personal experiences from being manipulated into promoting outcomes that ultimately seek to maintain a “white image.”[85]

III.  STUDENTS FOR FAIR ADMISSIONS V. HARVARD

In the 1920s, people asked: will Harvard still be Harvard with so many Jews? Today we ask: will Harvard still be Harvard with so many Asians? Yale’s student population is 58 percent white and 18 percent Asian. Would it be such a calamity if those numbers were reversed?[86]

SFFA filed an action against Harvard College, alleging the use of racially discriminatory policies in violation of Title VI of the Civil Rights Act of 1964.[87] To successfully challenge Harvard College’s admission policy under Title VI, SFFA must establish discriminatory intent, mirroring the constitutional standard, rather than the disparate impact standard.[88] Although the plaintiff originally argued six counts for relief, the suit ultimately relies on four main reasons that Harvard’s admission policy is racially discriminatory: (1) uses racial “quotas,” (2) engage[s] in racial balancing,” (3) fail[s] to use race merely as a plus factor’” in its undergraduate admissions process, and (4) fails to use race-neutral alternatives sufficient to achieve Harvard’s diversity goals.[89] SFFA asserts that it has “at least one member . . . who applied for and was denied admission to Harvard’s 2014 entering class.”[90] This unnamed applicant is described as being Asian American, having parents who are first-generation immigrants from China; graduating with a ranking of one out of 460 students in a high school that U.S. News and World Report places in the top 5 percent in the United States; obtaining a perfect score of 36 on the ACT; and being named an AP Scholar with Distinction, a National Scholar, and a National Merit Scholarship Finalist.[91] In addition to the applicant’s academic achievements, this applicant was

captain of the varsity tennis team, volunteered at a community tennis camp, volunteered for the high school’s student peer tutoring program, was a volunteer fundraiser for National Public Radio, and traveled to China as part of a program organized by the United States Consulate General and Chinese American Students Education and Exchange to assist students in learning English writing and presentation skills.[92]

The Harvard admissions process involves application evaluations by a first reader, a docket chair, and a final review by the full forty-person admissions committee.[93] When first readers review an application, they give numerical scores in the following categories: overall, academic, extracurricular, athletic, personal, teacher recommendations, school support recommendation, staff interview ratings, and alumni interview ratings.[94] The personal rating is based on the admissions officer’s “assessment of the applicant’s ‘humor, sensitivity, grit, leadership, integrity, helpfulness, courage, kindness and many other qualities.’”[95] The overall rating represents the officer’s view of the application as a whole, but instead of being determined “by a formula [or] . . . adding up the other ratings,” the first readers simply take “all the factors into account,” including race.[96] Once the full committee meets and makes its decisions, the dean and director confirm the final target of admitted students and consult a “one-pager” with race, gender, geographic region, and other statistics about the potential new class to determine whether some applicant need to “lopped” from the admitted list.[97]

In 2013, Harvard’s Office of Institutional Research (OIR) produced an internal report showing that the admission rate for Asian Americans was highest where the criteria for admission was solely based on academics and progressively decreased the more variables that were added.[98] In OIR’s second report, it found that the only category in which non-legacy, non-athlete white applicants performed significantly better than their similarly situated Asian American applicants was the personal rating, but the report failed to explain why.[99] This second report also found that non-legacy, non-athlete white applicants were admitted at higher rates than non-legacy, non-athlete Asia American applicants with the same academic scores and further concluded that Asian Americans were the only racial group with a negative association between being admitted and their race.[100] In 2015, Harvard established a Committee to Study the Importance of Student Body Diversity, which concluded in its report that student body diversity creates positive impacts and “is fundamental to the effective education of the men and women of Harvard College.”[101] In 2017, Harvard established the Smith Committee, which was dedicated to study whether race-neutral alternatives were workable for achieving the benefits concluded in the 2015 committee.[102] The Smith Committee concluded that there were no workable race-neutral alternatives that would allow Harvard to achieve the benefits of educational diversity without sacrificing other important educational objectives.[103]

An important step in understanding this case requires a closer look into SFFA and its goals. The President of SFFA, Edward Blum, has been instrumental in challenging affirmative action and voting rights laws in more than two dozen lawsuits.[104] He orchestrated Fisher I and II[105] as well as Shelby County v. Holder,[106] which successfully contested the Voting Rights Act of 1965. Blum challenges “racial policies he thinks are unfair” under the names of his several organizations, including SFFA, which have been criticized as being nothing more than Blum’s own “alter ego.”[107] Blum’s work from 2010 to 2015 received $2.9 million from several non-profits and the DonorsTrust, which distributes money from conservative and libertarian contributors, leading many to consider Blum a “tool of rich conservatives trying to extinguish efforts to help historically oppressed minorities overcome the long shadow of racism.”[108] Given the background of Blum, it seems likely that the overall goal of SFFA and Blum seems to be to eliminate race-conscious admissions policies altogether, not just negative action against Asian Americans.

A.  The Procedural History and Current Status of SFFA v. Harvard

Since the complaint was filed in November 2014, future applicants and current students at Harvard petitioned to intervene as defendants but were denied and subsequently given amicus status.[109] The presiding judge, Judge Allison D. Burroughs, determined that each side would have a ten to twelve month discovery process, beginning in May 2015 but denied SFFA’s explicit request for access to Harvard admissions data.[110] The case was temporarily stayed in anticipation of the Supreme Court’s ruling on Fisher II.[111] However, in September 2016, Judge Burroughs ordered that Harvard provide six cycles of admissions data as well as any information relating to any internal or external investigations into allegations of discrimination against Asian Americans in the undergraduate admissions process.[112]

Both sides have filed several motions to seal that have been granted by the Judge Burroughs, thus limiting the amount of evidence that is available to the public at this time.[113] Harvard filed a motion to dismiss for lack of subject matter jurisdiction in September 2016 that was denied in June 2017.[114] However, in June 2017, Judge Burroughs did grant Harvard’s motion for partial judgment on the pleadings of Count IV and VI, which respectively claimed violations based on Harvard’s failure to use race to merely fill the “last few spots” in an incoming class and “any use of race as a factor in admissions.”[115]

In September 2017, the Department of Justice (“DOJ”) formally notified Harvard that it was under investigation for its use of race in its admissions policies.[116] The DOJ’s Civil Rights Division sent a letter to Harvard on November 17, 2017, stating that Harvard was “not complying with its Title VI access requirements,” and if Harvard failed to provide the requested documents by December 1, 2018, the agency might file a lawsuit against the university.[117] Harvard challenged the agency’s authority to investigate and was willing to “provide the Justice Department with documents produced for the federal court case, ‘with redactions for relevance, privacy, and privilege/work product protection.’”[118] The core of the investigation was related to the same issues argued in the SFFA v. Harvard complaint. In 2015, the Obama administration dismissed the request to investigate without evaluating the merits due to the parallel lawsuit; however, in 2017, the Trump administration pursued the investigation, creating skepticism about the party divide and political motivations plaguing affirmative action policies.[119] In August 2018, the DOJ offered SFFA a public show of support through its statement of interest in court.[120] The DOJ did not make any conclusions of illegality, but it did urge the court to deny Harvard’s request for summary judgment.[121] From October to November 2018, Judge Burroughs heard oral arguments on the four remaining Counts, namely I, II, III, and V, from both SFFA and Harvard.[122] During the trial, there was a large reliance on student anecdotes and expert testimony, with SFFA using Peter S. Arcidiacono, an economics professor from Duke University,[123] and Richard D. Kahlenberg, a senior fellow at the Century Foundation,[124] and Harvard primarily relying on David E. Card, an economics professor from UC Berkeley.[125] In closing arguments, SFFA highlighted the expert testimony to demonstrate a “statistically significant Asian penalty,” while Harvard countered that SFFA had failed to prove any bias against Asian Americans but was instead a tool to take down “decades-old efforts toward racial diversity that enhances the educational experience.”[126] Although Judge Burroughs’s decision doesn’t have a definitive timeline, she is expected to release it in early 2019, and the decision is likely to be appealed by the losing side.[127] While a ruling at the district court in favor of SFFA would likely not eliminate the possibility of race-conscious admissions altogether, it could force Harvard, and other elite universities, to create policies that limit the consideration of race. It is quite possible the case could reach the Supreme Court of the United States, where the environment is drastically different from what it was when Fisher II was decided in 2016 given Justice Kennedy’s swing vote has been replaced by Justice Kavanaugh and the presidential administration’s view of affirmative action has shifted.[128]

B.  SFFA’s Arguments

SFFA makes several arguments describing why Harvard’s admissions policies are intentionally discriminatory on the basis of race and ethnicity in violation of Title VI. SFFA and Harvard filed a joint statement asking “that the requirement for a trial brief be stricken” based on their extensive summary judgment filings[129] and since SFFA’s motion for summary judgment was solely based on Counts I, II, III, and V of the complaint, which ultimately formed the basis of SFFA’s arguments at trial.[130] First, SFFA argues that Harvard’s holistic review process is historically discriminatory and is now being used to intentionally discriminate against Asian Americans.[131] Second, SFFA contends that Harvard is engaged in racial balancing based on evidence of stable admission percentages across races even as the application rates change over time.[132] Third, SFFA claims that Harvard’s pursuit of critical mass does not adhere to the Harvard Plan that was idealized in Bakke because it considers race as more than just a “plus factor.[133] SFFA argues that critical mass is an amorphous term that creates a delusion of pursuing diversity when it is really used “to achieve numerical goals indistinguishable from quotas” and results in race being used as more than just a plus factor.[134] Fourth, SFFA argues that Harvard’s race-conscious admissions policy is not narrowly tailored because there are race-neutral alternatives that could be used to achieve diversity based on policies used by other elite universities.[135]

1.  Count I: Harvard Intentionally Discriminates Against Asian Americans

In the first argument, SFFA contends that Harvard’s admissions policies were historically developed for “the specific purpose of discriminating against disfavored minority groups.”[136] SFFA points to the 1920s and 1930s when then Harvard President A. Lawrence Lowell placed a cap on Jewish enrollment through the use of an admissions system that was based on discretion rather than academic achievement.[137] Harvard began using legacy preferences and a subjective admissions system gauging “character and fitness and the promise of the greatest usefulness in the future as a result of a Harvard education” as strategies to reduce the number of Jewish students admitted.[138]

SFFA argues that Harvard’s current admissions plan uses the same subjective system to consider “race or ethnicity itself—not other factors that may be associated with race or ethnicity—[as] a distinguishing characteristic that warrants consideration in the admissions process” in order to create a quota of African American students.[139] SFFA goes on to claim that Harvard has a long history of intentional discrimination against Asian Americans, ranging from refusing to recognize Asian Americans as a minority by describing them as “over-represented” to holding Asian Americans to a higher standard of admissions.[140] In July 1988, the Office of Civil Rights of the U.S. Department of Education investigated the treatment of Asian American applicants at Harvard in comparison to white applicants and found that while Asian American applicants were accepted at a significantly lower rate than “similarly qualified” white applicants, the disparity was attributed to legacy preferences, not the byproduct of racial discrimination as claimed by SFFA.[141] SFFA continues by referencing the EspenshadeRadford study[142] on the role of race in elite undergraduate admissions, which found that “AsianAmerican students were dramatically less likely to be admitted than otherwise similar students who identified themselves as white or Caucasian.”[143] SFFA also cites to Ron Unz’s study[144] which found “sheer constancy of [Asian American enrollment] percentages, with almost every year from 1995-2011 showing an Asian enrollment within a single point of the 16.5 percent average, despite high fluctuations in the numbers of applications and the inevitable uncertainty surrounding which students will accept admission,” and this “exactly replicates the historical pattern . . . in which Jewish enrollment rose very rapidly, leading to the imposition of an informal quota system, after which the numbers fell substantially, and thereafter remained constant for decades.”[145] SFFA then cites to studies indicating that elite schools with race-neutral admissions policies have higher Asian American enrollment, with a table comparing Asian American enrollment at Harvard and the California Institute of Technology.[146] The complaint also refers to personal anecdotes of admission staff at Harvard and other elite universities, college counselors, and Asian American applicants, describing how “Asian Americans face difficulty because they cannot distinguish themselves within their community.”[147]

During the trial, each party relied on its own expert reports “to show the presence or absence of a negative effect of being Asian American on the likelihood of admission, highlight[ed] the purported flaws of its opponent’s statistical analysis, and claim[ed] that there is substantial—or zero—documentary and testimonial evidence of discriminatory intent.”[148] SFFA specifically relied on Arcidiacono’s testimony which concluded that Harvard gave lower personal ratings to Asian Americans at every level of academic achievement than applicants of all other racial groups and further showed that among applicants with the same overall rating, Asian Americans were the least likely to be admitted.[149] However, Harvard’s expert, Card, reviewed the same admissions data but found “no negative effect of being Asian American on the likelihood of admission to Harvard” because disparities were due to Asian American applications being “slightly less strong than those submitted by White applicants across a range of observable non-academic measures.”[150] Arcidiacono and Card reach different results from the same data due to divergent modeling choices, with Card criticizing Arcidiacono for excluding certain applicant information.[151] SFFA also uses the Harvard OIR reports to indicate that Harvard’s own internal research division found results consistent with Arcidiacono then took no further steps to investigate the potential bias, but Harvard claims that Card’s more comprehensive and reliable study contradicts the OIR report.[152] Lastly, SFFA uses personal anecdotes, specifically from an OIR employee and alumni interviewers, to demonstrate discriminatory intent, but Harvard asserts that statements made by non-decisionmakers or decisionmakers not involved in the process are insufficient to demonstrate discriminatory animus.[153]

2.  Count II: Harvard Engages in Racial Balancing

In the second argument, SFFA contends that Harvard’s current admissions policy engages in “racial balancing” in order to ensure a fixed quota of Asian American enrollees or proportional representation in its student body.[154] SFFA points to statistical data indicating that the racial demographics of Harvard’s admissions and enrollment have remained stable over approximately the last decade,[155] despite fluctuations in application rates.[156] SFFA contends the following:

[B]etween 2003 and 2012, the percentage of Asian Americans at Harvard wavered only slightly above and below approximately 17 percent. . . . [D]espite the fact that, by 2008, Asian Americans made up over 27 percent of Harvard’s applicant pool, and approximately 46 percent of applicants with academic credentials in the range from which Harvard admits the overwhelming majority of students.[157]

SFFA points to the “one-pagers” that provide statistics of the present representation of various racial groups as compared to the prior year as proof of Harvard’s quota for Asian Americans.[158] SFFA alleges that Harvard reconsiders applications from particular groups after receiving the one-pager in order to align the current class demographics with the prior year, which would effectively create a cap on Asian American enrollment regardless of the application rate or level of qualifications.[159] In the “lopping” process, the admissions committee allegedly takes into account the applicant’s race and whether it is currently underrepresented in the prospective class.[160] Harvard contends that the one-pagers break down applicants not only by race but also by gender, geography, intended concentration, legacy status, socioeconomic status, and other categories.[161] Harvard argues that the lopping process is an unbiased, necessary part of a process that involves an “overabundance of qualified applicants” for a limited availability of spots.[162] While SFFA points to a somewhat consistent admitted class breakdown for each racial group to show racial quotas, Harvard counters by claiming that there was a significant 11% increase in Asian American enrollment when it went from 18% (Class of 2014) to 20% (Class of 2017).[163]

3.  Count III: Harvard Considers Race as More than Just a “Plus Factor”

In its third argument, SFFA claims that Harvard is not considering race for the purpose of achieving “critical mass” because it considers race as more than just a “plus factor.[164] Although the Supreme Court gives deference to a university in determining if diversity is part of their educational goals and deference in determining if critical mass has already been achieved, SFFA argues that Harvard’s admissions policy fails in its methods for attaining educational diversity because they are not narrowly tailored to a goal of reaching critical mass.[165] In addition, SFFA argues that since Harvard is not pursuing a goal of critical mass, the race-conscious admissions could be used in perpetuity even though there may be some point in time where the “use of racial preferences will no longer be necessary to further the interest” in diversity.[166] Harvard has an obligation to “continually reassess its need for race-conscious review,” but Harvard claims that the Smith Committee evaluated the current need for race-conscious admissions and a re-evaluation would be done again five years after the Smith Committee issued its report.[167]

SFFA argues that Harvard uses race as more than just a “plus factor.”[168] However, Harvard counters with testimony from Card stating that the variability in admissions is better explained by an applicant’s academic, athletic, extracurricular, and personal ratings, rather than race.[169] Similar to the arguments for Count I, the outcome of this issue is heavily dependent on which expert is given greater credibility and the reliability of the anecdotal testimony of admissions office employees.

4.  Count V: Harvard Has Failed to Show There Are no Workable Race-Neutral Alternatives

In its last argument, SFFA offers race-neutral alternatives that Harvard could use to achieve student body diversity.[170] SFFA argues that Harvard should implement an admissions policy that creates diversity by placing emphasis on socioeconomic factors, including parental education and wealth, which are not specifically tied to race even though they may be strongly correlated.[171] In addition, SFFA proposes that Harvard use financial aid and scholarships for socioeconomically disadvantaged students to incentivize minority enrollment.[172] SFFA suggests that increasing recruitment into the applicant pool for “highly qualified, socioeconomically disadvantaged minorities” would lead to an increase in student body diversity and be sufficient to achieve Harvard’s educational goals.[173] SFFA contends that the need for race-conscious policies would not be necessary if other admissions policies that explicitly disadvantage minority applicants, such as legacy and wealthy donor preferences, were eliminated.[174] SFFA uses testimony from their expert Kahlenberg to support that Harvard can easily achieve diversity by race-neutral policies, such as increasing socioeconomic preferences; increasing financial aid;” and reducing legacy and donor preferences.[175] In response, Harvard asserts that the Smith Committee satisfied strict scrutiny when it determined that there were no available race-neutral alternatives.[176] Lastly, SFFA argues that Harvard has not considered race-neutral alternatives in good faith because the Smith Committee was developed after they became aware of the imminence of a lawsuit.[177]

D.  Criticisms of SFFA’s Arguments

1.  The Arguments in the Complaint Are Flawed

The complaint, as previously discussed, lays out four main arguments: (1) intentional discrimination; (2) racial balancing; (3) not using race as merely a plus factor; and (4) the existence of race-neutral alternatives. First, the argument surrounding the racial quota is flawed because SFFA uses evidence of a quota against Jewish Americans in the 1920s as an indication of a discriminatory intent currently in place against Asian Americans. The existence of a past discriminatory intent in the creation of the policies affecting Jewish applicants in the 1920s does not prevent Harvard from claiming to have benign intentions in the use of its policies now.[178] Since the discriminatory impact is not so severe as to allow a presumption of discriminatory intent as in Yick Wo, in which all permit applications by Chinese owners to set up a laundry business were denied,[179] SFFA would be required to show that constant admission rates of Asian Americans are due to a discriminatory intent to have an upper limit of Asian Americans at Harvard. Because SFFA’s proof is heavily reliant on the court finding its expert’s method of statistical analysis to be more compelling, it will be difficult to show that Arcidiacono’s conclusions are enough to prove discriminatory intent. Even if a racial quota is found to exist, it would only prove that Harvard itself is participating in an impermissible form of discrimination through the use of quotas against Asian Americans; that finding would not invalidate affirmative action in all higher education admissions or prevent the consideration of race in admissions policies elsewhere. SFFA’s use of statistics, such as those from the Espenshade–Radford study,[180] to support the existence of this racial quota falsely manipulates the data to conflate the negative action experienced by Asian Americans with affirmative action. In fact, an upper limit quota on Asian Americans is more likely to benefit white applicants than any minority applicants.[181] While the assertion of an upper limit quota against Asian Americans is highly possible given the constant admission rates of Asian Americans, it would not be due to affirmative action. Rather, it would be due to a combination of efforts to maintain a “white image” at elite universities, enflamed by the use of legacy preferences and the devaluation of Asian American diversity.

Second, SFFA’s argument that Harvard is conducting racial balancing in its admissions policy based on the same stable admission percentages used to indicate the racial quota in the first argument is flawed because diversity itself gains value from balance. Although critical mass is an immeasurable number, its definition inherently requires that it be attached to some ideal balance. While this balance should not solely be based on race, race does play a factor in contributing to the educational benefits of diversity, such that critical mass could definitely not be achieved if an elite university were made up entirely of one race. Any university that limits its number of accepted applicants requires a balance of diversity because not all qualified candidates can be accepted, so to claim there is impermissible racial balancing would be to argue that admissions policies instead need to be attached to something more quantitative like proportionate representation or application rates. The Supreme Court has not found this to be necessary given that Fisher II gave deference to universities in determining whether their admissions policies were narrowly tailored to achieving diversity. Unless there is evidence that Asian Americans are being “lopped” based on the one-pagers and a desire to create a racial demographic that is the same year after year, it will be difficult to show that Harvard is partaking in impermissible racial balancing. However, the balance universities achieve through their admissions policies should be subject to some scrutiny. While a balance may be inherently necessary, the conception of over-representation can lead to an unfair suppression of some groups in the consideration of this balance. The conception of over-representation is an issue because it leads to the idea that there can be too many of a certain group. While this may be true if the goal is to create a diverse class of individuals, it should be questioned when over-representation is only attached to minority groups.[182] Ultimately, there is distrust that SFFA would be welcoming to an outcome that eliminated racial balancing entirely if it meant that Harvard only accepted Asian Americans.[183]

Third, SFFA contends that Harvard does not use race as merely a plus factor because its consideration of race in admissions is not for the purpose of achieving critical mass. While Harvard’s creation of the Smith Committee seems correlated to the filing of the lawsuit, there is no indication that Harvard does not intend to follow its recommendation to re-evaluate in five years, which would be compliant with Fisher II’s mandate to continue reassessing critical mass.[184] Harvard’s admissions policy is to consider race as one factor among many, and almost all of the categories it creates ratings for do not allow the officers to consider race in their scores. While it is misguided for SFFA to challenge the consideration of race in Harvard’s policies as the exist on paper, there should be scrutiny placed on whether admissions officers allow unconscious bias and stereotypes about Asian Americans to influence the ratings of the other categories. When personal ratings of Asian American applicants are consistently lower than white applicants, it should lead to questions about whether admissions officers are more likely to undervalue humor, leadership, courage, and other traits that the personal ratings are based on when they are attached to an Asian American.

Fourth, SFFA suggests that Harvard could achieve diversity through race-neutral alternatives, such as socioeconomic status. Although socioeconomic disadvantage and race may overlap, they do not target identical problems, and thus, the consideration of race should not be completely replaced by solely considering socioeconomic status. They are both to be considered in the admissions process, among a multitude of other diversity factors. The Court in Fisher II allowed universities to use race-conscious admissions where there are no workable race-neutral alternatives that would sufficiently achieve their goals for educational diversity, so Harvard would not be required, under the current law, to adopt an inadequate socioeconomic status-based alternative. Admissions policies based on socioeconomic status may also be offered as a subtle way to assist race and genderbased affirmative action, but they should not be considered as a cure-all in college admissions.[185]

2.  Logical Fallacies

SFFA’s arguments are flawed due to their susceptibility to logical fallacies, such as the “causation fallacy”[186] and the “average-test-score-of-admitted-students”[187] fallacy. The causation fallacy is a term coined by California Supreme Court Justice Goodwin Liu to describe when “the fallacy erroneously conflates the magnitude of affirmative action’s instrumental benefit to minority applicants, which is large, with the magnitude of its instrumental cost to white applicants, which is small.”[188] For unsuccessful applicants, there is a reflex to blame affirmative action, but in a selection process as rigorous as the ones at elite universities, the likelihood of success for any candidate is low, regardless of affirmative action. Because white applicants greatly outnumber minority applicants and a large number of factors are considered, the average white applicant is not significantly more likely to be selected under a race-neutral process than a race-conscious one.[189] Although there are racial gaps in test scores, it is not evidence that affirmative action creates discriminatory acceptance rates, given that non-objective factors also play a role in admissions.[190] The causation fallacy leads to “a distortion of statistical truth, premised on an error in logic. . . . But that fact provides no logical basis to infer that white applicants would stand a much better chance of admission in the absence of affirmative action.”[191] Therefore, any presence of a racial quota or ceiling against Asian American admission cannot be due to affirmative action because the number of spots is too few to account for a constant admission rate despite increased application rates.[192]

The average-test-score-of-admitted-students fallacy is employed by SFFA in its argument that blames affirmative action for statistics showing Asian Americans need to score higher on standardized tests in order to be accepted. Because academic merits are only one factor of many in a holistic admissions process, “it is incorrect to infer Asian American applicants are required to meet a higher test standard even if the group average SAT score of all admitted Asian American students to a given university is higher than the SAT score of all African American admitted students.”[193] This is because SAT scores are not the only basis for admission to universities, and even though the group average SAT score of all admitted Asian American students to a university may be higher than all other groups, their group average non-academic scores may be collectively lower. While this explains why average test scores of Asian Americans may be higher at no fault of affirmative action, it also raises the question of whether Asian Americans’ non-academic qualities are being undervalued as a result of negative action and harmful stereotypes. However, it would be a mistake to want an admissions process that solely relies on academic criteria because scholastic ability, on its own, does not determine beneficial contribution to an elite university, and it has been shown that standardized tests are not racially neutral determinants of merit.[194] Both of these logical fallacies are employed in SFFA’s complaint and are used to appeal to the Asian American community as a way to manipulate blame for discriminatory ceilings against Asian Americans to create support for eliminating affirmative action.

IV.  Asian Americans and Affirmative Action in the Future

A.  Diversity Re-Evaluated

The use of an unnamed Asian American plaintiff and any possible evidence of an upper limit quota against Asian Americans should not bring into question whether diversity is a compelling interest. However, the conception of what this diversity should look like does need to change. There is a fear in the affirmative action discussion that any criticism of current race-conscious policies could be seen as an attack on affirmative action. That should not be the case; while affirmative action creates necessary benefits, it can also be improved.

The conception of diversity needs to evolve past even the idea of intra-racial diversity that was introduced in Fisher II. Diversity needs to be more than just having diversity within racial groups; the discussion needs to shift toward why diverse characteristics become more valuable when attributed to one race over another. When holistic admissions policies allow negative stereotypes about a group to bias their conception of diversity, the true educational benefits of a diverse student body cannot be achieved.

There is a concern that an admissions process that uses racial preferences as a means of enhancing educational diversity may stereotype applicants by race, expressing illegitimate assumptions about applicants’ viewpoints and experiences.[195] For Asian Americans, these stereotypes are harmful and can help explain any potential ceilings. Even when the stereotypes are deemed “positive,” such as the model minority myth, there can be a negative effect.[196] While these “positive” stereotypes may help Asian Americans break into the workforce, these same stereotypes may also prevent them from advancing upward through management.[197] This leads to data that may show “many Asian Americans are ‘underemployed’ relative to their educational background,”[198] creating an assumption within the Asian American community “that a fact of American life is that their efforts and accomplishments are discounted.”[199]

When the stereotypes are negative, there is an even greater impact. Negative stereotypes can lead to “admissions committees [concluding] unfairly that [Asian American] applicants were not well-balanced individuals.”[200] This stereotype that Asian Americans are one-dimensional fails to value the diversity associated with Asian Americans. This creates two main issues. First, while there is value in providing a characteristic that is unusual for your race because you have a unique experience, this does not account for why those same characteristics are valued differently across races, even where they create intraracial diversity[201] equally. For white or other minority applicants, the value of being a concert pianist or a chess player is seen as positive, while for an Asian American, it may be seen as negative because it does not distinguish the Asian American applicant from his or her perceived societal stereotype. While there is a large value to be placed on intraracial diversity and interracial diversity,[202] it is important to question whether there are any equivalent stereotypes that hold back white applicants.[203] Second, there is an additional failure to even recognize the intraracial diversity that already exists among Asian Americans. Asian Americans have diverse cultural backgrounds and experiences that are undervalued when they are viewed as a monolithic group.[204] There would be great intraracial diversity between two Asian American applicants, even if both have the same SAT scores and extracurricular activities, if one was the child of Vietnamese immigrants who came as refugees after the Vietnam War, and the other was the child of secondgeneration Punjabi Americans. To place less value on these distinct cultural experiences than would be placed on the diversity of “a farm boy from Idaho”[205] is illogical. When admissions officers reward candidates who “appear less Asian” or when professional admissions consultants recommend Asian Americans not talk about their immigrant backgrounds to avoid discrimination, it should raise the question of whether there is a devaluation of the Asian American identity in admissions policies.[206]

The diversity of Asian Americans is also devalued through the perception of Asian Americans as over-represented in education. The idea of over-representation itself creates the presumption that Asian Americans are not subjected to discrimination in admissions policies, which is not the case.[207] When schools are identified as being “too Asian,” the diversity of Asian Americans is reduced to an assumption that all Asian Americans are the same and are not valued as individuals who provide a unique benefit to a university. The comments crying “yellow peril” are not said in hushed tones or with backlash of racism, but are viewed as commonplace.[208] The claim of “too Asian” stems out of a fear of universities losing their “white image” due to competition with Asians.[209] With the combination of feeling over-represented while also being asked to “appear less Asian,” the effect has resulted in Asian Americans internalizing these beliefs and a lack of self-identity.[210] For elite universities looking to gain the educational benefits of diversity, creating admissions policies that value the broad range of Asian American experiences is necessary.

B.  Unity with Other Minorities

Asian Americans are traditionally viewed as a “reticent minority because in comparison to other ethnic groups, they tend to be less politically active and vocal.[211] There has been a recent increase in Asian American political activity, particularly in affirmative action,[212] which is necessary and important. However, it is crucial that Asian Americans not fall victim to a “race to the bottom” mentality by attacking other minority groups in a competition of who is worse off.[213] In considering affirmative action, Asian Americans should work with other minorities in discussing with universities “what the institutional and minority needs and priorities are.”[214] When Asian Americans criticize affirmative action, they must first ask themselves (1) even if you are individually innocent of any racial discrimination and face it yourself, do you not benefit from it? and (2) would you trade your Asian American experience to participate in the “piecemeal remedy of affirmative action programs?[215] While the unsuccessful candidate may feel that there are painful costs to affirmative action, Asian Americans should be protesting negative action based on the perpetuation of harmful stereotypes, rather than affirmative action, which continues to benefit Asian Americans. As a racial bourgeoisie, Asian Americans have not been included in affirmative action discussions, and they are caught between societal beliefs that they are receiving preferential treatment and personal feelings of experiencing discrimination.[216]

Conclusion

After Fisher II, diversity is the only justification accepted by the Supreme Court as a compelling interest for universities’ admissions policies to satisfy strict scrutiny, and although the Court claimed to require the university to show no race-neutral alternatives, it ultimately gave deference to the university’s good faith in determining whether the race-neutral alternatives would be plausible in achieving the educational benefits of diversity. The historical discrimination of Asian Americans and their existence as a group too different to be white and not different enough to be a “true minority” give context to why there is frustration and misunderstanding over affirmative action in the Asian American community. Although the negative repercussions of these circumstances and the stereotypes they come with are harmful to Asian Americans, they are not the result of affirmative action and would not be remedied by an elimination of affirmative action. SFFAs complaint and the arguments it made at trial against Harvard rest on misconceptions of the Asian American experience in the admissions processes. In its effort to get rid of race-conscious admissions programs, SFFA falls victim to logical fallacies and fails to address the true problem facing Asian Americans in admissions. While diversity continues to be a compelling interest, the conception of what types of diversity are valued needs to be re-evaluated to consider the stereotypes attributed to Asian Americans. For the Asian American community, their position as a racial bourgeoisie can have a significant impact in the affirmative action discussion if Asian Americans can target their efforts at attacking negative action while simultaneously supporting affirmative action.

 

 


[*] *.. Senior Editor, Southern California Law Review, Volume 92; J.D. Candidate, 2019, University of Southern California Gould School of Law; B.A., Economics and Legal Studies 2015, University of California, Berkeley. I greatly appreciate Professor Stephen Rich for his guidance and the editors of the Southern California Law Review for their excellent work. Thank you to my family—Mom, Dad, Jen, Andy, and Matt—and to my friends for their endless support and constant willingness to listen to me talk about this Note.

 [1]. Wesley Yang, Paper Tigers: What Happens to All the Asian-American Overachievers When the Test-Taking Ends?, N.Y. Mag. (May 8, 2011), http://nymag.com/news/features/asian-americans-2011-5 (expressing the author’s perspective on the Asian American experience). This puts into context the complexity of the role that Asian Americans play not only in the affirmative action discussion, but also in American society as a whole. When the stereotype that attaches to Asian Americans is that they are all the same, what value can be placed on an individual Asian American’s conception of self?

 [2]. Some of the experiences my maternal grandparents faced in the Japanese American internment camps are also discussed in an article published by USC Gould School of Law. See 75 Years Later: The Impact of Executive Order 9066, USC Gould School of Law (Feb. 16, 2017), https://gould.usc.edu
/about/news/?id=4352.

 [3]. This is not to diminish the experience of those applicants who have to check “Other” because the ethnicity or culture they identify with is not listed, which is a separate but serious issue as well. This is to highlight the feeling of being told that your chances of admission would be greater if the university does not know you are Asian American, indicating Asian Americans get deducted points in comparison to even white applicants. It is not a comforting notion when many applicants of Asian-American descent have first or last names that reveal their identity regardless of what ethnicity they mark on their application.

  The description of my experience applying to colleges is not to insinuate that I should have been accepted to a specific university based upon my qualifications. The qualifications I describe are those of a typical applicant, whereas the suggestion of checking the “Other” box is a less universal experience. It is part of what helps me to understand the frustrations felt by many in the Asian-American community who are pushing back against Harvard’s admissions policies.

 [4]. See infra note 57 and accompanying text.

 [5]. The concept of a “racial bourgeoisie” was coined by Mari Matsuda. Mari J. Matsuda, We Will not be Used: Are Asian Americans the Racial Bourgeoisie?, in Where Is Your Body? And Other Essays on Race, Gender, and the Law 149, 149–50 (1996). It refers to an idea that Asian Americans fall into a racial middle ground that acts as a buffer between whites and African Americans, with Asian Americans stuck being too privileged to be minorities and too foreign to be honorary whites. Id.

 [6]. Matsuda, supra note 5, at 150.

 [7]. Complaint at 100–01, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176 (D. Mass. Nov. 17, 2014), 2014 WL 6241935. This Note is limited in scope and does not discuss whether the Supreme Court is likely to hear this case or any likely outcome. This Note is limited to critiquing the arguments set out in Students for Fair Admissions’ (“SFFA’s”) complaint that were argued during the trial, which concluded in November 2018, trying to create background on why the Asian American community may be divided on this issue, and making a suggestion for the future of affirmative action as the discussion begins to include Asian Americans. See Chloe Foussianes, A Timeline of the Harvard Affirmative Action Lawsuit, Town & Country (Nov. 2, 2018), https://www.townandcountrymag.com/society/money-and-power/a24561452/harvard-lawsuit-affirmative-action-timeline.

 [8]. SFFA is a “newly-formed, nonprofit, membership organization whose members include highly qualified students recently denied admission to [Harvard and the University of North Carolina at Chapel Hill], highly qualified students who plan to apply to both schools, and parents.” Project on Fair Representation Announces Lawsuits Challenging Admissions Policies at Harvard Univ. and Univ. of North Carolina-Chapel Hill, Students for Fair Admissions, https://studentsforfairadmissions.org
/project-on-fair-representation-announces-lawsuits-challenging-admissions-policies-at-harvard-univ-and-univ-of-north-carolina-chapel-hill (last visited Jan. 21, 2019). The president of Students for Fair Admissions is Edward Blum, who is also the president of the Project on Fair Representation, which was founded in 2005 “to support litigation that challenges racial and ethnic classifications and preferences.” About Us, Project on Fair Representation, https://www.projectonfairrepresentation.org/about (last visited Jan. 21, 2019). The Project on Fair Representation has been involved in admissions lawsuits with other universities, including Fisher v. University of Texas at Austin. Brittany N. Ellis, The Harvard Admissions Lawsuit, Explained, Harv. Crimson (Nov. 7, 2016), http://www.thecrimson.com/article
/2016/11/7/harvard-admissions-lawsuit-explainer.

 [9]. Fisher v. Univ. of Tex. at Austin, 136 S. Ct. 2198, 2227 n.4 (2016) (Fisher II) (Alito, J., dissenting) (“The majority’s assertion that UT’s race-based policy does not discriminate against Asian-American students . . . defies the laws of mathematics. UT’s program is clearly designed to increase the number of African-American and Hispanic students by giving them an admissions boost vis-à-vis other applicants.”).

 [10]. I acknowledge that the term “Asian American” encompasses many different cultures and experiences, adding to some of the problems of Asian Americans being viewed as a monolithic group. However, the use of terms such as “Asian Americans,” “African Americans,” and “Hispanic Americans” is not intended to describe the experience of all individuals within such “groups,” but as a way to discuss the larger-scale issues surrounding affirmative action within the context of SFFA v. Harvard. The terms “Asian Americans,” “African Americans,” and “Hispanic Americans” were chosen based on how college admissions categorize ethnicity. See Admissions Statistics, Harvard C., https://college.harvard.edu
/admissions/admissions-statistics. The discussion of stereotypes in this Note is used solely to acknowledge their negative impact and not to recognize them as truth, and while stereotypes in any context may be harmful, it may be necessary to discuss them in order to understand our own internal biases. 

 [11]. See Rogers M. Smith, Civic Ideals: Conflicting Visions of Citizenship in U.S. History 212–17 (1999). In order to maintain dominance and power, wealthy white males recognized they would need to expand the civic identity to include poor white males. Id. By creating a dissonance between poor whites and minority groups, wealthy white males were able to maintain their power in the political system. Id.

 [12]. See id. at 197–242 (describing American ascriptivism). Smith offers a theory that the American political system developed with influence from an ascriptive tradition based on racist, sexist, and nativist assumptions that only allowed certain individuals to take part in the American civic identity. Id.

  SFFA’s complaint may be a reaction to the egalitarian civic reforms over the last few decades, showing that democratic principles have failed to create a shared sense of “peoplehood” and instead left people desiring for a return to some “superior culture” of the past. For Asian Americans to become included in those SFFA deem worthy enough to have earned their spots at Harvard, it comes at the cost of perpetuating stereotypes such as the model-minority myth, which are ultimately harmful to the Asian American community. SFFA may be willing to include Asian Americans in higher education, but does this inclusion also apply where it does not benefit the white community?

 [13]. See infra notes 73, 7677 and accompanying text.

 [14]. Throughout this Note, the terms “minority” and “white” were chosen to label groups in the admissions process as opposed to terms like “preferred” and “non-preferred” applicants or any other potential distinction. This is not to say that the admissions experience of all white applicants or all minority applicants is the same.

 [15]. See Matsuda, supra note 5, at 149–50.

 [16]. Adarand Constructors, Inc. v. Pena, 515 U.S. 200, 227 (1995). Strict scrutiny is the most stringent form of judicial review courts use in determining the constitutionality of laws. To pass strict scrutiny, the law must be “narrowly tailored” to achieve a “compelling state interest.” Id. Racial classifications are subject to strict scrutiny, and even where there is non-invidious motive, such as the case for affirmative action, strict scrutiny still applies. See Korematsu v. United States, 323 U.S. 214, 216–24 (1944) (representing the first official use of strict scrutiny for racial classifications, though the Court’s finding that the law was narrowly tailored to a compelling state interest of national security has been criticized for being based on unfounded data provided by the state and was expressly overruled in Trump v. Hawaii, 138 S. Ct. 2392, 2423 (2018)); Adarand, 515 U.S. at 227.

 [17]. Regents of Univ. of Cal. v. Bakke, 438 U.S. 265, 311–14 (1978). Justice Douglas’s dissenting opinion in Defunis v. Odegaard, 416 U.S. 312, 321–44 (1974), in which he argued that courts should give deference to educators in admissions policies, set the stage for Justice Powell’s opinion in Bakke. See Bakke, 438 U.S. at 311–14. The extent to which diversity would be able to apply as a compelling government interest to other areas outside of public education is uncertain. Grutter v. Bollinger, 539 U.S. 306, 329 (2003) (“We have long recognized that, given the important purpose of public education and the expansive freedoms of speech and thought associated with the university environment, universities occupy a special niche in our constitutional tradition.”).

 [18]. Bakke, 438 U.S. at 323.

A farm boy from Idaho can bring something to Harvard College that a Bostonian cannot offer. Similarly, a black student can usually bring something that a white person cannot offer. The quality of the educational experience of all the students in Harvard College depends in part on these differences in the background and outlook that students bring with them.

Id.

 [19]. Id. at 310, 315–17. A quota system using proportional representation to remedy a historical deficit was considered unconstitutional because racial balancing is unequal on its face. Acting as a counter-effect to societal discrimination is a valid reason, but it is not narrowly tailored enough to justify the unfairness to an “innocent” applicant. Id. at 308–09. 

 [20]. Id. at 316–18. “As the Harvard plan described by Justice Powell recognized, there is of course ‘some relationship between numbers and achieving the benefits to be derived from a diverse student body, and between numbers and providing a reasonable environment for those students admitted.’” Grutter, 539 U.S. at 336 (citing Bakke, 438 U.S. at 323).

 [21]. Grutter, 539 U.S. at 325. (“[W]e endorse Justice Powell’s view that student body diversity is a compelling state interest that can justify the use of race in university admissions.”).

 [22]. Id. at 328. Educational benefits of diversity include cross-racial understanding helping to break down racial stereotypes, livelier classroom discussion, better preparation for a diverse workforce and marketplace, and the creation of a military officer corps better suited to properly provide national security. Id. at 330–33. In Grutter, much of the support for the University of Michigan Law School’s compelling interest claim was “bolstered by its amici, who point to the educational benefits that flow from student body diversity.” Id. at 330.

  The Court cites to Plyler v. Doe, 457 U.S. 202, 221 (1982) and Brown v. Board of Education, 347 U.S. 483, 493 (1954) in acknowledging the Court’s emphasis on education as fundamental in “sustaining our political and cultural heritage” as well as the “foundation of good citizenship.” Grutter, 539 U.S. at 331. However, the Court fails to address the anti-subordination values of Plyler and Brown and simply focuses on the instrumental values of allowing an educational institution to create a policy that promotes a goal of diversity.

 [23]. Grutter, 539 U.S. at 330–33.

 [24]. Id. at 340.

 [25]. Id. at 318.

 [26]. Id. at 328.

The Law School’s educational judgment that such diversity is essential to its educational mission is one to which we defer. . . . Our scrutiny of the interest asserted by the Law School is no less strict for taking into account complex educational judgments in an area that lies primarily within the expertise of the university. Our holding today is in keeping with our tradition of giving a degree of deference to a university’s academic decisions, within constitutionally prescribed limits.

Id.

  This deference only applies to the question of whether the specific institution finds diversity to be part of its own interest, not whether diversity itself is a compelling interest. This deference also does not apply to whether the means chosen to obtain the diversity are narrowly tailored.

 [27]. Id. at 337–38.

 [28]. Id. at 339 (“Narrow tailoring does not require exhaustion of every conceivable race-neutral alternative. Nor does it require a university to choose between maintaining a reputation for excellence or fulfilling a commitment to provide educational opportunities to members of all racial groups.”).

 [29]. Id. The Supreme Court reasoned that the district court’s criticism of the law school for failing to consider race-neutral alternatives such as “using a lottery system” or de-emphasizing the importance of GPA and LSAT scores for all applicants was unfounded because “these alternatives would require a dramatic sacrifice of diversity, the academic quality of all admitted students, or both.” Id. at 339–40.

 [30]. Fisher v. Univ. of Tex. at Austin, 570 U.S. 297 (2013) (Fisher I); Fisher v. University of Tex. at Austin, 136 S. Ct. 2198 (2016) (Fisher II). In Fisher I, after being denied admission to the University of Texas at Austin, Abigail Fisher challenged the university’s admissions policy. Fisher I, 570 U.S. at 306–07. She did not qualify for the university’s Top Ten Percent Plan, which guaranteed admission to the top 10 percent of every in-state, high school graduating class. Id. at 304–05. For the remaining spots, the university’s admissions policy considered several factors, with race being one of them. Id. Fisher I centered around Abigail Fisher’s challenge of University of Texas’s use of race-conscious admissions as a violation of the Equal Protection Clause of the Fourteenth Amendment. Id. The Supreme Court in Fisher I held that the appellate court erred by not properly applying the strict scrutiny standard because narrow tailoring requires a showing that no race-neutral alternative was available and remanded the matter. Id. at 311–15. Fisher II then determined the constitutionality of the admissions policy based on the findings from the university on what race-neutral alternatives were plausible. Fisher II, 136 S. Ct. at 2198. 

 [31]. Fisher I, 570 U.S. at 312 (“Although ‘[n]arrow tailoring does not require exhaustion of every conceivable race-neutral alternative,’ strict scrutiny does require a court to examine with care, and not defer to, a university’s ‘serious, good faith consideration of workable race-neutral alternatives.’” (citing Grutter, 539 U.S. at 339–40)).

 [32]. Id. (“The reviewing court must ultimately be satisfied that no workable race-neutral alternatives would produce the educational benefits of diversity.”).

 [33]. Fisher I, 570 U.S. at 314–15 (“[A] university must make a showing that its plan is narrowly tailored to achieve the only interest that this Court has approved in this context: the benefits of a student body diversity . . . . and the case is remanded for further proceedings consistent with this opinion.”); Fisher II, 136 S. Ct. at 2208 (“Fisher I set forth these controlling principles, while taking no position on the constitutionality of the admissions program at issue in this case.”).

 [34]. Fisher II, 136 S. Ct. at 2211–12 (“[A] university bears a heavy burden in showing that it had not obtained the educational benefits of diversity before it turned to a race-conscious plan.”). As discussed in supra note 30, the University of Texas’s Top Ten Percent Plan (the “Plan”) guaranteed admission to the top 10 percent of every in-state, high school graduating class. Id. at 2205–06. The Plan was introduced by the University of Texas at Austin as a way to improve intra-racial diversity by increasing the amount of diversity within racial groups. Id. The Plan hoped to achieve this by accepting the top 10 percent from every Texas high school given the understanding that the racial and socioeconomic makeup of each school district may not already be diverse. Id.

 [35]. See Grutter, 539 U.S. at 318–20 (“[T]here is no number, percentage, or range of numbers or percentages that constitute critical mass. . . . [C]ritical mass means numbers such that underrepresented minority students do not feel isolated or like spokespersons for their race.” (citations omitted)).

  This is problematic because the “university’s goals cannot be elusory or amorphous—they must be sufficiently measurable to permit judicial scrutiny of the policies adopted to reach them,” while the conception of “critical mass” requires there be no quantitative measure in order to prevent it from appearing like a quota. Fisher II, 136 S. Ct. at 2211. This creates an issue for how to determine when “critical mass” for the purpose of achieving a diversity goal has been achieved.

 [36]. Fisher II, 136 S. Ct. at 2212 (“Though a college must continually reassess its need for race-conscious review, here that assessment appears to have been done with care, and a reasonable determination was made that the University had not yet attained its goals.”).

 [37]. Compare Fisher I, 570 U.S. at 312–15, with Fisher II, 136 S. Ct. at 2210–12.

 [38]. The conception of diversity established in Grutter has shifted slightly because Fisher II introduced the incorporation of intra-racial diversity, noting that “critical mass” may require something besides just a critical mass of each race, specifically, experiences within each race may be considered as well. See Fisher II, 136 S. Ct. at 2110–11. However, the test for diversity has remained the same as it was in Grutter, with specific emphasis on the Court’s continued efforts to give deference to the university’s good faith. Id. at 2211–14.

 [39]. Grutter, 539 U.S. at 325.

 [40]. Id. at 330–32; Stephen M. Rich, What Diversity Contributes To Equal Opportunity, 89 S. Cal. L. Rev. 1011, 1034–36 (2016) (“[I]t begs the question why the Court insisted on drawing such close connections between education and the value of diversity, and does not establish that diversity generally is sufficiently important to sustain the use of racial preferences when the success of a university’s educational mission is not at stake.”).

 [41]. Rich, supra note 40, at 1031–33 (“A more robust verification requirement, however, would have risked undermining the value of academic freedom that has provided the foundation for the Court’s diversity rationale.”); see also Grutter, 539 U.S. at 318–20.

 [42]. See Rich, supra note 40, at 1031–46. The goal of diversity may go beyond just a “critical mass” of racially and ethnically diverse individuals toward a goal of creating equal opportunity through the understanding of historical discrimination. If the true goal is to break down racial stereotypes, simply achieving “critical mass” of racial numbers in an attempt to integrate may not be enough. It may require going beyond the racial make-up of an applicant pool toward including diverse faculty, learning methods, and mentorship in order to truly achieve the educational benefits of diversity. Id. The concept of “critical mass” is unstable because the goals of diversity beyond integration may require a decrease in the quantity associated with critical mass. However, it is also argued that Grutter’s formulation of diversity may do more than just promote integration because it embodies anti-subordination values that look to the future in attempting to ensure there is no creation of a second-class status. Id.

 [43]. Id. at 1035–37 (“The current doctrine’s failure to distinguish between exploitative and egalitarian uses of diversity . . . is a direct consequence of this shift; the doctrine now focuses on whether a university’s pursuit of diversity advances the university’s educational mission, not on whether a university’s enrollments reflect an effort to provide equal opportunity.”). The exploitative use of diversity is to simultaneously profit from the educational benefits diversity can provide to a university and buy into the instrumental justification that diversity is only a compelling interest based on what it can contribute to the mission of a university. See id. at 1031–37. The egalitarian use of diversity is to pursue the belief that people deserve equal opportunities. Id. The current doctrine of diversity does not distinguish between these two objectives and places a larger focus on the instrumental value of how a university’s mission can be served by diversity. Id. at 1035–37. This creates an equal opportunity problem because unless diversity is viewed with an understanding of the unique challenges minorities face in education, minorities will not have a fair shot at the admitted student spots. Without equal opportunity to admission at elite universities, each admission spot becomes non-fungible and broken down into spots reserved for whites, African Americans, Asians, etc.

 [44]. See Lauren Camera, A Community Divided: Asian-Americans Are Divided Over an Affirmative Action Case that Argues Harvard Discriminates Against Them, U.S. News & World Rep. (Oct. 12, 2018, 6:00 AM), https://www.usnews.com/news/the-report/articles/2018-10-12/affirmative-action-case-drives-wedge-in-asian-american-community.

 [45]. If the objective is equal outcomes, this may lead to a solely integration-based conception of affirmative action where comparably “equal outcomes” rely on proportionate representation. If this is the case, there may be “equal outcomes” for a racial group, such that the group is represented by a “meaningful number” of individuals, but this fails to take into consideration histories of discrimination and the impact this historical oppression may have on the ability for individuals within groups to achieve “success.” If the objective is equal opportunity, then similarly situated minority groups should receive the same treatment. In order to understand what would create equal opportunities, an anti-subordination principle that takes into account remedial justifications for affirmative action may be necessary. However, this anti-subordination principle may fail to bring about true equal opportunity if the historical discrimination of some groups is not acknowledged or is undervalued. See Reva B. Siegel, Equality Talk: Antisubordination and Anticlassification Values in Constitutional Struggles Over Brown, 117 Harv. L. Rev. 1470, 1472–73, 1532–33 (2004).

  The recognition of a group’s history of discrimination should by no means be used to invalidate or undermine the patterns of oppression that plague other groups. Specifically, it should not be used to claim that Asian Americans have suffered equal oppression as other groups, particularly African Americans, when it is widely understood that Asian Americans do not face the same systematic racism and obstacles faced by African Americans.

 [46]. The ideal would be for affirmative action to be a discussion that includes minority voices to determine what diversity should look like in an admissions process, rather than an all-or-nothing debate. Giving voice to Asian Americans, who have largely been left out of the white–black discussion until recently, is necessary in order to create any solution that would further the goals affirmative action is based upon.

 [47]. Matsuda, supra note 5, at 153–54.

When university administrators have hidden quotas to keep down Asian admissions, this is because Asians are seen as destroying the predominantly white character of the university. Under this mentality, we cannot let in all those Asian over-achievers and maintain affirmative action for other minority groups. We cannot do both because that will mean either that our universities lose their predominantly white character or that we have to fund more and better universities. To either of those prospects, I say, why not? and I condemn the voices from my own community that are translating legitimate anger at ceilings on Asian admissions into unthinking opposition to affirmative-action floors needed to fight racism.

Id.

 [48]. Id. at 149–50.

 [49]. See Pat K. Chew, Asian Americans: The “Reticent” Minority and Their Paradoxes, 36 Wm. & Mary L. Rev. 1, 4 (1994).

Asian Americans are a “reticent” minority group. Compared to the other major ethnic groups in this country, for instance, Asian Americans are less politically organized and vocal. Their reticence, combined with other cultural factors, has made it difficult for all Americans—whites, Asian Americans and other minority groups—to understand who Asian Americans are.

Id. at 4–5 (footnotes omitted).

 [50]. Shaun R. Harper, Lori D. Patton & Ontario S. Wooden, Access and Equity for African American Students in Higher Education: A Critical Race Historical Analysis of Policy Efforts, 80 J. Higher Educ. 389, 397 (2009).

 [51]. Dana Takagi, The Retreat from Race: Asian-American Admissions and Racial Politics 21–22 (1992). From 1976 to 1982, enrollment increased nationwide by 1.3% for African Americans, 5% for whites, 32% for Hispanic Americans, and 62% for Asian Americans. Id. at 21.

 [52]. Id. at 77–78.

 [53]. For detailed discussion of the Harvard Plan, see supra note 20 and accompanying text.

 [54]. Id. at 51. Asian Americans began challenging admissions policies at elite universities nationwide, including Brown, Harvard, Princeton, Stanford, and UC Berkeley, but have yet to see any concrete judicial success. Id. at 23–51.

 [55]. E.g., Brief for Asian Am. Legal Def. & Educ. Fund et al. as Amici Curiae Supporting Respondents, Fisher II, 136 S. Ct. 2198 (2016) (No. 14-981); Brief for Asian Ams. Advancing Justice et al. as Amici Curiae Supporting Respondents, Fisher II, 136 S. Ct. 2198 (2016) (No. 14-981); Brief for 39 Undergraduate and Graduate Student Orgs. within the Univ. of Cal. as Amici Curiae Supporting Respondents, Fisher II, 136 S. Ct. 2198 (2016) (No. 14-981).

 [56]. Brief for the Asian Am. Legal Found. & the Asian Am. Coal. for Educ. et al. as Amici Curiae Supporting Petitioner at 23–28, Fisher II, 136 S. Ct. 2198 (2016) (No. 14–981) (discussing studies and anecdotal evidence to support the claim that Asian Americans are frequently discriminated against in the application of the SAT test score standard though none of these reported included references or data to University of Texas at Austin).  

 [57]. The model minority myth underscores institutional racism because it pins Asian Americans as successful in comparison to other minorities. It perpetuates an assumption that all minorities face the same experiences and barriers to success when it is clear that they do not. While some Asian Americans may have found success in America, it is in no way due to some inherent “Asian quality” that makes them more likely to succeed. To compare Asian Americans against other minorities is to discount the very real, lingering effects of slavery, Jim Crow laws, and mass incarceration that do not create obstacles for Asian Americans the same way they do for African Americans. Asian American successes are de-emphasized when those successes are attributed to simply being Asian and not from the individual’s hard work and sacrifice. When the stereotype is that Asian Americans cannot fail because of something inherent in “being Asian,” their successes appear less impressive. When one hears that the valedictorian of a high school is Asian American, and the response is “of course” as opposed to hearing that the valedictorian is white, then that Asian American valedictorian is harmed by some perception of the model minority myth. For further discussion of the model minority myth, see Kat Chow, ‘Model Minority’ Myth Again Used as a Racial Wedge Between Asians and Blacks, NPR: Code Switch (April 19, 2017, 8:32 AM), https://www.npr.org/sections/codeswitch/2017/04/19/524571669/model-minority-myth-again-used-as-a-racial-wedge-between-asians-and-blacks.

 [58]. Asian Americans were the first group of immigrants to be explicitly excluded from the United States, with the passage of the Chinese Exclusion Act of 1882. Yuning Wu, Chinese Exclusion Act, Encyclopedia Britannica (Nov. 13. 2013), https://www.britannica.com/topic/Chinese-Exclusion-Act. Then, Japanese immigration was specifically restricted in the Gentleman’s Agreement in 1907, and the 1924 Immigration Act barred immigrants from several other Asian countries. Univ. of Del., Comparison of Asian Populations During the Exclusion Years & Summary of Key Laws Regarding the Immigration and Citizenship of Asians in the United States (2006), http://www1.udel.edu/readhistory/resources/2005_2006/summer_06/hsu.pdf [hereinafter Summary of Key Laws].

 [59]. See generally United States v. Thind, 261 U.S. 204 (1923) (holding Asian Indians were not eligible to apply for U.S. citizenship); Ozawa v. United States, 260 U.S. 178 (1922) (holding Japanese were not eligible to apply for U.S. citizenship).

 [60]. Summary of Key Laws, supra note 58.

 [61]. United States v. Wong Kim Ark, 169 U.S. 649, 705 (1898).

 [62]. Regan v. King, 49 F. Supp. 222 (N.D. Cal. 1942) (plaintiff argued for United States v. Wong Kim Ark to be overruled and the removal of all individuals of Japanese ancestry born in the United States from voter rolls).

 [63]. The Supreme Court did not strike down anti-miscegenation laws, which applied to Asian Americans, as unconstitutional until Loving v. Virginia, 388 U.S. 1, 12 (1967). The “separate but equal” doctrine’s application to Asian Americans was sanctioned by the Supreme Court in Gong Lum v. Rice, 275 U.S. 78, 87 (1927) (allowing Mississippi to prevent a Chinese student from enrolling at an all-white school).

 [64]. Brian Niiya, The Last Alien Land Law, Densho Blog (Feb. 7, 2018), https://densho.org/last-alien-land-law. The large-scale economic disenfranchisement of Asian Americans was fueled by an increased threat of Asian competition in farming. Amy K. Buck, Alien Land Laws: The Curtailing of Japanese Agricultural Pursuits in Oregon 1–4 (1999) (unpublished M.A. thesis, Portland State University), https://pdxscholar.library.pdx.edu/open_access_etds/3988. These Alien Land Laws exacerbated the negative effects of the Japanese internment because many of the Japanese Americans were unable to own their land, so their land was taken from them by the time they returned from the internment camps. Id.

 [65]. Yick Wo v. Hopkins, 118 U.S. 356, 373–74 (1886) (facially race-neutral law applied in racially prejudicial manner violated Fourteenth Amendment). The San Francisco ordinance made it illegal to operate a laundry in a wooden building without a permit, but the Board of Supervisors had discretion in determining to whom to grant permit. Id. at 357–59. Of the 320 laundries at the time, about 95% of them were operated in wooden buildings, and approximately two-thirds of those laundries were owned by Chinese people. See id. at 358–59. The Board of Supervisors denied all two hundred applications that were submitted by Chinese owners. Id. at 359. At the same time, virtually all of the non-Chinese applicants were granted a permit with the exception of one applicant. Id.

 [66]. The Supreme Court upheld Executive Order 9066 in Korematsu v. United States, 323 U.S. 214, 223–24 (1944), which authorized the internment of more than 120,000 people of Japanese descent, two-thirds of which were U.S. citizens. Executive Order 9066 was signed by President Franklin D. Roosevelt on February 19, 1942. Id. at 226–27. Japanese Americans were given between 48 hours to one week to pack one bag and report to an assembly center. Exploration: Japanese-American Internment, Digital History, http://www.digitalhistory.uh.edu/active_learning/explorations/japanese_internment
/internment_menu.cfm (last visited Jan. 3, 2019). From there, they were sent to internment camps that were “surrounded by barbed wire and armed guards.” Id. The Japanese Americans were detained in these camps for three to four years and given a mere $25 upon their release. Ron Grossman, Flashback: When Japanese-Americans Were Sent to Internment Camps, Chi. Trib. (Feb. 9, 2017), https://www.chicagotribune.com/news/opinion/commentary/ct-japanese-internment-camps-war-trump-roosevelt-flashback-perspec-0212-jm-20170208-story.html. There were zero reported incidents of traitorous activity by Japanese Americans during this time, despite the government using this to support their “military necessity” justification. Bill Ong Hing, Lessons to Remember from Japanese Internment, Huffington Post (Apr. 22, 2012), https://www.huffingtonpost.com/bill-ong-hing/lessons-to-remember-from-_b_1285303.html. The compelling government interest of “military necessity” was later found to be based on unsubstantiated facts after a group of young Asian American attorneys filed a writ of coram nobis. Dale Minami: A Chance of a Lifetime, Fred T. Korematsu Inst. (Jan. 6, 2009), http://www.korematsuinstitute.org/news/dale-minami-a-chance-of-a-lifetime. Over forty years later, reparations of $20,000 and a formal apology were awarded to survivors, though most of those who had been interned were deceased by this time. Id. The Japanese internment is important because it reveals a lot about the nature and dangers of anti-Asian prejudice creating a stereotype of Asians as a “perpetual foreigner.” It begs the question of whether the mass imprisonment of U.S. citizens would have been executed against other groups who are not stigmatized by the concept of “foreignness.” Roger Daniels, Concentration Camps: North America—Japanese in the United States and Canada During World War II, at xvi (Robert E. Krieger Publ’g Co. 1981) (1971) (“[T]he legal atrocity which was committed against the Japanese Americans was the logical outgrowth of over three centuries of American experience, an experience which taught Americans to regard the United States as a white man’s country.”). 

 [67]. For this hate crime, the two men received three years of probation and a fine of $3,780 each, which sparked a movement toward political awareness and advocacy for the Asian American community. Lynette Clemetson, A Slaying in 1982 Maintains Its Grip on Asian-Americans, N.Y. Times (June 18, 2002), https://nyti.ms/2lqriDq.

 [68]. Acquittal in Doorstep Killing of Japanese Student, N.Y. Times (May 24, 1993), https://nyti.ms/2GK2ZuK. Hattori was attempting to attend a party with a fellow student, but they knocked on the wrong door. Hattori v, Peairs, 662 So. 2d 509, 511–13 (La. 1995). The owner of that property shot Hattori, but claimed it was in self-defense because he was reasonable to view Hattori as a threat. Id.

 [69]. See Chew, supra note 49, at 59 n.263 (“What if Hattori was black? One wonders if American society is more likely to attend to black/white confrontations than to confrontations between other groups.”). Had Hattori been white, would the jury be more likely to find this story unreasonable? Id. at 59. Does it make the fear the owner felt more reasonable because Hattori was Japanese? If Hattori was black, would the jury be more likely to be receptive to claims that it was the owner’s racism that made him fear Hattori and not a reasonable fear? We cannot be fooled into thinking that “reasonableness” is an objective standard when it is clearly influenced by what that jury views as reasonable, all of which is permeable to racism and negative stereotypes. Id.

 [70]. See U.S Comm’n on Civil Rights, Civil Rights Issues Facing Asian Americans in the 1990s 46 (1992).

 [71]. This is not to say that Asian Americans face the largest number or most violent hate crimes. It is attempting to bring attention to current manifestations of prejudice against Asian Americans that often go unreported or unacknowledged. Jenny J. Chen, First-Ever Tracker of Hate Crimes Against Asian-Americans Launched, NPR (Feb. 17, 2017), https://www.npr.org/sections/codeswitch/2017/02/17
/515824196/first-ever-tracker-of-hate-crimes-against-asian-americans-launched.

 [72]. Chen, supra note 71; Anti-Asian Hate Crimes in Los Angeles Surge After Trump Deems China an Enemy, Asian Am. Advancing Just. (Jan. 30, 2017), https://advancingjustice-aajc.org/news/anti-asian-hate-crimes-los-angeles-surge-after-trump-deems-china-enemy; Kamal S. Kalsi, Xenophobia Towards Asian Americans and Pacific Islanders Persists Under Trump Administration, Huffington Post (June 2, 2017), https://www.huffingtonpost.com/entry/xenophobia-towards-asian-americans-and-pacific-islanders-persists-under-the-trump-administration_us_592f1075e4b09ec37c313e66.

 [73]. Asian Americans are perceived as “perpetual foreigners.” This stems from Asian Americans arriving in America as immigrants, much like other ethnic groups. However—unlike European immigrants and, to some extent, Hispanic American immigrants—Asian Americans’ facial characteristics cannot provide them any possibility of being “white-passing.” In addition, Asian culture is often seen as exotic and not assimilable to American culture.

                My mother’s family has lived in the United States for three generations; her own parents barely spoke Japanese and had never been to Japan. Yet I continue to get asked “why is your English so good?” or “where are you really from?” as though I am not equally as American as a fourth-generation immigrant from a European country. How often are those questions asked of a white person or even an African American person? 

  I recognize that many of these issues are not unique to Asian Americans. For example, Middle Eastern Americans and, to some extent, Hispanic Americans also do not have the benefit of being “white-passing” or being viewed as part of American culture.

  The caveat of being “foreign” means Asian Americans are accepted into American society so long as they don’t pose a threat. The minute the country of their ancestors does something “against America,” they are no longer American, they are Japanese or Chinese, or in the current climate, Muslim.

 [74]. Matsuda, supra note 5, at 150. Asian Americans act as a “racial bourgeoisie” because they are never going to be “white enough” to be white, but other people of color view them as too privileged to truly be considered minorities. This means that Asian Americans are neither accepted by whites nor people of color. See Emily S. Zia, Note, What Side Are We On? A Call to Arms to the Asian American Community, 23 Asian Am. L.J. 169, 169–75 (discussing her experience as an Asian American trying to participate in a “die-in” as part of a “Boalt With Ferguson” protest at UC Berkeley School of Law) (“All of these events made me feel like the other students of color did not view Asian Americans as allies, let alone people of color. . . . [W]hy did my fellow students of color view us as closer to White than to Black?”). Although her point about being viewed as closer to white than African American is valid, it is important to make clear that it is not Asian Americans’ place to intrude on an experience that does not affect them the same way it does African Americans. The goal is not to tell African Americans how to lead a Ferguson protest, but there should be room to include those who are willing to be active listeners. The danger of being in a racial middle ground is that Asian Americans are often excluded from the discussion, but it also means Asian Americans have a powerful position to effect change.

 [75]. Frank H. Wu, Yellow: Race in American Beyond Black and White 58 (2002) (“DePaul University law professor Sumi Cho has explained that Asian Americans are turned into ‘racial mascots’ giving right-wing causes a novel messenger, camouflaging arguments that would look unconscionably self-interested if made by whites about themselves.”); William C. Kidder, Negative Action Versus Affirmative Action: Asian Pacific Americans Are Still Caught in the Crossfire, 11 Mich. J. Race & L. 605, 621 (2006); Chew, supra note 49, at 66.

 [76]. See generally Claire Jean Kim, The Racial Triangulation of Asian Americans, 27 Pol. & Soc’y 105 (1999) (explaining racial triangulation). Racial triangulation is the concept of having “foreignness” and “superiority” on x-y axes. Id. at 107–08. Whites and African Americans are on opposite ends of the “superiority” y-axis spectrum but at the lowest end of the x-axis “foreignness,” while Asian Americans are on the peak of “foreignness” and lie in the middle on the “superiority” axis. Id. This creates a triangle that place Asian Americans in a racial bourgeoisie between whites and African Americans that no amount of success (attributable to the model minority myth) can overcome due to the conception of foreignness. Id. The use of this racial triangulation may be used to benefit conservative groups looking to preserve a “white image” and create a pitting of racial minorities against each other in order to maintain political dominance. Id. at 122–23.

This payoff is so rich that conservatives have actually manufactured conflicts between Blacks and Asian Americans in order to achieve it. . . . [In the 1980s, conservative affirmative action opponents] shifted public debate from the real issue at hand—whether or not several leading universities imposed racial quotas on Asian American students to preserve the whiteness of their student bodies—to the false issue of whether affirmative action programs designed to benefit Blacks and Latinos unfairly discriminated against Asian Americans.

Id.

 [77]. The concept of Asian Americans as perpetual foreigners has occurred throughout history and continues to exist in American culture. Plessy v. Ferguson, 163 U.S. 537, 561 (1896) (Harlan, J., dissenting) (“There is a race so different from our own that we do not permit those belonging to it to become citizens of the United States. Persons belonging to it are, with few exceptions, absolutely excluded from our country. I allude to the Chinese race.”); Schutte v. Coal. to Defend Affirmative Action, 572 U.S. 291, 381 (2014) (Sotomayor, J., dissenting).

Race matters to a young woman’s sense of self when she states her hometown, and then is pressed, “No, where are you really from?”, regardless of how many generations her family has been in the country. Race matters to a young person addressed by a stranger in a foreign language, which he does not understand because only English was spoken at home. Race matters because of the slights, the snickers, the silent judgments that reinforce that most crippling of thoughts: “I do not belong here.”

Schutte, 572 U.S. at 381.

 [78]. This was seen during World War II, where Italian and German Americans were not conflated with their ancestor country to the same extent as Japanese Americans, who were placed in internment camps. Asian Americans are easy targets for this type of discrimination because they are seen as different and inherently un-American. It brings into question whether this is something that Muslim Americans and Middle Eastern Americans face in twenty-first century America.

 [79]. It is intentional that the term is “model minority” and not “model American.” See Chew, supra note 49, at 32–35.

 [80]. Gabriel J. Chin et al., Beyond Self-Interest: Asian Pacific Americans Toward a Community of Justice, a Policy Analysis of Affirmative Action, 4 UCLA Asian Pac. Am. L.J. 129, 149 (1996) (“[Asian Americans] generally have more individuals contributing to household income than the national average . . . .”). Asian Americans also tend to live in geographic areas that tend to have higher costs of living and above-average incomes for all residents, indicating that Asian Americans are no more successful than any other race. Id. Immigration laws historically favored highly-educated Asian professionals, which greatly influenced the Asian immigrant demographics, which could affect the average income levels and perceived socioeconomic mobility of Asian Americans. Id. at 150.

 [81]. See supra notes 6768.

 [82]. See Chin et al., supra note 80, at 154 (discussing how Asian Americans are “under-parity” in numerous fields and would not have their current representation in those areas without the aid of affirmative action policies).

 [83]. Kimberly West-Faulcon, Obscuring Asian Penalty with Illusions of Black Bonus, 64 UCLA L. Rev. Disc. 590, 629 n.153 (2017).

My point is that accusing Harvard of racial balancing is a promising means of convincing the federal court to strike down the institution’s racial affirmative action policy but, if Harvard admissions officials have an either conscious or unconscious enrollment limit they are inclined to impose on Asian American enrollment to preserve Harvard’s predominantly white character, eliminating racial affirmative action will neither expose or rectify that type of anti-Asian bias in admissions.

Id.; Jerry Kang, Negative Action Against Asian Americans: The Internal Instability of Dworkin’s Defense of Affirmative Action, 31 Harv. C.R.-C.L. L. Rev. 1, 14–18 (discussing that negative action rather than affirmative action is the main source of any limits in admissions for Asian Americans).

 [84]. Jaweed Kaleem, Asian Americans Are Divided After the Trump Administration’s Move on Affirmative Action, L.A. Times (Aug. 3, 2017), http://www.latimes.com/nation/la-na-asian-americans-affirmative-action-20170803-story.html (“Affirmative action opponents often cite a 2009 study that found Asian Americans had to score 140 points higher on SAT exams in order to be on equal footing with whites in private university admissions—a difference they sometimes call the ‘Asian tax.’”) (“But the test score phenomenon exists regardless of whether the university considers race in its admission. So there is something else happening.”) (quoting Asian Americans Advancing Justice Attorney Nicole Gon Ochi).

 [85]. Id.

This is primarily about conservative leaders protecting the privilege of access to society’s resources and opportunities for certain white constituents . . . . Such leaders’ purported concern for discrimination against Asian Americans is politically opportunistic. . . . I don’t see many of them concerned about discrimination against Asian Americans in other contexts . . . such as the “bamboo ceiling” in corporate America, where such discrimination does not harm white interests.

Id. (quoting Professor Kim Forde-Mazrui, University of Virginia School of Law).

 [86]. Carolyn Chen, Opinion, Asians: Too Smart for Their Own Good?, N.Y. Times (Dec. 19, 2012), https://nyti.ms/2jKMeQF (“For middle-class and affluent whites, overachieving Asian-Americans pose thorny questions about privilege and power, merit and opportunity. Some white parents have reportedly shied away from selective public schools that have become ‘too Asian,’ fearing that their children will be outmatched.”). For the Harvard class of 2022, the numbers are approximately 23% Asian and 47% white. Harvard Admitted Students Profile, Harv. C.: Admissions & Fin. Aid, https://college.harvard.edu
/admissions/admissions-statistics (last visited Jan. 21, 2019).

 [87]. Complaint, supra note 7, at 1. The action is being brought under Title VI of the Civil Rights Act of 1964 because Harvard College is a private university and would not be subject to constitutional challenges under the Equal Protection Clause. However, because Harvard College accepts federal funding, it is subject to the statutory obligations under Title VI. Education and Title VI, U.S. Dep’t of Educ., https://www2.ed.gov/about/offices/list/ocr/docs/hq43e4.html (last updated Sept. 25, 2018); see also Complaint, supra note 7, at 94.

 [88]. Alexander v. Sandoval, 532 U.S. 275 (2001) (deciding that Title VI regulations did not include a private right of action based on evidence of disparate impact).

  It seems the Court will likely allow a private right of action under Title VI. See generally Lau v. Nichols, 414 U.S. 563 (involving the Court allowing a private right of action under Title VI to non-English speaking Chinese students seeking relief against the San Francisco School District, but the existence of a private right of action was never disputed in this case); Regents of Univ. of Cal. v. Bakke, 438 U.S. 265 (1978) (involving four justices assuming, without deciding, that a private right of action was available under Title VI, one justice denying a private right of action could be implied, and the remaining four justices concluding that the private action was available).

 [89]. Complaint, supra note 7, at 3–5, 100–01. 

 [90]. Id. at 8. When the complaint was filed, the unnamed applicant was the only Standing Member (other than his father). Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *37 (D. Mass. Sept. 28, 2018). SFFA has since added additional members to the suit, including several that it identified as “Standing Members,” several of whom were Asian American applicants rejected from Harvard. Id. These members filed affidavits and testified in court stating they would be able and ready to transfer if Harvard ceases using race-conscious admissions. Id. at *39–41. Harvard alleged that the Standing Members ability to challenge has become moot because they are now ineligible to transfer or no serious intention to. However, based on the testimony of two Standing Members still eligible for transfer, the court found there was enough to support SFFA’s associational standing. Id. at *41. 

 [91]. Complaint, supra note 7, at 8. It is of note that the plaintiff is unnamed, and the suit is being brought on behalf of an organization that is claiming to represent the interests of its members, including the unnamed plaintiff. Whether the Supreme Court will determine SFFA has standing to bring the suit is uncertain since equal protection is generally to provide individual relief and all other affirmative action cases have been brought by named individuals rather than a curated “litigation vehicle.” Defendant’s Motion for Summary Judgment at 1, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901 (D. Mass. Sept. 28, 2018), ECF No. 417. According to Adarand Constructors, Inc. v. Pena, 515 U.S. 200, 224 (1995), the right to equal opportunity is a personal right, so what matters is the treatment of the individual plaintiff not the average Asian American plaintiff. However, the district court denied Harvard’s motion for summary judgment based on lack of standing. See SFFA, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *41. There is skepticism that using one unnamed Asian American plaintiff shows Asian Americans are being manipulated in an effort to eliminate affirmative action on behalf of a non-Asian American membership. While this may have merit, it is also important that the concerns voiced by Asian Americans not be dismissed by supporters of affirmative action simply because they are being wielded by a group like SFFA.

 [92]. Complaint, supra note 7, at 8.

 [93]. SFFA, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *16–23 (describing the undisputed facts regarding the Harvard admissions process).

 [94]. Id. at *18–21.

 [95]. Id. at *20. The assessment of an applicant’s personal rating is subject to racial bias if unconscious stereotypes are able to affect an officer’s view of whether a candidate possesses these traits.

 [96]. Id. at *20–21. By not having a specific formula, there is a possibility that some categories may be given more weight than others. While it may be useful to allow a university to have discretion to view every candidate holistically, there may be reason for skepticism if there is a large disparity between the overall ratings given to Asian Americans and what the summed total of their other ratings would have been. If Asian Americans were to score higher than white applicants in the other categories, including extracurricular, personal, and interview ratings, but still receive lower overall ratings, it may be an indication that Asian Americans’ race negatively affects how they are viewed overall.

 [97]. Id. at *22–23.

 [98]. Id. at *28–31. Is the reason for Asian American admission decreasing with the consideration of non-academic variables truly due to Asian Americans only being good at academics or is it because their other traits and activities are undervalued in comparison to other racial groups?

 [99]. Id. at *30. If the only difference accounting for the higher admittance rates of non-legacy, non-athlete white applicants is the personal rating, it begs the question of whether white applicants receive a biased preference over Asian American applicants based on amorphous personal traits that may be subject to cultural differences.

 [100]. Id. at *30–31.

 [101]. Id. at *26.

 [102]. Id. at *26–27.

 [103]. Id. at *27–28.

 [104]. Anemona Hartocollis, He Took on the Voting Rights Act and Won. Now He’s Taking on Harvard, N.Y. Times (Nov. 19, 2017), https://nyti.ms/2jFMkOb.  

 [105]. Id. Blum chose the University of Texas at Austin, his own alma mater, as the subject of the challenge. Id. Abigail Fisher was the daughter of Blum’s friend. Id.

 [106]. Id. The Voting Rights Act of 1965 was a response to the deep-rooted history of discrimination in voting. Shelby County v. Holder, 570 U.S. 529, 529–30 (2013). The Act required certain “eligible” districts with a history of voting discrimination to gain official authorization before they could enact any changes to their election laws. Id. at 537–39. To gain authorization, these districts had to prove that the new changes did not have the purpose nor the effect of negatively impacting any individual’s right to vote based on their race. Id. The Supreme Court determined that this Section of the Act was unconstitutional because it imposes current burdens that are no longer responsive to the current conditions of the voting districts. Id. at 555–57.

  Blum’s challenge of the Voting Rights Act of 1965 was rooted in his experience in losing a race for Congress in Houston as a Republican. Hartocollis, supra note 104. He was bothered by the district’s “tortured shape, designed to make it easier for a minority candidate to win the seat.” Id.

  Affirmative action sits in a uniquely similar position to the Voting Rights Act of 1965 in that it may be vulnerable to accusations of unconstitutionality based on a court’s determination that the historical discrimination that created the need for such protections are no longer a concern.

 [107]. Hartocollis, supra note 104.

 [108]. Id.

 [109]. Ellis, supra note 8.

 [110]. Id.

 [111]. Id. It is of note that Justice Kennedy was the swing vote in Fisher II, but he has since been replaced by Justice Brett Kavanaugh. Chas Danner, Brett Kavanaugh Sworn in as 114th Supreme Court Justice, Intelligencer (Oct. 7, 2018), http://nymag.com/intelligencer/2018/10/brett-kavanaugh-sworn-in-as-114th-supreme-court-justice.html.

 [112]. Ellis, supra note 8.

 [113]. See generally Docket, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 1:14-cv-14176 (D. Mass.).

 [114]. Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., 261 F. Supp. 3d 99, 102 (D. Mass. 2017).

 [115]. Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., No. 1:14-cv-14176, 2017 U.S. Dist. LEXIS 84656, at *2–3 (D. Mass. June 2, 2017); see also Complaint, supra note 7, at 109–11, 114–19; Ellis, supra note 8.

 [116]. Laura Jarrett, Justice Department. Investigating Harvard Over Affirmative Action Policies, CNN (Nov. 21, 2017), http://cnn.it/2hGzjj7.

 [117]. Merrit Kennedy, Justice Department Threatens to Sue Harvard in Admissions Probe, NPR (Nov. 21, 2017), https://n.pr/2mNx1UY.

 [118]. Id.

 [119]. Kirk Carapezza, DOJ Looks Into Whether Harvard Discriminates Against Asian-Americans, NPR (Aug. 3, 2017), https://www.npr.org/541430130 (“Civil rights groups and legal experts are skeptical. ‘It seems entirely consistent with President Trump’s campaign rhetoric,’ says Tomiko Brown-Nagin, a constitutional law professor at Harvard. Brown-Nagin points out that the Trump administration’s decision to target affirmative action policies comes as racial tensions are rising on many campuses.”).

 [120]. David Shortell, Justice Department Sides With Asian-Americans Suing Harvard Over Admissions Policy, CNN (Aug. 30, 2018), https://cnn.it/2POYxf9 (“The record evidence demonstrates that Harvard’s race-based admissions process significantly disadvantages Asian-American applicants compared to applicants of other racial groups—including both white applicants and applicants from other racial minority groups . . . .” (quoting United States’ Statement of Interest in Opposition to Defendant’s Motion for Summary Judgment, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 1:14-cv-14176 (D. Mass. Sept. 28, 2018), ECF No. 497)).

 [121]. Id. It is uncertain what impact the DOJ’s involvement will have on the outcome of SFFA v. Harvard or affirmative action in general, though if a federal judge finds Harvard has violated Title VI, the court could order the university to change its admissions policies. Melissa Korn & Nicole Hong, Harvard Faces DOJ Probe Over Affirmative-Action Policies, Wall St. J. (Nov. 21, 2017, 3:12 PM), https://www.wsj.com/articles/harvard-faces-doj-probe-over-affirmative-action-policies-1511260380.

 [122]. Foussianes, supra note 7.

 [123]. Expert Report of Peter S. Arcidiacono at 5, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176 (D. Mass. June 15, 2018), ECF No. 415-1. Professor Arcidiacono has an extensive background in studying admissions decisions in higher education. Id.

 [124]. Expert Report of Richard D. Kahlenberg, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176 (D. Mass. June 15, 2018), ECF No. 416-1.

 [125]. Report of David Card, Ph.D., Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176 (D. Mass. June 15, 2018), ECF No. 419-33; see also Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *44–68 (D. Mass. Sept. 28, 2018). Professor Card specializes in labor economics. Colleen Walsh, Attorney Appears Confident Admissions Case Ruling Will Favor Harvard, Harv. Gazette (Nov. 4, 2018), https://news.harvard.edu/gazette/story/2018/11/harvard-attorney-appears-confident-in-admissions-case-ruling.

 [126]. Joan Biskupic, Harvard Affirmative Action Trial Arguments Come to a Close, CNN (Nov. 3, 2018, 10:00 AM), https://cnn.it/2QbHaVw.

 [127]. Foussianes, supra note 7.

 [128]. Id.

 [129]. Joint Statement Regarding the Submission of Trial Briefs at 1, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176 (D. Mass. Aug. 13, 2018), ECF No. 478.

 [130]. Plaintiff’s Motion for Summary Judgment at 2, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901 (D. Mass. Sept. 28, 2018), ECF No. 412.

 [131]. Complaint, supra note 7, at 3–4.

 [132]. Id.

 [133]. Id.

 [134]. Id. at 4–5 (quoting Grutter v. Bollinger, 539 U.S. 306, 389 (2003) (Kennedy, J., dissenting)).

 [135]. Id. at 5–6.

 [136]. Id. at 11.

 [137]. Id. at 12–22 (“In 1920, in a letter to William Hocking, a Harvard philosophy professor, President Lowell wrote that the increasing number of Jewish students enrolling at Harvard would ultimately ‘ruin the college’.”). A Harvard alum wrote a letter to President Lowell indicating desires to maintain the school’s “white image” through the reduction of Jewish students, claiming

[t]he Jew is undoubtedly of high mental order, desires the best education he can get CHEAPEST, and is more persistent than other races in his endeavors to get what he wants. It is self evident, therefore, that by raising the standard of marks he can’t be eliminated from Harvard, whereas by the same process of raising the standard “White” boys ARE eliminated.
. . . Are the Overseers so lacking in genius that they can’t devise a way to bring Harvard back to the position it always held as a “white man’s” college?

Id. at 17–18. President Lowell accepted the perpetuation of these stereotypes in order to protect a “white image” that would be achieved through a subjective, “character” based admissions policy that was undoubtedly created with a purpose to discriminate. Id. at 20 (“President Lowell was elated by these changes, realizing that they ‘provided a tremendous opportunity to impose, at long last, the policy of restriction he had favored since 1922.’”).

 [138]. Id.

 [139]. Id. at 28–34.

 [140]. Id. at 34–36. However, the former Dean of Admissions Fred Jewett, explained that the 112-point disparity in average SAT scores of admitted Asian Americans compared to admitted white students were due to “choosing people who bring talents underrepresented in the applicant pool.” Id. at 36. In addition, the current Dean of Admissions, William Fitzsimmons, recognized the slightly stronger academics of Asian Americans as compared to white applicants, but “blamed the disparity in admissions on Asian Americans, as a group, being ‘slightly less strong on extracurricular criteria.’” Id.

 [141]. Id. at 36–37. However, the complaint stipulates that the Office of Civil Rights’s report was highly criticized for allowing “racial balancing” and creating a pretext for intentional discrimination. Id.at 37.

 [142]. See generally Thomas J. Espenshade & Alexandria W. Radford, No Longer Separate, not yet Equal: Race and Class in Elite Admission and Campus Life (2009) (analyzing college admissions data to explore the composition of applicant pools to selective universities).

 [143]. Complaint, supra note 7, at 40–50.

 [144]. Ron Unz, The Myth of American Meritocracy, Am. Conservative, Dec. 2012, at 14.

 [145]. Complaint, supra note 7, at 49–50 (alteration in original).

 [146]. Id. at 53–55 (specifically referencing Table B).

 [147]. Id. at 56–67. Princeton Review, the “leading guide to college admissions,” gives recommendations for Asian American students applying to elite colleges, stating “the more you sound like”

Asian Joe Bloggs . . . an Asian American applicant with a very high math SAT score, a low or mediocre verbal SAT score, high math- or science-related SAT II scores, high math and science grades, few credits in the humanities, few extracurricular activities, an intended major in math or the sciences, and an ambition to be a doctor, an engineer, or a research scientist,

“the more likely admissions officers will be to treat you as part of the ‘Asian invasion’ and reject your application, or at the very least make you compete against other Asian applicants with similar characteristics, rather than against the applicant pool as a whole.” Id. at 57–58. According to Princeton Review, suppressing one’s ethnic background is important to better an Asian American applicant’s chances of acceptance at elite institutions. See id. at 58–59.

If you’re given an option, don’t attach a photograph to your application and don’t answer the optional question about your ethnic background. . . . Do not write your application essay about the importance of your family or the positive/negative aspects of living in two cultures. These are Asian Joe Bloggs topics, and they are incredibly popular. Instead, write about something entirely unrelated to your ethnic background.

Id.

  There is danger in anecdotal testimony because it is based on personal perception and can be susceptible to bias. While the stories told by the individuals and groups in SFFA’s complaint are useful to understand the way a community of applicants may feel and may potentially be accurate reflections of a situation, it should not be considered direct evidence of discrimination in an admissions policy.

 [148]. Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *43–44 (D. Mass. Sept. 28, 2018).

 [149]. Expert Report of Peter S. Arcidiacono at 1–10, Students for Fair Admissions, Inc. v. President and Fellows of Harvard College, No. 14-cv-14176 (D. Mass. June 15, 2018), ECF No. 415-1.

 [150]. SFFA, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *43–46.

 [151]. See Walsh, supra note 125 (describing Card’s criticisms and some basis for what other experts in the field may believe the proper modeling choice is) (“Lawyers for Harvard also cited an amicus brief field by 16 economists, including two Nobel laureates and former chair of the Federal Reserve Janet Yellen, who backed Card’s approach and labeled Arcidiacono’s findings ‘implausible.’”). Although Arcidiacono’s model may be subject to criticism, there may also be some bias in Card’s approach which includes factors in his regression that are already subject to racial bias.

 [152].               SFFA, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *48.

 [153]. Id. at *49–51.

 [154]. Complaint, supra note 7, at 67–72.

 [155]. This approximation is from when the complaint was originally filed. The admissions statistics are from 2006 to 2014, and the enrollment statistics are from 2003 to 2013. Id. at 67–69 (specifically referencing Table C, Table D, and Table E).

 [156]. Id. at 65–66 (“[T]he proportion of Asian Americans with top SAT scores . . . who sent their scores to the most selective Ivy League schools fell from 39.7 percent in the mid-1990s to only 27.4 percent during the 2008, 2010, and 2012 cycles.”). This could indicate that Asian American applicants believe there is some bias in the application process and choose not to even apply to elite Ivy League schools because the perceived odds are against them despite their top SAT scores.

 [157]. Id. at 70.

 [158]. Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *51–52 (D. Mass. Sept. 28, 2018).

 [159]. Id. at *52–53.

 [160]. Id. Are Asian Americans more likely to be “lopped” than applicants from other racial groups? If there is evidence that Asian Americans have consistently higher rates of “lopping,” then there may be an indication that Asian Americans receive some negative action when their race is considered.

 [161]. Id. at *53–54.

 [162]. Id. at *54.

 [163]. Id. at *54–55. For SFFA to show a racial quota, stable enrollment numbers may not be enough. It may be necessary for SFFA to show that Asian American application rates substantially increased in comparison to white application rates, but their enrollment stayed the same. Indicating that Asian Americans make up a larger portion of the qualified applicant pool but the same proportion of the admitted class would be more helpful than just stable enrollment rates.

 [164]. Id. at *56.

 [165]. Id. at *57.

 [166]. Id. at *59 (quoting Grutter v. Bollinger, 539 U.S. 306, 343 (2003)). This is a similar argument to the one made by Edward Blum in Shelby County v. Holder, 133 S. Ct. 2612, 2630–31 (2013), which invalidated the Voting Rights Act of 1965 based on reasoning that the historical discrimination that led to the passage of the act is no longer an issue. See supra note 106 and accompanying text.

 [167]. SFFA, No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *59–60 (quoting Fisher v. Univ. of Texas at Austin, 136 S. Ct. 2198, 2212 (2016) (Fisher II)).

 [168]. Id. at *61–62.

 [169]. Id. at *62.

 [170]. Complaint, supra note 7, at 72–93.

 [171]. Id. at 72–73. SFFA argues that Harvard fails to give proper weight to these socioeconomic factors in its admissions policy based on the lack of socioeconomic diversity in comparison to racial diversity that exists in its student body. Id. at 76.

 [172]. Id. at 77–78.

 [173]. Id. at 78–81 (“Harvard focuses its recruitment in parts of the country with small numbers of socioeconomically disadvantaged achievers and neglects regions with a significant number of such students. . . . This failure to recruit socioeconomically disadvantaged students is reflected in Harvard’s applicant pool.”).

 [174]. Id. at 81–86. Harvard’s acceptance rate for legacy applicants is “about 30 percent, which is roughly five times the rate at which all other applicants are admitted to Harvard.” Id. at 81. Legacy preferences tend to “give a competitive advantage to mainly white, wealthy applicants, while undermining the chances for admission of socioeconomically disadvantaged and minority applicants.” Id. Harvard’s propensity to give preferences to non-legacy, wealthy donor applicants also gives a competitive advantage to mainly white applicants. Id. at 83 (“Minority students are far less likely to be children of wealthy donors.”).

  This creates a separate discussion about the use of legacy preferences and whether they are merely a thinly-veiled way for universities to give admissions preferences to a group of applicants that tend to be whiter and wealthier than the general applicant pool.

 [175]. Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., No. 14-cv-14176, 2018 U.S. Dist. LEXIS 167901, at *66 (D. Mass. Sept. 28, 2018).

 [176]. Id. at *64–66.

 [177]. Id. at *66–67.

 [178]. See Shelby County v. Holder, 570 U.S. 529, 551–52 (2013) (reevaluating the legality of policies under the lens of their current existence, even if there was a “long history as a tool for perpetuating the evil”).

 [179]. Yick Wo v. Hopkins, 118 U.S. 356, 360 (1886). The constant admission rates of Asian Americans are unlikely to be a severe enough discriminatory impact to allow a presumption of discriminatory intent as it was in Yick Wo, so SFFA will have to find other evidence to indicate Harvard’s intent to discriminate against Asian Americans in their admissions policy. This is a high burden for SFFA to meet. See supra note 65 (describing how all two hundred applications that were submitted by Chinese owners were denied while virtually all of the non-Chinese applicants were granted a permit).

 [180]. See Espenshade & Radford, supra note 142, at 412.

 [181]. Kidder, supra note 75, at 614–16.

The upshot of the fact that White admitees outnumber Blacks/Latinos 3-to-1, and the aforementioned discussion about the composition of actual and likely pool of admitees is that Espenshade and Chung’s study contains a “yellow peril causation fallacy” that misidentifies [Asian Americans] as the group poised to be the biggest numerical winners if affirmative action ended at elite universities. In other words, when an [Asian American] applicant in their dataset is denied admission because of negative action despite a strong transcript and say a 1510 or 1430 or 1360 on the SAT, it is exceedingly more likely that the student admitted instead was a White applicant with slightly lower academic credentials, not a Black or Latino applicant given an affirmative action plus factor.

Id. at 615–16.

 [182]. Is it possible for schools to consider an over-representation of white students? There is a perception that schools can be “too Asian,” damaging the appeal of a university, but the same is not said for schools that are predominately white. Does the conception of over-representation apply the same to other minorities? Because while it seems that our society would be appalled at the prospect of a school being considered “too black” or “too Hispanic,” why doesn’t our society believe calling a school “too Asian” is equally racist?

 [183]. If there was a hypothetical where diversity was deemed not to be a compelling interest and the entire Harvard class consisted only of Asian Americans accepted by “objective” criteria, would SFFA be satisfied with the result? What if the entire Harvard class consisted only of white students? If neither of these outcomes are satisfactory to a society, we cannot deny the compelling interest of diversity and the potential “balancing” required to achieve it.

 [184]. See Fisher v. Univ. of Texas at Austin, 136 S. Ct. 2198, 2211–15 (2016) (Fisher II) (“[A] university bears a heavy burden in showing that it had not obtained the educational benefits of diversity before it turned to a race-conscious plan.”) (“It is the University’s ongoing obligation to engage in constant deliberation and continued reflection regarding its admission policies.”).

 [185]. Chin et al., supra note 80, at 161.

A genuine commitment to class equality would lead one to target resources at an individual’s formative years as with anti-poverty programs that provide adequate housing, nutrition, and education to children. But oddly enough, the programs mentioned so far would instead give mild preferences late in life, in admissions or employment. This should give us cause for skepticism.

Id.

 [186]. Goodwin Liu, The Causation Fallacy: Bakke and the Basic Arithmetic of Selective Admissions, 100 Mich. L. Rev. 1045, 1048 (2002).

 [187]. West-Faulcon, supra note 83, at 594.

 [188]. Liu, supra note 186, at 1048. “Many white students who were denied admission did not lose out because of minority students, but because of tight limits on enrollment. In other words, many qualified white applicants probably would have been turned down even if no minority students had applied.” Id. at 1048 n.13 (quoting John Iwasaki, Affirmative Action Aids White Students Too; Stereotype False, State Study Says, Seattle Post-Intelligencer, Nov. 19, 1995, at A9).

 [189]. Liu, supra note 186, at 1078.

 [190]. Id. at 1064–68 (“[B]lack and white applicants with similar SAT scores might not be similarly situated with respect to nonacademic admissions criteria.”).

 [191]. Id. at 1046.

 [192]. Affirmative action sits within the broader idea of race-conscious admissions, but they are not the same thing. Not all admissions policies that consider race are affirmative action policies. An example of this would be a policy that enables bias against Asian American applicants in comparison to white applicants, thus giving white applicants a type of plus factor over those Asian American applicants. I think Asian Americans could potentially fare better if race-conscious admissions were banned but would not if just affirmative action was due to the causation fallacy. The difference would be that race-conscious admissions have the ability to contain negative action against Asian Americans while affirmative action inherently does not. There is space in this discussion to both remedy the grievances Asian Americans feel through the devaluation of their personal attributes and maintain the affirmative action policies necessary to fulfill the compelling interest of educational diversity.

 [193]. West-Faulcon, supra note 83, at 603.

 [194]. Id. at 604–05 (“[U]niversities do not select students solely based on SAT scores and . . . SAT scores are racially skewed as a general matter.”) (“[F]or reasons that range from the theoretical and measurement limitations of g-based standardized tests like the SAT to the fact that African Americans belong to the racial group that has been most severely harmed by American Jim Crow racism, housing segregation, public educational opportunity gaps, and disparities in economic opportunities.” (footnotes omitted)).

 [195]. See Liu, supra note 186, at 1096. At the very least, we would be better off urging top colleges to commit to genuine educational diversity that places a greater emphasis on different types of diversity like first-generation status, diversity in faculty, and diversity in the types of cultural histories taught at these schools, rather than attacking affirmative action. How often are general education classes taught from the point of view of an African American student or from the perspective of a woman? So often the education system focuses on the accomplishments of white males and fails to recognize the value of a diverse core curriculum, and this affects the way our future leaders exist and shape our society.

 [196]. For example, the “positive” stereotype that Asian Americans are successful works to diminish the success achieved by Asian Americans as expected or ordinary. This requires Asian Americans to be held to a higher standard in comparison to each other in order to stand out. There is a feeling among the Asian American community that one must be extraordinary to just seem average. In addition, a positive stereotype of Asian Americans as hard workers easily becomes translated into Asian Americans being unfair competitors.

 [197]. Chew, supra note 49, at 40–41.

Employers might tend to see Asian Americans as homogeneous and suited for certain defined roles that are consistent with society’s image. . . . While society may consider Asian Americans hard working and intelligent, especially in math, Asian American faculty may be considered “too nice” to be intellectually demanding and rigorous professors and scholars.

Id.

 [198]. Id. at 53.

A comparison of the number of Asian Americans in managerial and professional positions versus the number of Asian Americans with bachelor and graduate degrees evidences this disparity. One would generally expect individuals with bachelor or graduate degrees to hold managerial or professional positions. For example, 23.6 million whites hold bachelor or graduate degrees and, comparably, 26.5 million whites hold managerial or professional positions—a ratio of 1.12. Accordingly, one would expect the number of Asian Americans with this education level to correspond to the number of Asian Americans in these positions. Instead, the number of Asian Americans with these degrees (1.3 million) is significantly higher than the number in managerial or professional positions (1 million)—a ratio of 0.77.

Id. (footnotes omitted).

  This should lead us to question whether the traditional beliefs about what constitutes an exemplary manager or professional are correct. If what we value as an ideal manager has race and gender stereotypes built in, a re-conception of what good leadership qualities are may be necessary. For example, if Asian Americans tend to value humility but our society rewards those who are assertive, are Asian Americans under-promoted because they are less qualified or because our society is not open to the concept that a better manager may be soft-spoken instead of self-promoting? In the educational context, what do we expect from the ideal candidate? Is it possible that the qualities we revere are subject to bias based on racial stereotypes?

 [199]. Id. at 55. There is a stigma that Asian Americans have inherent advantages compared to other minorities that enable them to succeed without deserving it, perpetuating the model minority myth.

 [200]. Id. at 63.

 [201]. Intraracial, Your Dictionary, https://www.yourdictionary.com/intraracial (last visited Jan. 21, 2019).

 [202]. Intraracial diversity is diversity within a race, while interracial diversity is diversity of races. Intraracial, supra note 201; Interracial, Merriam-Webster, https://www.merriam-webster.com
/dictionary/interracial (last visited Jan. 21, 2019). Intraracial diversity works to break down racial stereotypes by demonstrating a wide array of experiences within races, while interracial diversity works to take down segregation and inequality of opportunity in the education system. The argument urging for equality in the conception of diversity is separate from wanting intraracial diversity.

 [203]. For example, an Asian American cannot play an instrument, be good at math or science, or want to be a doctor or engineer without being considered “a typical Asian candidate.” Are white applicants allowed to excel in any area without it being considered a byproduct of their racial background? Do we view a white applicant who is a concert pianist, a varsity basketball player, an exceptional painter, or a national merit scholar as creating intra-racial diversity? In addition, when Asian Americans go against racial stereotypes, such as by participating in sports, it is often greeted with skepticism or under-valued. See Ling Woo Liu, Opinion, Why Jeremy Lin’s Race Matters, CNN (Feb. 14, 2012), https://www.cnn.com/2012/02/13/opinion/jeremy-lin-race/index.html (describing how Asian American basketball player Jeremy Lin was met with skepticism based on stereotypes that Asian Americans do not play basketball).

Lin himself has been candid about the racism he’s encountered along the way. “It’s a sport for white and black people,” he told the San Francisco Chronicle in 2008. “You don’t get respect for being an Asian-American basketball player in the U.S. . . . I hear everything. ‘Go back to China. Orchestra is on the other side of campus. Open up your eyes.’”

Id. If the stereotype associated with Asian Americans is one of “overachievement,” is the only way to break down the stereotype to underachieve? See Jeff Yang, Opinion, Harvard Lawsuit Is not what It Seems, CNN (Nov. 4, 2014), http://www.cnn.com/2014/11/24/opinion/yang-harvard-lawsuit/index.html (describing how he would have been denied admission based on his grades but an interviewer made the case that he had intangibles that would be an asset to the student body, though the assets that distinguished him were to be an “underachiever” academically and in stereotypically “Asian” activities) (“What saved my application was the optional interview I’d done on campus, in which I’d ended up talking about everything that wasn’t in my application: My aspirations to be a writer. . . . The fact that I actually really, really suck at piano.”). Although this Note focuses on stereotypes attached to Asian Americans, they are not the only minority group to be adversely affected by negative and positive stereotypes, and they should be questioned for all racial groups. See generally Geoffrey L. Cohen & Julio Garcia, “I Am Us”: Negative Stereotypes as Collective Threats, 89 J. Personality & Soc. Psychol. 566 (2005) (discussing how negative stereotypes of a group impact individuals within that group); Exploring the Negative Consequences of Stereotyping, Univ. of Ariz. News (Nov. 20, 2003), https://uanews.arizona.edu/story
/exploring-negative-consequences-stereotyping (same); Laura Green, Negative Racial Stereotypes and Their Effect on Attitudes Toward African-Americans, Ferris St. U., https://www.ferris.edu/htmls/news
/jimcrow/links/essays/vcu.htm (last visited Jan. 21, 2019) (discussing racial stereotypes of African Americans).

 [204]. Complaint, supra note 7, at 58–59 (describing recommendations that Asian American applicants not write application essays related to their ethnic background). Asian American encompasses many different groups of people and to dismiss the value this diversity could bring to elite universities should be questioned. The immigrant story of an Asian American should not be viewed any less favorably toward a “personal rating” than the story from another applicant.

 [205]. Regents of Univ. of Cal. v. Bakke, 438 U.S. 265, 323 (1978).

A farm boy from Idaho can bring something to Harvard College that a Bostonian cannot offer. Similarly, a black student can usually bring something that a white person cannot offer. The quality of the educational experience of all the students in Harvard College depends in part on these differences in the background and outlook that students bring with them.

Id.

 [206]. Bella English, To Get Into Elite Colleges, Some Advised to “Appear Less Asian, Boston Globe (June 1, 2015), https://www.bostonglobe.com/lifestyle/2015/06/01/college-counselors-advise-some-asian-students-appear-less-asian/Ew7g4JiQMiqYNQlIwqEIuO/story.html.

 [207]. Kang, supra note 83, at 15 (“The glib assertion that Asian Americans are ‘overrepresented’ at certain universities is less a description of empirical fact than a value judgment. It presumes that the percentage of Asian Americans at each university should reflect their percentage of the national population.”).

 [208]. Stephan Thernstorm, Farewell to Preferences?, 130 Pub. Int., Winter 1998, at 34, 42–43 (quoting Bob Beckel, CNN Crossfire co-host) (“Would you like to see the UCLA Law School 80 percent Asian? Because at the rate it is going . . . by the year 2007 UCLA will be 80 percent Asian. Will that make you happy?”); Student Quits at U.C.L.A. over Rant, N.Y. Times (March 19, 2011), https://nyti.ms/2q8wlak (describing Alexandra Wallace, a UCLA student, who posted a video complaining about Asians in the library where she stated, “the problem is these hordes of Asian people that U.C.L.A. accepts into our school every single year”); Emma Whitford, When Asians Are Targets of Racism, Inside Higher Educ. (Oct. 11, 2018), https://www.insidehighered.com/news/2018/10/11/anti-asian-messages-spread-washington-university-st-louis (explaining a series of messages between Washington University in St. Louis students with one stating, “[w]hy are Asians invading our study room”).

 [209]. See Matsuda, supra note 5, at 153.

 [210]. For Asian Americans, the model minority myth has created pressure for performance to require “super-achievement.” This norm of “super-achievement” and needing to distinguish oneself from the rest of the Asian American community can be debilitating. To add to this, when Asian Americans are told it is better to not check anything than to check the “Asian box” on a college application, this outward demonstration of society’s lack of acceptance can lead to negative self-image in young Asian Americans. See Jean S. Phinney, The Multigroup Ethnic Identity Measure: A New Scale for Use with Diverse Groups, 7 J. Adolescent Res. 156, 156–57 (1992) (describing that ethnic identity is central to the self-identity of minority individuals); Chew, supra note 49, at 84 (“Many Asian Americans believe that they are more likely to be successfully assimilated into American society if they do not publicly identify their minority status.”). See generally Joan E. Rigdon, Exploding Myth—Asian American Youth Suffer Rising Toll from Heavy Pressures: Suicides and Distress Increase as They Face Stereotypes and Parents’ Expectations, Wall St. J., July 10, 1991, at A1.

 [211]. Chew, supra note 49, at 73 (“They have pinned their hopes for economic survival on individual efforts rather than on collective political activities . . . .”). See generally Michelle Diggles, The Untapped Political Power of Asian Americans, Third Way (Jan. 15, 2015), https://www.thirdway.org/report/the-untapped-political-power-of-asian-americans (describing how and why Asian American political participation has lagged behind other racial and ethnic groups).

 [212]. See Agnes Constante, In California, Asian Americans Find Growing Political Power, NBC News (April 19, 2018, 5:42 AM), https://www.nbcnews.com/news/asian-america/california-asian-americans-find-growing-political-power-n866611 (illustrating the rise in Asian American political participation); Ross Douthat, Opinion, The Asian-American Age: At the Movies and in Court, a Rising Minority Claims the Spotlight, N.Y. Times (Sept. 1, 2018), https://nyti.ms/2MLuEyA (describing Asian American political participation with special focus on affirmative action).

 [213]. Chin et al., supra note 80, at 51.

Pitting racial minority groups against one another represents the worst form of divide-and-conquer political strategy. [Asian Americans] must refuse to believe that they are superior to Whites, non-Whites, or anyone else. . . . History teaches us that not long ago, the exact same criticisms were leveled at us: that we were the stupid, the unassimilable, the depraved, the criminal.

Id. (emphasis in original).

 [214]. Chew, supra note 49, at 88.

 [215]. Chin et al., supra note 80, at 133–34 (posing these same questions to white people). For the first question, Asian Americans can benefit from racial discrimination because while the model minority myth is damaging to Asian Americans, it is also damaging to other minorities by categorizing them as something less than “model.” In addition, Asian Americans benefit from affirmative action, both historically in the education context and continuously, in areas where there is “under-parity” of Asian Americans, such as in many professional contexts. Kidder, supra note 75, at 623–24. For the second question, the systematic and rampant racism against African Americans that stems from several historical factors including slavery, Reconstruction, Jim Crow laws, unequal prison sentencing, and de facto segregation means that the opportunity for the American Dream is not equally available for all minority groups. See Angela Hanks et al., Systematic Inequality: How America’s Structural Racism Helped Create the Black-White Wealth Gap, Ctr. for Am. Progress (Feb. 21, 2018), https://www.americanprogress.org/issues/race/reports/2018/02/21/447051/systematic-inequality. This does not invalidate discrimination felt by Asian Americans but should be clearly understood when considering this question.

 [216]. Chew, supra note 49, at 75; Matsuda, supra note 5, at 153–54.

Book Review: Law and Legitimacy in the Supreme Court by Richard H. Fallon, Jr.

From Volume 92, Postscript (December 2018)
DOWNLOAD PDF


 

 

Toward a Reflective Equilibrium: Making Our Constitutional Practice Safe for Constitutional Theory

Book Review: Law and Legitimacy in the Supreme Court,[*]
Richard H. Fallon, Jr.

André LeDuc[†]

Richard Fallon has written another important book about American constitutional law.[1] Indeed, it brings to mind Hilary Putnam’s definition of a classic: the smarter you get, the smarter it gets. Fallon presents a rich, thick description of our constitutional law and practice and an argument for how we may best continue and improve this practice. While intended to be accessible to a broad readership, Fallon’s arguments cut to the core of much current constitutional scholarship, even while urging us to move past many of these sterile debates. Most importantly, Fallon takes seriously his mission of speaking to the Court, as well as to the academy, and takes a real run at changing how the Justices decide cases and articulate their decisions.[2] He accomplishes all of this in a startlingly concise book, running only 174 pages of text and 36 pages of notes and without even a subtitle.

Fallon sets out to explain the nature of constitutional law, the constitutional disagreements of cases, constitutional argument, and the nature of the legitimacy of Supreme Court decisions and, ultimately, the Court itself. That’s a tall order for a little book, but Fallon can make a claim to have accomplished his mission.

Contemporary constitutional scholarship falls into two dominant styles. Most common are the systematic works. They articulate a unifying theory of the Constitution, prescriptively reinterpreting the nature of our process of constitutional adjudication and resulting constitutional doctrine to create a systematic, unifying account of our constitutional law. These projects are often embodied in dense and lengthy tomes with catchy titles like The Living Constitution,[3] The Invisible Constitution,[4] The Unwritten Constitution,[5] The Flexible Constitution,[6] Living Originalism,[7] and The Classic Liberal Constitution,[8] among others.[9] The second style of analysis is marked by its granularity and attention to the details of constitutional doctrine and the particularity of our constitutional practices. They are rarely self-consciously therapeutic, but they are edifying, urging the reader to enrich her understanding of our constitutional law and practice, not to radically revise her view of what the Constitution says or requires. Prominent examples of such an approach include classics like Charles Fried’s Saying What the Law Is, Laurence Tribe’s Constitutional Choices, and John Hart Ely’s Democracy and Distrust. Fallon undertakes something like the scholarship of this minority, edifying style in Law and Legitimacy, despite its aspirational title. He pursues his task of explaining the nature of constitutional law and legitimacy modestly, eschewing the common practice of discovering (and christening) a new Constitution. He is comfortable acknowledging the ways in which his views have developed and the views that he no longer holds.[10] Fallon’s mastery of the literature is impressive[11] and his treatment of its authors is both penetrating and charitable (sometimes perhaps too charitable).[12]

The infelicities in Fallon’s account are few. Notably, he rarely distinguishes between indeterminacy and underdetermination of legal texts and rules.[13] That’s an important distinction, however. Recognizing that legal authorities are underdetermined is consistent with an account of how the argument and resolution of constitutional controversies are channeled and constrained. These constraints make our practice of constitutional law far less vulnerable to challenges of radical indeterminacy or lawlessness. (Fallon believes that the practice of constitutional law is constrained in this way, so the error is more one of infelicity of expression than of substance.)[14] Sometimes the charity of Fallon’s reading of other scholars work glosses over profound issues. For example, he appears to accept the New Originalists’ move to distinguish constitutional provisions that require only interpretation from those that allow construction without ever questioning whether the two types of provisions can be adequately distinguished and, if not, what the implications of that failure would be for New Originalism.

The richness of Fallon’s argument and analysis requires a reviewer to choose among the important themes of the book. I will engage two principal subjects. First, I focus on what Fallon doesn’t address and suggest what those omissions tell us about the direction of American constitutional legal scholarship in the early twenty-first century. Those omissions generally do not reflect significant gaps in Fallon’s argument. They instead are part of a subtle strategy to redirect our approach to the Constitution and the Court in our Republic. Underlying Fallon’s argument is an implicit account of who’s not who, as it were, in the current pantheon of American constitutional scholarship. But Fallon gracefully (and graciously) does this only by showing how our discourse should proceed, rather than stating his argument that we need not engage these theorists expressly.

Second, I explore the two most important elements of Fallon’s book, his project to move us beyond the current debates about constitutional theories of interpretation and his argument that the Court ought to adopt a process of pursuing a reflective equilibrium in its constitutional decision and constitutional practice in order to enhance the legitimacy of our constitutional law and the Court. The first strategy is commendable, but his proposed path reflects an unstated and misplaced commitment to the logical priority of theory. Fallon purports to articulate an account of constitutional practice, but he cannot cast off a fundamental commitment to the priority of concepts, theory, and interpretation. The second argument for a practice of reflective equilibrium may generate a more plausible account of constitutional adjudication than the dominant models in the legal academy, but Rawlsian reflection—even in the situated, historical, thick sense defended by Fallon—is not likely the path forward in understanding the nature of constitutional decision in adjudication or in enhancing the legitimacy of the Constitution and the Court.

I

Fallon begins his account of law by outlining a theory of legal meaning and legal interpretation. His analysis comprises one of the most detailed parts of the book, reflecting the importance Fallon accords the linguistic meaning of the constitutional text and the importance of interpretation of the text in constitutional adjudication. Fallon has previously explored originalism’s claims about constitutional language and its interpretation in some depth.[15] In his earlier analysis he was more critical of originalism, denying that originalism could be reconciled with our actual practice and emphasizing the inadequacy of originalist approaches to non-originalist precedent.[16] His account is more sympathetic in Law and Legitimacy, although he does not endorse the complete originalist theory. Fallon is more sympathetic to originalism because his own analysis and constitutional theory has moved more deeply into questions of the nature of constitutional language and its interpretation.

Fallon makes Scott Soames’s philosophical analysis of the meaning and interpretation of legal texts a central anchor of his own analysis of constitutional meaning.[17] Soames, along with his former colleague at the University of Southern California Andrei Marmor, is among the leading philosophers of language who have explored the particular issues of meaning in legal texts. Soames argues for a version of an originalist theory he terms deferentialism.[18] In this theory the spare semantic meaning of the text is expressly augmented with the force of its pragmatics and the shared presuppositions that the linguistic community holds.[19] It is a representational account that views language as representing the world.[20] It is also an interpretative account that accords priority to the original linguistic meaning of the constitutional text, not a later linguistic meaning or its purpose, although intent figures as an evidentiary matter in determining the legal text’s meaning.[21] But while Soames recognizes the performative dimension of legal texts, his focus on legal texts as stipulations (assertions that make something so) allows him to focus on the element of assertion in the legal text. It is to the assertions made by legal texts that Soames directs his linguistic philosophical analysis.

For reasons I have defended elsewhere, I think Soames has it backwards: the analysis should begin with what the legal text does, not what it says. The enacting legislature was principally concerned to do something, not to say something. When we begin with what the constitutional text is doing rather than what it is saying, the analysis proceeds differently, without overemphasis upon linguistic meaning. Fallon follows the philosophers into this same error.

Fallon is not concerned to match the academic philosophers of language nuance for nuance, distinction for distinction.[22] He is expressly satisfied to articulate a practical account of meaning.[23] It’s a theory of meaning that’s good enough to use for our constitutional theory. Moreover, Fallon argues that the determination of the nature of constitutional meaning is a matter of our ordinary practice of language and law.[24] Accordingly, Fallon argues, philosophers do not have a persuasive claim to special knowledge with respect to the analysis and description of such meaning.[25] At a more conceptual level, Fallon, like Soames, adopts a representational account of language.[26] Language represents the world and constitutional language represents the Constitution-in-the-world. But that implicit foundation receives little attention in Law and Legitimacy. This commitment is, however, more express in one of the articles preceding Law and Legitimacy, The Meaning of Meaning.[27]

There are alternative, non-representational accounts of language, linguistic meaning, and linguistic truth.[28] Even if we endorse these theories, however, it is not clear that Fallon’s representational theory of language leads his constitutional theory astray. Even if Fallon’s tacit representational account of constitutional language is wrong, because of the limited granularity with which Fallon wants to articulate his account of constitutional meaning and employ it in his account of the Constitution and legitimacy, it is not clear that the error has damaging consequences. Fallon’s account of meaning is employed principally to show the sources and extent of ambiguity, polysemy, and underdetermination of constitutional texts and authorities.[29] Those claims of ambiguity, polysemy, and underdetermination—and the implications of those features of constitutional language—are as applicable to constitutional language understood on a representational theory as of an inferentialist, non-representational theory.[30]

Fallon argues from the ambiguity, polysemy, and underdetermination that he identifies in the meaning of authoritative constitutional texts to a different conclusion than Lawrence Solum and Scott Soames, however. Fallon asserts that such linguistic indeterminacy permits and requires Justices to make choices among potential interpretations and associated decisions. Because the nature of the underdetermination of meaning is so expansive for Fallon, even the New Originalist strategy of distinguishing constitutional texts requiring interpretation and those permitting a more open-ended construction is inadequate to encompass the authorities Fallon wants to recognize and the interpretations he wants to adopt for the decision process he endorses. [31]

Academic concerns with the legitimacy of the Supreme Court and its decisions focused upon two problems in the late twentieth century. The first was the countermajoritarian dilemma. First articulated by Alexander Bickel, the countermajoritarian dilemma asserts that judicial review by an unelected Court is inconsistent with democracy.[32] While some scholars have rejected that challenge, others continue to believe that Bickel articulated a genuine problem in our constitutional theory and practice.[33] The second problem, emphasized by Ronald Dworkin’s response to the dominant positivist jurisprudence,[34] was the role of judicial discretion in constitutional adjudication. Twentieth century constitutional theorists worried that judicial discretion undermined the rule of law and the dominant positivist theory of law. Neither problem figures prominently in Fallon’s analysis of legitimacy. Indeed, to the extent that Fallon welcomes the inevitable role of normative values in constitutional decision, he rejects the positivist premise.[35]

The countermajoritarian dilemma receives only passing attention in Fallon’s account.[36] Although Fallon has explored the countermajoritarian arguments and offered his own proposed solution, he doesn’t apparently think that addressing those issues is particularly important for his contemporary analysis of the legitimacy of the Constitution and the Court. Although he doesn’t expressly explain why the problem of judicial review can be so easily passed over, I think his argument can be reconstructed along the following lines. First, our constitutional practice has accepted and incorporated the practice of judicial review. Judicial review therefore has a sociological legitimacy. Second, judicial review has a moral legitimacy because it is important in protecting constitutionally protected rights.[37] These two sources of legitimacy explain why there is no fundamental problem with judicial review in our democratic republic.

Fallon’s argument reduces the legitimacy of judicial review to these two disjunctive forms. Judicial review also has a legal, constitutional legitimacy that his theory ignores. While that form of legitimacy may be described as sociological because, as a matter of legal positivism, it is a matter of social fact, constitutional and legal legitimacy (I here conflate the two) also have a normative dimension, as captured by H. L. A. Hart’s concept of the internal point of view. The legal legitimacy of our constitutional practice of judicial review is more than a shared social behavior. It is freighted with normative commitments and beliefs, but these are not principally moral commitments and beliefs. It is not clear that these normative commitments are moral commitments. We can imagine a judge or citizen endorsing our practice of judicial review while believing that as a matter of political morality a more direct form of democracy would be preferable.

In light of Fallon’s defense of judicial review, why does he recommend greater deference by the Court to the legislature’s judgment? Fallon grounds his argument for the desirability of greater deference to the legislature on constitutional questions as a matter of enhancing and reinforcing democracy in the Republic. Thus, Fallon appears at once to stand Ely’s defense of the democracy-enhancing judicial activism on its head and to tacitly acknowledge Bickel’s countermajoritarian challenge after having neatly dispatched it.

But both appearances are largely unfair. First, Fallon wants to focus the exercise of greater deference on highly controversial, politicized issues. Matters of procedural fairness—which would encompass much of the Warren Court jurisprudence that Ely wanted to put on a firm foundation—would not be entitled to greater deference on Fallon’s account. While counseling greater deference as a means to enhance and revivify American democracy, Fallon’s does not argue that the exercise of stricter judicial review would be illegitimate. It would, however, prejudice a fuller development of American democracy and compromise the pursuit of democratic legitimacy.[38]

Fallon’s argument would appear to face the celebrated Brown v. Board of Education challenge[39] and would seemingly fail the challenge even more clearly with respect to Bolling v. Sharpe and Loving v. Virginia. Those decisions, striking down state and federal legislation, would not appear to easily satisfy Fallon’s test for a more assertive judicial review. The Court’s efforts, led by Justice Frankfurter, to avoid challenges to state anti-miscegenation statutes for more than a decade after Brown is powerful evidence for this claim. But the price of deference would have been to permit the continued enforcement of statutes that we now almost universally recognize as morally repugnant. Fallon makes it very clear that he endorses Brown as a litmus test for plausible theories of constitutional theories and accounts of the Court’s legitimacy.[40]

Although Fallon thus acknowledges this concern with how he can reconcile his theory with Brown (and expressly asserts his commitment to the decision in Brown), it is not clear how he would reconcile his argument for a more deferential practice of judicial review.[41] He argues, somewhat unpersuasively, that his theory is not meant to discredit Brown. His argument is not persuasive because while his argument might not discredit Brown, once decided, it is hard to see how his call for increased deference could have allowed the Warren Court to have decided Brown as it did and to reject Plessy v. Ferguson. It may be that the importance of the moral commitments that Fallon would include in constitutional argument and to support constitutional decision would allow him an exception to his principle of greater deference.  How do we tell which moral propositions have this constitutional force? I am not sure Fallon explains, and I suspect that an explanation might require him to introduce a discussion of constitutional judgment that would fit only awkwardly into his theoretical account. Alternatively, it may simply be that his call for enhanced judicial deference to the legislature is best heard as a whisper.

Fallon’s analysis of the challenge of legitimacy for the Court and the Constitution focuses less on the academy and more on the polity as a whole. He is less worried with theoretical puzzles like the countermajoritarian dilemma and the scope of judicial discretion than with fundamental questions of when and how the Constitution and the Court provide authoritative legal obligations that are accepted and followed by the citizens.[42] In Hartian terms, he is interested both in when we can say from the external point of view that there is a shared behavior and when we can say from the internal point of view that such shared behavior follows the law. This is a welcome and important move in our constitutional jurisprudence. I don’t know if the legitimacy of the Court and the Constitution are more in question than they were in the wake of either the Dred Scott or Brown decisions, but the nature of the confirmation process for many recent nominees to the Court and our constitutional rhetoric certainly reveal significant live questions about legitimacy.

Fallon’s account of the moral legitimacy of the Court and the Constitution does not expressly address the challenge of moral relativism, but it is arguably compatible with it. Moral relativism challenges the claim that moral obligations are timeless and universal for all persons, instead arguing that moral obligations may vary over time and across communities. The challenge of moral relativism to non-positivist theories of the Constitution underlies some important threads in both the originalist canon[43] and the efforts of critics like Philip Bobbitt and John Hart Ely to rehabilitate the legacy of the Warren Court.[44] In each case, concern about the difficulties inherent in finding common moral ground led those theorists (with the exception of Bobbitt) to a positivist account of constitutional legitimacy that was not grounded on moral theory. Fallon discounts these concerns by welcoming Justices’ non-constitutional normative values into their decision process, on the grounds that such a role is both inevitable and proper. [45]

Judicial discretion does not figure in Fallon’s analysis as an important problem in constitutional theory or for the legitimacy, either for the Court or for the Constitution, because Fallon argues that judicial decision is circumscribed in a number of institutional and normative ways, and he describes how.[46] He understands that judicial authorities are underdetermined, not entirely indeterminate.[47] The sources of that constraint are several; the constraints imposed by the constitutional text are not a significant part of Fallon’s practice-centered account. Linguistic meaning, as informed by our understandings and practices, and our constitutional and institutional practices and expectations are all important.[48] These constraints on judicial discretion are, for Fallon, sufficient to disarm the nihilist challenge of indeterminacy and the more traditional concerns with judicial discretion. While I think there are somewhat richer ways to describe the sources of the constraint and to reconcile them with the authority and discretion Justices have, the core of Fallon’s analysis seems right.[49]

Fallon believes that the fundamental problems of legitimacy facing the Court and the Constitution are both sociological and moral.[50] We need to explain both why we do accept the Court’s authority and why we should accept that authority. We need constitutional practices that reinforce this acceptance and the associated authority of the Court. Expressed in these more general terms, Fallon’s restatement of the problem of legitimacy is a twenty-first century account. While Fallon is right to emphasize both the sociological and moral dimensions of constitutional legitimacy, inherent in his dichotomy is a disregard for, or at least a lack of interest in, a third dimension of legitimacy, legal legitimacy. In the current divided political climate that has deeply shaped the Justices’ confirmation process and the public reactions to the Court’s decisions, the Court’s legitimacy is not only an academic concern.

Having set a bold agenda, Fallon’s account of the moral legitimacy is cautious and almost anodyne. While he acknowledges the challenge that racial discrimination poses for claims of legitimacy, he doesn’t explore the extent to which this discrimination affects minorities and, indeed, all of us. He does not acknowledge the chilling challenges that Richard Rothstein’s The Color of Law or Michelle Alexander’s The New Jim Crow pose for white complacency with respect to the extent of racial discrimination in our society and the Court’s profound and continuing role in preserving and protecting that discrimination. Fallon also ignores the originalists’ challenge to the Court’s legitimacy. Many originalists—including Justice Antonin Scalia and Robert Bork—sometimes suggest that the failure to follow the original understanding of the constitutional text generates an illegitimate constitutional law.[51] That appears descriptively mistaken as a matter of sociological legitimacy and at best highly problematic as a matter of moral legitimacy. But the originalists don’t generally offer an express descriptive or prescriptive account of constitutional legitimacy or the role of the Court in place of that implicit claim. The claim also calls into question the legitimacy of these originalists’ own position. Nearly thirty years ago Philip Bobbitt called out Bork’s challenge to the legitimacy of the Court. Bobbitt argued that Bork’s theoretical commitment to originalist interpretative principles and his corresponding criticism of the Warren and Burger Courts’ non-originalist decisions as illegitimate constituted dispositive grounds for denying him a seat on that Court.[52] That’s a powerful claim, but one Fallon does not engage when he asserts that Justices must accept the authority of the Constitution and, albeit to a lesser degree, the authority of the Court’s own precedent. Fallon ought to have acknowledged that any criticism of the Court’s own precedents by members of the Court must be limited to a criticism of the merits of those decisions, not their legitimacy. There is no comparable clarity in Fallon’s analysis of the challenges of legitimacy today.

Fallon’s exploration of the legitimacy of the Court and the Constitution is, however, refreshingly express. By confronting those issues directly, Fallon avoids some of the confusions that infect much of our contemporary constitutional discourse. By confronting the challenge of legitimacy directly, Fallon articulates a theory that can be assessed and accepted or challenged.

II

Fallon’s first principal goal is to shift the focus of our academic—and our public—constitutional discourse away from the current, longstanding disputes about constitutional interpretative methodology. He offers a brief survey of the principal outstanding theories. After canvassing the principal originalist theories, the pluralist theory of Bobbitt, the pragmatic realism of Posner, and the Critical Legal Studies’ challenge of indeterminacy, Fallon argues very briefly that all of those theories are inadequate. His principal objection to the originalist theories is that they cannot accomplish the mission for which they were created and that constitutional adjudication requires more tools than originalists—at least classical originalists—can provide.[53]

Fallon offers some of his harshest criticism of what he terms Cynical Realists.[54] This category lumps together some unidentified law professors and political scientists; he names only Professor Eric Segall and Judge Richard Posner.[55] According to Fallon, these theorists reject any dimension of autonomy for law, reducing judicial decision to politics. Certainly the classical Critical Legal Studies theorists reduced the account of constitutional law to power and politics. It’s not clear Fallon is fair here to Posner. In his early, utilitarian phase Posner clearly did not reduce law to politics. More importantly, in his more recent analysis of the nature of law, while he is far more critical of theory in general (and moral theory in particular) as a source of legal decision, his pragmatist emphasis upon the exercise of judgment in decision and the doctrinal and factual context of decision is inconsistent with the reductive account Fallon attributes to him. But Fallon is right that the Cynical Realists who deny that the Constitution is law and deny that constitutional rules constrain judges purport to offer a better description of our constitutional practice. Fallon argues that they neither describe the outcomes of judicial controversies better than competing theories but that they must inject the additional complexity of arguing that the Court either deceives itself or seeks to deceive us when it articulates the rationales for its decisions.[56] Fallon does not have much to say about Bobbitt’s pluralist theory. I think that gap reflects the extent to which Fallon has not fully thought through how an account of constitutional law that makes practice prior to theory works.

Fallon argues that none of the dominant theories offers an adequate account of our constitutional law or the Court’s constitutional practice.[57] His principal objection is that these accounts begin by putting the theory first, then asks the Justice to apply the theory in the decision of the cases that come before her.[58] While that criticism is apt for many contemporary constitutional theories, it is probably unfair of the most plausible pluralist theories, like those offered by Philip Bobbitt and Dennis Patterson.[59] Those theories emphasize the role of incommensurable arguments and the exercise of situated judgment. They deny that any constitutional theory can provide answers to constitutional controversies. In place of a decision theory that proceeds directly from theoretical foundations, Fallon endorses an iterative account that emphasizes constitutional practice. In this practice, constitutional theory does not have pride of place. It figures in the iterative process, together with our intuitions about the proper outcomes in actual and related hypothetical cases. But Fallon nevertheless believes that constitutional interpretation is logically prior to decision; that assumption is questionable. Moreover, while it’s a common assumption, shared with many of the other theorists Fallon discusses, Fallon does not defend it.

Fallon’s second central and ultimately more important argument is that we should adopt an iterative methodology drawn from analogy to John Rawls’s concept of reflective equilibrium in moral philosophy in our constitutional decision. The pursuit of constitutional reflective equilibrium is the process by which Fallon proposes to situate constitutional decision and to incorporate our moral and constitutional intuitions and competing modes of constitutional argument within sometimes-inconsistent constitutional interpretive theories.[60]

Reflective equilibrium is central to Rawls’s moral theory of the nature of justice in the modern, advanced liberal democracies. According to Rawls, to determine the requirements of distributive justice, we should imagine ourselves in the original position. In the original position we are separated from our actual selves by a veil of ignorance. That veil prevents us from knowing who we are and how we have fared in the allocation of natural capabilities and the distribution of social and economic resources. From the original position we are to consider what fairness and justice require in the design of a social and political system with respect to the allocation of social and economic resources. Rawls emphasizes that the requirements that are imposed by the principles of distributive justice are abstract and general. The principles of justice are compatible with various particular political systems. Nevertheless, this process imposes substantial constraints on political systems.

Fallon argues that this approach offers the best description of how our practice of constitutional adjudication goes as well as delivering the best normative prescription for how our constitutional decisional practice should proceed.[61] Originalists may fear that Fallon is answering affirmatively to Justice Scalia’s withering rhetorical question whether the Constitution incorporates Rawls’s moral theory.[62] This concern is mistaken, at least in its simplest and starkest form. Fallon’s incorporation of Rawlsian methods does not commit him to the substantive commitments of Rawls’s moral theory. Indeed, on balance Fallon’s invocation of Rawls is a little misleading: Fallon’s account of constitutional judicial decision is consistent with accounts of practical reasoning more generally. It misleadingly highlights the role of theory in that process. Fallon is really describing a role of practical inference, from premises and underlying grounds to conclusions and implications. (The originalists’ fear is not misguided, however, to the extent that Fallon endorses a role for Justices’ substantive moral and other normative commitments in constitutional argument and decision that is inconsistent with the dominant, positivist originalist theories. This incorporation is not pursuant to a peculiarly Rawlsian methodology, however.)

It is important to define the relationship of Fallon’s constitutional methodology to the philosophical methodology of Rawls. The most important difference between the methods of Rawls and Fallon are three. First, Rawls’s methods are methods of moral philosophy. A full metaphilosophical discussion of the implications of classifying Rawls’s theory and argument as philosophical is unnecessary here. But both important originalist and legal pragmatist critics of philosophical methods capture some of the implications of that classification when they lament the essentially contested nature of much philosophical argument.[63] Moral philosophy is no exception. Rawls’s arguments yield theoretical conclusions, not practical judgments. This difference matters if we take the concept of our existing constitutional practices of constitutional argument and decision as fundamental to our constitutional law. That practice is a pluralist practice of argument, as Fallon acknowledges. The various arguments made are not obviously commensurable.[64] The process of reflective equilibrium and the arguments and conclusions that it generates in the abstract, are relevant in our constitutional law and practice only if and to the extent that they may be articulated within the constraints and conventions of that constitutional practice. Fallon thinks that the process of iterated articulation of constitutional judgment from a position of reflective equilibrium can generate authoritative, binding constitutional judgments. By contrast, for Rawls, reflective equilibrium yields a moral theory that supersedes any of our prior moral thinking to the extent inconsistent with where we end up in reflective equilibrium as a result of our deliberations from the original position.

Second, Rawls pursues reflective equilibrium from the original position, a place where we imagine ourselves without all of the elements that make us who we are—our entitlements, capabilities, limitations, history, and personal commitments, for example. From the original position we are disembodied spirits imagining our future corporeal selves and seeking fairness and justice. Fallon’s process unfolds in the real world and real time of constitutional adjudication, with full knowledge of our history and ourselves.

Third, the iterated process that Fallon contemplates is modest and circumscribed; as such, it is very different from the open-ended, no-holds-barred theoretical inquiry of Rawls. In the constitutional context, Fallon believes that reflection on the demands of decision will result in “significant revisions . . . but . . . no troubling disruptions” to our constitutional law and practice.[65] In Rawls’s pursuit of reflective equilibrium, there can be no comparable confidence in the status quo. While the account of justice derived bears a noted resemblance to our advanced liberal western democracies, the role of the state and the commitment to redistribution looks very different from any actual sovereign states.

One of the most powerful criticisms offered against Rawls’s method was that it fails to capture the richness of who we are and what makes us human individuals.[66] Rawls’s description of who we are maximizes the abstraction of our self-descriptions. Critics have argued that we can’t have an adequate account of justice if we excise so much of what we are. Justice, from the perspective of these critics, is not nearly so abstract a concept as Rawls suggests. Justice for us, the argument goes, but take into account more fully who we are—what our desires are, what our capabilities are, and what our history has been. It’s the difference between the ahistorical account of Kant and the historicist account of Hegel.

For Fallon, the process of constitutional reflection begins with a working theory of constitutional interpretation.[67] Fallon believes that a theory of constitutional interpretation must have a logical priority in the process of constitutional adjudication because he believes that the texts of constitutional authorities must be interpreted (in a manner that Fallon defines broadly) so that their meaning may be applied in constitutional decision.[68] To the extent that the meaning is underdetermined or manifestly undesirable, Justices are generally empowered to interpret and apply the Constitution accordingly. Fallon wants to shift the focus of our analysis to the process by which working theories of interpretation are refined and corrected as we confront constitutional controversies and decide constitutional cases.[69]

Fallon doesn’t intend for the process of reflective equilibrium to begin from the original position. But it is less clear what beliefs or other conceptual commitments Justices should or may bring with them to the decision of constitutional cases. They are certainly entitled to bring a methodological stance with respect to interpretation.[70] This stance is, however, subject to testing and refinement against the Justices’ (and our) moral intuitions about particular potential actual and hypothetical judicial decisions.[71] The Justices may bring—indeed, on Fallon’s account, sometimes must bring—their own normative moral values to their work on the Court.[72] Are there, then, any beliefs or commitments that Justices may not take into account in their decisions?

There would appear to be at least three categories of belief that are out of bounds. First, procedurally, Fallon is at pains to recognize that any account of our constitutional law must preserve the important distinctions between what the law holds and what we think that the law should state and what we would want the law to state.[73] In their decision practice Justices must recognize the limits of their authority within our constitutional republic. Second, substantively, to the extent that a Justice holds a belief that is inconsistent with the Constitution, the substance of the Constitution should prevail. Third, to the extent that a Justice holds a moral belief that she recognizes is not shared within the community, that moral belief should not form the basis for a judicial decision that is otherwise indefensible.

These limits are more complex and difficult to apply than this bare statement may suggest. When is a substantive moral or other normative position inconsistent with the Constitution? How should a Justice determine whether a moral belief is shared (however that would be determined) or idiosyncratic? Before District of Columbia v. Heller and McDonald v. Chicago were decided, upholding a fundamental right to hold firearms without onerous state or federal regulation, was a broad understanding of a protected right to own or carry firearms inconsistent with the Constitution? Is a belief that the abortion of a human fetus is murder inconsistent with the Constitution? Is a belief that lashing is not a cruel and unusual punishment because not so originally understood at the time of the adoption of the Bill of Rights inconsistent with the Constitution? Is a belief that non-originalist precedent of the Court is not authoritative law inconsistent with an acknowledgment of the limits of the Court’s authority? None of these cases are easily classified within Fallon’s framework, even if our intuitions about them are clear. They are hard even with Fallon’s account of the constraints that should figure in constitutional adjudication. Articulating the ways in which Justices’ own moral commitments may figure in decision while preserving the moral legitimacy of decision is a project that Fallon has foreshadowed rather than completed.

Readers may also wonder whether Fallon’s position is vulnerable to the criticisms that have been made of Dworkin’s account of Justice Hercules.[74] Focusing upon Dworkin’s claim that law required the comprehensive articulation of a theory grounded on, and derived from, fundamental moral and political theory, Cass Sunstein famously characterized Justice Hercules as an oddball.[75] Sunstein emphasized the inability of such a Justice, committed to constructing a comprehensive and complete decisional theory, to decide cases together with other members of an appellate court.[76] When we look at Fallon’s reflective equilibrium methodology, we may wonder whether any Justice adopting it would face a similar criticism. Fallon’s methodology is ambitious, requiring both sophisticated historical research and sophisticated philosophical argument, even if it doesn’t require the formulation of a single, unified theory that Dworkin’s law as integrity demands.[77] Critics may wonder whether the process of seeking reflective equilibrium belongs to philosophers in their arm chairs, not judges charged with deciding hard cases in the hurly burly pressures of our deeply divided pluralistic constitutional republic. Fallon goes further than most in the academy in recognizing the untheoretical nature of much our practice of constitutional adjudication, but he does not reject a foundational role for theory and an obligation on the part of a Justice to formulate and apply such a theory.

Fallon thinks he has disarmed critics who might argue that the process of reflective equilibrium would be impracticable or result in absolute, uncompromisable judgments in constitutional controversies. His requirement that Justices proceed in good faith appears to be an important part of his argument for the collegiality and integrity of judicial decision-making.[78] But Fallon does not explain the requirement of good faith in much depth. Good faith imposes a duty of consistency, in the absence of a change in view. But the constraint does more in Fallon’s theory. It requires the introduction of an implicit distinction between the arguments that may be made to the Court and the arguments made by the Court. In the case of the arguments made to the Court much, perhaps all, of any requirement of good faith would appear to be properly subordinated to requirements of effective argument—an advocate can surely make arguments to the Court that she does not herself endorse. Moreover, as Fallon acknowledges, the desideratum of good faith, in the face of prudential considerations that may support more artificial approaches, like that pursued by the Court in the period between its decision in Brown and its decision in Loving, is controversial. The constraint of good faith warrants a fuller development if Fallon is to be persuasive in his claim that it can play the important role he ascribes to it.

Fallon believes that the process of reflection is practicable, at least in a limited, practical way because it is a description of how much of our judicial constitutional decisionmaking actually proceeds.[79] He argues that by articulating the process more formally we may improve our judicial decisionmaking, without needing to change it in any fundamental way. With respect to Sunstein’s objection to Dworkin, Fallon argues that by requiring that his Justices proceed reasonably, taking into account the perspectives and values of the other Justices he can insure that his theory is consonant with the need for multimember panels to achieve consensus, even if members of the panel begin from different normative points of departure and apply different decisional methods.[80]  But can Fallon so easily pair his notion of reflective equilibrium with a commitment to collegiality and reasonableness on the part of his Justices?

Fallon may argue that while his reflective equilibrium generates substantive constitutional outcomes and doctrine, the requirement of reasonableness addresses the epistemic dimension of the adjudication process. The requirement of reasonableness limits the confidence that Justices should take in the conclusions that the process of pursuing reflective equilibrium generates, and the doctrine and decisions that arise from it. If this is the way to understand Fallon’s theory, it is very different from the concept of reflective equilibrium that Rawls defends, at least in A Theory of Justice.[81] For Rawls, the pursuit of a reflective equilibrium is a theoretical, philosophical inquiry. There are no epistemic limits on the conclusions generated in reflective equilibrium. Fallon’s reconciliation of his more situated, historical, and practical account of constitutional practical reasoning that makes a place for reasonableness and collegiality in our constitutional practice is not implausible.

When we understand how Fallon wants his process of historically situated reasoning to reflective equilibrium to work, we are left wondering what Rawls has to do with it. The iterated articulation of a constitutional reflective equilibrium is a far more practical exercise than Rawls’s theoretical exercise from the original position. On Fallon’s account, we begin with a great deal of knowledge about and commitment to our constitutional law and practice and to our socially instantiated moral intuitions and expectations. We can see this if we compare Fallon’s account with Gilbert Harman’s account of how we change our views as a matter of practical reason.[82] Fallon’s description of the process of reasoning to a constitutional reflective equilibrium is not inconsistent with Harman’s account of how we change our beliefs and actions as a matter of practical reason. Briefly, on Harman’s account, we reason by inference to the best explanation, adding and culling beliefs and inferential commitments until we arrive at the most persuasive, most coherent overall relevant view. Fallon also dispenses with the most salient features of Rawls’s method (principally, the original position and the veil of ignorance) in his proposed constitutional decision and theory-building process. The process of reflective equilibrium is the means by which Fallon limits the power of the competing theories of constitutional interpretation. But if we don’t begin by according the competing theories of constitutional interpretation a logical priority in our practice of constitutional adjudication, then we don’t need to emphasize the complicated process of iterated reasoning to a reflective equilibrium. This is the most important way in which Fallon betrays his unarticulated commitment to the priority of theory. I think Fallon’s invocation of Rawls’s concept of reflective equilibrium—admittedly only as analogy—may be best understood as reflecting his misplaced commitments to a pride of place for theoretical and conceptual reasoning in our constitutional practice.

Fallon’s Rawlsian tack is not easily reconciled with Rawls’s own later political philosophy.[83] Rawls’s later work appears to retreat from the systematic claim of A Theory of Justice that philosophy could derive the formulation of the political institutions that would create a just society that could and should be accepted by all.[84] Instead, Rawls later appears to argue that a just society requires pluralism and continuing tolerance for dissent, because a shared understanding of moral doctrine can only be maintained by oppression.[85] (Note how consistent the commitment of the later Rawls to continuing argument and dissent and the absence of an agreed upon comprehensive canon is with a modal, pluralist account of constitutional law. This parallel does not seem to have been highlighted by the constitutional pluralists.)

If this reading is right, then the later Rawls poses a substantial challenge for Fallon’s claim that our goal should be a constitutional decision process that decides cases on the basis of constitutional reflection that aims at a reasonably comprehensive account of the proper understanding and application of the Constitution. Constitutional adjudication yields authoritative, binding legal decisions. If the Rawls of Political Liberalism is right, the resulting law is either incomplete or sustainable only with force, not reason. For Fallon, constitutional adjudication is fundamentally a matter of using constitutional interpretative theory to find the right constitutional meaning, not to choose among essentially contested or otherwise inconsistent resolutions of constitutional controversies on the basis of structured, canonical forms of constitutional argument. While Fallon makes a place for dissent and disagreement, it does not take the pride of place that features in more fundamentally pluralist accounts. His focus falls on argument and disagreement as a means for developing the underlying constitutional theory in modest and incremental ways, not as a fundamental or constitutive feature of our constitutional law and practice. For Fallon, with reflective equilibrium comes consistent, reasoned constitutional decision and constitutional theory. Despite invoking Rawls’s theory at multiple levels, Fallon does not adequately address the challenge posed by the later Rawls.[86]

Doctrinal coherence is also important for an inferentialist account of constitutional decision. Constitutional opinions, like the text of the Constitution itself, both do things and say things.[87] When opinions say things in their holdings and in their reasoning, they make discursive commitments that are part of our constitutional law (This dimension of the way Justices say things accounts for much of the reason why the celebrated (infamous?) analogy with umpires is so manifestly inadequate to explain what Justices do.[88])

As suggested above, Fallon gets it backwards. We ought to begin with our constitutional practice—and the importance of discursive inferential commitments in the opinion writing part of that practice. From that practice we can understand the need for doctrinal and inferential coherence with respect to the Court’s holdings and in the doctrine articulated in the Court’s opinions, because the discursive commitments of those authoritative constitutional texts inform and ultimately constitute much of our constitutional law.

But, contrary to Fallon’s account, we can insist on consistency and coherence as an important requirement for our discursive commitments without a commitment to the priority of constitutional interpretative theory. An inferentialist account accomplishes this directly. According to an inferentialist account, the meaning of statements and assertions arises not simply from their use, but also from the discursive commitments that follow from them. Most simply, when the Court asserts, for example, “[s]eparate educational facilities are inherently unequal,[89] that assertion carries a number of important inferential commitments but also leaves open other important questions. The assertion, at least as a matter of linguistic if not semantic meaning,[90] holds racial segregation unconstitutional in schools. It does not appear to admit of exceptions. The assertion does not explain whether it speaks to schools that are in fact separate or separate by law, but on its face it does not appear to distinguish the two. It does not expressly foreclose all forms of racial discrimination or even all forms of racial segregation. It does not determine what remedies may exist for racial segregation in schools. It appears inconsistent on its face with Plessy,[91] and the opinion elsewhere makes this inconsistency express—but does not expressly overrule that case.[92] Attention to these inferential dimensions of the assertion gives the linguistic content, its meaning and force, to the text. They also impose some consistency and coherence on constitutional doctrine and law. If a holding or an argument is inconsistent with the constitutional text or with other authoritative assertions of constitutional law, we can call that flaw out. If an opinion fails to offer a canonical, authoritative argument for the decision made, we can call that out, too—again without the need to construct a theoretical superstructure.[93] We don’t first need a theory of constitutional meaning and interpretation before making such judgments or deciding cases.

It may appear that an inferentialist account, with its emphasis on the discursive commitments that flow from the assertions made in constitutional authorities—the text of the Constitution and of constitutional precedents—is itself inconsistent with a modal account of constitutional argument and decision. The modal, pluralist account asserts that there are multiple, sometimes inconsistent forms of argument that we invoke and rely upon to decide constitutional cases. This conflict is not best understood as a conflict about meaning so much as a conflict about what the Constitution says and should be understood to do. The modal conflict—and central prudential and doctrinal arguments, while sometimes couched in terms of the meaning of the relevant authoritative texts—are better understood in terms of what we should do, how we should hold in a constitutional case. The conflicts inherent in a pluralist theory are not inconsistent with an inferentialist account of the meaning of our constitutional texts.

Although Fallon long ago endorsed something that he himself termed a pluralist theory,[94] it’s not clear that he remains a pluralist today. Moreover, his defense of his reflective methodology appears vulnerable to important criticisms from pluralist theory. Constitutional pluralism asserts plurality, variously asserting the existence of multiple, independent theories of interpretation and construction, readings of the Constitution that inform constitutional adjudication, and modes of constitutional argument. Pluralism, most fundamentally, recognizes the limits of constitutional theory and the corresponding priority of our faculty of constitutional judgment in our constitutional practice. The locus classicus for this claim—albeit in an often-misunderstood and admittedly opaque expression—is Philip Bobbitt’s Constitutional Fate.[95] Subtitled Theory of the Constitution, the book has sometimes been misunderstood to articulate six dueling theories of the Constitution, although Bobbitt introduced these forms archetypes, but he later came to refer to them as modalities.[96] Bobbitt acknowledged that some of his readers had mistakenly thought that he was describing multiple theories, not a single theory of the Constitution.[97] The confusion likely arose because Bobbitt’s theory made constitutional practice central and constitutive of our constitutional law; that theory doesn’t look much like other constitutional theories. Central to Bobbitt’s account is that there is no algorithm or decision methodology that can resolve conflicts among competing modalities of argument. (While many constitutional theorists implicitly discount the role of constitutional judgment, few (perhaps none) expressly assert that an algorithm could determine the proper resolution of constitutional cases.) For Bobbitt, the resolution of the conflict was a matter of conscience.[98] Secular readers found that account problematic.[99] But one can imagine a secularized account of judgment, even an account that is consistent with moral relativism.[100]

Pluralism, with the logical priority that it assigns to our practice of constitutional argument and decision, is inconsistent with Fallon’s reflective account that begins with a theoretical approach to constitutional interpretation.[101] Choosing between Fallon’s emphasis on the contribution and role of theory in constitutional adjudication and the social practice account of pluralism requires us to make a judgment about the nature of constitutional judgment. Constitutional judgment requires wisdom as well as mastery of constitutional methods and doctrine. The lingering question is whether Fallon offers a compelling account of the role and relative importance of each.

Finally, it is helpful to examine Fallon’s account against the constitutional jurisprudence of another, more conservative member of Rawls’s posse, Fallon’s colleague Charles Fried. There are important parallels between the two descriptions of our constitutional law and the normative perspectives each holds. For example, both Fried and Fallon believe that reasoning about constitutional doctrine is important in constitutional adjudication.[102] For Fallon, doctrinal and precedential reasoning explicates the meaning of the constitutional text; for Fried, precedent shapes and determines constitutional doctrine and decision. But the differences between the two accounts are also significant and these differences highlight some central elements of Fallon’s argument. Leaving aside the differences in the substantive constitutional law each would endorse, Fried’s emphasis on the granularity of constitutional doctrine and on the importance of judgment[103] reflects his view that downplays the role of theories of constitutional interpretation in our constitutional law and constitutional adjudication. For Fried, constitutional law and the resolution of constitutional controversy requires very careful attention to the facts of the case and the relevant constitutional doctrine with respect to which the case arises. It is in that particularized context that situated constitutional judgment may be best made.[104] Theories of meaning and interpretation, which sometimes impair the exercise of good constitutional judgment, do not play for Fried the central role that Fallon’s theory accords them.

III

Fallon’s new book makes an important contribution to our thinking about the Constitution and the Court. The arguments Law and Legitimacy makes expressly, as well as the unstated assumptions that underlie these arguments and the focus of the book more generally, would move our constitutional thinking forward if others master its lessons. Fallon’s book is more likely, however, to elicit criticism both for what it says and what it doesn’t bother to say. Legal pragmatists may feel slighted by Fallon’s brief engagement with their claims, for example, as well as by being termed Cynical Realists. Most of them don’t self-identify either as cynical or as realists. The committed interpretivists on both sides of the originalism debate will likely forcefully reject Fallon’s argument that Justices may properly look to their own moral commitments in deciding certain constitutional cases. To the extent that the originalists are tempted by Fallon’s account their project of delegitimizing the constitutional jurisprudence of the Warren and Burger Courts will be called into question. 

To the extent that the constitutional academy does not respond critically, it will likely attempt to assimilate Law and Legitimacy into the canon of our current practice of normal constitutional theory. That response will be, at least in important respects, misleading. Thus, for example, we may anticipate that New Originalists like Solum will emphasize Fallon’s openness to originalist methodologies. They will emphasize the centrality of the constitutional text to Fallon’s account of constitutional interpretation and decision. Although Fallon endorses much of Soames’s theory (including employing without objection Soames’s barbarism of precisification),[105] Soames must surely reject Fallon’s methodological claims about ordinary language and our knowledge thereof. Leaving aside the modest substantive disagreements, while Soames is interested in natural language, methodologically he is no ordinary language philosopher. He is committed to a canonical analytical metaphilosophical account of his project.[106] For analytic philosophers of language, ordinary language users are not authoritative informants about the nature of linguistic meaning or other, related philosophical questions. Soames should reject Fallon’s methodological claim to participate in the analysis of constitutional meaning, because the nature of meaning, ambiguity, truth, and knowledge are matters as to which philosophers have special expertise and knowledge. Fallon, as a legal scholar, does not have this professional expertise or knowledge. Originalists are more likely to focus critically on Fallon’s willingness to incorporate underlying normative values into constitutional judgments. Originalist critics like Sunstein will emphasize the role of consensus and collegiality in appellate constitutional adjudication and Fallon’s call for greater deference to Congress, overlooking Fallon’s tacit denial of a central role for incompletely theorized opinions.[107] They may also emphasize Fallon’s suggestion that the Court should be more deferential to the Congress. They will likely emphasize Fallon’s reliance on the earlier rather than the later, Rawls. Because of the measured style and the balance of Fallon’s argument, it is possible, indeed, perhaps likely, that other scholars will selectively find in Fallon’s arguments what is most in harmony with their own positions. Some may find the same tendency in this review. This may result in underestimating the originality and importance of Fallon’s contribution.

Implicit in this review’s narrative is the claim that we should recognize how far Fallon departs from the traditional traces of our contemporary constitutional theory. He is not just providing new answers; he is redirecting us to new or lost questions about the nature of the Constitution, the role of the Court, and the nature of the legitimacy of the Republic. By focusing on the foundations for the moral legitimacy of the Court and the Constitution, Fallon would shift our constitutional discourse away from the sterile debate over constitutional interpretation and originalism and other theoretical issues. That would be a signal achievement in its own right.[108] By casting the discussion of legitimacy in the fundamental new terms that look expressly to our moral and political theory and our constitutional practice—rather than in the narrower, traditional terms of the countermajoritarian dilemma and the role of, and limits on, judicial discretion—Fallon tacitly challenges the dominant positivism that has informed both most originalism and the competing constitutional theories of originalism’s critics. But in so doing, he needs to acknowledge the challenges that originalists and their critics have historically posed to reliance on underlying normative values in our constitutional adjudication.

Within the realm of the possible, Fallon’s new book accomplishes a lot. How important it will prove to have been in reshaping our constitutional theory and practice, to echo Zhou Enlai, it’s simply too soon to say. If Law and Legitimacy should have that impact, it will be more a matter of changing what we do than of changing what we merely say.


[*] *.. Harvard University Press, 2018.

[†] †.. I am grateful to Laura Litten for comments on an earlier draft of this review. © 2018 André LeDuc.

 [1]. Another reflects books Fallon has himself written, including The Dynamic Constitution and Implementing the Constitution.

 [2].  Other academics may claim the same ambition, of course, but the disconnect between how those scholars write about the Court and Constitution and how the Justices write about their decisions reveals how implausible that claimed mission is.

 [3].  David A. Strauss, The Living Constitution (2010).

 [4].  Laurence H. Tribe, The Invisible Constitution (2008).

 [5].  Akhil Reed Amar, America’s Unwritten Constitution: The Precedents and Principles We Live By (2012).

 [6].  Sean Wilson, The Flexible Constitution (2013).

 [7].  Jack M. Balkin, Living Originalism (2011).

 [8].  Richard A. Epstein, The Classic Liberal Constitution: The Uncertain Quest for Limited Government (2014).

 [9].  Randy E. Barnett, Restoring the Lost Constitution: The Presumption of Liberty (2004); Louis Michael Seidman, The Unsettled Constitution: A New Defense of Constitutionalism and Judicial Review (2001). Admittedly, Fallon has already gone down that road with The Dynamic Constitution: An Introduction to American Constitutional Law and Practice.

 [10].  Thus, for example, Fallon disavows his 1987 claim that linguistic meanings would not conflict in ways that would generate constitutional controversies. Richard H. Fallon, Jr., Law and Legitimacy in the Supreme Court 80, 193 n.42 (2018) [hereinafter Fallon, Law and Legitimacy].

 [11].  See, e.g., id. at 188, nn.149–54 (discussing Scott Soames’s philosophical arguments). The index, unfortunately, does not adequately capture the depth of Fallon’s analysis, either substantively or in its entries for the scholars and scholarship that Fallon addresses.

 [12].  Examples of Fallon’s charity include his characterization of Steven Sachs’s arguments for a positivist originalism as “bracing.” and Bruce Ackerman’s radical theory of de facto constitutional change as “theoretically ambitious and highly provocative,” and his willingness to glide past continuing confusion in the New Originalist camp over the distinction between the broader concept of linguistic meaning and the narrower, less relevant concept of semantic meaning. Id. at 204 n.7 (Sachs), 196 n.28 (Ackerman).

 [13].  See id. at 48–49, 137–40.

 [14].  See id. at 48–49.

 [15].  Richard H. Fallon, Jr., Implementing the Constitution 13–25 (2001).

 [16].  Id. at 3, 15–16.

 [17].  Fallon, Law and Legitimacy, supra note 10, at 61–64; Scott Soames, Deferentialism: A Post-Originalist Theory of Legal Interpretation, 82 Fordham L. Rev. 597 (2013) [hereinafter Soames, Deferentialism]; 1 Scott Soames, Interpreting Legal Texts: What Is, and What Is Not, Special about the Law, in Philosophical Essays: Natural Language: What It Is and How We Use It 403 (2009).

 [18].  Soames, Deferentialism, supra note 17, at 597 (characterizing deferentialism as originalism without the baggage). While characterizing deferentialism as jettisoning originalism’s baggage Soames never expressly articulates what he thinks he has accomplished. I think he means to claim that he has eliminated some of the more implausible claims originalists have made about the determinacy of semantic meaning, and dispensed with a need for those claims by amplifying the recourse to semantic meaning with reference to the pragmatics of utterances and texts.

 [19].  Id. at 597–98.

 [20].  Scott Soames, Philosophy of Language 1 (2010) (“The central fact of language is its representational character.”).

 [21].  Soames, Deferentialism, supra note 17, at 597.

 [22].  See Fallon, Law and Legitimacy, supra note 10, at 61–62.

 [23].  Id. at 62–65.

 [24].  Id. at 64.

 [25].  Id. at 64–65.

 [26].  Admittedly, Fallon does not make this claim expressly. But in discussing other theorists who are committed to a representational account of language he expresses no reservations about those accounts. Id. at 188, nn.50–56.

 [27].  Richard H. Fallon, Jr. The Meaning of Legal “Meaning” and Its Implications for Theories of Legal Interpretation, 82 U. Chi. L. Rev. 1235, 1307 (2015) [hereinafter Fallon, Meaning] (unreflectively writing of the referents of interpretations of meaning).

 [28]. André LeDuc, The Anti-Foundational Challenge to the Philosophical Premises of the Debate over Originalism, 119 Penn. St. L. Rev. 131 (2014).

 [29].  See Fallon, Law and Legitimacy, supra note 10, at 49–51.

 [30].  By contrast, many of the participants in the debates over constitutional originalism employ their representational accounts of language to make claims about the precision and determinativeness of language that fit more easily with representational theories. See André LeDuc, The Ontological Foundations of the Debate over Originalism, 7 Wash. U. Juris. Rev. 263 (2015).

 [31].  See Fallon, Law and Legitimacy, supra note 10, at 43–44, 76–78.

 [32].  See Alexander M. Bickel, The Least Dangerous Branch: The Supreme Court at the Bar of Politics 16–23 (1962) (arguing that the fundamental challenge of constitutional theory is to explain the legitimacy of judicial review).

 [33].  See, e.g., Jeremy Waldron, The Core of the Case against Judicial Review, 115 Yale L.J. 1346, 1406 (2006) (concluding that judicial review is inappropriate as a matter of democratic political philosophy in reasonably democratic societies).

 [34].  See Ronald M. Dworkin, The Model of Rules: I, in Taking Rights Seriously 14, 43–45 (1977).

 [35].  Here, too, Fallon is indifferent to the jurisprudential debate between legal positivists and natural law theorists. While asserting the importance of moral commitments in deciding constitutional cases and thereby determining our constitutional law, he nevertheless presses Hart’s positivist notion of a rule of recognition into service.

 [36].  Fallon offered his defense of judicial review in Richard H. Fallon, Jr., The Core of an Uneasy Case for Judicial Review, 121 Harv. L. Rev. 1693 (2008) (arguing against Waldron’s indictment if judicial review and offering an affirmative theoretical defense thereof). Alexander Bickel, The Least Dangerous Branch, and the countermajoritarian difficulty do not even merit entries in the brief index.

 [37].  See Fallon, Law and Legitimacy, supra note 10, at 159–60.

 [38].  See id. at 159–165.

 [39].  The Brown challenge asserts that any constitutional theory that characterizes Brown as wrongly decided (as distinguished from wrongly reasoned) is thereby discredited and must be rejected.

 [40].  See Fallon, Law and Legitimacy, supra note 10, at 145, 162.

 [41].  See id.at 162–63.

 [42].  Id. at 22–24, 41–46.

 [43].  Antonin Scalia, Common Law Courts in a Civil-Law System: The Role of United States Federal Courts in Interpreting The Constitution and Laws, in A Matter of Interpretation: Federal Courts and the Law 45–46 (Amy Gutmann ed., 1997).

 [44].  Philip Bobbitt, Constitutional Fate: Theory of the Constitution (1982); John Hart Ely, Democracy and Distrust: A Theory of Judicial Review (1980).

 [45].  See Fallon, Law and Legitimacy, supra note 10, at 68.

 [46].  See id. at 105–24.

 [47].  See id. at 48–49.

 [48].  See id. at 107–09.

 [49].  See Robert B. Brandom, A Hegelian Model of Legal Concept Determination: The Normative Fine Structure of the Judges’ Chain Novel, in Pragmatism, Law, and Language 19, 19–20 (Graham Hubbs & Douglas Lind eds., 2014). Fallon occasionally hints at a perspective like this but does not develop it.  See Fallon, Law and Legitimacy, supra note 10, at 107.

 [50].  See Fallon, Law and Legitimacy, supra note 10, at 7.

 [51].  Robert H. Bork, The Tempting of America: The Political Seduction of the Law 143 (1990) (characterizing originalism as the only approach to constitutional interpretation that possesses “democratic legitimacy” and is “consonant with the design of the American Republic”).

 [52].  Philip Bobbitt, Constitutional Interpretation 83–108 (1991).

 [53].  See Fallon, Law and Legitimacy, supra note 10, at 49–51.

 [54].  See id. at 169–71.

 [55].  Id. at 169, 212 n.43.

 [56].  See id. at 169–71.

 [57].  Id. at 136–38.

 [58].  Id.

 [59].  Bobbitt, supra note 44; Dennis Patterson, Law and Truth (1996).

 [60].  Fallon, Law and Legitimacy, supra note 10, at 142–48.

 [61].  Id. at 142–48, 170–71.

 [62].  Scalia, supra note 43, at 45.

 [63].  See, e.g., Scalia, supra note 43, at 44–45; Bork, supra note 51, at 253–55; Richard Posner, The Problematics of Moral and Legal Theory, 111 Harv. L. Rev. 1637 (1998).

 [64].  Fallon, Law and Legitimacy, supra note 10, at 125–27.

 [65].  Id. at 147.

 [66].  Michael Walzer, Spheres of Justice: A Defense of Pluralism and Equality 79 (1983) (arguing that Rawls’s argument as to what is just in the abstract from behind the veil of ignorance cannot offer a rich enough account to give us answers as to what justice requires in the rich historical context in which we find ourselves in life).

 [67].  Fallon, Law and Legitimacy, supra note 10, at 126–27.

 [68].  Id. at 41–46.

 [69].  See id. at 126–27.

 [70].  Id. at 144.

 [71].  Id.

 [72].  Id. at 128.

 [73].  See id. at 10–11, 121–23.

 [74].  See Ronald Dworkin, Law’s Empire 379–92 (1986).

 [75].  Cass R. Sunstein, Legal Reasoning and Political Conflict 49 (1996).

 [76].  Id. at 48–50.

 [77].  Compare Dworkin, supra note 74, at 264–65 (acknowledging but dismissing the objection to his account of adjudication based on the practical impossibility of human judges adopting and following the ambitious methodology of law as integrity) with Fallon, Law and Legitimacy, supra note 10, at 149 (history), 48–49 (theoretical analysis of language).

 [78].  Fallon, Law and Legitimacy, supra note 10, at 130–32.

 [79].  Id. at 147–48.

 [80].  Id. at 151–53.

 [81].  John Rawls, A Theory of Justice 48–51 (1971).

 [82].  Gilbert Harman, Change in View: Principles of Reasoning 1 (1986). Harman’s account of belief change is embedded in a representational account of language, but I believe that his account of practical reasoning could be recast in a non-representational, inferentialist form.

 [83].  John Rawls, Political Liberalism (paperback ed. 1996).

 [84].  Id. at 37.

 [85].  See Burton Dreben, On Rawls and Political Liberalism, in The Cambridge Companion to Rawls 316, 317–18 (Samuel Freeman ed., 2003).

 [86].  To the extent we read Cass Sunstein’s judicial minimalism and defense of incompletely theorized decisions as relying fundamentally on the later Rawls, Fallon’s focus on the earlier Rawls is also reflected in his relative non-engagement with Sunstein’s constitutional theory. See Sunstein, supra note 75, at 46–48, 199 nn.13–14 (citing Political Liberalism).

 [87]. See André LeDuc, Making the Premises about Constitutional Meaning Express: The New Originalism and Its Critics, 31 BYU J. Pub. L. 111 (2016).

 [88].  See Charles Fried, Balls and Strikes, 61 Emory L.J. 641 passim (2012) (exploring the metaphor Chief Justice John Roberts offered in his confirmation hearings but arguing, most importantly, that the role and contribution of the judge to adjudication in the law is more complex and more important than the role of the umpire in playing sports games). It also accounts for why Sunstein’s argument for incompletely theorized opinions is overstated, if not mistaken. Sometimes constitutional cases are best resolved by the Court, despite the important inherent limitations on the Court, by a more comprehensive or sweeping opinion to announce the decision. When and why that may be the case is not a question that Fallon engages directly, but unlike Sunstein, he does not reject the possibility that certain constitutional cases may require a decision on the basis of an argument with broad application or implications.

 [89]. Brown v. Board of Education of Topeka, 347 U.S. 483, 495 (1954).

 [90]. While the pragmatics of the text—context and role in the decision of the constitutional case—make it clear that it speaks as a matter of federal constitutional law, even though it does not expressly assert its conclusion as a matter of federal constitutional law.

 [91]. Plessy v. Ferguson, 163 U.S. 537 (1896).

 [92]. Brown, 347 U.S. at 494–95.

 [93]. Bernard Wolfman et al., Dissent Without Opinion: The Behavior of Justice William O. Douglas in Federal Tax Cases (1975) (arguing that the consistent failure of Justice Douglas to articulate any grounds as the basis on which he struck down federal taxes contested before the Court was illegitimate).

 [94].  Richard H. Fallon, Jr., A Constructivist Coherence Theory of Constitutional Interpretation, 100 Harv. L. Rev. 1189 (1987).

 [95].  Bobbitt, supra note 44.

 [96].  Id. at 7; Bobbitt, supra note 52, at 11–22.

 [97].  Bobbitt, supra note 52, at xi.

 [98].  Id. at xvii, 184–86.

 [99].  Patterson, supra note 59, at 142–46, 149–50.

 [100].  Harman’s account of practical judgment would appear to be such an example.

 [101]. It may appear that Bobbitt’s notion of the style of a particular Justice, reflected in his preference for one or more particular modes of argument, is analogous to Fallon’s claim that a Justice begins the decision of a constitutional case with a working theory of constitutional interpretation. I think the parallel is misleading because the modes of arguments are not theories of the Constitution, still less theories of interpretation. Moreover, while not foundational (because they are merely types or classes of argument) and because they are not confirmed or reinforced by intuitions about the best resolution of constitutional controversies.

 [102].  Fallon, Law and Legitimacy, supra note 10, at 98–99; see Charles Fried, Saying What the Law Is: The Constitution in the Supreme Court 241–42 (2004).

 [103].  See Charles Fried, On Judgment, 15 Lewis & Clark L. Rev. 1025 passim (2011) (emphasizing the often underestimated importance of judgment in constitutional cases in lieu of emphasizing the importance of interpretive theory). Even the title of Fried’s earlier book—Saying What the Law Is—emphasizes the performative, character of our constitutional law and practice, at least if we understand the Court to make the law so by saying.

 [104].  Id. at 1043–44 (highlighting the power of Justice Scalia’s non-originalist opinions and decisions).

 [105].  Fallon, Law and Legitimacy, supra note 10, at 67.

 [106].  Soames, supra note 20, at 1–10 (beginning his theoretical analysis with Frege).

 [107].  Fallon mentions Sunstein’s concept and argument only in passing. Fallon, Law and Legitimacy, supra note 10, at 208, n.65. While Fallon argues for greater judicial deference to the legislature, he does not endorse the systematic judicial minimalism that Sunstein calls for.

 [108].  For a more cautious view that it will take more than merely compelling or even dispositive, rational argument to reach that result, see André LeDuc, Striding Out of Babel: Originalism, Its Critics, and the Promise of Our American Constitution, 26 Wm. & Mary Bill of Rts. J. 101 (2017).

 

Supreme Court Reform: Desirable—And Constitutionally Required

From Volume 92, Postscript (November 2018)
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Supreme Court Reform: Desirable—and Constitutionally Required

David Orentlicher[*]

As decisions by—and appointments to—the Supreme Court have become increasingly divisive,[1] many observers have renewed calls for reform.[2] For example, we could replace lifetime tenure with non-renewable terms of eighteen years, such that one term ends every two years.[3] That way, less would be at stake with each nomination, Justices could not time their retirements for partisan reasons, and appointments would be divided more evenly between Democratic and Republican presidents. Or we could establish a non-partisan, judicial nominating commission.[4]

Concerns about the Supreme Court are not new, but increasing political polarization and partisan maneuvering over the two most recent Court appointments have accentuated tensions. With the legitimacy of the Court at stake, reform to depoliticize the Court seems essential. And whichever reform is promoted, it is generally assumed that implementation would require a constitutional amendment, legislation, or a change in Senate rules.

But the conventional wisdom is wrong. There is a sound argument to be made that Supreme Court reform is constitutionally required.[5]

DUE PROCESS AND ideological baLANCE

With Justice Brett Kavanaugh’s appointment to the Supreme Court, it seems pretty clear that President Donald Trump and Senate Republicans have been able to solidify a staunchly conservative majority on the Court. In all likelihood, this new majority will stake out firmly conservative positions on a range of critical issues, including voting rights, reproductive rights, and corporate rights. With a second Trump nominee on the bench, the Supreme Court will bring a strong ideological bias to its decision making. While that is highly controversial, it is one of the features of our judicial appointment process. As is often said, elections have consequences.

Or should they when it comes to the judicial branch? We ought to consider the constitutional implications of ideological bias on the Supreme Court. In particular, principles of due process and the framers’ original intent provide good reason to think that neither a conservative nor liberal Court majority should be able to impose its views on the country. 

A.  Ideological Bias and Due Process

The Due Process Clause promises litigants that they will receive an impartial hearing before a neutral court.[6] And a neutral court decides cases without any personal, political, or other bias.[7] With a fifth strongly conservative Justice on the Supreme Court, it is not a neutral court. Any party promoting a liberal viewpoint before the Justices will not be able to count on a fair shot at prevailing.[8]

To be sure, if Justices merely acted like umpires, doing something akin to the calling of balls and strikes, as suggested by Chief Justice John Roberts in his confirmation hearings,[9] a Justice’s political philosophy would not matter. But of course, a Justice’s political philosophy does matter.[10] Otherwise, Republican Senators would have considered Judge Merrick Garland’s nomination to the Supreme Court in 2016, and other nominations also would not fail because of partisan opposition. Some Justices take more conservative positions, while others take more liberal positions.[11] A conservative majority will render different decisions on environmental regulation, consumer protection, or voting rights than will a liberal majority. When Court decisions reflect the philosophical leanings of the Justices, and decisions can be determined by one side of the ideological spectrum, our system denies an impartial hearing to parties on the other side of the ideological spectrum. And that is fundamentally unfair in a constitutional system that promises litigants due process in court.

Because it is unfair for litigants to have their cases decided by an ideologically-biased court, other countries have designed their highest courts so decisions do not reflect only one side of the philosophical spectrum. Arguably, due process requires something similar for the Supreme Court.

A strong view of due process would demand ideological moderation for each Justice, an approach taken in some European countries. In Germany, for example, nominees to the Constitutional Court must receive a two-thirds vote of approval and therefore must appeal to legislators on both sides of the partisan aisle.[12] Instead of getting judges who are either strongly conservative or liberal, German litigants get judges who are moderate. Like Germany, Portugal and Spain require supermajority votes for appointments to their constitutional courts.[13] So we might say that due process requires restoration of a strong filibuster rule in the Senate or a strong supermajority on final voting for judicial nominations. That would force presidents to nominate Justices acceptable to both conservatives and liberals.[14]

A less demanding view of due process would focus on overall balance on the Court rather than on the ideologies of individual Justices. While there are different ways to achieve overall balance,[15] the simplest path for the Supreme Court would be to follow the example of a number of countries. In many European nations, high court decisions are made by consensus, or at least a supermajority vote, so Justices on both sides of the ideological spectrum have to support the courts’ opinions.[16] The U.S. Supreme Court itself observed a norm of consensual decision-making for most of its history. Until 1941, the Justices typically spoke unanimously.[17] Only about 8% of cases included a dissenting opinion. Now, one or more Justices dissent in about 60% of rulings.[18] Chief Justice John Roberts has pushed for greater consensus on the Court,[19] saying that the court functions best “when it can deliver one clear and focused opinion.”[20]

An advantage of this path to ideological balance is that it allows for a greater range of perspectives among the different Justices. Instead of nine relatively moderate Justices, we would get a mix of conservative and liberal Justices. And that would make for a stronger decision making process. Studies on group decision making demonstrate that better outcomes result when the decision makers bring a range of viewpoints to the table.[21] Accordingly, I discuss this path to ideological balance in the remainder of this essay.

How large should a supermajority be? Since there may be times when six Justices are either conservative or liberal, it probably would be necessary to require more than a two-thirds supermajority to ensure that decisions always reflect the perspectives of both sides of the philosophical divide. We could require at least a 7-2 vote or even decisionmaking by consensus of the entire Court.

B.  Ideological Bias and Original Intent

What would the framers think about this? On one hand, they did not include in Article III of the Constitution a requirement for ideological balance on the Supreme Court. On the other hand, they did not reject ideological balance. Moreover, they recognized the need to amend the Constitution with a Bill of Rights that includes the Due Process Clause’s guarantee of impartial courts.

The framers’ intent is consistent with this essay’s due process analysis. With ideological balance, the Supreme Court would be more faithful to the framers’ design for our constitutional system. The Founding Fathers worried greatly about “factions” pursuing their self-interest to the detriment of the overall public good. Accordingly, the constitutional drafters devised a system that they thought would block factional control of the national government.[22] But the framers did not anticipate the extent to which political parties would form dominant factions that could gain command of government power. For example, the framers did not anticipate how partisan ties between presidents and members of Congress would limit the legislative branch’s checking and balancing of the executive branch.[23] Similarly, the framers did not expect—nor did they want—a Supreme Court that would reflect the views of only one side of the ideological spectrum. Indeed, when Alexander Hamilton explained the Constitution’s appointment provisions in The Federalist Papers, he emphasized the need to avoid nominations that reflect partiality instead of the overall public interest.[24]

The Due Process Clause and original intent both support ideological balance on the Supreme Court. As discussed in the next section, Supreme Court precedent is consistent with such a requirement.

C.  Ideological Bias and Supreme Court Precedent

In previous cases, the Supreme Court has observed that constitutional concerns are not raised when a judge favors one or another ideological view.[25] Anyone with the appropriate training and experience for the judiciary will have opinions on important legal issues. According to the Court, due process prohibits judicial bias against a party to a proceeding, not bias against a legal view that the party might advocate.[26]

But there are important reasons to distinguish Court discussions of the issue. First, these discussions were dicta. The question whether it is impermissible for an appellate court to have an overall ideological bias has not been decided by the Court. Rather, it has come up in cases addressing other issues of judicial neutrality. In Republican Party of Minnesota v. White, for example, the issue before the Court was whether a state could prohibit judicial candidates from announcing their positions on issues that might come before them if elected.[27] In another case, Tumey v. Ohio, the issue before the Court was whether judges could have a financial stake in the outcome of their decisions.[28]

Second, the Court’s reasoning is consistent with a due process argument against a Court that has an overall ideological bias. In Republican Party of Minnesota, the Justices discussed the kinds of personal biases that should disqualify a judge, and the Court wrote that a judge’s ideological bias is not disqualifying in the way that a personal financial bias is disqualifying. It took that view in Republican Party of Minnesota and earlier cases because anyone who has the experience and training that would be desirable in a judge will inevitably develop an ideological bias.[29] But the fact that we must accept individual judges with ideological leanings does not prevent us from ensuring an overall ideological balance on the Court. Under a fair reading of the Constitution, litigants ought to be able to ensure that their cases are decided in an ideologically-balanced way.

In addition, it is difficult to identify a good reason for permitting the Court to function with a majority on one side or the other of the ideological spectrum. While we can point to the principle of majority rule to justify partisan control in the executive or legislative branches, popular majorities do not deserve special recognition in a judicial branch that should be guided by legal principle rather than prevailing sentiment.

d.  Potential concerns with a requirement of ideological balance

In general, concerns about cost, efficiency, and fairness have limited policies to address judicial bias.[30] For example, one solution to judicial bias is recusal of the biased judge. But if reasons for recusal are not strictly limited, litigants might clog the courts with baseless recusal motions,[31] and lawyers might exploit the rules to game the system in favor of their clients.[32] Supreme Court Justices also have resisted strict recusal rules on the ground that there is no one who can step in for the disqualified Justice.[33] A supermajority requirement avoids the problems raised by judicial disqualification. It addresses bias not by removing partial Justices, but by counterbalancing their partialities. 

Still, one might worry that a supermajority requirement would lead the Court to deadlock with some frequency and leave too many issues to be decided by the lower courts. However, a few considerations indicate that it is unlikely to do so. First, the Justices would have a strong incentive to find common ground. Supreme Court Justices want to leave their imprint on the law—after spending years, if not decades, maneuvering for a Court appointment and having reached the pinnacle of the judiciary, they would be driven by their desire to leave an important judicial legacy. If the Justices spent their years on the Court bogged down in gridlock, they would not be able to issue key decisions that would allow them to make a difference in resolving critical legal questions. Accordingly, they would come to accommodations that would allow them to issue important decisions.

Empirical evidence supports this prediction. High courts operate successfully under a supermajority requirement in other countries. In addition, the U.S. Supreme Court has effectively operated under a supermajority requirement from time to time. On a number of occasions, the Court has heard cases with only eight members and therefore has needed a 62.5% supermajority (5/8) to reach a decision. Sometimes this happens when a seat is temporarily unfilled; other times when Justices take ill or have to recuse themselves.[34] In a study of the 1,319 cases in which a tie could have occurred between the 1946 and 2003 terms of the Court, researchers found that a tie vote occurred less than 6% of the time.[35] And, of course, a number of landmark decisions have been decided by a supermajority vote. A 9-0 Court issued its opinion in Brown v. Board of Education,[36] a 7-2 Court issued its opinion in Roe v. Wade,[37] and a 4-0 Court issued its opinion in Marbury v. Madison.[38]

The experience with juries also suggests that supermajority courts would reach decisions regularly. Criminal court juries typically have twelve members, and they usually have to reach unanimous decisions. Hung juries occur, but not very often.[39] Moreover, juries reach their unanimous decisions in a setting that allows for less compromise than does a decision by the Supreme Court. A criminal jury must acquit or convict.[40] The example of juries is important for a second reason. I have argued that to be impartial, the Court should issue decisions that reflect the views of Justices from both sides of the ideological spectrum.[41] Similarly, in defining the meaning of an impartial jury, the Supreme Court has required that jurors be drawn from a fair cross-section of the community.[42]

Game theory provides further reason to believe that the Court would find middle ground regularly under a supermajority requirement. Game theory can identify the kinds of relationships that are likely to encourage cooperative rather than oppositional strategies.[43] The Supreme Court includes important elements of cooperative relationships. For example, when individuals have an ongoing relationship with frequent and repeated interactions, as with members of the Court, they are much more likely to choose cooperation with each other than when they have a one-shot relationship. Cooperation is also more likely in relationships with an indefinite time horizon, as with Justices who have lifetime appointments, than when there is a finite time horizon. Finally, cooperation is more common among individuals who come to their relationship with equal status and authority. That is true about Supreme Court Justices, except perhaps with Chief Justices. The extra authority of a Chief Justice may not be that important, but if it is, we could make the Chief’s role a rotating position, as is the case with some state supreme courts.[44]

Conclusion

There is much dissatisfaction among Supreme Court observers with the Court and its appointment process. And as the Court’s decisions and appointment process have become increasingly divisive, public approval of the Supreme Court has declined. A majority of Americans once expressed strong confidence in the court. According to a July 2018 Gallup poll, only 37% do now.[45] Reforming the Supreme Court would do much to restore public faith in the Court. And it also would bring the Court into conformity with the requirements of due process.

 


[*] *. Cobeaga Law Firm Professor of Law, UNLV William S. Boyd School of Law; M.D., Harvard Medical School; J.D., Harvard Law School. This essay draws on my earlier discussions of ideological bias, infra note 2, and makes the novel argument that ideological balance is constitutionally required. I am grateful for the comments of Judy Failer and Ruben Garcia, the research assistance of Lena Rieke, and the editorial assistance of Daniel Brovman and other Southern California Law Review editors.

 [1]. While the U.S. Senate approved the appointment of Justice Anthony Kennedy by a 97-0 vote, his successor, Justice Brett Kavanaugh, squeaked by on a vote of 50-48. Similarly, the Senate approved Justice Antonin Scalia by a vote of 98-0, while the vote on his successor, Justice Neil Gorsuch, was 54-45. Supreme Court Nominations: present-1789, U.S. Senate, https://www.senate.gov/pagelayout
/reference/nominations/Nominations.htm (last visited Oct. 20, 2018).

 [2]. I have previously discussed the desirability of ideological balance on the Supreme Court in David Orentlicher, Politics and the Supreme Court: The Need for Ideological Balance, 79 U. Pitt. L. Rev. 411 (2018), and David Orentlicher, Two Presidents Are Better Than One: The Case for a Bipartisan Executive 2731 (2013).

 [3]. See generally Roger C. Cramton & Paul D. Carrington, Reforming the Court: Term Limits for Supreme Court Justices (2006).

 [4]. Many states have judicial nominating commissions, though they tend to be partisan since the governor appoints many of the commission members. See, e.g., Ind. Const. art. VII, § 9; Kan. Const. art. III, § 5(e).

 [5]. The logic of my argument also would apply to the circuit courts of appeal, as well as state appellate courts.

 [6]. Martin H. Redish & Jennifer Aronoff, The Real Constitutional Problem with State Judicial Selection: Due Process, Judicial Retention, and the Dangers of Popular Constitutionalism, 56 Wm. & Mary L. Rev. 1, 34, 3637 (2014).

 [7]. Charles Gardner Geyh, The Dimensions of Judicial Impartiality, 65 Fla. L. Rev. 493, 499–509 (2013).

 [8]. Likewise, if a fifth liberal Justice had joined the Court, parties promoting a conservative viewpoint would not be able to count on a fair shot at prevailing.

 [9]. Confirmation Hearing on the Nomination of John G. Roberts, Jr. to Be Chief Justice of the United States: Hearing Before the S. Comm. on the Judiciary, 109th Cong. 56 (2005).

 [10]. Lee Epstein et al., The Behavior of Federal Judges: A Theoretical and Empirical Study of Rational Choice 103 (2013).

 [11]. Lee Epstein et al., Ideological Drift Among Supreme Court Justices: Who, When, and How Important?, 101 Nw. U. L. Rev. 1483, 1491 (2007).

 [12]. Georg Vanberg, The Politics of Constitutional Review in Germany 83 (2005); Bruce Ackerman, The New Separation of Powers, 113 Harv. L. Rev. 633, 669 (2000).

 [13]. John Ferejohn & Pasquale Pasquino, Constitutional Adjudication: Lessons from Europe, 82 Tex. L. Rev. 1671, 1682 (2004).

 [14]. This approach would be especially valuable at the district court level, where there is a single judge deciding cases.

 [15]. Orentlicher, supra note 2, at 417–23.

 [16]. European Parliament, Dissenting Opinions in the Supreme Courts of the Member States (2012),  http://www.europarl.europa.eu/document/activities/cont/201304/20130423ATT64963
/20130423ATT64963EN.pdf

 [17]. Cass R. Sunstein, Unanimity and Disagreement on the Supreme Court, 100 Cornell L. Rev. 769, 771 (2015).

 [18]. Id. at 776–77.

 [19]. Hope Yen, Roberts Seeks Greater Consensus on Court, Wash. Post (May 21, 2006), http://www.washingtonpost.com/wp-dyn/content/article/2006/05/21/AR2006052100678.html.

 [20]. Geoffrey R. Stone, Chief Justice Roberts and the Role of the Supreme Court, Huffington Post (May 25, 2011), https://www.huffingtonpost.com/geoffrey-r-stone/chief-justice-roberts-and_b
_40277.html.

 [21]. Alan Blinder, The Quiet Revolution: Central Banking Goes Modern 43 (2004); Scott E. Page, The Difference: How the Power of Diversity Creates Better Groups, Firms, Schools, and Societies 2–3 (2007); Lu Hong & Scott E. Page, Groups of Diverse Problem Solvers Can Outperform Groups of High-Ability Problem Solvers, 101 Proc. Nat’l Acad. Sci. 16385 (2004).

 [22]. Geoffrey R. Stone et al., Constitutional Law 18–21 (7th ed. 2013).

 [23]. Daryl J. Levinson & Richard H. Pildes, Separation of Parties, Not Powers, 119 Harv. L. Rev. 2311, 2313, 232324 (2006).

 [24]. The Federalist No. 76 (Alexander Hamilton).

 [25]. The Court’s opinion in Republican Party of Minnesota v. White, 536 U.S. 765 (2002), provides a nice summary of the Court’s discussions of the topic.

 [26]. Id. at 77778.

 [27]. Id. at 768. The Court held that the prohibition violated the First Amendment. Id. at 788.

 [28]. Tumey v. Ohio, 273 U.S. 510, 514–15 (1927). The Court held that the judges’ financial interests violated due process. Id at 534.

 [29]. Republican Party of Minnesota, 536 U.S. at 77778.

 [30]. Geyh, supra note 7, at 514–15.

 [31]. Caperton v. A.T. Massey Coal Co., 556 U.S. 868, 890–91, 899–900 (2009) (Roberts C.J., dissenting).

 [32]. Id. at 903 (Scalia, J., dissenting).

 [33]. Gabriel Serbulea, Due Process and Judicial Disqualification: The Need for Reform, 38 Pepp. L. Rev. 1109, 1136–38 (2011).

 [34]. There also have been periods when the Court had an even number of Justices. For most of the period between 1789 and 1807, the Court had six members. Why Does the Supreme Court Have Nine Justices?, Const. Daily (July 6, 2018), https://constitutioncenter.org/blog/why-does-the-supreme-court
-have-nine-justices.

 [35]. Ryan Black & Lee Epstein, Recusals and the “Problem” of an Equally Divided Supreme Court, 7 J. App.  Pract. & Proc. 75, 85–86 (2005).

 [36]. Brown v. Bd. of Educ., 347 U.S. 483 (1954).

 [37]. Roe v. Wade, 410 U.S. 113 (1973).

 [38]. Marbury v. Madison, 5 U.S. 137 (1803). The Marbury Court had six Justices, but two did not take part because of illness.

 [39]. Studies suggest an average hung jury rate of around 6% nationwide. Paula L. Hannaford-Agor et al., Are Hung Juries a Problem?: Executive Summary 2 (2002), https://www.ncjrs.gov
/pdffiles1/nij/grants/199372.pdf.

 [40]. In some cases, juries can compromise if they have the option of convicting on a less serious charge.

 [41]. See supra notes 921 and accompanying text.

 [42]. Taylor v. Louisiana, 429 U.S. 522, 526–27 (1975).

 [43]. Robert Axelrod, The Evolution of Cooperation 12432 (1984); Itzhak Gilboa, Rational Choice 10001 (2010); Ming Zeng & Xiao-Ping Chen, Achieving Cooperation in Multiparty Alliances: A Social Dilemma Approach to Partnership Management, 28 Acad. Mgmt. Rev. 587 passim (2003).

 [44]. See, e.g., Supreme Court Judges, Mo. Cts. https://www.courts.mo.gov/page.jsp?id=133 (last visited Nov. 8, 2018) (“[T]he chief justice typically is elected on a rotating basis by a vote of all seven Supreme Court judges to a two-year term.”). Or consider a model from Switzerland. The members of the Swiss Federal Council rotate through the position of president so they remain true equals in the Swiss executive branch.

 [45]. Megan Brenan, Confidence in Supreme Court Modest, but Steady, Gallup (July 2, 2018), https://news.gallup.com/poll/236408/confidence-supreme-court-modest-steady.aspx.

Profound Sophistication or Legal Sophistry?

From Volume 92, Postscript (November 2018)
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Profound Sophistication or Legal Sophistry?

Ediberto Roman,[*] Katryna Santa Cruz,[†] Melissa Gonzalez,[‡] and Dianet Torres[§]

In the midst of growing debate andaccording to widely publicized news accountsgrowing evidence against President Donald Trump’s impeachment, esteemed former Harvard Law Professor and public intellectual, Alan Dershowitz, recently published The Case Against Impeaching Trump.[1] In this brief, but passionate, defense of the President, Professor Dershowitz provides arguably the strongest legal argument against impeaching the Forty-Fifth President of the United States. Professor Dershowitz’s argument, while beautifully written, is largely a selectively applied textualist attempt to thwart the mounting evidence against President Trump and his administration.

Dershowitz argument boils down to the following: “[I]f a president has not committed any of these specified crimes [those specified in the Constitution], it would be unconstitutional to remove him, regardless of what else he may have done or may do.”[2] The Dershowitz defense focuses on the Constitution’s Impeachment ClauseArticle II, Section 4which provides: “The President, Vice President and all civil officers of the United States, shall be removed from Office on Impeachment for, and Conviction of, Treason, Bribery, or other high Crimes and Misdemeanors.”[3] Dershowitz’s argument is based on the premise that because “the Constitution speaks in clear terms, [its] plain meaning must prevail over other considerations.”[4] This argument is interesting because Dershowitz himself examines all of the subtle ambiguities that the Constitution’s lack of explanation creates, including: Can evidence be introduced? Who rules on admissibility? Common law? Exclusionary rule? Further, even Dershowitz recognizes the Constitution is missing a good deal of information on the issue of impeachment (in terms of Congressional trials for impeachment), but yet, according to Dershowitz, the Clause’s plain meaning should only allow for impeachment for treason and bribery.[5] Seems like his reading of the Constitution is a little too convenient.

According to Dershowitz’s argument, the Constitution provides the only basis for impeaching and removing the President of the United States, and in Trump’s case, there is no grounds for impeachment. The first part of his position—the Constitution provides the exclusive basis for impeachment—is uncontroversial. What is far more problematic is Dershowitz’s use of textualism. Dershowitz is both a self-professed champion of civil liberties as well as a textualist reader of the Constitution. Yet in this defense of Trump, the good professor fails to recognize one of the Constitution’s three stated grounds for impeachment, which is far from engaging in a textualist approach. In doing so, this champion of civil liberties fails to acknowledge a constitutional provision aimed at protecting the citizenry’s rights from tyrannical executive power. Dershowitz’s legitimate basis for impeachment focuses on only two of the three constitutional bases for impeachment: 1) treason and 2) bribery. Dershowitz’s lack of focus on a recognized reading of the third stated basis for impeachment is nothing short of perplexing especially given his textualist leaning and prior textualist positions. For example, he does not believe the Constitution includes privacy rights that protect a right to abortion because the document fails to specifically provide for such a right.[6]

Indeed, Dershowitz’s dismissal of the Constitution’s third specifically stated ground for impeachmentother high Crimes and Misdemeanors”is insufficiently explained in the book. This blatant omission leaves the reader wanting for a less partisan analysis. But before focusing on this shortcoming, an analysis of Dershowitz’s argument on what he views as the legitimate grounds for impeachment—treason and bribery—is in order.

In terms of his first legitimate basis for impeachment, Dershowitz notes that only treason is defined. The Constitution defines treason as “levying War against [the United States], or in adhering to their Enemies, giving them Aid and Comfort.”[7] This constitutional definition applies within Dershowitz’s textual approach, and is therefore a legitimate basis for impeachment. Though he admits that the second and third enumerated basesbribery, and high crimes and misdemeanorsare not defined in the Constitution, it is only the high crimes and misdemeanors basis that Dershowitz apparently finds fatally vague and therefore is an unavailable basis for impeachment.[8] Dershowitz apparently has less of a concern for bribery because it is a crime.[9] Dershowitz doesn’t openly state his antipathy for the high crimes or misdemeanors basis for impeachment. Instead, in what is an overall cryptic and truncated analysis, which amounts to no more than thirtytwo pages (including the book’s conclusion) of new materials (the remaining 114 pages of the book are excerpts of the professor’s previous editorials and interviews arguably related to his main thesis), Dershowitz spends the bulk of his argument addressing the purported procedural shortcomings of the high crimes impeachment basis attempting to limit its use to crimes.[10] Indeed, while Dershowitz spends virtually no time objecting to the bribery basis for impeachmentwhich he admits is not defined in the text of the Constitution, causing him to look to bribery’s common law definitionhe harps on the high crimes basis, without effectively explaining this choice. Then instead of looking to what the drafters of the constitution stated concerning the high crimes or misdemeanor grounds for impeachmentor even looking to judicial or congressional pronouncements on the subjectDershowitz shifts his focus to attacking those that advocate a broad interpretation of the “and other high crimes and misdemeanor” basis. He ultimately rejects any reading of the impeachment clause that does not make a crime a prerequisite to impeachment.[11] As a result, he rejects previous interpretations by both President Ford, when he served in Congress, and current Congresswoman Maxine Waters; each have argued that high crimes and misdemeanors is whatever the house of representatives  deems appropriate.[12] Another questionable aspect of Dershowitz’s argument against impeachment is his effort at equating the process of impeachment to the procedural requirements of a criminal trial. Yet the Impeachment Clause does not call for a criminal proceeding for impeachment. Instead, it provides for a trial by the House of Representatives, a political endeavor by definition. Thus, Dershowitz’s criminal law and criminal procedure-based arguments may very well be misplaced. While the text of the Impeachment Clause is far from clear on this point, interestingly, Dershowitz does not consider that the very placement of “and other high crimes and misdemeanor” in the list of impeachable acts alone strongly suggests this clause is in fact the broadest, or even the catch-all, basis for impeachment.[13] Further, as a matter of statutory interpretation and basic sentence construction, the fact the broadest language happens to be listed last similarly suggests this basis should be read broadly. Indeed, such a broad reading was exactly what the framers of the Constitution intended. While Dershowitz, as a self-professed textualist, is no fan of anything other than the text of the Constitution if the text is unambiguous,[14] it is in interpreting the Constitution’s Impeachment Clause where the shortcomings of his approach are highlighted. Indeed, it is here where textualism falls short because it utterly fails to seek or acknowledge what the drafters of the Constitution intendedevidently because, according to Dershowitz, the text is in fact unambiguous. If the text is in fact unambiguous, why is the debate over its language still the subject of dispute 200 years later? Protestations to the contrary, the legislative history of the Impeachment Clause makes clear that the third basis for impeachment—high crimes and misdemeanors—was drafted and intended to be a broad catch-all provision. As Yale Professor Thomas I. Emerson observed:

[T]he founding fathers did not wish to take over the English practice lock, stock and barrel. Impeachment was intended to be applicable only in a narrower set of circumstances and with more limited results. Hence, after some preliminary discussion, the proposal was made that the President could be removed from office by impeachment and conviction “for treason, or bribery.” This was deemed too restricted and, after rejecting “maladministration” as a cause for impeachment, on the ground it was too broad, the Convention settled on the addition of other high crimes and misdemeanors.” The grounds for impeachment were thus intended to be limited but, apart from a narrow definition of treason elsewhere in the Constitution, the limits were not precisely delineated.[15]

Further, at the Constitutional Convention, the substitute phrase “high Crimes and Misdemeanors” was to be interpreted broadly. Madison in fact believed that it allowed the President to be tried “for any act which might be called a misdemeanor.”[16] Indeed, while debate remains on how broadly the high crimes or misdemeanors basis should be read,[17] even a narrow reading of the clause allows for impeachment for a host of wrongs in a variety of settings:

[A] standard that the framers intentionally set at this extraordinarily high level to ensure that only the most serious offenses and in particular those that subverted our system of government would justify overturning a popular election. Impeachment is not a remedy for private wrongs. It is a method of removing someone whose continued presence in office would cause grave danger to the Nation.[18]

The weight of scholarly authority recognizes the “high Crime and Misdemeanors” Clause should be interpreted to address serious wrongs, but ultimately those wrongs can arise in a wide variety of ways.[19] As one scholar observed, Congressional practice confirms that “high Crimes and Misdemeanors” is broad enough in scope to reach all misconduct that undermines fitness to serve.[20] Professor Stephen Presser, a leading scholar on this constitutional provision, for instance, agreed with Gerald Ford’s famous suggestion that high Crimes and Misdemeanors means anything the House of Representatives wants it to mean when arguing that the provision reflects the essential notion that the Constitution confers broad discretion on the House of Representatives to make up its own mind about what kinds of conduct should lead to an impeachment proceeding. [W]hile giving members of Congress discretion to determine whether a particular act or series of acts amounts to grounds for impeachment, [the Constitution] requires them to move forward to impeach if they determine there are such acts.”[21] Professor Gary L. McDowell, similarly found, “[i]n the end, the determination of whether presidential misconduct rises to the level of ‘high Crimes and Misdemeanors,’ as used by the Framers, is left to the discretion and deliberation of the House of Representatives. No small part of that deliberation . . . must address what effect the exercise of this extraordinary constitutional sanction would have on the health of the Republic . . . .[22] Imminent constitutional scholar, Professor Cass R. Sunstein, likewise observed: “[t]ext, history, and longstanding practice suggest that the notion of ‘high Crimes and Misdemeanors’ should generally be understood to refer to large-scale abuses that involve the authority that comes from occupying a particular public office.”[23]

Dershowitz spends no time addressing either this legislative history or scholarly analysis. Instead of contending with the bulk of authority on the matter, he employs a tried and true lawyerly tact: instead of defending a difficult position, it is far easier and perhaps at times more persuasive to go the offensive and attack the position of others that take a differing view. Indeed, instead of examining the case law explaining and interpreting “other high Crimes or Misdemeanors,” which he briefly undertakes with respect to the bribery cases, Dershowitz proceeds to attack “the most extreme and reductionist” defenses of a broad reading of the high crimes and misdemeanor basis.[24] Yet, even under the tenets of his own textualist philosophy, his argument fails. Under a textualist approach, recourse to the ‘legislative history’ or intended ‘original meaning’ is inappropriate when the words are unambiguous. The plain meaning under such circumstances must prevail over all other interpretative mechanisms, since it was the word, not the intentions behind them, that were voted on and accepted. But even under a textualist approach, if the text is ambiguousand the high crimes and misdemeanor language is far from unambiguousfurther inquiry is necessary, particularly into the Framers intent.[25] It is here where the book’s analysis is weakest because Dershowitz fails to accept the value of further inquiry when text is ambiguous. Thus, a reader is left with a scant interpretation, lacking any significant legal reinforcement.

In terms of President Trump’s potential impeachment, Dershowitz, somewhat unsurprisingly argues that impeachment would be inappropriate because the alleged wrongs purportedly committed by President Trump involve neither treason nor bribery—two of his legitimate enumerated wrongs under Article II’s Impeachment Clause.[26] While Dershowitz may be correct that any charges or claims against President Trump may not involve bribery, there are growing calls arguing President Trump has in fact committed treason.[27] Perhaps more importantly, Dershowitz’s primary analytical flaw is that he simply ignores the text of the Constitution, its interpretation in terms of legislative history, and case law on the third impeachable basis under Article II’s Impeachment Clause: high crimes or misdemeanors.

In the end, Dershowitz attempts to largely ignore a broad reading of “other high Crimes and Misdemeanors” either because he may appreciate they provide problems for his client,[28] or following his stated reasons, such wrongs are not defined in Article II or other parts of the Constitution and there are no procedural requirements set forth for convictions of such crimes.[29] Yet his stated reasons are supported with slight authority and scant analysis. Dershowitz’s analysis is accordingly incomplete, thereby allowing the professor to accept bribery as a legitimate ground for impeachment (even permitting him to look to the common law, ever so briefly, on bribery), but in almost the same breath, he refuses to examine the legislative history of the Constitution, the common law, or the weight of authority on the high crimes or misdemeanor basis for impeachment. Any of these inquiries would have provided not only a more thoughtful undertaking, but also valuable guidance for interpreting the high crimes and misdemeanors basis for impeachment. It should not be forgotten, and he may himself point out, that he refuses to engage in an analysis that goes beyond the text’s “plain meaning.” However, in his own words, “‘other Crimes and Misdemeanors’ are not defined.”[30] So, according to his own preferred interpretive approach, we should not become inflexible and inexplicably resort to the plain meaning when there is textual ambiguity in this case. Not only will case law and legislative history analysis provide the reader with a more thoughtful undertaking, they are essential to understanding the text itself.

Ultimately, in what appears to be an apologist’s vain effort, Dershowitz does not address historical precedent, including the obstruction of justice charges brought in President Clinton’s impeachment proceedings,[31] and the proposed charges against President Nixon,[32] which were each based on high Crimes and Misdemeanors, and specially contained obstruction of justice charges (the likely charges against President Trump if impeachment is recommended).[33] Moreover, in the four lengthy legal opinions on impeachment and criminal charges against a president drafted by the Justice Department’s Legal Office and the Office of Special Counsel in the Nixon impeachment effort, as well as in Clinton’s impeachment, there was no hesitation to accept that a president could be impeached under the high Crimes and Misdemeanors provision of the Impeachment Clause of Article II.[34] Despite these historical facts, in one chapter of the book, Dershowitz tries to defend the President against any impending charge by arguing Trump cannot be charged with obstruction of justice where he was just basically doing what he has the power to do.[35] The problem with this argument is that it not only disregards the law of obstruction of justice, on which there is extensive caselaw and scholarship,[36] but also that Dershowitz, as a champion of civil liberties, astonishingly argues for a form of executive supremacy that would in fact make a sitting president above the law.[37]

In essence, despite the wealth of authority stating the contrary, Dershowitz asserts that a president can only be impeached for a crime. Yet his textual argument falls flat under its own weight—Dershowitz wants the interpretation of the Constitution’s Impeachment Clause to follow the enumerated wrongs listed in the Clause while also completely ignoring a specifically stated basis for impeachment that has historically and repeatedly been interpreted to be the broadest basis for impeachment. In the end, Dershowitz asserts that it would be dangerous to use a broad reading of “high Crimes and Misdemeanors because doing so could jeopardize our system of government.[38] How it would do so remains unclear, however. And even for somewhat playful arguments’ sake, if Dershowitz is correct in his selective reading of Article II’s Impeachment Clause, as he himself admits, more than one political candidate, including Professor Richard Painter, who is running for the U.S. Senate, has asserted that Trump’s actions amount to Treason.[39] Dershowitz harshly criticizes Painter, saying that he “should read the words of the Constitution, rather than making up crimes for partisan and personal advantage.”[40] Interestingly, Dershowitz defends his own “pure motives” for writing the book by noting how many individuals and even legal scholars have accused him of doing the very same thing: “My motives have also been questioned by some of my academic and political colleagues. Am I being paid? Am I auditioning to be Trump’s lawyer?”[41]

In conclusion, Dershowitz asserts that he merely wants to focus on the importance of following precedent,[42] arguably the most interesting assertion in the book. Yet in his defense of President Trump, Professor Dershowitz fails to examine the legal precedent on the law concerning impeachment. Much like his attacks on those he differs with in this book, Professor Dershowitz is being selectively principled with his arguments and review of the law. Perhaps the following best highlights a flaw in this book: it is evidently shameless for Painter to attack President Trump while Painter is running for office, but it is not shameless for Dershowitz to defend Trump while Dershowitz is selling books? Further, by his own admission, Dershowitz wants all to appreciate the importance of precedence,[43] but he fails or refuses to address legal precedence when dismissing “high Crimes and Misdemeanors” as a basis for impeachment, despite said basis being used against both President Clinton and President Nixon.

 


[*] *.. Professor of Law, Florida International University College of Law.

[†] †.. J.D. Candidate 2020, Florida International University College of Law.

[‡] ‡.. J.D. Candidate 2020, Florida International University College of Law.

[§] §.. J.D. Candidate 2020, Florida International University College of Law.

 [1]. Alan Dershowitz, The Case Against Impeaching Trump (2018).

 [2]. Id. at 1.

 [3]. U.S. Const. art. II, § 4.

 [4]. Dershowitz, supra note 1, at 10.

 [5]. See Dershowitz, supra note 1, at 5.

 [6]. Sandy Fitzgerald, Alan Dershowitz: Constitution Doesn’t Guarantee Right to Abortion, Newsmax (Oct. 27, 2013), https://www.newsmax.com/newsfront/dershowitz-constitution-abortion
/2013/10/27/id/533294.

 [7]. U.S. Const. art. III, § 3.

 [8]. See Dershowitz, supra note 1, at 3.

 [9]. See Dershowitz, supra note 1, at 2–3, 10.

 [10]. Id. at 3–7.

 [11]. Id. at 12.

 [12]. Id. at 7–8.

 [13]. Dershowitz’s attack on the “ejusdem generis” argument is peculiar. He says that that the argument is built on a ‘logical fallacy’ but (1) that’s absolutely untrue because this argument is based on the basics of grammar and (2) he doesn’t back up his point. Further, he goes on to talk about how a crime is needed. But we have that in Trump’s case: obstruction of justice.

 [14]. See Dershowitz, supra note 1, at, 17.

 [15]. Thomas Emerson, Impeachment: The Constitutional Problems, 74 Colum. L. Rev. 131, 131 (1974) (emphasis added).

 [16]. John O. McGinnis, Impeachment: The Structural Understanding, 67 Geo. Wash. L. Rev. 650, 653 (1999).

 [17]. See generally Mark Slusar, Comment, The Confusion Defined: Questions and Problems of Process in The Aftermath of the Clinton Impeachment, 49 Case W. Res. L. Rev. 869 (1999).

 [18]. Id. at 872.

 [19]. See generally, e.g., Lawrence Tribe, Defining “High Crimes And Misdemeanors”: Basic Principles, 67 Geo. Wash. L. Rev. 712 (1999).

 [20]. Id. at 712–15.

 [21]. Stephen B. Presser, Would George Washington Have Wanted Bill Clinton Impeached?, 67 Geo. Wash. L. Rev. 666, 676 (1999).

 [22]. Gary L. McDowell, “High Crimes and Misdemeanors”: Recovering the Intentions of the Founders, 67 Geo. Wash. L. Rev. 626, 649 (1999).

 [23]. Cass R. Sunstein, Impeachment and Stability, 67 Geo Wash. L. Rev. 699, 711 (1999)

 [24]. See Dershowitz supra note 1, at 7–8.

 [25]. See generally Linda Jellum, The Art of Statutory Interpretation: Identifying The Interpretive Theory of the Judges of the United States Court of Appeals for Veterans’ Claims and the United States Court of Appeals for the Federal Circuit, 49 U. Louisville L. Rev. 59 (2010); Elliot M. Davis, The Newer Textualism: Justice Alito’s Statutory Interpretation, 30 Harv. J.L. & Pub. Pol’y 983 (2007).

 [26]. Id. at 23–24.

 [27]. See, e.g., Matthew Bell, Did Trump Commit Treason in Helsinki?, PRI (July 17, 2018), https://www.pri.org/stories/2018-07-17/did-trump-commit-treason-helsinki; Grace Panetta, Former CIA Director John Brennan Said Trump’s Press Conference with Putin Was ‘Treasonous’ — Here’s What Legal Experts Say, Bus. Insider (July 16, 2018), https://www.businessinsider.com/did-trump-committ-treason-russia-summit-2018-7; Ian Schwartz, Ralph Peters: Trump “Committed Treason” if He Got Info from Russians, Attacking Press Like Goebbels, Real Clear Pol. (Aug. 1, 2018), https://www.realclearpolitics.com/video/2018/08/01/ralph_peters_trump_committed_treason_if_he_got_info_from_russians_attacking_press_like_goebbels.html.

 [28]. Though he has repeatedly denied he represents Trump, he at least takes the position of an apologist for Trump.

 [29].  See Dershowitz supra note 1, at 7–8.

 [30]. See The Clinton Impeachments, Justia: US Law, https://law.justia.com/constitution/us/article
-2/55-the-clinton-impeachment.html (last visited Nov. 5, 2018).

 [31]. Approved Articles of Impeachment, Wash. Post, https://www.washingtonpost.com/wp-srv/politics/special/clinton/stories/articles122098.htm (last visited Oct. 23, 2018) (presenting the text of the articles of impeachment against Bill Clinton).

 [32]. Dan Nonicki, In 1974, Goldwater and Rhodes Told Nixon He Was Doomed, AZCentral (Aug. 2, 2014), https://www.azcentral.com/story/azdc/2014/08/03/goldwater-rhodes-nixon-resignation
/13497493.

 [33]. Articles of Impeachment, Watergate.info, http://watergate.info/impeachment/articles-of-impeachment (last visited Oct. 23, 2018) (presenting Article 1 of the Articles of Impeachment against Richard Nixon adopted by the House Judiciary Committee on July 27, 1974, contain an obstruction of justice charge).

 [34]. Charlie Savage, Newly Discovered Clinton-era Memo Says Presidents Can Be Indicted, N.Y. Times (July 22, 2017), https://www.nytimes.com/interactive/2017/07/22/us/document-Savage-NYT-FOIA-Starr-memo-presidential.html (Appendix to the article); see also Jack Maskell, Cong. Res. Serv., Status of a Senator Who Has Been Indicted for or Convicted of a Felony (2015), https://fas.org/sgp/crs/misc/RL34716.pdf; A Sitting President’s Amenability to Indictment and Criminal Prosecution, Dep’t of Justice, https://www.justice.gov/olc/opinion/sitting-president%E2%80%99s-amenability-indictment-and-criminal-prosecution (last visited Oct. 23, 2018).

 [35]. Dershowitz supra note 1, at 24.

 [36]. See Ediberto Roman et al., Collusion, Obstruction of Justice, and Impeachment, 45 Notre Dame J. Legis. (forthcoming 2018).

 [37]. Dershowitz supra note 1, at 24.

 

 [38]. Dershowitz supra note 1, at 5–6.

 [39]. Id.

 [40]. Id.

 [41]. Id. at 54.

 [42]. Id. at 27.

 [43]. Id. at 3.

 

Volume 92, Number 1 (November 2018)

Volume 92, Number 1 (November 2018)