Category Archive: Notes

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

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 right-to-try 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-to-try movement by (1) revising their existing expanded access policies and (2) improving clinical trial access.

From Presentation to Presence: Immersive Virtual Environments and Unfair Prejudice in the Courtroom – Note by Khirin Bunker

In the courtroom environment, oral presentations are becoming increasingly supplemented and replaced by advancing digital technologies that provide legal practitioners with effective demonstrative capabilities. 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. 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”), 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, 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. The issue in the case was whether a patient’s death was the result of the design of a cholesterol-removing stent or a surgeon’s error in implanting it upside down.

Justice or Just Us?: SFFA v. Harvard and Asian Americans in Affirmative Action – Note by Cynthia Chiu

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. The complaint filed by Students for Fair Admissions (“SFFA”) 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. 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 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.

What’s in a Claim? Challenging Criminal Prosecutions Under the FTAIA’s Domestic Effects Exception – Note by Jay Kemper Simmons

Americans recently awoke to a startling revelation: “Our country is getting ripped off.” Indeed, the purportedly deleterious effects of international trade on the United States domestic economy have claimed top billing in President Donald Trump’s nascent “America First” agenda. As the White House publicly excoriates international free trade for the first time in recent memory, global trade deals and domestic tariffs are cast in stark relief. China and Mexico, along these lines, are cast as chief culprits in a system of international exchange allegedly designed to subjugate American workers to nefarious foreign interests. Overall, recent politics underscore the practical importance of, and interdependence between, competition and cooperation in international economic regulation.

In the arena of hard-nosed international competition, it’s all fun and games––until somebody starts a trade war. But beyond the scope of trade deals and tariffs, sovereign states’ domestic antitrust laws are also critical regulatory levers. Americans at the Antitrust Division of the Department of Justice and the Federal Trade Commission have the power to influence incentives in markets across the globe. For example, although domestic by nature, U.S. antitrust laws do not exclusively apply to conduct in domestic markets—the Sherman Act may extend far beyond American shores to activities conceived and executed abroad.

Quid Pro No: When Rolexes, Ferraris, and Ball Gowns Are Not Political Currency – Note by Daniel Brovman

In its recent decision in McDonnell v. United States, a case concerning corruption charges against the former Governor of Virginia, Robert McDonnell, the Supreme Court faced a seemingly simple question of statutory interpretation: what constituted an “official act” for the purposes of the bribery statute, 18 U.S.C. § 201(a)(3). In reality, not only did it answer a question far more complicated, but also, it provided far more than a simple answer.

In its attempt to reinforce democracy, the Court failed. Instead, it validated a pernicious definition of access, in which paid-for access, pay-to-play schemes, and bribery are the norm. Specifically, in claiming that this maligned form of access was necessary for a functioning democracy, the Court endorsed political norms that are, in fact, corrosive to society: stratified access to politicians and by association, democratic institutions. The Court ignored the reality of pervasive and systemic inequality—ranging from political, economic, social, and racial—in contemporary American society and the effect that inequality has on access. However, the Court did not arrive there alone—the many amici filing on behalf of the petitioner blinded it—at least partially—to the aforementioned realities and public opinion.

Friendly Skies or Turbulent Skies: An Evaluation of the U.S. Airline Industry and Antitrust Concerns – Note by Kevin Kinder

Recent antitrust decisions and policy initiatives by both the Department of Justice (“DOJ”) and Department of Transportation (“DOT”) have shaped the current U.S. airline landscape. The consolidation trend is not unique to the U.S. domestic air transportation market. The emergence of three global airline alliances—together accounting for around 80% of air traffic across the transatlantic, transpacific, and Europe–Asia markets—has transformed the international air transportation market as well. This Note evaluates the results of the DOJ’s antitrust approach to U.S. airline mergers and reconciles these results with the DOT’s “public interest” emphasis in determining airline applications for antitrust immunity (“ATI”). Given the current domestic market, it is likely that the remaining legacy carriers will leverage their respective global alliances and seek ATI with foreign airlines for continued network growth.

Part I of this Note tracks the tumultuous history of the U.S. airline industry from deregulation to its current health. Part II presents the legal framework, including U.S. antitrust laws, that govern domestic airline mergers and international ATI. Part III proposes practical solutions for the DOT to improve the ATI regulatory process and incubate open market competition, thereby better serving passengers and airlines by edging closer to deregulation.

An Impossible Standard: The California Parole Board Process for Inmates with Cognitive Impairments – Note by Amber Heron

How can one be expected to demonstrate something they are incapable of, and what if that something meant the difference between freedom and remaining in prison? Thousands of inmates in California face this issue, and many are kept incarcerated for life without any recognition of their cognitive capabilities.

Take Maria’s story, for example; she is a client I became familiar with as a student working in the University of Southern California Gould School of Law’s (“USC”) Post-Conviction Justice Project (“PCJP”). Maria had extensive cognitive impairments that went undiscovered while incarcerated in a California prison for nearly three decades. Because of this, Maria was denied parole an astounding six times with the parole board citing lack of “insight” each time. Maria’s continued denials persisted despite state-issued psychological evaluations concluding that her intellectual functioning was minimal.

Unfortunately, Maria’s predicament is not uncommon. There are several similarly situated inmates who are unable to effectively advocate for themselves due to their cognitive impairments, yet they are not provided with necessary accommodations. As a result, individuals are denied parole even though they do not pose a current danger to society. This culminates in the gravest deprivation of liberty without due process—denial of their freedom.

Whose Bathroom Is It, Anyway?: The Legal Status of Transgender Bathroom Access Under Federal Employment Law – Note by Allison Bader

In many ways, Michael C. Hughes is an average American family man. He is a middle-aged father of four from Rochester, Minnesota. He has been married to his wife for twelve years. He has a broad, muscular frame and is partial to cowboy hats and wide belt buckles. But Hughes is unlike the average American family man in one fundamental way: he was born biologically female. Hughes is one of the more than 1.4 million transgender adults in the United States, a small but increasingly visible group of people who are currently facing a unique legal battle to use restrooms and single-sex facilities that align with their gender identity.

Hughes garnered publicity with a viral photo taken in a public restroom, in protest of “bathroom bills”—laws that require Hughes to use women’s restrooms and facilities, despite his gender identity. “Bathroom bill” is the common name for legislation that prohibits individuals from using bathrooms (or other private, single-sex facilities like locker rooms) that do not match their biological sex or sex markers on their identification documents, depending on the bill. Posing in front of the bathroom mirror in a women’s restroom, as female patrons look on questioningly, Hughes “presents” as a male—making him appear out of place in the restroom that nonetheless matches his biological sex. Hughes’ photo and its accompanying hashtag, “#WeJustNeedtoPee,” went viral in 2016, reflecting Americans’ rapt attention on transgender issues.

“Moore” Than Just a Number: Why IQ Cutoffs Are an Unconstitutional Measure for Determining Intellectual Disability – Note by Courtney Johnson

Bobby James Moore was twenty years old when he “fatally shot a store clerk” while robbing a grocery store in April 1980. On paper, this is a tragic felony murder, but behind the scenes lies a different story. Bobby was not a typical twenty-year-old; he did not understand “the days of the week, the months of the year, [or] the seasons.” Bobby could barely tell time, and he could not understand standard measurements or that subtraction is the opposite of addition. Bobby suffered an “abuse-filled childhood.” Bobby dropped out of high school due to “his limited ability to read and write,” and he lived on the streets after being kicked out of his home for being “stupid.” Bobby is intellectually disabled, and despite the evidence put forth demonstrating his disability, he was sentenced to death pursuant to a set of factors used by a Texas court; these factors are largely based on stereotypes and caricatures from literature. As the United States Supreme Court decided in 2017, this was a gross violation of the Eighth Amendment’s protection against cruel and unusual punishment to rely on “wholly nonclinical” factors rather than the “medical community’s diagnostic framework.”

Eyewitness Identifications: Recommendations to the Third Circuit – Note by Brady Witbeck

Just before two o’clock in the afternoon on October 22, 1991, two high school students, Chedell Williams and Zahra Howard, ascended the steps of the Fern Rock train station in North Philadelphia, planning to take a train back to their homes. Seemingly out of nowhere, two men appeared, blocked the girls’ way up to the station, and demanded Chedell’s earrings. Terrified, the girls bolted in opposite directions. The two men followed Chedell. They soon caught her and tore out her earrings. Then “[o]ne of the men grabbed her, held a silver handgun to her neck, and shot her.” The perpetrators fled. Chedell was pronounced dead within the hour.

Police soon focused their investigation on James Dennis, who lived relatively close to the train station in the Abbotsford Homes projects. Detectives would later explain that they heard rumors that Dennis was involved in the shooting, though they were at that time “unable to identify the source of the rumors.” The detectives obtained preliminary descriptions of the perpetrators from three eyewitnesses. These initial descriptions did not align well with Dennis’s actual appearance. Nonetheless, a few eyewitnesses identified Dennis during subsequent photo lineups, live lineups, and the trial. In presenting the government’s case, the prosecution relied heavily on these eyewitness identifications. Dennis was found guilty of “first-degree murder, robbery, carrying a firearm without a license, criminal conspiracy, and possession of an instrument of a crime.” He was sentenced to death.