Tag: Healthcare & Life Sciences

Is California Committed?: Why California Should Take Action to Address the Shortcomings of its Assisted Outpatient Commitment Statute – Note by Andrea Reynoso

From Volume 88, Number 4 (May 2015)
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The history of the treatment of mental illness in the United States is anything but simple. While both social and scientific understanding of mental illness have developed tremendously in recent decades, there remain significant barriers to implementing effective treatment and rehabilitation programs for people with mental illness. Inherent in this intersection of law and mental health is the delicate balance between preserving liberty and autonomy interests on the one hand, and providing for individual and societal safety on the other. This balance is not easily achieved and remains the core debate surrounding much of today’s mental health legislation.

 

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Runaway Preemption: The Reckless Doctrine of Pliva and Mutual Pharmaceutical – Note by Michael E. Bowlus

From Volume 88, Number 4 (May 2015)
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In March 2014, Gordon Johnston issued an urgent warning to members of Congress: the Food and Drug Administration was “[d]isregarding decades of regulatory stability” by proposing a new regulation that “raises patient safety concerns and threatens the system that created thousands of affordable options for consumers.” Johnston, himself a former deputy director at the FDA, was joined at a press briefing by economist Alex Brill, who estimated that the proposed regulation, if approved, would raise annual U.S. health care costs by $4 billion. 

Just what, exactly, was the FDA proposing to do? In the Agency’s words, it sought to “clarify procedures” allowing drug manufacturers “to change . . . product labeling to reflect certain types of newly acquired information.” In plain English, the ultimate consequence of the rule would be explicitly to permit generic drug manufacturers to update their labels with new safety warnings on a temporary basis, pending subsequent agency approval. Under current regulations, brand-name drug manufacturers are already able to update their warning labels in a similar fashion. However, the Agency has taken different positions over the years regarding whether generic drug manufacturers may update their labels. The proposed rule, announced in November 2013, would eliminate the ambiguity by establishing parity between both types of drug manufacturers with respect to label updates.

 

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“The Dustbin of Quackery”? Senate Bill 1172 and the Legal Implications of Banning Reparative Therapy for Homosexual Minors – Note by Marlena McMurchie

From Volume 87, Number 6 (September 2014)
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On September 30, 2012, California became the first state in the nation to place restrictions on the practice of attempting to change an individual’s sexual orientation. The passage of this landmark legislation, known as Senate Bill (“SB”) 1172, set off a firestorm of protest, with multiple lawsuits being filed within twenty-four hours of the bill’s passage. Though the issue of SB 1172’s validity has been decided by the Ninth Circuit, which upheld the law in August 2013, other states are considering passage of similar measures, and many issues were debated minimally or not at all in the California cases. Thus, this Note seeks to examine the potential claims that may be brought on behalf of parents and children against these laws and how such challenges may be overcome. As it is thus far the only law of its kind, SB 1172 is treated as a case study and model in many parts of this Note, and some time is spent discussing the law itself in detail. For the purposes of analysis and simplicity, it is assumed that future laws will be substantively similar to SB 1172.

 

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The Defibrillation of NOTA: How Establishing Federal Regulation of Waitlist Eligibility May Save Organ Transplant Patients with Disabilities from Flat-Lining – Note by Danielle Richards

From Volume 87, Number 1 (September 2013)
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Imagine this: thirty-five-year-old identical twin males are admitted into a hospital for congestive heart failure. Neither twin smokes nor drinks. Neither has other underlying medical conditions. There is, however, one distinct difference between them: at birth, twin “A,” Alex, was delivered normally, but twin “B,” Brian, had his umbilical cord wrapped around his neck, causing oxygen deprivation and resulting in moderate mental disability. As adults, Alex is completely independent, but Brian is not, as he lives with his elderly parents. Both twins are stubborn, but a few times, Brian has reacted especially negatively when placed in new and stressful situations.

The twins have the same doctor who determines that both are equally sick, concluding that each will survive only with a heart transplant. Although it seems Alex can comply with postoperative treatment—first, with help from family and later, alone—Brian may not be able to comply by himself. His parents and his sister, however, are willing to provide Brian with the additional support he needs to comply, such as ensuring he takes his medication, follows other medical restrictions, and attends regular follow-up appointments. If Brian can comply with the postoperative treatment with or without help from his family, the doctor predicts Brian’s long-term prospects for life-prolongation will be the same as Alex’s prospects.

After evaluating the twins, the doctor has to decide independently whether to place each on the national heart transplant waitlist. Knowing the above, what should the doctor decide? Should Alex be placed on the heart transplant waitlist? Should Brian? Should the doctor consider Brian’s mental disability when making his decision? Should it matter that Brian’s parents and sisters have agreed to provide him with additional support?

 

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Gerontology and the Law: A Selected Annotated Bibliography: 2009-2011 Update – Bibliography by Judy K. Davis & Karen Skinner

From Volume 86, Number 6 (September 2013)
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This bibliography serves as the 2009–2011 update to Gerontology and the Law: A Selected Annotated Bibliography. First published in 1980 by Law Library Journal the bibliography has since been updated nine times between 1982 and 2010 in the Southern California Law Review. The original bibliography and the first five updates provided citations to a variety of books, articles, and other law related materials on various aspects of the law and gerontology. Starting with the sixth update, the style and content of the bibliography was changed in two ways: first, the bibliographers took a more selective approach in choosing resources to include and second, the bibliographers added annotations briefly describing the source after each citation.

For this update, the bibliographers chose a selection of scholarly books and articles discussing legal issues related to gerontology, aging, and the elderly in the United States published between the years 2009–2011. This bibliography does not include sources that are directed toward the general public, such as popular literature and self-help guides, and sources that do not deal with both law and gerontology. Other sources not included, some of which have been included in prior updates, are book reviews, newspaper articles, government documents, Congressional documents, conference proceedings, dissertations, and sources written in a language other than English. Although the focus of this 2009–2011 update is on the United States, a limited number of sources with an international or foreign perspective are included if deemed useful to researchers in the United States. Newer editions of older works are included if they were published between 2009–2011; however, if more than one edition was published between these dates, only the latest edition is included.

To locate sources to include in this bibliography, the bibliographers searched the following databases periodically from February 2013 to April 2013:

Ageline (produced by the American Association of Retired Person; searched via OvidSP or EBSCO) Journals and Law Reviews (Westlaw Classic database) Legal Resource Index (produced by the Information Access Company; searched via Westlaw Classic) Medline (produced by the National Library of Medicine; searched via OvidSP) Social Sciences Citation Index (produced by Thomson Reuters; searched via ISI Web of Knowledge) WorldCat (produced by OCLC Online Computer Library Center, Inc.; searched via OCLC FirstSearch) As with prior updates, the citations in the bibliography do not conform to The Bluebook: A Uniform System of Citation or to The Chicago Manual of Style. Instead, the citation format is a combination of the two styles and is consistent with previous updates of the bibliography.

 

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A Matter of Life, Death, and Children: The Patient Protection And Affordable Care Act Section 2302 and a Shifting Legal Paradigm – Note by Ryan A. Walsh

From Volume 86, Number 5 (July 2013)
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Nick Snow was diagnosed with neuroblastoma, a rare and deadly form of cancer, at the age of six. After undergoing “chemotherapies, surgeries, four types of radiation, a bone marrow transplant and many experimental therapies,” Nick saw his cancer finally go into remission six years after diagnosis. Twice during this grueling ordeal, doctors told Nick that he would soon die and enrolled him in a hospice program. Unexpectedly, Nick’s general health improved during hospice treatment, enabling him to resume the fight against his cancer. Under then-existing federal laws, Nick’s improved health and decision to seek a long-term cure simultaneously rendered him ineligible for hospice services. As this Note discusses and as Nick Snow explained in his own words, this legally mandated result is unsatisfactory.

 

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The Rise of U.S. Food Sustainability Litigation – Article by Stephanie Tai

From Volume 85, Number 4 (May 2012)
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This Article provides one of the first critical looks at the interface between the values of the sustainable food movement and its rising use of litigation. In particular, it focuses on two growing areas of food sustainability litigation–challenges to Concentrated Animal Feeding Operations (“CAFOs”) and challenges to the use of genetically modified organisms (“GMOs”) in the food system–chosen because they involve growing sectors of U.S. agriculture over which members of the sustainable food movement have raised significant concerns.

 

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Taxing Youth: Health Care Reform Writes a Costly Prescription that Leaves the Young and Healthy Paying the Bill – Note by Charles P. Litchfield

From Volume 85, Number 2 (January 2012)
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With the American health care system facing a looming crisis due to unsustainable rates of medical cost inflation, the government has reacted by passing the Patient Protection and Affordable Care Act. While the present ubiquity of third-party payers in the form of health insurance or government programs spawns inefficiencies and perverse incentives that drive market forces to work against, rather than toward, maximum social welfare, the reform bill threatens to exacerbate the very inefficiencies it seeks to avoid. Rather than focusing on controlling medical cost inflation, the bill seeks to include high-risk groups that are normally priced out of the insurance market, thus placing more stress on the payment model. The individual mandate—making health insurance mandatory—ensures that the low-risk young and healthy demographic will bear the cost of this increased burden on the insurance system. This Note examines how the recent health reform bill proposes to restructure the insurance market itself and analyzes the inadequacies of the individual mandate. Further, it briefly explores the constitutional challenges to the mandate and discusses whether the health reform bill is salvageable in light of its deficiencies.

 

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