Law Commons^™

On The Defensive: Analyzing Insurers' Duty To Defend Pharmaceutical Companies For Contributing To The Opioid Epidemic, Madison Perry

Vanderbilt Law Review

Opioids have had a devastating impact on the United States. They have drained governmental agencies’ resources, decreased property values, and destroyed families and entire communities. A growing number of individuals, local governments, and states have filed lawsuits, aiming to hold pharmaceutical companies accountable for their negligent contributions to the epidemic. Such manufacturers, distributors, and retailers have called upon their insurers, asserting that their commercial general liability policies demand an insurer- backed and bankrolled defense. Courts are divided in their interpretation of the language contained within the at-issue policies. Some consider the claims made by certain states and local governments to …

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

Too Stubborn To Care For: The Impacts Of Discrimination On Patient Noncompliance, Alice Abrokwa

Vanderbilt Law Review

The role of implicit racial biases in police interactions with people of color has garnered increased public attention and scholarly examination over time, but implicit racial bias in the healthcare context can be as deadly, particularly when it intersects with ableism and sexism. Researchers have found that medical providers are more likely to consider Black patients “noncompliant,” meaning the patient has not adhered to recommended treatment, even without evidence Black patients are less compliant than other patients. Being labeled noncompliant can have grave health consequences; providers are less likely to treat pain aggressively when they consider a patient noncompliant and, …

Mixed-Up Origins: The Case For A Gestational Presumption In Embryo Mix-Ups, Betsy A. Sugar (J.D. Candidate)

Vanderbilt Law Review

Embryo mix-ups-instances in which fertility clinics mistakenly implant one couple with another couple's embryo confound courts' determinations of who, between the two couples, are the legal parents. Lax regulation of the fertility industry permitted this relatively new injury to develop, and it has led to morally and legally fraught questions of parenthood and personal autonomy. This Note reviews parentage doctrines, beginning with a discussion of the martial presumption; it also tracks how courts have traditionally responded to parentage questions that fertility medicine has generated, including embryo division in divorce and parentage in surrogacy contracts. It then analyzes potential approaches to …

How Are You Holding Up? The State Of Judges' Well-Being: A Report On The 2019 National Judicial, Terry Maroney, David X. Swenson, Joan Bibelhausen, David Marc

Vanderbilt Law School Faculty Publications

Judges have always faced significant stressors, including the burden of consequential decision-making, exposure to disturbing evidence, and isolation. While every judicial assignment has its own mix of concerns, challenge is a constant. Recurrent experiences of serious stressors place judges at risk of burn-out, secondary trauma, poor mental and physical health, and substance use disorders.

Historically, such issues have been addressed primarily in the context of judicial fitness - that is, only when individual judges were suffering to the degree that they could no longer competently perform their duties would the system respond, and then usually for the purpose of discipline …

Is A Child's Life Twice As Valuable As An Adult's?, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

The rise of interest in evidence-based policymaking has created incentives for regulatory agencies to demonstrate the overall benefit-cost merits of their policies. An agency can use evidence to choose more cost-beneficial policies, or it can create the appearance of desirable policies by changing the ground rules by which it assesses a policy's merits.

The Consumer Product Safety Commission (CPSC) recently chose the latter course when monetizing the benefit of mortality risk reductions for children from a proposed safety standard for operating cords on custom window coverings. The cords are currently estimated to be responsible for nine fatal injuries annually. Each …

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

A Game Theoretic Approach To Balance Privacy Risks And Familial Benefits, Ellen W. Clayton, Jia Guo, Murat Kantarcioglu, Et Al.

Vanderbilt Law School Faculty Publications

As recreational genomics continues to grow in its popularity, many people are afforded the opportunity to share their genomes in exchange for various services, including third-party interpretation (TPI) tools, to understand their predisposition to health problems and, based on genome similarity, to find extended family members. At the same time, these services have increasingly been reused by law enforcement to track down potential criminals through family members who disclose their genomic information. While it has been observed that many potential users shy away from such data sharing when they learn that their privacy cannot be assured, it remains unclear how …

Human-Centered Design To Address Biases In Artificial Intelligence, Ellen W. Clayton, You Chen, Laurie L. Novak, Shilo Anders, Bradley Malin

Vanderbilt Law School Faculty Publications

The potential of artificial intelligence (AI) to reduce health care disparities and inequities is recognized, but it can also exacerbate these issues if not implemented in an equitable manner. This perspective identifies potential biases in each stage of the AI life cycle, including data collection, annotation, machine learning model development, evaluation, deployment, operationalization, monitoring, and feedback integration. To mitigate these biases, we suggest involving a diverse group of stakeholders, using human-centered AI principles. Human-centered AI can help ensure that AI systems are designed and used in a way that benefits patients and society, which can reduce health disparities and inequities. …

Returning Integrated Genomic Risk And Clinical Recommendations: The Emerge Study, Ellen W. Clayton, Jodell E. Linder, Aimee Allworth, Sara T. Bland, 100 Others...

Vanderbilt Law School Faculty Publications

The potential of artificial intelligence (AI) to reduce health care disparities and inequities is recognized, but it can also exacerbate these issues if not implemented in an equitable manner. This perspective identifies potential biases in each stage of the AI life cycle, including data collection, annotation, machine learning model development, evaluation, deployment, operationalization, monitoring, and feedback integration. To mitigate these biases, we suggest involving a diverse group of stakeholders, using human-centered AI principles. Human-centered AI can help ensure that AI systems are designed and used in a way that benefits patients and society, which can reduce health disparities and inequities. …

Call Me, Beep Me, If You Want To Reach Me: Utilizing Telemedicine To Expand Abortion Access, Samantha A. Hunt

Vanderbilt Law Review

In June 2022, the Supreme Court handed down its decision in Dobbs v. Jackson Women’s Health Organization. The decision confirmed what the public already knew. An anonymously leaked draft version of what ultimately became Justice Samuel Alito’s majority opinion had braced the country for Dobbs’s keyholding. Overturning decades of precedent, the Court found that there is no right to abortion in the United States Constitution. Shortly thereafter, states began implementing restrictions and near-total bans on abortion. These laws had an immediate effect on the safety of pregnant people. In Tennessee, a state where abortion is now outlawed, one woman had …

An Epidemic In Enforceability: A Growing Need For Individual Autonomy In Health Care Data-Privacy Protection In An Era Of Digital Tracking, Madeline Knight

Vanderbilt Journal of Entertainment & Technology Law

The health care system in the United States is under conflicting pressures. From one angle, there is a demand for the highest standard of care, which includes efficient, confidential communications between doctors and patients. From another, however, the technology that has facilitated such efficiency has outpaced the security mechanisms currently in place to protect a long-recognized right to privacy. In an era of data tracking, the important privacy interest that Congress has recognized since 1996 confronts a growing threat of data commodification. Despite significant potential consequences, however, there is neither guaranteed statutory recovery nor cohesion among states for the process …

Abortion, Pregnancy Loss, & Subjective Fetal Personhood, Greer Donley, Jill Wieber Lens

Vanderbilt Law Review

Long-standing dogma dictates that recognizing pregnancy loss threatens abortion rights-—acknowledging that miscarriage and stillbirthinvolve the loss of something valuable, the theory goes, creates a slippery slope to fetal personhood. For decades, antiabortion advocates have capitalized on this tension and weaponized the grief that can accompany pregnancy loss in their efforts to legislate fetal personhood and end abortion rights. In response, abortion rights advocates have at times fought legislative efforts to support those experiencing pregnancy loss and, more recently, remained silent, alienating those who suffer a miscarriage or stillbirth.

This Article argues that this perceived tension can be reconciled through the …

Innovation Policy And Chronic Emergencies, Robert Burrell, Catherine Kelly

Vanderbilt Journal of Entertainment & Technology Law

The COVID-19 pandemic has thrust the potential role of the state as a driver of scientific innovation onto center stage. Vaccines have been developed and brought to market in a timescale that seemed almost impossible when the crisis first struck. The pivotal nature of government intervention in this crisis has added to calls from academics and policy makers to adopt a more proactive, mission-oriented approach to innovation policy to tackle other key global challenges.

This Article considers the merits of these calls and argues that an important distinction must be drawn between what this Article terms acute and chronic emergencies. …

Sociotechnical Safeguards For Genomic Data Privacy, Ellen W. Clayton, Zhiyu Wan, Et Al.

Vanderbilt Law School Faculty Publications

Recent developments in a variety of sectors, including health care, research and the direct-to-consumer industry, have led to a dramatic increase in the amount of genomic data that are collected, used and shared. This state of affairs raises new and challenging concerns for personal privacy, both legally and technically. This Review appraises existing and emerging threats to genomic data privacy and discusses how well current legal frameworks and technical safeguards mitigate these concerns. It concludes with a discussion of remaining and emerging challenges and illustrates possible solutions that can balance protecting privacy and realizing the benefits that result from the …

Your Body, Your Cells? Direct-To-Consumer Marketing Of Autologous Stem Cell Therapies In The United States, Japan, And Australia, Kathleen C. Laird

Vanderbilt Journal of Transnational Law

Stem cell tourism has relocated; patients in search of stem cell therapies to treat nearly any disease can find clinics selling miracle cures without traveling beyond their national borders. Businesses marketing unproven autologous stem cell therapies are now plentiful in highly regulated, wealthy countries, including the United States, Japan, and Australia. Despite regulatory oversight of stem cell therapies and strong support for scientific innovation in these countries, the internet and social media have facilitated the rapid growth and success of a new industry selling unproven treatments directly to consumers. Clinics selling unproven autologous stem cell therapies have succeeded by developing …

The Duties Of Occupying Powers In Relation To The Prevention And Control Of Contagious Diseases Through The Interplay Between International Humanitarian Law And The Right To Health, Dr. Marco Longobardo

Vanderbilt Journal of Transnational Law

This Article explores the rules governing the prevention and control of contagious diseases in occupied territory under international law. Although the Article refers to the ongoing COVID-19 pandemic, its scope is broader and encompasses instances of state practice that have occurred over the last two centuries. After a careful analysis of the relevant treaties and episodes of state practice, the Article concludes that occupying powers have duties under international humanitarian law and international human rights law to prevent and control contagious diseases, through cooperating with the local authorities and bringing the necessary medical supplies in the occupied territory. The Article …

A Zebra's Trust: How Rare Disease Communities' Participation In Data Trusts' Governance Builds Trust And Drives Research, Samantha C. Smith

Vanderbilt Journal of Transnational Law

Data sharing plays an increasingly prominent role in society, but it remains a necessary component of rare disease research. Because rare diseases are--as the name indicates-- rare, researchers have only a small number of patients from whom to collect data, and the expense of cross-border data sharing to increase research data is significant. Nevertheless, the rise of artificial intelligence and precision medicine increases the need for usable rare disease data. Current legislation and regulations aimed at addressing rare diseases fall short in addressing these data sharing needs for rare disease research. While the European Union (EU) has invested in rare …

The Reckoning: The Return Of Genomic Results To 1444 Participants Across The Emerge3 Network, Ellen W. Clayton, Kathleen A. Leppig, Et Al.

Vanderbilt Law School Faculty Publications

The goal of Electronic Medical Records and Genomics (eMERGE) Phase III Network was to return actionable sequence variants to 25,084 consenting participants from 10 different health care institutions across the United States. The purpose of this study was to evaluate system-based issues relating to the return of results (RoR) disclosure process for clinical grade research genomic tests to eMERGE3 participants.

Honoring The Public Trust: Curbing The Bane Of Physician Sexual Misconduct, Rebecca H. Allensworth, K. S. Sindhu, Et Al.

Vanderbilt Law School Faculty Publications

The Federation of State Medical Boards defines physician sexual misconduct as any "behavior that exploits the physician-patient relationship in a sexual way." Although several attempts have been made in recent years to clarify its incidence in the United States, physician sexual misconduct is almost certainly underreported. Physician sexual misconduct represents a severe and irreversible violation of the compact underlying the patient–physician relationship and can have far-reaching consequences on the lives of patients and their families. In addition, the credibility of and trust in physicians, both essential to the provision of medical care, could well erode in the eyes of the …

Direct-To-Consumer Genetic Testing, Ellen W. Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals’ responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such …

The Perceived Risks Of E-Cigarettes To Others And During Pregnancy, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Background

Public Health England has concluded that e-cigarettes are much safer than cigarettes for the user and for secondhand exposures, but it has not reached a definitive conclusion regarding pregnancy risks. How people perceive the risks to others is less well understood.

Methods

This study uses an online UK sample of 1041 adults to examine perceived e-cigarette risks to others and during pregnancy. The survey examines relative risk beliefs of e-cigarettes compared to cigarettes and the percentage reduction in harm provided by e-cigarettes.

Results

A majority of the sample believes that secondhand exposure to e-cigarette vapors poses less risk than …

Make Hay While The Sun Shines: Private Equity And The False Claims Act, Gregory F. Maczko

Vanderbilt Law Review

For years, the federal government has used the False Claims Act to police fraud in the healthcare industry. Every year, the Department of Justice recovers billions of dollars from healthcare companies for their False Claims Act violations, both penalizing wrongdoers and providing incentives for whistleblowers to come forward. Over the past decade, however, private equity activity within the healthcare industry has increased significantly, presenting questions as to how the False Claims Act applies when a private equity firm’s portfolio company is accused of wrongdoing. This Note analyzes the ambiguity in how different courts have previously applied the False Claims Act …

Intellectual Property As A Determinant Of Health, Ana S. Rutschman

Vanderbilt Journal of Transnational Law

Public health literature has long recognized the existence of determinants of health, a set of socioeconomic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Re-Emphasizing African Bioethics In Light Of Potential Crispr-Based Treatment For Hiv And Sickle Cell Disease, Taylor Daniel

Vanderbilt Journal of Transnational Law

Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African …

A World Of Their Own: Illiberal Religious Communities Struggle To Comply With Covid-19 Public Health Regulations, Shai Stern

Vanderbilt Journal of Transnational Law

The COVID-19 pandemic did not eliminate existing social tensions; rather, it at times intensified them. Thus, it is unsurprising that. the tension between the liberal state and illiberal religious communities likewise intensified, as those communities were late to comply with COVID-19 public health regulations issued by state authorities. This Article suggests that alongside the behavioral and psychological explanations for individual non-compliance, illiberal religious communities' late response to the COVID-19 threats stems out of these communities' unique characteristics and deeply held norms. It provides five explanations supporting this argument and argues that all result from the interventionist liberal-centric policies embraced by …

A Regulatory Policy Strategy For Protecting Immigrant Workers, W. Kip Viscusi, N. Marquiss

Vanderbilt Law School Faculty Publications

Immigration has become a focal point of many political campaigns, most notably that of President Trump in 2016 and again in 2020. Populist rhetoric also decries immigrant workers for taking Americans' jobs and depressing wages for U.S.-born workers. Yet immigrants serve a constructive role by working in some of the most dangerous occupations in the country. It is well-known that immigrant workers, particularly those from Mexico with limited English language skills, face a higher workplace fatality rate than native workers. Efforts to reverse this trend have long been the focus of the Occupational Safety and Health Administration (OSHA), which undertook …

Equal Protection And Ectogenesis, Brit J. Benjamin

Vanderbilt Journal of Entertainment & Technology Law

Ectogenesis is the gestation of a fetus in an artificial womb. This suite of technologies, now in use to preserve the lives of premature infants, is on the cusp of being a viable method of reproduction from conception to term. This Article argues that an equal protection challenge to a ban on utilizing ectogenetic technologies should be analyzed under intermediate or strict scrutiny. Should the US Supreme Court apply the rational basis or rational basis “with bite” standard of review to such a challenge, the petitioner should prevail.

The nature of ectogenesis is a technological alternative for a sex-specific organ. …

Identifying Meaningful Dietary Intake And Physical Activity Questions For Individual And Population Health, Jennifer Bennett Shinall, David G. Schlundt, Et Al.

Vanderbilt Law School Faculty Publications

We aimed to identify valid screening questions for adults regarding physical activity and dietary behaviours that (a) were correlated with BMI, (b) were deemed by patients and providers to be relevant to clinical care, and (c) have utility for longitudinal understanding of health behaviours in populations. The goal was to identify screening questions that could be implemented at annual health care visits. First, we identified dietary behaviour questions and solicited patient input. Next, we tested both physical activity and dietary behaviour questions in a large sample to test their potential utility. Finally, we used cognitive interviews with patients and physicians …

We Need A Cole Memorandum For Magic Mushrooms, Robert Mikos

Vanderbilt Law School Faculty Publications

In fall 2020, as the nation elected Joe Biden to be our Forty-Sixth President, Oregon voters also passed a noteworthy new drug law reform. Known as Measure 109, Oregon’s path-breaking law legalizes the use of psilocybin, a hallucinogenic substance found in magic mushrooms. Measure 109 is designed to unlock the therapeutic potential of psilocybin, which advocates tout as an effective and safe treatment for depression and other psychological conditions.

Given the burgeoning interest in psychedelics, many people are excited to see how Oregon’s psilocybin experiment pans out. But at this point, it remains unclear whether the experiment will even get …