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 …

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 …

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. …

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 …

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 …

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. …

Redefining Lgbtq And Abortion Rights In Latin America: A Transnational Toolkit, Alyssa Julian

Vanderbilt Journal of Transnational Law

Throughout Latin America, the Lesbian, Gay, Bisexual, Trans, and Queer (LGBTQ) and abortion rights movements have progressed at divergent strengths and speeds, with significant variation among countries. The region is home to some of the most restrictive and discriminatory laws when it comes to these contentious issues. This Note explores some of the reasons behind the variation in LGBTQ and abortion rights throughout the region.

This Note traces the economic and political history of Latin America to illustrate the climate in which these social movements are operating. Further, this Note offers a brief snapshot of recent global developments in LGBTQ …

Evaluating A Concussion Clause: Why The Nfl's Assumption Of Risk Defense Fares No Better As Time Goes On, Ramsey W. Fisher

Vanderbilt Journal of Entertainment & Technology Law

This Article explores the future of National Football League (NFL) concussion litigation. Currently, hundreds of retired NFL players who previously brought negligence claims against the NFL are seeking compensation under a settlement agreement reached in 2012. With many retired players exempting themselves from the 2012 agreement and current players learning more about the long-term risks of football, the potential for future negligence lawsuits against the NFL is still ripe. In any such suit, a key issue will be the NFLs'assumption of risk defense. The allure of the defense is intuitive-when one chooses to play professional football for a living, he …

Neuronal Testimonial: Brain-Computer Interfaces And The Law, Jessica L. Haushalter

Vanderbilt Law Review

Scientific researchers have developed a method of using brainscanning technology to determine if patients in a coma-like condition, known as a "vegetative state," are conscious despite their inability to communicate verbally or via motor actions. While in a brain scanner, patients "answer" yes-or-no questions by envisioning specific scenarios that activate different parts of the brain. A researcher interprets a brain scan image as a yes-or-no response based on which areas of the brain demonstrated activation. Exciting as this technology may be, there are difficulties in terms of the ability to use it within the legal system. This Note considers those …

Ebola Does Not Fall From The Sky: Structural Violence & International Responsibility, Matiangai Sirleaf

Vanderbilt Journal of Transnational Law

This Article challenges the conventional understanding that international crises are limited to instances of direct physical violence. Instead, it argues that the disproportionate distribution of infectious diseases like Ebola is a form of structural violence that warrants international intervention. In the field of global public health, structural violence is a concept used to describe health inequities and to draw attention to the differential risks for infection in the Global South, and among those already infected, for adverse consequences including death, injury, and illness. This Article clarifies how the concept of structural violence can be operationalized in law. It illustrates the …

Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik

Vanderbilt Journal of Entertainment & Technology Law

How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …

Fashioning Worker Protections To Combat The Thin Ideal's Cost On Fashion Models And Public Health, Erin E. Meyers

Vanderbilt Journal of Entertainment & Technology Law

Studies linking thin-obsessed media consumption to poor health outcomes for women have permeated the medical literature for years. The pressures female fashion models face to sacrifice their health for their jobs are perhaps even more disturbing. These harrowing issues are symptoms of the "thin ideal," the social norm glorifying a female body type so thin it is unattainable for most women. Despite the clear harm imposed by the thin ideal, the United States has done little to combat its effect on the working conditions of fashion models and on public health more generally. This Note suggests that the US fashion …

When Trade Secrecy Goes Too Far: Public Health And Safety Should Trump Corporate Profits, Julie E. Zink

Vanderbilt Journal of Entertainment & Technology Law

This Article addresses the historical and ongoing use of trade secrets to withhold critical information from the public. Through its text and footnotes, the Article discusses the positives and negatives of trade secret protection; addresses historical and current examples of trade secret abuse; analyzes the inadequate solutions that have been tried and proposed; and, ultimately, recommends changing trade secret law by incorporating the precautionary principle into the definition of a trade secret to ensure that protection will no longer be available for information that endangers public health.

This Article is both timely and necessary, as the public is continually bombarded …

Cedaw And Treaty Compliance: Promoting Access To Modern Contraception, Katherine Sochacki

Vanderbilt Journal of Transnational Law

Modern contraception is widely recognized as a crucial component of family planning services and is recognized as a reproductive right under international human rights law. However, unmet need for contraception remains high, as many women in the developing world lack access to family planning services. This Note examines the role of the Committee on the Elimination of All Forms of Discrimination Against Women (CEDAW) and its powers as a treaty monitoring body in increasing access to modern contraception. Drawing on empirical research, the example of CEDAW's influence on abortion rights, and the domestic politics theory of treaty compliance, this Note …

Restore, Revert, Repeat: Examining The Decompensation Cycle And The Due Process Limitations On The Treatment Of Incompetent Defendants, Margaret W. Smith

Vanderbilt Law Review

Though correctional facilities are one of the largest providers of mental health care in the country, the treatment provided often fails to address the needs of many mentally ill inmates. Indeed, after receiving treatment at a state mental health facility, many pretrial detainees who have been recently restored to competency revert to an incompetent state-or decompensate-upon their return to jail, at which point they must return to the state treatment facility to be restored to competency once again. This Note is the first to explore this "decompensation cycle," highlighting the significance of the problem and demonstrating how mental health treatment …

Reading Remedially: What Does "King V. Burwell" Teach Us About Modern Statutory Interpretation, And Can It Help Solve The Problems Of Cercla § 113(H)?, Benjamin Raker

Vanderbilt Law Review

In the latter half of the twentieth century, Congress drafted a law to solve a problem. As decades passed, that problem became increasingly complex. In the new millennium, Congress became increasingly polarized, and increasingly unproductive. In the face of that inaction, the executive branch decided to rely on a provision of that earlier law to address a modern facet of that earlier problem. Or litigants decided to ask a court to rely on a provision of that earlier law to address a modern facet of that earlier problem. The Congress that drafted the law might not have understood this modern …

No Vip Treatment: Acos Should Not Get Waiver Protection From The Prohibition On Beneficiary Inducement, Soraya Ghebleh

Vanderbilt Law Review

Virgil is known for saying "the greatest wealth is health."' Based on the astronomical amount spent on healthcare, the United States has taken his idea literally-spending more "wealth" will lead to greater "health." In 2006, the United States spent over seven thousand dollars per person annually on healthcare. While that number may not seem very high to spend on an individual level, the total amounted to approximately 2.1 trillion dollars in 2006. In 2014, that number hit three trillion, or seventeen percent of the country's Gross Domestic Product ("GDP"). One justification for spending nearly one-fifth of the United States GDP …

Genome Editing And The Jurisprudence Of Scientific Empiricism, Paul Enriquez

Vanderbilt Journal of Entertainment & Technology Law

Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable.

This Article …

Following Footsteps: How Federal District Court Jurisprudence Protects Health Data In The Workplace, J. T. Parisi

Vanderbilt Journal of Entertainment & Technology Law

With the growing popularity of fitness tracking technology, employers have started to provide their employees with fitness tracking devices in order to obtain a subsidy on employer group health plans. Access to this data creates an opportunity to abuse the data by using it when making employment decisions. This Note analyzes how the current legal framework does not adequately protect the data and employees. The solution suggests using a recent case to provide the Equal Employment Opportunity Commission with authority to regulate employers' use of the health data until adequate privacy and data security laws can address the problem.