Health Law and Policy Commons^™

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …

On The Limits Of Supremacy: Medical Marijuana And The States' Overlooked Power To Legalize Federal Crime, Robert A. Mikos

Vanderbilt Law Review

Using the conflict over medical marijuana as a timely case study, this Article explores the overlooked and underappreciated power of states to legalize conduct Congress bans. Though Congress has banned marijuana outright, and though that ban has survived constitutional scrutiny, state laws legalizing medical use of marijuana not only survive careful preemption analysis, they constitute the de facto governing law in thirteen states. This Article argues that these state laws and most related regulations have not been and, more interestingly, cannot be preempted by Congress, given constraints imposed on Congress's preemption power by the anti-commandeering rule, properly understood. The Article …

Mental Illness And Self-Representation: Faretta, Godinez And Edwards, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In the recent decision of Indiana v. Edwards the Supreme Court held that the right to represent oneself may be denied to defendants who are competent to stand trial if they "still suffer from severe mental illness to the point where they are not competent to conduct trial proceedings by themselves." Edwards was a surprise, given the Court's holding 15 years earlier in Godinez v. Moran that Nevada courts did not err when they permitted a mentally ill person who had been found competent to stand trial to waive the right to counsel, plead guilty and waive the presentation of …

The Ethical Health Lawyer: An Empirical Assessment Of Moral Decision Making, Ellen Wright Clayton, Joshua E. Perry, Ilene N. Moore, Bruce Barry, Amanda R. Carrico

Vanderbilt Law School Faculty Publications

The empirical literature exploring lawyers and their moral decision making is limited despite the “crisis” of unethical and unprofessional behavior in the bar that has been well documented for over a decade. In particular we are unaware of any empirical studies that investigate the moral landscape of the health lawyer’s practice. In an effort to address this gap in the literature, an interdisciplinary team of researchers at Vanderbilt University designed an empirical study to gather preliminary evidence regarding the moral reasoning of health care attorneys. The primary research question was how health lawyers respond when they encounter ethical or moral …

Managing Incidental Findings In Human Subjects Research: Analysis And Recommendations, Ellen Wright Clayton, Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Et Al.

Vanderbilt Law School Faculty Publications

Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem - how should incidental find- ings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant's physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require? An IF is a finding concerning an individual research participant that has potential health or …

The Circle Of Assent: How "Agreement" Can Save Mandatory Arbitration In Long-Term Care Contracts, Lauren Gaffney

Vanderbilt Law Review

On September 28, 1997, a resident at the Comanche Trail Nursing Center physically attacked his eighty-one-year-old roommate, Tranquilino Mendoza. As a result of the attack, Mr. Mendoza suffered a concussion and brain damage. His daughter claimed that her father was never the same after the attack and filed a lawsuit against the long-term care facility alleging negligence. In 2006, a jury awarded Mr. Mendoza $160 million.

Similarly, on April 26, 2003, a resident of the Heritage House Nursing and Rehabilitation Center allegedly attacked Carolyn Mason, another resident at the same facility. Mrs. Mason suffered a broken hip.6 Like Mr. Mendoza, …

Ten Fingers, Ten Toes: Newborn Screening For Untreatable Disorders, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

This movie makes two important points despite its admitted unreality. The first, which the screen writer probably did not fully appreciate at the time, is that genetic testing cannot now and probably will never be able to predict with complete certainty the occurrence and course of complex diseases. It is not true that "Genes-R-Us." Rather, we are the products of complex interactions of our genes, the genomes of other organisms (many of which we live in relation with), and the environment, broadly understood to include the air we breathe, the water we drink, the food we eat, the drugs we …

Can Clinical Genetics Laboratories Be Sued For Medical Malpractice?, Ellen Wright Clayton, Alexandra L. Foulkes, Jessica L. Roberts, Et Al.

Vanderbilt Law School Faculty Publications

From a legal perspective, is a clinical laboratory a healthcare provider? Physicians are clearly healthcare providers who owe their patients the associated fiduciary duties. It is less clear, however, which-if any-legal duties genetic testing labs owe to the individuals who seek their services.

The question of whether clinical genetics laboratories are healthcare providers for legal purposes may be thornier than it could initially appear. Clinical genetics laboratories perform multiple tasks. Most significantly, they sequence genetic samples and then interpret the results. As "next generation sequencing" has become more accessible,' labs can generate and interpret more sequence data for a growing …

Advertising Obesity: Can The U.S. Follow The Lead Of The Uk In Limiting Television Marketing Of Unhealthy Foods To Children?, David Darwin

Vanderbilt Journal of Transnational Law

Childhood obesity has tripled in the U.S. since the 1970s, and television advertisement of unhealthy foods has been linked to the unhealthy eating habits of children. The United Kingdom, facing a similar problem, promulgated regulations in 2007 banning the advertisement of foods high in fat, sodium, and sugar during programming directed at children below age 16.

In the U.S., industry representatives, public policy advocates, and government officials are debating whether to rely on self-regulation efforts or to implement government-established guidelines. Industry representatives argue that government guidelines would do little to solve the childhood obesity problem and that the UK regulations …

You Get What You Pay For?: Rethinking U.S. Organ Procurement Policy In Light Of Foreign Models, J. Andrew Hughes

Vanderbilt Journal of Transnational Law

The U.S. organ transplant system is in crisis due to the paucity of transplantable organs. Such a shortage exists because otherwise viable organs are too often buried along with the bodies in which they reside. Organs are wasted because the existing U.S. organ transplant system sets up barriers to organ donation--chiefly the legal presumption of unwillingness to donate ("voluntary donation') and the National Organ Transplant Act's ban on the transfer of organs for valuable consideration. This Note surveys the qualified successes of Austria, Belgium, Brazil, and France with their various "presumed consent" models of organ procurement. It also considers other …

The Search For Due Process In Civil Commitment Hearings: How Procedural Realities Have Altered Substantive Standards, Christyne E. Ferris

Vanderbilt Law Review

The civil commitment of mentally ill individuals presents the legal system with an intractable question: When should the law deprive someone of the fundamental right to liberty based on a prediction of future dangerousness? Advocates of both increased and decreased levels of civil commitment offer compelling case studies to help resolve the question. The former point to high profile events like the Virginia Tech shooting, in which mandatory incapacitation of the perpetrator at the first sign of mental illness could have prevented a senseless tragedy. The latter highlight the lives of individuals like Kenneth Donaldson, whose father had him committed …

Reformulating Outrage: A Critical Analysis Of The Problematic Tort Of Iied, Russell Fraker

Vanderbilt Law Review

The intentional infliction of emotional distress ("IIED"), also known as the tort of outrage, is a relatively new cause of action, first appearing in the legal academic literature during the 1930s. Since that time, IIED has gained widespread acceptance and is now recognized in all U.S. jurisdictions, with most courts invoking the definition set forth in the Restatement (Second) of Torts. Despite this general acceptance of the tort, courts routinely assert that IIED is a disfavored cause of action. Courts appear wary of holding defendants liable for plaintiffs' emotional injuries and therefore seek to discourage such claims.

In their efforts …

Do Norms Still Matter? The Corrosive Effects Of Globalization On The Vitality Of Norms, Patrick J. Keenan

Vanderbilt Journal of Transnational Law

Why does the process of globalization undermine the power of social norms to regulate behavior? Norms are the social regularities that shape individual behavior and help to create vibrant--or dysfunctional--communities. Most theories of norms do not account for the many ways that globalization affects the foundations of norms. This Article fills the gap by developing a more robust theory of the informal regulation of behavior that considers the ways that the process of globalization can interfere with the creation of norms and erode their power.

Drawing on behavioral economics, sociology, and criminology, the theory proposed in this Article contains three …

The Regulation Of Ddt: A Choice Between Evils, Ashley K. Martin

Vanderbilt Journal of Transnational Law

DDT has the potential for great benefit and great harm. It is currently the most efficient method for controlling malaria, particularly for those countries the disease affects most. However, it also causes global pollution and damages the health of humans and wildlife. These characteristics of DDT make regulating DDT difficult because they create a need for the continued use of DDT to prevent the debilitating effects of malaria, but also a need to ban the use of DDT in order to prevent its negative environmental and health effects. These conflicting needs correlate to diverging interests of developing and developed countries. …

Access This: Why Institutions Of Higher Education Must Provide Access To The Internet To Students With Disabilities, Nina Golden

Vanderbilt Journal of Entertainment & Technology Law

No one questions whether the ADA applies to institutions of higher education. Title II applies to public colleges and universities, while Title III applies to private ones. With some exceptions, colleges and universities must make their programs and services accessible by providing reasonable accommodations to students with disabilities. What is significantly less clear, and thus the topic of dispute among courts and commentators, is whether the ADA requires colleges and universities to provide access to the Internet to students with disabilities. Much of the dispute revolves around the meaning of the term "place of public accommodation." Some courts have required …

Do Citizens Care About Federalism? An Experimental Test, Robert A. Mikos, Cindy D. Kam

Vanderbilt Law School Faculty Publications

The ongoing debate over the political safeguards of federalism has essentially ignored the role that citizens might play in restraining federal power. Scholars have assumed that citizens care only about policy outcomes and will invariably support congressional legislation that satisfies their substantive policy preferences, no matter the cost to state powers. Scholars thus typically turn to institutions-the courts or institutional features of the political process-to cabin congressional authority. We argue that ignoring citizens is a mistake. We propose a new theory of the political safeguards of federalism in which citizens help to safeguard state authority. We also test our theory …

Allocating Responsibility For The Failure Of Global Warming Policies, W. Kip Viscusi, Joni Hersch

Vanderbilt Law School Faculty Publications

A recent series of climate change lawsuits has sought to mimic the "regulation through litigation" approach of the claims brought by the states against cigarette manufacturers. What is distinctive about the cigarette cases relative to conventional tort claims is that they were not brought on behalf of individual smokers, but rather sought to recoup the Medicaid-related costs of smoking. A parallel climate change litigation approach seeks payments from public utilities, energy producers, and other parties responsible for greenhouse gas emissions to reflect the long-term societal damages that the plaintiffs claim will be caused by this pollution. While environmental litigation of …

Multinational Enterprises And Workplace Reproductive Health: Extending Corporate Social Responsibility, Rebecca K. Atkins

Vanderbilt Journal of Transnational Law

Corporate social responsibility is a relatively new approach to the protection of human rights. While the human rights to whole-body health and workplace health are long-standing, the right to reproductive health is a new topic of discussion. This Note examines the right to reproductive health in the workplace and proposes that it would be best protected by imposing an affirmative duty on multi-national enterprises via corporate social responsibility. Origins of human rights, corporate social responsibility, and reproductive health are discussed before turning to the developing stalemate between multi-national enterprises and less developed countries.

Attack Of The Balloon People, Keith E. Sealing

Vanderbilt Journal of Transnational Law

Any discussion of food security would, at first blush, seem to focus primarily on world hunger and other threats to the safety of the food supply, whether intentionally man-made (e.g., terrorism), inadvertently man-made (e.g., global warming), made-for-profit by industrial agriculture (referred to as "industrial food" throughout this Article), or "natural" although arguably man-abetted (such as bovine spongiform encephalopathy, or mad cow disease). And hunger is indeed a problem and likely to become more of a problem. However, this Article focuses on the long term threat to world health and world food security caused by the American way of eating; the …

Foodborne Infections And The Global Food Supply: Improving Health At Home And Abroad, Robert V. Tauxe

Vanderbilt Journal of Transnational Law

In recent years, fourteen percent of the U.S. food supply has been imported from other countries, including many fresh and perishable foods. Although most outbreaks of illness and individual cases are related to foods from the United States, large and unusual outbreaks have been traced to imported foods that were likely contaminated in the country of origin. Investigation of these outbreaks requires collaboration across several disciplines as well as across international borders. Successful investigation can not only control the original problem, but can also inform public authorities in both countries about the need for strategies to prevent similar outbreaks from …

Patients And Biobanks, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

The question about the privacy of medical information can be stated simply: To what extent can and should patients control what the medical record contains and who has access to it and for what purposes? Patients often have apparently conflicting views on this subject. On the one hand, we, as patients, say that we prize privacy and that we fear that information will be used to harm us. On the other hand, we value the benefits that come from improved communication among providers, such as having our visits covered by third party payers and advances in medical science, which often …

High-Deductible Health Plans: New Twists On Old Challenges From Tort And Contract, E. Haavi Morreim Ph.D.

Vanderbilt Law Review

In just a few decades American health care financing has, in a sense, come full circle. After being largely patient-financed in the early twentieth century, generous insurance coverage in mid-century largely permitted providers to do as they wished and charge what they pleased-an Artesian Well of Money that left patients and physicians well-insulated from the costs of care. That system's inevitable explosion of costs spurred urgent efforts to contain health care expenditures, as payors sought to control or at least influence medical decisions. In many ways this "managed care" was clinically vexatious and economically disappointing. Its medically intrusive tactics have …

Plaintiffs' Lawyers, Specialization, And Medical Malpractice, Stephen Daniels, Joanne Martin

Vanderbilt Law Review

Our interest is in medical malpractice as an area of specialized practice for plaintiffs' lawyers, and we want to explore this area because plaintiffs' lawyers are key actors in the medical malpractice system. An understanding of their role is necessary in identifying what problems may exist in this system and in evaluating both proposed and enacted solutions. Indeed, some reforms appear to be specifically aimed at plaintiffs' lawyers who handle medical malpractice cases-especially the repeat players whose experience and expertise may give them, and hence their clients, a strategic advantage.

Like most of the political rhetoric surrounding medical malpractice, the …

The Web Of Relations: Thinking About Physicians And Patients, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

Like the other contributors to this symposium, I owe a profound debt to Jay Katz for his intellectual rigor, his gentle but firm Socratic pedagogy, and his unparalleled generosity of time and friendship. I first met Jay during my last year of law school when, at the urging of friends, I enrolled in his seminar on informed consent. By that time, he had collected most of the materials on which he based his important book. Not surprisingly, a single semester could not contain all of that material, so many of us continued on into the second semester. During that time …

A Tale Of Two Countries: Parallel Visions For Informed Consent In The United States And The United Kingdom, Ben Sones

Vanderbilt Journal of Transnational Law

In recent years, the proper role of informed consent doctrine in an environment of healthcare cost containment has been a hotly contested legal and policy issue. The purpose of this Note is to probe the current informed consent debate in the United States and the United Kingdom and to draw out the respective roles informed consent ought to play in those two systems. In doing so, this Note draws on the history of the doctrine and several recent scholarly proposals, and offers a modest proposal synthesizing the best aspects of those proposals.

Toward Facilitating A Voice For Politically Marginalized Minorities And Enhancing Presidential Public Accountability And Transparency In Foreign Health Policymaking, Nina J. Crimm

Vanderbilt Journal of Transnational Law

Residents of underdeveloped countries who belong to ethnic, racial, sexual, and political minorities usually endure relatively ineffective political voices. More than any other world population segment, these marginalized people are vulnerable to, and suffer from, compromised health and life expectancies. Their immense human tolls have spawned severe global humanitarian, economic, social, political, and security dilemmas contrary to the strategic interests of the United States. Despite recognition of these devastating harms here and abroad, the president as de facto primary U.S. foreign policymaker continues to formulate foreign health policy in an insular policymaking environment. The insularity enables the president to design …

Hmos Behind Bars: Constitutional Implications Of Managed Health Care In The Prison System, Richard Siever

Vanderbilt Law Review

In 1991, the Correctional Corporation of America (CCA) entered into a contract with the State of Tennessee to house and treat state prisoners at CCA facilities. In response to increased costs, CCA negotiated a contract with a physician to be the exclusive provider of medical services for one of its facilities. Essentially, this contract formed a managed health care system: the doctor's payment structure included a base salary, but it also incorporated financial incentives that could increase his overall compensation if he were to provide less care to inmates.

Later, Anthony Bowman, a prison inmate with sickle cell anemia, died …

Taking One For The Team: Should Colleges Be Liable For Injuries Occurring During Student Participation In Club Sports?, Nick White

Vanderbilt Journal of Entertainment & Technology Law

Since the 1970s, colleges have not been liable for their adult students' actions or injuries, but courts have since delineated many exceptions to this rule. This Note will analyze the effect of college involvement in club sports as to whether it creates a duty for a college to protect its club athletes and those they might injure. This Note will also examine whether such a duty might exist in the future if the current trends in the law and college policy continue unchecked. Finally, this Note will address the effectiveness of the current defenses to liability and the effect of …

The Civilization Of The Criminal Law, Christopher Slobogin

Vanderbilt Law School Faculty Publications

This article explores the jurisprudential and practical feasibility of a "preventive" regime of criminal justice. More specifically, it examines an updated version of the type of government intervention espoused four decades ago by thinkers such as Barbara Wooton, Sheldon Glueck, and Karl Menninger. These individuals, the first a criminologist, the latter two mental health professionals, envisioned a system that is triggered by an antisocial act but that pays no attention to desert or even to general deterrence. Rather, the sole goal of the system they proposed is individual prevention through assessments of dangerousness and the provision of treatment designed to …

Shifting Out Of Neutral: A New Approach To Global Road Safety, Kevin M. Mcdonald

Vanderbilt Journal of Transnational Law

On April 14, 2004, the United Nations dedicated "World Health Day" to improving global road safety. In explaining the need to focus the world's attention on road safety, Secretary General Kofi Annan declared that "World Health Day is an occasion for us to highlight the [road safety] problem and ... to underscore the fact [that crashes] are avoidable, they are not just accidents, they are human errors which [,] with proper governmental policy[,] can be dealt with." Just what the "proper governmental policy" should be, however, requires an understanding of the factors associated with vehicle crashes. After examining these factors, …