Law Commons^™

Climate Change, Human Health, And The Post-Cautionary Principle, Lisa Heinzerling

O'Neill Institute Papers

In this Article, I suggest two different but related ways of reframing the public discourse on climate change. First, I propose that we move further in the direction of characterizing climate change as a public health threat and not only as an environmental threat. Second, I argue that we should stop thinking of responses to climate change in terms of the precautionary principle, which counsels action even in the absence of scientific consensus about a threat. We should speak instead in terms of a ?post-cautionary? principle for a post-cautionary world, in which some very bad effects of climate change are …

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

O'Neill Institute Papers

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

O'Neill Institute Papers

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …

Meeting Basic Survival Needs Of The World's Least Healthy People: Toward A Framework Convention On Global Health, Lawrence O. Gostin

Georgetown Law Faculty Lectures and Appearances

This article searches for solutions to the most perplexing problems in global health - problems so important that they affect the fate of millions of people, with economic, political, and security ramifications for the world's population. There are a variety of solutions scholars propose to improve global health and close the yawning health gap between rich and poor: global health is in the national interests of the major State powers; States owe an ethical duty to act; or international legal norms require effective action. However, arguments based on national interest, ethics, or international law have logical weaknesses. The coincidence of …

From A Civil Libertarian To A Sanitarian: “A Life Of Learning”, Lawrence O. Gostin

Georgetown Law Faculty Lectures and Appearances

I left Harvard 15 years ago to come to Georgetown University, formed in the year of our Constitution and established by an Act of Congress. More than Oxford or Harvard, Georgetown embodied my highest ideals of using world-class scholarship to serve the needs of the most disadvantaged. The Jesuit mission of social justice, which permeates our scholarship and teaching, has deep meaning to me. And the Jesuit ideal of “the human being fully alive,” resonates with my view of the salient importance of human health and wellbeing. The ideals of equity and human fulfilment are embodied in the inscription on …

Pandemic Influenza: Ethics, Law, And The Public's Health, Lawrence O. Gostin, Benjamin E. Berkman

Georgetown Law Faculty Publications and Other Works

Highly pathogenic Influenza (HPAI) has captured the close attention of policy makers who regard pandemic influenza as a national security threat. Although the prevalence is currently very low, recent evidence that the 1918 pandemic was caused by an avian influenza virus lends credence to the theory that current outbreaks could have pandemic potential. If the threat becomes a reality, massive loss of life and economic disruption would ensue. Therapeutic countermeasures (e.g., vaccines and antiviral medications) and public health interventions (e.g., infection control, social separation, and quarantine) form the two principal strategies for prevention and response, both of which present formidable …

Global Regulatory Strategies For Tobacco Control, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Recent tobacco control regulation in North America and Western Europe has had a salutary effect, even if smoking remains a pressing public health hazard. But in the 21st century, the tobacco industry has quietly moved its locus of activity to lucrative, emerging markets: the vast populations in Africa, Asia, Eastern Europe, and Latin America. The poorest, least educated, and sickest people on earth inhabit these regions. "Big Tobacco's" new marketing strategy will cause untold morbidity for the world's most vulnerable.

However, there are a variety of effective tobacco control policies that nations can and should enact. The World Health Organization …

Mris And The Perception Of Risk, Steven Goldberg

Georgetown Law Faculty Publications and Other Works

The most important safety decision concerning MRIs was to change the name of the procedure. In the late 1970s, the procedure known as nuclear magnetic resonance (NMR) became magnetic resonance imaging (MRI) because of the negative connotations the word “nuclear” invited. The change was understandable since MRIs do not expose patients to dangerous radiation: “nuclear” was in the original name because basic research on the atomic nucleus led to the development of MRIs. The main cost of the name change was to obscure the important link between basic research and useful medical technologies.

In recent years, however, MRIs, a generally …

Law As A Tool To Facilitate Healthier Lifestyles And Prevent Obesity, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health agencies face considerable challenges trying to prevent overweight and obesity in society, primarily because a person's own behavior is often the root cause of the disease. Individuals make personal choices about their diet, exercise, and lifestyle, so disease is often thought of as a matter of personal, not governmental, responsibility. This Commentary shows how law can be used as a tool to prevent overweight and obesity (see Table).

The tools discussed in this article include:

- Disclosure - e.g., labels and consumer information

- Tort liability - e.g., inadequate disclosure of risks, misleading advertisements, and targeting children

- …

Public-Private Health Law: Multiple Directions In Public Health, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

No public law is more public than public health law. Its defining subject is the use of state power to control and prevent death and disease. Its primary institutions are a cluster of state actors, the governmental agencies that comprise the American public health "system.,, The system grew out of the eighteenth century boards of health that produced the beginnings of administrative law. Public health law is grounded on statutory provisions that authorize various forms of state action and on judicial decisions that resolve constitutional challenges to those actions.

Book Review: Social Justice: The Moral Foundations Of Public Health And Health Policy, Robin West

Georgetown Law Faculty Publications and Other Works

This essay is a review of Social Justice: The Moral Foundations of Public Health and Health Policy by Madison Powers & Ruth Faden (2006).

In this pathbreaking book, senior bioethicists Powers and Faden confront foundational issues about health and justice. How much inequality in health can a just society tolerate? In a world filled with inequalities in health and well-being, which inequalities matter most and are the most morally urgent to address? In order to answer these questions, Powers and Faden develop a unique theory of social justice that, while developed for the specific contexts of public health and health …

A Theory And Definition Of Public Health Law, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

I offer a brief excerpt from my book, Public Health Law: Power, Duty, Restraint. My definition of public health law follows, and the remainder of this excerpt offers a justification as well as an expansion of the ideas presented: Public health law is the study of the legal powers and duties of the state, in collaboration with its partners (e.g., health care, business, the community, the media, and academe), to assure the conditions for people to be healthy (to identify, prevent, and ameliorate risks to health in the population) and the limitations on the power of the state to constrain …

Biomedical Research Involving Prisoners: Ethical Values And Legal Regulation, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Until the early 1970's, approximately 90% of all pharmaceutical research was conducted on prisoners, who were also subjected to biochemical research, including studies involving dioxin and chemical warfare agents. By the mid-1970's, biomedical research in prisons sharply declined as knowledge of the exploitation of prisoners began to emerge and the National Commission for the protection of Human Subjects of Biomedical Research was formed. Federal regulations to protect human subjects of research were established in 1974. Special protections for prisoners were added in 1978, severely limiting research involving prisoners. However, the US correctional system has undergone major changes since the adoption …

The "Tobacco Wars" - Global Litigation Strategies, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The Framework Convention on Tobacco Control (FCTC) identifies civil and criminal litigation as a public health strategy and promotes international cooperation (reporting, technical assistance, and information exchange). Holding the tobacco industry accountable through civil and criminal liability serves a number of public health objectives: punishes companies for hiding known health risks, manipulating nicotine content, and misleading the public; deters and preve nts future harmful behavior; compensates individuals and stake-holders for health care and other costs associated with smoking and exposure to environmental tobacco smoke (ETS); raises prices, resulting in lower tobacco consumption; increases disclosure of health risks, through labeling and …