Health Law and Policy Commons^™

Ensuring Effective Pain Treatment: A National And Global Perspective, Allyn L. Taylor, Lawrence O. Gostin, Katrina A. Pagonis

O'Neill Institute Papers

Medical availability of effective pain medication is vitally important domestically and globally. Medical advances have substantially improved the technical capacity to control pain and diminish its consequences. Worldwide, millions of persons with chronic, acute, and terminal conditions have found relief from excruciating pain through medical intervention. However, richer countries have disproportionately benefited from improvements in access to and use of pain medication. The tragedy is that for most of the world's population, particularly persons in poorer countries, effective pain control is entirely unavailable.

Paying With Their Lives: The Status Of Compensation For 9/11 Health Effects: Hearing Before The H. Comm. On The Judiciary, 110th Cong., Apr. 1, 2008 (Statement Of Kenneth Feinberg, Adjunct Prof. Of Law, Geo. U. L. Center), Kenneth R. Feinberg

Testimony Before Congress

No abstract provided.

The Duty Of States To Assist Other States In Need: Ethics, Human Rights, And International Law, Lawrence O. Gostin, Robert Archer

O'Neill Institute Papers

This article deals with a foreign policy question of extraordinary importance: What responsibilities do States have to provide economic and technical assistance to other states that have high levels of need affecting the health and life of their citizens? The question is important for a variety of reasons. There exist massive inequalities in health globally, with the result that poorer countries shoulder a disproportionate burden of disease and premature death. While poor countries have by far the greatest ongoing health needs, they also have the least capacity to meet those needs. In addition to the pervasive and debilitating effects of …

Addressing The Global Tragedy Of Needless Pain: Rethinking The United Nations Single Convention On Narcotic Drugs, Allyn L. Taylor

O'Neill Institute Papers

The lack of medical availability of effective pain medication is an enduring and expanding global health calamity. Despite important medical advances, pain remains severely under-treated worldwide, particularly in developing countries. This article contributes to the discussion of this global health crisis by considering international legal and institutional mechanisms to promote wider accessibility to critical narcotic drugs for pain relief.

Socioeconomic Disparities In Health: A Symposium On The Relationships Between Poverty And Health, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The disparities in health between the rich and poor are so striking, and the results so dire, that reducing the gap is an ethical imperative.

A strong and consistent finding of epidemiological research is that socioeconomic status (SES) is correlated with morbidity, mortality, and functioning. SES is a complex combination of income, education, and occupation. Theorists posit that material disadvantage, diminished control over life's circumstances, and lack of social acceptance all contribute to poor health outcomes. The relationship between SES and health often is referred to as a "gradient" because of the graded and continuous nature of the association; health …

Risk Governance And Deliberative Democracy In Health Care, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

I argue in this article that the concept of risk-centered governance is the best theoretical paradigm for understanding health law and the health care system. Over the past 20 years, an insurance-inflected discourse has migrated from the purely financial side of the health system into the heart of traditional medicine - the doctor-patient relationship. Rather than focus on doctrinal strands, I argue that scholars should analyze the law of health care as a set of governance practices organized around managing and allocating financial, as well as clinical, risk.

Over the same period, the body of law that structures most private …

National And Global Health Law: A Scholarly Examination Of The Most Pressing Health Hazards, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The health of individuals, families, and communities has deep, intuitive meaning. So much of what we aspire to be as individuals or as members of society relies on health. Our shared intuitions about the value of health manifest themselves in public and political concerns. The media widely reports threats to the public's health, such as a traveler with multi-drug resistant tuberculosis, E-coli from contaminated spinach, miners' deaths, unsafe children's toys, and dangerous pharmaceuticals. Election years predictably spur new, or refashioned, proposals for health care reform. And there remain enduring, intractable health hazards, such as tobacco, obesity, motor vehicle crashes, and …

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 …

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

- …

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 …

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.

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 …

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 …

Race, Money And Medicines, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. The literature on race as a classifying tool in clinical research poses this core dilemma: On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. On the other hand, racial distinctions have social mean­ ings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. Our country's troubled past in this regard and the persistence of race-related disadvantage should keep us …

What Does Social Justice Require For The Public’S Health? Public Health Ethics And Policy Imperatives, Lawrence O. Gostin, Madison Powers

Georgetown Law Faculty Publications and Other Works

Justice is so central to the mission of public health that it has been described as the field's core value. Our account of justice stresses the fair disbursement of common advantages and sharing of common burdens. It captures the twin moral impulses that animate public health: to advance human well-being by improving health and to do so particularly by focusing on the needs of the most disadvantaged. This commentary explores how social justice sheds light on major ongoing controversies in the field, and it provides examples of the kinds of policies that public health agencies guided by a robust conception …

Managed Process, Due Care: Structures Of Accountability In Health Care, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

Almost unnoticed, a new kind of adjudication system has appeared in American law. In forty-one states and the District of Columbia, special entities have been established to resolve contract and tort claims. State law created and mandates each system; these are not arbitrations agreed to by contract between the parties. Despite their public nature, however, these systems are not offered or operated by courts; the public function of adjudication is entirely outsourced to private actors. The decision-makers are neither elected nor appointed, nor are they public sector employees; they work in private companies. Most do not write opinions, and they …

American Medicine And The Politics Of Race, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Straw men play a major role in the debate over racial disparity in American medicine. Most have been deployed by the disparities-denying right, but progressives intent on “outing” racism have sent forth their share. This essay flushes out the straw men while attempting to understand the competing moral premises that drive the politics of health care disparity. At bottom, arguments about the scope of disparity and discrimination in medical care are disputes about the appropriate scope of personal responsibility for life circumstances. Further research into the factors that correlate with racial differences in health care can shed light on the …

Turning From Damage Caps To Information Disclosure: An Alternative To Tort Reform, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

Medical malpractice damage caps are among the most popular instruments of tort reform at the state level. The Bush administration proposed a federal damage cap on non-economic damages to quell the rise of medical malpractice insurance premiums despite the paucity of empirical evidence demonstrating that damage caps actually decrease premiums. This case study argues that imposing statutory caps on medical malpractice damages is not an effective method of remedying the medical malpractice insurance crisis: therefore, policymakers should consider alternatives to damage caps. In particular, evidence suggests that implementing mandatory disclosure of the contract terms between managed care organizations and physicians …

Law's Nobility, Robin West

Georgetown Law Faculty Publications and Other Works

This article first aims to set out the feminist theory of Catharine MacKinnon as explicitly as possible and in a way that accounts for its incredible power. To strengthen MacKinnon's theoretical project, the article proposes some modifications to the original that are drawn from, in part, the critiques of queer theorists. The crucial departure proposed here concerns MacKinnon's "critique of desire," which in my view is deeply mistaken. Rather than distrusting the sexual desires of women as hopelessly polluted by subordination, we should be neutral -- neither critical nor confident -- regarding the degree to which our desires, if fulfilled, …

World Health Law: Toward A New Conception Of Global Health Governance For The 21st Century, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The international community joined together during the late twentieth century to form a world trade system. Although imperfect, the world trade system contains adjudicable and enforceable norms designed to facilitate global economic activity. Human health is at least as important as trade in terms of its effects on the wellbeing of populations. Moreover, health hazards-biological, chemical, and radionuclear-have profound global implications. Whether these threats' origins are natural, accidental, or intentional, the harms, as well as the response, transcend national frontiers and warrant a transnational response. Despite their high importance, the International Health Regulations (IHR) are antiquated, limited in scope, and …

Obesity And The Struggle Within Ourselves, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues that we ought to treat our eating, exercise habits, and girth as personal matters, for the most part, but that law can and should make a contribution, as an ally of our longer-term will against our immediate cravings. Law can be our ally in this fashion without command-and-control intrusion into our private lives. Such intrusion is at odds with our core beliefs and unlikely to produce public health success. It is more likely to provoke popular backlash--one reason why some who stand to gain from our unhealthy dining choices try to cast government efforts to inform these …

Preemption And Regulatory Failure, David C. Vladeck

Georgetown Law Faculty Publications and Other Works

This symposium was convened to address the growing and seemingly conflicting jurisprudence governing federal preemption of state damage actions. One way to evaluate the evolution of preemption law is to examine it through the lens of litigation under the preemption provision of the 1976 Medical Device Amendments ("MDA") to the federal Food, Drug, and Cosmetic Act - a provision that in many respects is typical of express preemption provisions in regulatory statutes and has spawned a high volume of litigation. The question raised in cases under the MDA is whether the Act's preemption provision nullifies state damage actions based on …