Health Law and Policy Commons^™

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 …

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

- …

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 …

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 …

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 …

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 …

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 …

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, …

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 …

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 …

Health Of The People: The Highest Law?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Law and ethics in population health are undergoing a renaissance. Once fashionable during the Industrial and Progressive eras, the ideals of population health began to wither with the rise of liberalism in the late twentieth century. In their place came a sharpened focus on personal and economic freedom. Political attention shifted from population health to individual health and from public health to private medicine.

The field of public health law and ethics needs a theory and definition (what is public health law and ethics and what are its doctrinal boundaries?); a well-articulated vision (why should health be a salient public …

Pandemic Influenza: Public Health Preparedness For The Next Global Health Emergency, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Severe Acute Respiratory Syndrome (SARS) garnered a great deal of public attention because it was novel and its potential for spread was unknown. However, the SARS corona virus is significantly less virulent than pandemic influenza viral infections. The annual number of deaths for seasonal influenza is 36,000 people in the United States and 250,000- 500,000 worldwide. However, highly pathogenic influenza pandemics have occurred roughly 2-3 times per century, causing untold morbidity and mortality. The Spanish influenza pandemic of 1918 was believed to have caused over 20 million deaths in a world less than one-third the size of the current global …

Sars And International Legal Preparedness, Lawrence O. Gostin, Jason W. Sapsin, Jon S. Vernick, Stephen P. Teret, Scott Burris

Georgetown Law Faculty Publications and Other Works

This article does not advance arguments regarding the efficacy or circumstances under which governments should exercise personal control measures such as quarantine or isolation. A literature on this aspect of SARS disease control strategies is just starting to develop more fully. Instead, we highlight the legal aspects of personal control measures employed against SARS in order to emphasize the importance of understanding public health law's role in authorizing and constraining disease control strategies, as well as the importance of legal preparedness in nations governed under the rule of law. In the contemporary international environment, one nation's failure in legal preparedness …

The Human Rights Of Persons With Mental Disabilities: A Global Perspective On The Application Of Human Rights Principles To Mental Health, Lawrence O. Gostin, Lance Gable

Georgetown Law Faculty Publications and Other Works

This Article examines the human rights of persons with mental disabilities and the application and development of these rights by the various international and regional systems that have been established to protect human rights. An international system of human rights with universal application has been developed under the auspices of the United Nations. Regional human rights systems have applied additional human rights protections to their respective geographic regions. Both the international and regional systems have addressed the human rights of persons with mental disabilities through treaties, declarations, and thematic resolutions. Moreover, regional institutions have incrementally formulated a body of law …

A Tribute To Gene W. Matthews, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Conference Center, across the street from the Centers for Disease Control and Prevention (CDC) on Clifton Road in Atlanta, I sat on a leather sofa with one of my oldest, dearest friends-Gene Matthews, Legal Adviser to the CDC. Gene asked to meet me to talk about how we might invigorate the field of public health law. Matthews and his colleagues at CDC were hatching an idea to commence a grass-roots movement in public health law.

When Terrorism Threatens Health: How Far Are Limitations On Personal And Ecomonic Liberties Justified, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The government is engaged in a homeland-security project to safeguard the population's health from potential terrorist attacks. This project is politically charged because it affords the state enhanced powers to restrict personal and economic liberties. Just as governmental powers relating to intelligence, law enforcement, and criminal justice curtail individual interests, so too do public health powers.

Clinical Uncertainty And Healthcare Disparities, Maxwell Gregg Bloche, Ana I. Balsa, Thomas G. Mcguire, Naomi Seiler

Georgetown Law Faculty Publications and Other Works

The Institute of Medicine Report, Unequal Treatment: Confronting Racial and Ethnic Disparities, affirms in its first finding: "Racial and ethnic disparities in health care exist and, because they are associated with worse outcomes in many cases, are unacceptable." The mechanisms that generate racial and ethnic disparities in medical care operate at the levels of the health care system and the clinical encounter. Research demonstrates the role of health care system factors, including differences in insurance coverage and other determinants of healthcare access, in producing disparities. Research also shows, however, that even when insurance status and other measures of access are …

The Politics Of Public Health: A Response To Epstein, Lawrence O. Gostin, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Conservatives are taking aim at the field of public health, targeting its efforts to understand and control environmental and social causes of disease. Richard Epstein and others contend that these efforts in fact undermine people’s health and well-being by eroding people’s incentives to create economic value. Public health, they argue, should stick to its traditional task—the struggle against infectious diseases. Because markets are not up to the task of controlling the transmission of infectious disease, Epstein says, coercive government action is required. But market incentives, not state action, he asserts, represent our best hope for controlling the chronic illnesses that …

The Invention Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

By default, the courts are inventing health law. The law governing the American health system arises from an unruly mix of statutes, regulations, and judge-crafted doctrines conceived, in the main, without medical care in mind. Courts are ill-equipped to put order to this chaos, and until recently they have been disinclined to try. But political gridlock and popular ire over managed care have pushed them into the breach, and the Supreme Court has become a proactive health policy player. How might judges make sense of health law's disparate doctrinal strands? Scholars from diverse ideological starting points have converged toward a …

Pushing Drugs: Genomics And Genetics, The Pharmaceutical Industry, And The Law Of Negligence, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

This article presents a piece of a larger, ongoing project on the phenomenon of market-driven manufacturing (MDM) and how tort law should address it. In contrast to the larger project, this article provides a relatively brief overview of the general phenomenon of MDM, but zeros in on how pharmaceutical manufacturers specifically practice MDM. MDM is a well-documented, much practiced activity, although American courts do not recognize MDM as a discrete category of conduct. The basic idea of MDM is that marketing considerations should continuously control every aspect and stage of a product's lifecycle. When a company engages in MDM, it …

The Global Reach Of Hiv/Aids: Science, Politics, Economics, And Research, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

This Article examines the major social, political, economic, and ethical issues involved in the global HIV pandemic. First, it examines the steps needed to prevent and treat HIV effectively and examines why many leaders have not responded more forcefully. This Part discusses the intangible, but crucial, aspect of political will. Second, this Article looks at the divisive issue of drugs, patents, and international trade law. Highly developed countries usually want to uphold the patent system to protect the proprietary interests of drug companies, which keeps the price of HIV/AIDS drugs high, placing them out of the reach of resource-poor countries. …

Trust And Betrayal In The Medical Marketplace, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues in this Comment that disingenuity as first resort is an unwise approach to the conflict between our ex ante and our later, illness-endangered selves. Not only does rationing by tacit deceit raise a host of moral problems, it will not work, over the long haul, because markets reward deceit's unmasking. The honesty about clinical limit-setting that some bioethicists urge may not be fully within our reach. But more candor is possible than we now achieve, and the more conscious we are about decisions to impose limits, the more inclined we will be to accept them without experiencing …

Commentary: Public Health And Civil Liberties In An Era Of Bioterrorism, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Safeguarding the public's health, safety, and security took on new meaning and urgency after the attacks on the World Trade Towers in New York and the Pentagon in Washington, D.C., on September 11, 2001. The subsequent intentional dispersal of anthrax through the U.S. postal system resulted in five confirmed deaths, hundreds treated, and thousands tested. The potential for new, larger, and more sophisticated attacks have created a sense of vulnerability. National attention has urgently turned to the need to detect and react rapidly to bioterrorism as well as to naturally occurring infectious diseases.

Conceptualizing The Field After September 11th: Forward To A Symposium On Public Health Law, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Safeguarding the public's health, safety, and security took on new meaning and urgency after the attacks on the World Trade Center in New York and the Pentagon in Washington, D.C. on September 11, 2001. On October 4, 2001, a Florida man named Robert Stevens was diagnosed with inhalational anthrax. The intentional dispersal of anthrax through the U.S. postal system in New York, Washington, Pennsylvania and other locations resulted in at least five deaths, hundreds treated, and thousands tested. The prospects of new, larger, and more sophisticated attacks have created a sense of deep vulnerability. The need to rapidly detect and …

Public Health Law: A Renaissance, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health seeks to assure the conditions for people to be healthy. Public health can be distinguished from health care in several critical respects. Public health focuses on: (1) the health and safety of populations rather than the health of individual patients; (2) prevention of injury and disease rather than treatment and care; (3) relationships between the government and the community rather than the physician and patient; and (4) population based services grounded on the scientific methodologies of public health (e.g., biostatistics and epidemiology) rather than personal medical services. These critical features - populations, prevention, government and communities, and epidemiological …

The Nationalization Of Health Information Privacy Protections, Lawrence O. Gostin, James G. Hodge Jr., Lauren Marks

Georgetown Law Faculty Publications and Other Works

In Part II, this article examines the justifications for implementing comprehensive national health information privacy regulations, including the personal nature of health information and the increasing threats to personal privacy from the shift to an electronic health information infrastructure. In doing so, it looks at historical attempts by federal and state officials to regulate the use and disclosure of personal health information, and concludes that prior standards have been largely inadequate. In Part III, this article explains the new national health information privacy regulations: (1) what do they cover?; (2) to whom do they apply?; (3) how do they safeguard …