Law Commons^™

Going To Pot, Carl E. Schneider

Articles

In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.

Performance-Based Regulation: Prospects And Limitations In Health, Safety And Environmental Protection, Cary Coglianese, Jennifer Nash

All Faculty Scholarship

Regulation aims to improve the performance of individual and organizational behavior in ways that reduce social harms, whether by improving industry's environmental performance, increasing the safety of transportation systems, or reducing workplace risk. With this in mind, the phrase "performance-based regulation" might seem a bit redundant, since all regulation should aim to improve performance in ways that advance social goals. Yet regulators can direct those they govern to improve their performance in at least two basic ways. They can prescribe exactly what actions regulated entities must take to improve their performance. Or they can incorporate the regulation's goal into the …

Reforming Civil Rights With Systems Reform: Health Care Disparities, Translation Services, & Safe Harbors, Sidney D. Watson

All Faculty Scholarship

Looking gaunt but determined, 59 year-old Robert Tools was introduced on August 21, 2001, as a medical miracle-the first surviving recipient of a fully implantable artificial heart. At a news conference, Tools spoke with emotion about his second chance at life and the quality of his care. His physician looked on with obvious affection, grateful and honored to have extended Tools's life. Mr. Tools has since lost his battle for life, but will be remembered as a hero for undergoing an experimental technology and paving the way for other patients to undergo the procedure. Moreover, the fact that Tools was …

The New Economic Credentialing: Protecting Hospitals From Competition By Medical Staff Members, Elizabeth Weeks

Scholarly Works

This Article addresses hospitals' use of economic criteria to determine a physician's qualifications for staff privileges. Hospitals are resorting to economic conflict-of-interest credentialing policies in an attempt to ensure physicians' loyalty and mantain their own economic viability. Physicians, however, argue that entrepenurial activities are necessary for them to meet the economic challenges posed by declining reimbursement and rising insurance costs. This Article surveys the numerous legal theories that litigants and enforcement authorities could employ in attacking these new types of credentialing policies. The Article concludes that, in most jurisdictions, hospitals should be able to implement their policies in ways that …

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.

Regulating Clinical Research: Informed Consent, Privacy, And Irbs, Sharona Hoffman

Faculty Publications

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task.

Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical …

Walking The Talk Of Trust In Human Subjects Research: The Challenge Of Regulating Financial Conflicts Of Interest, Robert Gatter

All Faculty Scholarship

There has been a call for more stringent regulation of financial conflicts of interest in human subjects research following the deaths of several individuals who volunteered to participate in human subjects research, which deaths were linked to the financial conflicts of interest of participating researchers and research institutions. Each proposal argues that regulation is necessary to restore trust in medical research. This Article examines whether proposed strategies for regulating financial conflicts of interest are likely to achieve the goal of a trustworthy human research enterprise. It does not question whether enhancing trustworthiness is an appropriate goal; rather, it assumes that …

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.

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 Right To Health And The Nevirapine Case In South Africa, George J. Annas

Faculty Scholarship

Thanks to activists in South Africa, the right to health as a human right has returned to the international stage, just as it was being displaced by economists who see health through the prism of a globalized economy and by politicians who see it as an issue of national security or charity. The current post-apartheid debate in South Africa is not about race but about health, and in this context, the court victory by AIDS activists in the nevirapine case has been termed not only, as stated in one British newspaper, “the greatest defeat for [President Thabo] Mbeki's government” but …

Disasters First: Rethinking Environmental Law After September 11, Michael B. Gerrard

Faculty Scholarship

Many environmental statutes were enacted, or at least spurred along, in direct response to disasters. The Federal Water Pollution Control Act of 1972 followed from the Santa Barbara Oil Spill; the Emergency Planning and Community Right-to-Know Act (EPCRA) resulted from the chemical gas disaster in Bhopal, India; the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) was sparked by the Love Canal incident; and the Oil Pollution Acte was a reaction to the Exxon Valdez oil spill.

The terrorist attacks of September 11, 2001 have led to the Homeland Security Act and to several other enactments. The collapse of the …

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 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. …

Looking Backward: The Twentieth Century Revolutions In Psychiatry, Law And Public Mental Health, Sheldon Gelman

Law Faculty Articles and Essays

Do histories of psychiatry make a difference--or have legal implications--in the present? Does our current situation help explain what historians say about psychiatry's past? Focusing on the past half century--the era of medications-- this paper explores the reciprocal relationship between the present and the past in psychiatry. Part II sketches the medical developments that constitute the subjects of any history of psychiatry. This Part also examines related developments in law. Part III introduces some problems of psychiatric historiography and examines some historians' attempts to deal with them. Part IV analyzes the account of psychiatry's past contained in Edward Shorter's well-regarded …

Why We Need The Independent Sector: The Behavior, Law, And Ethics Of Not-For-Profit Hospitals, Jill R. Horwitz

Articles

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made, …

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 …

Rethinking Legally Relevant Mental Disorder, Christopher Slobogin

Vanderbilt Law School Faculty Publications

The law insists on maintaining mental disorder as a predicate for a wide array of legal provisions, in both the criminal justice system and the civil law. Among adults, only a person with a "mental disease or defect" can escape conviction for an intentional, unjustified crime on grounds of cognitive or volitional impairment.' Only people with "mental illness" or "mental disorder" may be subjected to indeterminate preventive commitment based on dangerousness. Under the laws of many states, only people with a mental disorder are prevented from making decisions about treatment, criminal charges, wills, contracts, and a host of other important …

Privatization As Delegation, Gillian E. Metzger

Faculty Scholarship

Recent expansions in privatization of government programs mean that the constitutional paradigm of a sharp separation between public and private is increasingly at odds with the blurred public-private character of modern governance. While substantial scholarship exists addressing the administrative and policy impact of expanded privatization, heretofore little effort has been made to address this disconnect between constitutional law and new administrative reality. This Article seeks to remedy that deficiency. It argues that current state action doctrine is fundamentally inadequate to address the constitutional challenge presented by privatization. Current doctrine is insufficiently keyed to the ways that privatization involves delegation of …

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 …

A Healer Or An Executioner: The Proper Role Of A Psychiatrist In A Criminal Justice System, Gregory Dolin

All Faculty Scholarship

This article argues that despite the benefits of ridding the criminal justice system of some uncertainty and ignorance with respect to mental health issues, the very close involvement of psychiatrists in the criminal justice system as practiced in the United States is not only illogical and bad policy, but also unethical from the viewpoint of medical ethics. Part II of this article will lay the groundwork for the argument by discussing the history of the insanity defense, and of science's involvement with criminal justice; while Part III, will look into the association of science and the administration of justice in …

Puppy Love: Bioterrorism, Civil Rights, And Public Health, George J. Annas

Faculty Scholarship

Florida has been the state humorists most like to make fun of since the 2000 presidential election, especially when it comes to politics. And humorists are almost the only commentators who can be counted on to tell us the truth about the state of American politics today. When Californians decided to recall their Governor, for example, Conan O'Brien observed: "Yesterday Arnold Schwarzenegger announced he would run for governor of California. The announcement was good news for Florida residents, who now live in the second-flakiest state in the country."' And when more than 200 people filed to run for Governor, Jay …