Health Law and Policy Commons^™

Proxy Consent To Participation Of The Decisionally Impaired In Medical Research - Maryland's Policy Initiative, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.

Tobacco Litigation's Third Wave: Has Justice Gone Up In Smoke?, David A. Hyman

Faculty Scholarship

No abstract provided.

Racial Disparities In The Delivery Of Health Care, Barbara A. Noah

Faculty Scholarship

This Article focuses on the role of conscious and unconscious racial bias in the delivery of care; it does not begin to address the larger issue of inadequate access to care at the outset. Improving access to health care for minorities will undoubtedly have a positive effect on these groups' overall health status; however, to the extent that racial bias in the delivery of care exists apart from problems of inadequate access, the disparity in health status between whites and African Americans will no doubt continue.

Part II of this Article describes racial disparities in a variety of health care …

Protecting Patients From Discrimination: The Americans With Disabilities Act And Hiv Infection, George J. Annas

Faculty Scholarship

The Americans with Disabilities Act (ADA) was passed in 1990 to expand the reach of the Rehabilitation Act of 1973 and make discrimination on the basis of disability unlawful. The wheelchair symbol has become a universal sign of disability, but there are, of course, many types of disability that have been the basis of discrimination over the years, including blindness, deafness, epilepsy, cancer, heart disease, and mental retardation. AIDS is a disability under the ADA, and most commentators have assumed that infection with the human immunodeficiency virus (HIV) also qualifies as a disability under this act. It was not, however, …

The Shadowlands: Secrets, Lies, And Assisted Reproduction, George J. Annas

Faculty Scholarship

Americans love babies and technology, and most Americans applaud the ability of the new assisted-reproduction techniques to help infertile couples have children. But these techniques have also given birth to a wide variety of new legal issues, including questions about the identity of the mother and father of the child, the enforcement of preconception contracts, the elements of informed consent, and the disposition of frozen embryos. After almost 20 years of experience and the growth of infertility clinics into a multibillion-dollar industry, it is time to consider establishing national standards and a federal regulatory scheme. Two recent court cases, one …

Partial-Birth Abortion, Congress, And The Constitution, George J. Annas

Faculty Scholarship

The political debate over abortion during the past 25 years has shifted among various dichotomous views of the world: life versus choice, fetus versus woman, fetus versus baby, constitutional right versus states' rights, government versus physician, physician and patient versus state legislature. Hundreds of statutes and almost two dozen Supreme Court decisions on abortion later, the core aspects of Roe v. Wade, 1 the most controversial health-related decision by the Court ever, remain substantially the same as they were in 1973. Attempts to overturn Roe in both the courtroom and the legislature have failed. Pregnant women still have a constitutional …

A National Bill Of Patients' Rights, George J. Annas

Faculty Scholarship

In one of the most enthusiastically received proposals in his January State of the Union address, President Bill Clinton called on Congress to enact a national bill of rights in health care. The President said, “You have the right to know all your medical options, not just the cheapest. You have the right to choose the doctor you want for the care you need. You have the right to emergency room care, wherever and whenever you need it. You have the right to keep your medical records confidential.”

Protecting Soldiers From Friendly Fire: The Consent Requirement For Using Investigational Drugs And Vaccines In Combat, George J. Annas

Faculty Scholarship

In 1990, following Iraq's invasion of Kuwait, the Department of Defense (DOD) sought a waiver of the informed consent requirements of existing human experimentation regulations from the Food and Drug Administration (FDA). With this waiver, DOD could authorize military use of investigational drugs and vaccines on soldiers involved in the Gulf War without their informed consent. The basis of the waiver request was military expediency. In DOD's words: "In all peace time applications, we believe strongly in informed consent and ethical foundations... but military combat is different." DOD's rationale was that informed consent under combat conditions was "not feasible" because …

Human Rights And Maternal-Fetal Hiv Transmission Prevention Trials In Africa, George J. Annas, Michael A. Grodin

Faculty Scholarship

The human rights issues raised by the conduct of maternal-fetal human immunodeficiency virus transmission trials in Africa are not unique to either acquired immunodeficiency syndrome or Africa, but public discussion of these trials presents an opportunity for the United States and other wealthy nations to take the rights and welfare of impoverished populations seriously. The central issue at stake when developed countries perform research on subjects in developing countries is exploitation. The only way to prevent exploitation of a research population is to insist not only that informed consent be obtained but also that, should an intervention be proven beneficial, …

Judicial Opinions Involving Health Insurance Coverage: Trompe L'Oeil Or Window On The World?, William M. Sage

Faculty Scholarship

This essay offers a few thoughts about using judicial decisions as the dataset for research into health insurance coverage. Part I offers a general overview of insurance coverage law. Part II considers why students of health insurance coverage gravitate toward studying published opinions. Part III then discusses what is wrong with the approach, and suggests alternatives. Finally, Part IV turns to what may be right with the approach, concluding that judicial opinions in coverage litigation may reveal the functionality (or dysfunctionality) of the coverage process in managed care. Although the basic critique which the essay presents applies to areas other …

Toward A Framework Of Mutualism: The Jewish Community In Genetics Research, Karen H. Rothenberg, Amy B. Rutkin

Faculty Scholarship

No abstract provided.

Can Patents Deter Innovation? The Anticommons In Biomedical Research, Michael Heller, Rebecca S. Eisenberg

Faculty Scholarship

The "tragedy of the commons" metaphor helps explain why people overuse shared resources. However, the recent proliferation of intellectual property rights in biomedical research suggests a different tragedy, an "anticommons" in which people underuse scarce resources because too many owners can block each other. Privatization of biomedical research must be more carefully deployed to sustain both upstream research and downstream product development. Otherwise, more intellectual property rights may lead paradoxically to fewer useful products for improving human health.

Is There A Future For Future Claimants After Amchem Products, Inc. V. Windsor?, Alex Raskolnikov

Faculty Scholarship

In September 1990, the Chief Justice of the U.S. Supreme Court appointed an Ad Hoc Committee on Asbestos Litigation in response to what was widely perceived as a "'failure of the federal court system to perform one of its vital roles in our society.'" Less than a year later, the Judicial Panel on Multidistrict Litigation transferred all untried asbestos cases to the eastern district of Pennsylvania for pretrial proceedings. In January 1993, these proceedings produced a global settlement class action of historic proportions, which the district court eventually approved in August 1994. In May 1996, in Georgine v. Amchem Products, …

Physician Assisted Suicide And The Supreme Court: Putting The Constitutional Claim To Rest, Wendy K. Mariner

Faculty Scholarship

Like the debate about many controversial questions of ethics and medical care in America, public debate about physician assisted suicide became focused on questions of constitutional law. On June 26, 1997, the United States Supreme Court unanimously rejected any constitutional right of terminally ill patients to physician assisted suicide. An analysis of the Court's reasoning reveals that its decisions resolved only a narrow constitutional question that affects relatively few people--mentally competent, terminally ill patients who wish to hasten their imminent deaths by having a physician prescribe medication that they intend to use to commit suicide. Although suicide is not a …

Cancer Genetic Susceptibility Testing: Ethical And Policy Implications For Future Research And Clinical Practice, Benjamin S. Wilfond, Karen H. Rothenberg, Elizabeth J. Thomson, Caryn Lerman

Faculty Scholarship

No abstract provided.

Bioethics Policy: Looking Beyond The Power Of Sovereign Governments (Foreword), Robert L. Schwartz

Faculty Scholarship

Lawyers are trained to think in terms of power exercised by a sovereign-an institution authorized to enforce a procedurally appropriate decision with coercive force.' Generally, lawyers have a broad notion of what constitutes a sovereign. In the United States, for example, this notion includes the federal government, state governments, most tribal units, traditional territorial governments and their agencies-e.g., school boards, local public park districts, water run-off management districts, and flea abatement boards-and a host of other institutions. As a result, it is difficult for lawyers to recognize that policy also may emanate from other institutions that possess only persuasive authority, …

The Laws Of Genetics, Michael S. Baram

Faculty Scholarship

It used to be that high technology meant nuclear physics and missile systems, and presented the threat of physical destruction. Today, "high tech" means biotechnology and electronic communication systems, and the focus has shifted to concerns about more subtle problems like loss of privacy, inability to control personal information, and the discriminations and other adversities that often follow.

Genetic Information And The Workplace: Legislative Approaches And Policy Challenges, Karen H. Rothenberg, Barbara Fuller, Mark Rothstein, Troy Duster, Mary Jo Ellis Kahn, Rita Cunningham, Beth Fine, Kathy Hudson, Mary-Claire King, Patricia Murphy, Gary Swergold, Francis Collins

Faculty Scholarship

No abstract provided.

Emergency Care And Managed Care - A Dangerous Combination, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.

Enterprise Liability And The Emerging Managed Health Care System, William M. Sage

Faculty Scholarship

“Enterprise medical liability” is a term used to describe a system in which health care organizations bear responsibility for medical malpractice in addition to or instead of individual health professionals. Enterprise liability is in many senses a natural outgrowth of the increasing dependence of medical practice on institutional resources and expertise. Proposals for enterprise liability surfaced briefly from the academic literature into the political spotlight during the 1993-94 health care reform debate. At that time, objections to the concept as a basis for medical malpractice liability, even in a restructured health care system, were nearly universal.

Just five years later, …

Tobacco Litigation As Cancer Prevention: Dealing With The Devil, George J. Annas

Faculty Scholarship

Tobacco companies have come to personify the devil, and strategies to exorcise tobacco smoking from the United States proliferate. Tobacco's demonic status is even reflected in popular fiction. John Grisham's latest bestseller, The Runaway Jury, for example, is a broadside attack on tobacco companies. He opens the book by noting that tobacco companies “had been thoroughly isolated and vilified by consumer groups, doctors, even politicians.” This was bad, but it was getting even worse: “Now the lawyers were after them.”

The Bell Tolls For A Constitutional Right To Physician-Assisted Suicide, George J. Annas

Faculty Scholarship

For Whom the Bell Tolls, Ernest Hemingway's novel about the Spanish Civil War, ends with its American hero, Robert Jordan, mortally wounded and trying to decide whether to commit suicide with a machine gun or risk capture by trying to retain consciousness long enough to cover the retreat of his comrades. Confronting his impending death, Jordan thinks, “Dying is only bad when it takes a long time and hurts so much that it humiliates you.” Hemingway, one of the most American of American writers, committed suicide with a shotgun. Most suicides in the United States are committed with guns, but …

Reefer Madness: The Federal Response To California's Medical-Marijuana Law, George J. Annas

Faculty Scholarship

Marijuana is unique among illegal drugs in its political symbolism, its safety, and its wide use. More than 65 million Americans have tried marijuana, the use of which is not associated with increased mortality. Since the federal government first tried to tax it out of existence in 1937, at least partly in response to the 1936 film Reefer Madness, marijuana has remained at the center of controversy. Now physicians are becoming more actively involved. Most recently, the federal drug policy against any use of marijuana has been challenged by California's attempt to legalize its use by certain patients on the …

Patients' Rights In Managed Care - Exit, Voice, And Choice, George J. Annas

Faculty Scholarship

The ability of consumers to complain effectively about services and products is a key ingredient of the market. In Exit, Voice, and Loyalty, economist Albert O. Hirschman argues that the ability to take one's business elsewhere may not be enough to empower consumers in markets where all providers act similarly. Instead of simply going elsewhere, consumers need to have an effective way to voice their complaints, in order to give providers an incentive to be more responsive to consumers' interests. Marc Rodwin has suggested that the Hirschman analysis may be particularly relevant to members of managed-care organizations and ``individuals with …

Medical Discipline In The Twenty-First Century: Are Purchasers The Answer?, Frances H. Miller

Faculty Scholarship

Millenia prompt reflection about change, both past and future. Tons of newsprint have already been devoted to documenting the astonishing developments in medicine during the past century, and to speculating about what breakthroughs to expect in the next one.¹ Health economists generally accept that these changes, particularly advances in technology, have been the dominant factor propelling U.S. health care costs into the stratosphere over the past hundred years.' Analysts by the score have also examined the myriad ways in which this nation's health care delivery system has been (and must continue to be) transformed to cope with these expensive …

The Managed Care Dilemma: Can Theories Of Tort Liability Adapt To The Realities Of Cost Containment?, Barbara A. Noah

Faculty Scholarship

Over the years, the United States health care system has undergone a transformation from a market comprised mainly of self employed physicians· in solo or small group practices to one in which far fewer physicians engage in this type of independent practice. More than three quarters of the physicians in this country now practice medicine within some form of managed care organization ("MCO") or see some managed care patients. The public increasingly perceives the care provided through MCOs as inferior to traditional feefor-service care. Responding to constituent pressures, legislatures in more than twenty states recently have considered bills regulating managed …

Breast Cancer, The Genetic "Quickfix," And The Jewish Community: Ethical, Legal, And Social Challenges, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Principles And Passions: The Intersection Of Abortion And Gun Rights , Nicholas J. Johnson

Faculty Scholarship

In this article, Professor Nicholas J. Johnson explores the parallels between the right of armed self-defense and the woman's right to abortion. Professor Johnson demonstrates that the theories and principles advanced to support the abortion right intersect substantially with an individual's right to armed self-defense. Professor Johnson uncovers common ground between the gun and abortion rights - two rights that have come to symbolize society's deepest social and cultural divisions - divisions that prompt many to embrace the abortion right while summarily rejecting the gun right. Unreflective disparagement of the gun right, he argues, threatens the vitality of the abortion …

State Regulation Of Managed Care And The Employee Retirement Income Security Act, Wendy K. Mariner

Faculty Scholarship

The federal Employee Retirement Income Security Act (ERISA)1 is the federal law that governs employee-benefit plans offered by private employers and unions. ERISA has long hindered state efforts to expand access to health care, because it prohibits states from requiring all employers to offer benefits to their employees.2 States have shifted their attention from seeking universal insurance coverage for health care to regulating the benefits of people who already have health insurance. Reports describing how some managed-care organizations limit the care provided to their enrollees have prompted a rash of legislative efforts intended to protect patients from receiving …

Funding Fairness: Public Investment, Proprietary Rights And Access To Health Care Technology, William M. Sage

Faculty Scholarship

In her accompanying Article, "Public Research and Private Development: Patents and Technology Transfer in Government-Sponsored Research," Professor Rebecca Eisenberg suggests that federal technology transfer policies should be reexamined in light of actual experience with patented technologies. Indeed, the relationship among federal research funding, patent law, and medical innovation has become more complicated in the years since the passage of the Bayh-Dole Act. Rising health care spending despite slowing overall economic growth has fostered the development of private sector managed care, has led to cutbacks in government support for both research and clinical services, and has increased the percentage of uninsured …