Health Law and Policy Commons^™

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 …

Blinded By Bioterrorism: Public Health And Liberty In The 21st Century, George J. Annas

Faculty Scholarship

In Blindness, Nobel Prize laureate Jos6 Saramago chronicles the quarantining of the first victims of a plague of blindness.1 We meet many people who become blind in Saramago's novel, including an opthamologist, a one-eyed man with an eye patch, and a man born blind. Saramago reminds us that we are all blind in one way or another, and that there are many things about ourselves and our society that we can't or won't see. The quarantine itself turns out to be isolating, inhumane, and degrading; the interred blind being portrayed by themselves and others as pigs, dogs, and "lame crabs." …

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 …

Independent External Review Of Health Maintenance Organizations' Medical-Necessity Decisions, Wendy K. Mariner

Faculty Scholarship

States may have more freedom to regulate the practices of managed-care organizations than many observers previously believed. In the absence of congressional action on the federal Bipartisan Patient Protection Act, the primary source of patient-protection legislation remains at the state level. Nevertheless, the federal Employee Retirement Income Security Act (ERISA) of 19742restricts state regulation of health maintenance organizations (HMOs) that serve private employee group health plans. On June 20, 2002, the U.S. Supreme Court, in Rush Prudential HMO, Inc. v. Moran, upheld an Illinois state law that requires binding independent external review when an HMO disagrees with the …

Protecting The Endangered Human: Toward An International Treaty Prohibiting Cloning And Inheritable Alterations, George J. Annas, Lori B. Andrews, Rosario M. Isasi

Faculty Scholarship

We humans tend to worry first about our own happiness, then about our families, then about our communities. In times of great stress, such as war or natural disaster, we may focus temporarily on our country but we rarely think about Earth as a whole or the human species as a whole. This narrow perspective, perhaps best exemplified by the American consumer, has led to the environmental degradation of our planet, a grossly widening gap in living standards between rich and poor people and nations and a scientific research agenda that focuses almost exclusively on the needs and desires of …

Medical Privacy And Medical Research: Judging The New Federal Regulations, George J. Annas

Faculty Scholarship

Americans support both protecting the privacy of medical records and encouraging medical research. Thus, it is not surprising that a move to change practices in these two areas has generated attention and comment. The new federal regulations, promulgated under the authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), were adopted to protect the privacy of medical records. They were not specifically designed to facilitate or limit medical research. Nonetheless, the regulations have prompted strong objections from the biotechnology industry and from academic medicine. The Association of American Medical Colleges and the Biotechnology Industry Organization have argued …

Bioterrorism, Public Health, And Civil Liberties, George J. Annas

Faculty Scholarship

The prospect of having to deal with a bioterrorist attack, especially one involving smallpox, has local, state, and federal officials rightly concerned. Before September 11, most procedures for dealing with a bioterrorist attack against the United States were based on fiction. Former President Bill Clinton became engaged in the bioterrorism issue in 1997, after reading Richard Preston's novel The Cobra Event. In Tom Clancy's 1996 Executive Orders, the United States is attacked by terrorists using a strain of Ebola virus that is transmissible through the air. To contain the epidemic, the President declares a state of emergency, orders that …

Foreword: Phase Ii Of The Genetics Revolution: Sophisticated Issues For Home And Abroad, Frances H. Miller

Faculty Scholarship

The distinguished health law and policy scholars we invite to contribute to the American Journal of Law & Medicine's annual symposium issue are given carte blanche to write about any aspect of the designated topic that appeals to them. The authors in this year's genetics symposium, The Genetic Revolution: Conflicts, Challenges and Conundra, are already well known for their work in the field-in fact three of them have just co-authored the only casebook specifically dedicated to the law, policy and ethics of geneticsl-and we deliberately asked them for relatively short pieces on the theory that taken together their articles would …

Moral Progress, Mental Retardation, And The Death Penalty, George J. Annas

Faculty Scholarship

Two major aspects of the death penalty in the United States directly involve physicians: how the death penalty is carried out and who is subject to execution. As a matter of constitutional law, both are governed by the prohibition against “cruel and unusual” punishment in the Eighth Amendment. The meaning of “cruel and unusual,” unlike every other part of the U.S. Constitution, is determined by public opinion as it reflects society's evolving standards of decency. With regard to how the death penalty is carried out, the role of physicians in capital punishment has been controversial for more than two decades. …

Cloning And The U.S. Congress, George J. Annas

Faculty Scholarship

In the immediate aftermath of the birth of Dolly the sheep, the national debate over the banning of human cloning focused almost exclusively on the issue of safety. President Bill Clinton's National Bioethics Advisory Commission, for example, recommended in 1997 that Congress impose a five-year moratorium on attempts to clone a human because of the likely physical harm to the cloned infant. Congress did not act on this suggestion, but even if it had, that moratorium would already be almost over. Cloning is now back on the congressional agenda, with a new focal point: the creation of cloned embryos for …

Medical Error Reporting: Professional Tensions Between Confidentiality & Liability, Wendy K. Mariner, Frances H. Miller

Faculty Scholarship

Improving patient safety depends on a sophisticated understanding of what can jeopardize it. Reports of adverse patient events and "near misses" constitute valuable information that can foster that understanding. Knowing what has gone wrong in the past facilitates the search for systems improvements, which can prevent recurrence. Unfortunately, providers have been generally unenthusiastic about reporting medical error, whether from a sense of shame, from a fear of liability and institutional sanctions, or from anxiety about reputation and relationships with peers. This Issue Brief lays out the factors that may affect reporting, and explores the limited evidence about whether providers' confidentiality …

The Hormesis Challenge For Environmental Health Regulators, Michael S. Baram

Faculty Scholarship

The hormesis hypothesis provides that human, animal or plant exposure to a low external dose of a hazardous chemical substance or physical agent may have beneficial health outcomes'. For example, human exposure to a precisely defined, low external dose of a carcinogenic pollutant in the workplace or ambient environment may lead to an internal dose or concentration, which stimulates a dormant defense mechanism that inhibits the growth of tumors.

Legal Issues In Hiv/Aids Prevention And Treatment In The Russian Federation – Summary And Conclusions Of The Boston University Hiv/Aids Project, Wendy K. Mariner

Faculty Scholarship

The Russia Federation faces an urgent need to control the spread of HIV. Although infection has been concentrated primarily among high risk groups so far, the risk that it will spread rapidly throughout the general population is growing daily. Controlling the HIV epidemic requires leadership and strategies that are somewhat different from traditional infectious disease control models because there is no vaccine yet available to prevent disease and people spread infection by engaging in activities that are hidden from public view and not susceptible to simple prohibitions.

Boston University conducted several studies as part of USAID’s HIV/AIDS Strategy to assist …

Trusting Doctors: Tricky Business When It Comes To Clinical Research, Frances H. Miller

Faculty Scholarship

This article examines the troublesome ethical dilemmas arising out of physician conflicts of interest in the context of research on human beings. It focuses on the inevitable conflict between the objectives of clinical investigators and those of their human subjects to illuminate subtle divergences of interest in doctor-patient relationships that patients often do not recognize - or want to believe. Once perceived, however, these potentially corroding conflicts can stun research subjects and their families, and leave them feeling deeply betrayed by their clinicians. The article concludes that a researcher's substantial financial conflicts constitute material information which, absent compelling circumstances, the …

The Role Of Law In Russian Health Reform: Report To The United States Agency For International Development, Wendy K. Mariner, Frank G. Feeley

Faculty Scholarship

True reform necessarily entails new law. In the newly independent Russian Federation, law has played a formative role in efforts to reform the health care system. Both historically and structurally, the health care system in Russia is more dependent on legal authorization than that in most Western industrialized countries. Reforms that providers might institute independently elsewhere are not likely to happen in Russia without specific laws authorizing them. Policy makers often formulate the substance of policy in the context of developing legislation, instead of drafting legislation to codify settled policy decisions. Thus, identifying and developing suitable laws has become an …

Genetic Testing For Susceptability To Disease From Exposure To Toxic Chemicals: Implications For Public And Worker Health Policies, Michael S. Baram

Faculty Scholarship

The Environmental Genome Program intends to identify "susceptibility genes" that would indicate if a person is more vulnerable to cancer or other disease as a result of exposure to certain chemicals in the workplace, the environment, foods, or other products. Research findings and the capability to test persons for such genes are likely to impugn and challenge health policies and regulatory programs that do not take genetic susceptibility into account when conferring health benefits and restricting chemical exposures. This article focuses on the Occupational Safety and Health Administration (OSHA) and discusses four options available to this agency for protecting genetically …

Health Care, Technology And Federalism, Kevin Outterson

Faculty Scholarship

The regulation of health care has traditionally been the province of the states, most often grounded in the police power. In Colonial times, this division of responsibility was a rational response to the technological level of the eighteenth century, although even in the youth of the Republic some health and safety regulation required national and international action. With the growth of distancecompression technology, the increase in mobility of goods and services, and a significant federal financial role in health care, the grip of the police power on the regulation of health care has been weakened. Discussion of the police power …

The Limits Of Law At The Limits Of Life: Lessons From Cannibalism, Euthanasia, Abortion, And The Court-Ordered Killing Of One Conjoined Twin To Save The Other, George J. Annas

Faculty Scholarship

The subject is law at the beginning and end of life. Most of my work is in the area of general health law: law and medicine, public health law, and health and human rights. But this is my favorite subject area, and I expect you to ask me the hardest questions you can. I am not saying I can answer them, but if I cannot that is my fault, not yours. I am going to make a pretty broad argument today about law and medicine; specifically about how new medical technology and medical practice standards have eclipsed religion (and sometimes …

The Limits Of State Laws To Protect Genetic Information, George J. Annas

Faculty Scholarship

During the 2000 presidential campaign, Al Gore characterized the DNA code as a secret code like that of the Nazis. In his words, “with the completion of the Human Genome, we are on the verge of cracking another enemy's secret code. When we intercept and decipher the coded messages that cancer sends from cell to cell, we will turn the tide, and win the war against cancer.” Gore was expanding the metaphor of the war on cancer, and commandeering the DNA code in the service of that metaphor. At about the same time, then president Bill Clinton called the DNA …

“Partial-Birth Abortion” And The Supreme Court, George J. Annas

Faculty Scholarship

Aortion has long been, and remains, the most politicized medical procedure in the United States. It has been the subject of more state and federal legislation than all other medical procedures combined. The U.S. Supreme Court, which almost never hears cases about medical procedures, has regularly heard cases over the past 25 years concerning the constitutionality of various state laws designed to limit abortion. Thus, it was only a matter of time before the Court would hear a case on the constitutionality of laws restricting so-called partial-birth abortion. When the Court heard a challenge to Nebraska's law, statutes relating to …

Slouching Toward Managed Care Liability: Reflections On Doctrinal Boundaries, Paradigm Shifts, And Incremental Reform, Wendy K. Mariner

Faculty Scholarship

Following the seemingly endless debate over managed care liability, I cannot suppress thoughts of Yeats’s poem, “The Second Coming.” It is not the wellknown phrase, “Things fall apart; the centre cannot hold,” that comes to mind; although that could describe the feeling of a health-care system unraveling. The poem’s depiction of lost innocence — “The best lack all conviction, while the worst/Are full of passionate intensity” — does not allude to the legislature, the industry, the public, or the medical or legal profession. What resonates is the poem’s evocation of humanity’s cyclical history of expectation and disappointment, with ideas as …

Quality Control, Enterprise Liability, And Disintermediation In Managed Care, John V. Jacobi, Nicole Huberfeld

Faculty Scholarship

The authors examine the potential of enterprise liability for managed care organizations in light of current health-care finance realities. They conclude that, despite the recent trend toward more loosely structured managed care organizations, such as disintermediated or patient-directed plans, plan-based enterprise liability best serves the goal of reducing medical injury by permitting a focus on entities with sufficient scope to translate liability pressure into support for systemic risk-reduction measures. Advancing plan-based enterprise liability in an era of disengaged managed care organizations will require an extension of tort liability to firms with little control but much influence over their business partners.

The Merger Between Public Health And Health Law – The Us Situation, Wendy K. Mariner

Faculty Scholarship

Law is an essential tool for protecting the public’s health. It is often the law that turns public health science into public health action. Sanitation, clean air and water, universal vaccination, injury prevention, tobacco control, drug policy, and a vast array of other interventions are achieved through a complex web of local, provincial and national statutes, regulations and judicial cases. The Institute of Medicine in the United States defines public health as “what we, as a society, do collectively to ensure the conditions in which people can be healthy.” And society acts collectively most often through law.

Thus, the merging …

Testing Poor Pregnant Women For Cocaine: Physicians As Police Investigators, George J. Annas

Faculty Scholarship

In 1989, Supreme Court Justice Thurgood Marshall surmised that “declaring a war on illegal drugs is good public policy . . . [but] the first, and worst, casualty of war will be the precious liberties of our citizens.” The same year, in the midst of President George Bush's “war on drugs,” the Medical University of South Carolina initiated a program to screen selected pregnant patients for cocaine and to provide positive test results to the police. At a time of high public concern about “cocaine babies,” this program seemed reasonable to the university and local public officials. Drug-screening programs in …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Conjoined Twins: The Limits Of Law At The Limits Of Life, George J. Annas

Faculty Scholarship

Conjoined twins have been the subject of scientific exhibits, medical study, human curiosity, and even entertainment, but until the year 2000, conjoined twins had never been the subject of a courtroom battle. A unique case that was the subject of two British court decisions deserves study.1 The case illustrates the difficulty of applying legal principles to unprecedented life-and-death decisions involving proposed medical interventions for children — particularly when parents and physicians disagree about what should be done.

What Recourse?—Liability For Managed Care Decisions And The Employee Retirement Income Security Act, Wendy K. Mariner

Faculty Scholarship

Should managed-care organizations be accountable to patients injured by the company's negligence or wrongdoing? The general rule is that all organizations, including managed-care organizations, are legally liable for causing personal injury as a result of their own negligence or the negligence of their employees or agents.1-4 However, as most observers of the U.S. health care system know by now, there is an exception to this basic legal rule of accountability. The Employee Retirement Income Security Act of 1974 (ERISA) has been interpreted to grant health benefit plans provided by employers or unions (and the managed-care organizations that sell or …

Ulysses And The Fate Of Frozen Embryos - Reproduction, Research, Or Destruction?, George J. Annas

Faculty Scholarship

On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there would be “no sailing home for him, no wife rising to meet him, /no happy children beaming up at their father's face.” Ulysses accordingly ordered his men to stop their ears with beeswax and bind him firmly to the mast and instructed them that if he gestured to be set free, they should stick to the original agreement and bind him tighter still. Making an agreement that has as a …

Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas

Faculty Scholarship

Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …

Symposium: Advances In Biomaterials And Devices, And Their Financing, Ronald A. Cass, Michael S. Baram, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …