Health Law and Policy Commons^™

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 …

Unemployment Insurance And Wealth Redistribution, Gillian Lester

Faculty Scholarship

This Article evaluates the merit of liberalizing unemployment insurance eligibility as a means to achieve progressive wealth redistribution-an idea that has recently gained popularity among policymakers and legal scholars. Unemployment insurance (UI) provides temporary, partial wage replacement to workers who suffer unexpected job loss, but it tends to exclude workers who have very low wages or hours of work, or who quit for reasons considered "personal" (for example, to accommodate family demands). Professor Lester argues that while redistribution to workers who are poor or who have caregiving obligations is a desirable goal, expanding UI is a poor way to do …

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.

Health Care Fraud And Abuse: A Tale Of Behavior Induced By Payment Structure, Arti K. Rai

Faculty Scholarship

The campaign to curtail "fraud and abuse" in the Medicare and Medicaid programs represents an attempt by regulators to evade more fundamental and difficult questions regarding cost and quality control. In the Medicare arena, tackling these larger questions will require dismantling the program's fee-for-service structure and imposing on providers financial incentives to evaluate carefully health care costs and benefits. Commentary on, David A. Hyman, Health Care Fraud and Abuse: Market Change, Social Norms and the Trust "Reposed in Workmen," 30 Journal of Legal Studies 531 (2001)

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 …

Regulating Research With Decisionally Impaired Individuals: Are We Making Progress?, Diane E. Hoffmann, Jack Schwartz, Evan G. Derenzo

Faculty Scholarship

No abstract provided.

Hormone Replacement Therapy, Or Just Eat More Meat: The Technological Hare Vs. The Regulatory Tortoise, Leticia M. Diaz

Faculty Scholarship

Is meat with its high fat content the real culprit, or is it the FDA-approved growth hormones, the same hormones that have been rejected in Europe, that should bear the blame? Why is eating less meat associated with a lower incidence of many types of cancer? Could it be chemical overload? American women are about five times more likely to develop breast cancer than are women in less developed countries.

Social Risk And The Transformation Of Public Health Law: Lessons From The Plague Years, Elizabeth B. Cooper

Faculty Scholarship

Acquired Immune Deficiency Syndrome (AIDS) was the wake-up call that disturbed America from its mid-twentieth century slumber concerning the dangers of communicable diseases. Until AIDS was identified in 1981, most Americans felt largely impervious to health threats posed by viruses or bacteria. Polio, smallpox, and tuberculosis had been brought under control by the "magic bullets" of antibiotics and vaccines." We felt more susceptible to the ravages of cancer or the debilitation of heart disease. But, over the last twenty years, the (re)emergence of serious or life-threatening microbial- based conditions such as Ebola, hantavirus, Lyme disease, West Nile virus, and even …

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 …

Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil

Faculty Scholarship

No abstract provided.

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Faculty Scholarship

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

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, …

Tobacco, The Food And Drug Administration, And Congress, Leonard H. Glantz, George J. Annas

Faculty Scholarship

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices. The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. The …

Adverse Drug Reactions: Harnessing Experiential Data To Promote Patient Welfare, Barbara A. Noah

Faculty Scholarship

Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of postapproval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization …

Introduction: Fifteenth Anniversary Of The Edward V. Sparer Public Interest Law Fellowship Program, Elizabeth M. Schneider

Faculty Scholarship

No abstract provided.

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …

Regulating Through Information: Disclosure Laws And American Health Care, William M. Sage

Faculty Scholarship

Efforts to reform the American health care system through direct government action have failed repeatedly. Nonetheless, an alternative strategy has emerged from these experiences: requiring insurance organizations and health care providers to disclose information to the public. In this Article, Professor Sage assesses the justifications for this type of regulation and its prospects. In particular, he identifies and analyzes four distinct rationales for disclosure. He finds that the most commonly articulated goal of mandatory disclosure laws-improving the efficiency of private purchasing decisions by giving purchasers complete information about price and quality- is the most complicated operationally. The other justifications-which he …

The Second Revolution In Informed Consent: Comparing Physicians To Each Other, Neil B. Cohen, Aaron D. Twerski

Faculty Scholarship

No abstract provided.

Standards Of Care And Standard Form Contracts: Distinguishing Patient Rights And Consumer Rights In Managed Care, Wendy K. Mariner

Faculty Scholarship

There is hardly a legislature in the country that is not currently debating the issue of patient rights in managed care. Not surprisingly, legislators, as well as reporters covering the debate, have called upon George J. Annas, Edward R. Utley Professor of Health Law and Chair of the Health Law Department at Boston University, for information and advice. Professor Annas has earned the title of "father of patient rights" for his decades of research, writing, and advocacy on behalf of individuals who need health care and deserve justice.

Today, however, one might ask whether patient rights are compatible with managed …

Genetic Privacy: There Ought To Be A Law, George J. Annas

Faculty Scholarship

If you don't believe in privacy, you probably don't believe in genetic privacy. I believe in privacy, including the constitutional right of privacy. But my interest is not to persuade you to believe in privacy, but rather to expose the major issues involved in genetic privacy. What makes genetic information different from other sensitive medical information? Are we getting carried away? Are we just treating DNA-based information differently because it is new?

Privacy In Genetics Research, Barbara Fuller, Mary Jo Ellis Kahn, P. A. Barr, L. Biesecker, E. Crowley, J. Garber, M. K. Mansoura, Patricia Murphy, J. Murray, J. Phillips, Karen H. Rothenberg, Mark Rothstein, J. Stopfer, Gary Swergold, B. Weber, Francis Collins, Kathy Hudson

Faculty Scholarship

No abstract provided.

Competing On Quality Of Care: The Need To Develop A Competition Policy For Health Care Markets, William M. Sage, Peter J. Hammer

Faculty Scholarship

As American health care moves from a professionally dominated to a marketdominated model, concerns have been voiced that competition, once unleashed, will focus on price to the detriment of quality. Although quality has been extensively analyzed in health services research, the role of quality in competition policy has not been elucidated. While economists may theorize about non-price competition, courts in antitrust cases often follow simpler models of competition based on price and output, either ignoring quality as a competitive dimension or assuming that it will occur in tandem with price competition. This unsystematic approach is inadequate for the formulation of …

"Being Human": Cloning And The Challenges For Public Policy, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Physicians As Advocates, William M. Sage

Faculty Scholarship

The principal theme of this Article is that many dimensions of physicians' advocacy in managed care remain to be established, and those dimensions may turn out to be inconsistent with one another or with normative goals for the health care system. Specifically, attempting to map physician behavior onto an advocacy template created for lawyers raises three difficult questions. First, given the undisputed importance of clinical expertise to an efficient health care system, should physicians' primary role be to advocate for causes or to direct the provision of care? Second, would the medical professions' reputation for independent competence withstand the adversarial …

Social, Legal, And Ethical Issues, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Municipal Home Rule In New York: Tobacco Control At The Local Level,, Laura Hermer

Faculty Scholarship

This paper will examine the nature and scope of the ability of both municipalities and local public health departments to govern the local sale, use, availability and advertising of tobacco products in the context of New York state law and the recent Multistate Settlement Agreement.

Part I will begin with a description of municipalities in New York and a summary of the provisions of article 9 of the New York Constitution and section 10 of the state Municipal Home Rule Law, which delimit spheres in which municipalities may act without state interference and others in which the state may act …

Stem Cell Politics, Ethics And Medical Progress, George J. Annas, Arthur Caplan, Sherman Elias

Faculty Scholarship

Controversy over how to fund and regulate stem cell research continues in the US and is unlikely to be resolved anytime soon. The National Institutes of Health (NIH) has announced that it is prepared to fund stem cell research under yet-to-be-specified guidelines. The National Bioethics Advisory Commission (NBAC) issued a report on stem cells in mid-September, recommending that Congress change the law to permit the derivation and use of stem cells from embryos no longer needed for reproduction purposes that are stored at in vitro fertilization (IVF) clinics. The NBAC also recommended that the Department of Health and Human Services …