Health Law and Policy Commons^™

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 …

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 …

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, …

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 …

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 …

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 …

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?

Burden Of Proof: Judging Science And Protecting Public Health In (And Out Of) The Courtroom, George J. Annas

Faculty Scholarship

The breast implant cases alleging systemic disease would in all likelihood have been lost had recipients been properly warned of potential dangers by the manufacturer or their surgeons.

Preface: Electronic Medical Information: Privacy, Liability And Quality Issues, Frances H. Miller

Faculty Scholarship

This symposium issue explores the timely topic of health care information and information technology, and their impact on health care delivery. The potential for mischief in this area has been the subject of many a dire prediction, but documented instances of negligence or abuse are thus far relatively rare. As information technology becomes more and more sophisticated and pervasive, however, legal problems are increasingly possible-if not probable-and these articles examine a wide range of issues related to the phenomenon.

The Last Resort: The Use Of Physical Restraints In Medical Emergencies, George J. Annas

Faculty Scholarship

Public awareness of the use of restraints in medicine has been greatly heightened by a five-part investigative series on physical restraints in psychiatric hospitals by the Hartford Courant and reaction to it by Connecticut's U.S. senators, Joseph Lieberman and Christopher Dodd. In October 1998 the Courant 's 50-state survey identified 142 patients who had died while in restraints or seclusion in the past decade, and the total number is probably much higher. The newspaper advocated the need for national standards for the use of restraints, impartial oversight, and accountability “for behavior that is cruel and even criminal.” The use of …

Waste And Longing: The Legal Status Of Placental Blood Banking, George J. Annas

Faculty Scholarship

Waste is not always what it seems. In his Cold War novel Underworld, for example, Don DeLillo explores the multifaceted qualities of waste. “Waste,” he notes, “is the secret history, the underhistory, the way archaeologists dig out the history of early cultures, every sort of bone and broken tool, literally from under the ground.”1 And waste can also be transformed into money:

They are trading garbage in the commodity pits in Chicago. They are making synthetic feces in Dallas. You can sell your testicles to a firm in Russia that will give you four thousand dollars and then remove …

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Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …

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 …

Medical Ethics And Human Rights: Legacies Of Nuremberg, George J. Annas, Michael A. Grodin

Faculty Scholarship

Many of our most important human rights documents are the product of the world's horror during the carnage of World War II. The broadest and most powerful declaration of human rights, the Universal Declaration of Human Rights, was adopted by the membership of the new United Nations in 1948. But there are also much more specific statements of the world's aspirations for all of its inhabitants. August 1997 marked the 50th anniversary of the conclusion of the trial of Nazi physicians at Nuremberg, a trial which has been variously designated as the "Doctors' Trial" and the "Medical Case."² In …

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, …

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 …

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.

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 …

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 …

Liability For Managed Care Decisions: The Employee Retirement Income Security Act (Erisa) And The Uneven Playing Field, Wendy K. Mariner

Faculty Scholarship

As managed care organizations expand their programs of quality assurance and physician evaluation, more medical malpractice lawsuits may be brought against managed care organizations on the ground that, like hospitals, they are legally responsible for negligent corporate acts that injure patients. However, the federal Employee Retirement Income Security Act (ERISA) shields managed care organizations from liability when they are part of an employee group health plan governed by ERISA. Unlike patients with other types of insurance, patients in ERISA health plans do not have a malpractice remedy for a managed care organization's negligence. A few federal appeals courts recently recognized …