Health Law and Policy Commons^™

Getting To Market: The Scientific And Legal Climate For Developing An Aids Vaccine, Wendy K. Mariner, Robert C. Gallo

Faculty Scholarship

Expectations of a vaccine to prevent acquired immunodeficiency syndrome (AIDS) are rising. Not only are the prospects for an effective immunogen improving, but immunization appears to hold the greatest promise for halting the spread of infection and disease.' Identification of the causal agent-the retrovirus called HTLV-III, LAV, or generically, HIV (human immunodeficiency virus)-has provided the direction and limited the options for containing the disease.

Prevention is, of course, critical where the disease must be presumed to be fatal in all cases. Although there is no clear evidence that any single exposure to HIV will result in infection or disease, prudence …

Surrogate Parenthood, George J. Annas, John Robertson

Faculty Scholarship

Does a surrogate mother have the right to change her mind? Not according to the Baby M court, which enforced a $10,000 contract between Mary Beth Whitehead and William and Elizabeth Stern that it found was "in the best interests of the child." The decision is now on appeal before the New Jersey Supreme Court.

The case has produced sharply divided reaction-some denounce surrogate arrangements as Orwellian while others see them as a boon to childless couples.

George Annas, a professor of health law at Boston University's School of Public Health, would void these contracts on policy grounds. He believes …

Trying To Live Forever, George J. Annas

Faculty Scholarship

Since the case of Karen Ann Quinlan, legal actions regarding the dying have become commonplace. Unfortunately, so has legal misinformation, misapplication, fantasy, and inhumanity. We seem to have frightfully underestimated the ability of lawyers to focus on trivia and self protection, and to ignore the basic human rights of dying persons. As the authors of the Hasting Center's Guidelines declare in the introduction:

Hospital legal counsel, lawyers serving other health care institutions, and legal advisors to individual health care professionals have a critical role to play in seeing that medicine is not driven by law, and health care professionals are …

Protecting The Liberty Of Pregnant Patients, George J. Annas

Faculty Scholarship

We are seeing the beginning of an alliance between physicians and the state to force pregnant women to follow medical advice for the sake of their fetuses. No irreversible commitments to such an alliance have yet been made, but only a principled discussion of the issues is likely to prevent forced treatment from becoming standard medical practice.

In her futuristic novel The Handmaid's Tale, Margaret Atwood envisions a world in which physicians and the state combine to strip fertile women of all human rights. These women come to view themselves as "two-legged wombs, that's all; sacred vessels, ambulatory chalices." …

The Nuclear Regulatory Commission's Regulation Of Radiation Hazards In The Workplace: Present Problems And New Approaches To Reproductive Health, Neal Smith, Michael S. Baram

Faculty Scholarship

On December 20, 1985, the Nuclear Regulatory Commission (NRC) proposed revisions to its Standards for Protection Against Radiation [hereinafter Standards].¹ If adopted, the new Standards will provide additional protection for millions of workers and their unborn children. The effects of the Standards will extend, however, far beyond the health of those exposed to radiation. Specifically, the NRC's proposal may provide a new paradigm for regulating health hazards that have no safe threshold level of exposure. It will also focus debate on whether or not women should be precluded from working in fetotoxic environments

Informed Consent For The Man On The Clapham Omnibus; An English Cure For The "American Disease"?, Frances H. Miller

Faculty Scholarship

No abstract provided.

Made In The U.S.A.: Legal And Ethical Issues In Artificial Heart Experimentation, George J. Annas

Faculty Scholarship

The death of William Schroeder in Louisville, Kentucky, on August 6, 1986, brought to a close a remarkable chapter in public human experimentation. Artificial heart implants represent the most public experiments in the history of the world. The manner in which they are conducted is a matter of utmost public and professional concern, since it graphically portrays the seriousness with which we take our laws and ethical rules regarding the protection of the rights and welfare of human subjects. Unfortunately, the brief history of artificial heart implants is neither a happy nor a proud one. Begun with high hopes and …

Confronting The Immunization Problem: Proposals For Compensation Reform, Wendy K. Mariner, Mary E. Clark

Faculty Scholarship

After decades of reports on the need for considered
public policy on immunization,' it is time for action. The
"problem" of immunization is complex, but the constituent complexities have been recognized for years. In a recent report on Vaccine Supply and Innovation, the Institute of Medicine referred to vaccines as "an elegant solution to one of the perennial problems of the human race-infectious
disease." Vaccines are effective, inexpensive, simple to produce, and easy to deliver. They have succeeded in quelling the threat to public health of such formerly devastating diseases as smallpox, poliomyelitis, and diphtheria. Today, however, the prospects for …

The Painful Prescription: A Procrustean Perspective?, Frances H. Miller, Graham A.H. Miller

Faculty Scholarship

The United States and Great Britain have often been called two countries divided by a common language. In the field of medicine, common language facilitates comparisons, but it can obscure basic value differences as well. Henry Aaron, Ph.D., and William Schwartz, M.D., in their influential book The Painful Prescription: Rationing Hospital Care,1 analyzed how and why Britain (as compared with the United States) has apparently limited the use of such high-technology procedures as kidney dialysis, CT scans, coronary-artery surgery, x-ray films, and intensive care beds. The authors then speculated about whether similar responses will be forthcoming in this …

The Right Of Elderly Patients To Refuse Life-Sustaining Treatment, George J. Annas, Leonard H. Glantz

Faculty Scholarship

Some legislation, such as law permitting living wills, has addressed the problem of decisions regarding life-sustaining treatment for the elderly. Most of the developing law on the subject is, however, being made by the courts, often in prospective decisions about treatment. These rulings have followed a variety of approaches to the ends of protecting incompetent patients and enforcing the right of the competent to make their own decisions.

Access To Health Care And Equal Protection Of The Law: The Need For A New Heightened Scrutiny, Wendy K. Mariner

Faculty Scholarship

Proposals to reduce national expenditures for health care under Medicare and other programs raise questions about the limits on legislative power to distribute health care benefits. The constitutional guarantee of equal protection has been a weak source of protection for the sick, largely because they fail to qualify for special scrutiny under traditional equal protection analysis. Recent decisions of the United States Supreme Court suggest that the Justices seek a newer, more flexible approach to reviewing claims of unequal protection. This Article examines the application of the equal protection guarantee to health-related claims. It argues that traditional equal protection analysis …

Prospective Payment For Hospital Services: Social Responsibility And The Limits Of Legal Standards, Wendy K. Mariner

Faculty Scholarship

The author advances the argument that Diagnosis Related Groups (DRGs) should be recognized as a health care resource allocation technique. In addition, the author offers four societal goals as a gauge for measurement of DRG performance and reviews the incentives and disincentives connected with utilization of DRGs in health care allocation. Finally, the author examines the dichotomous attitudes toward health care distribution which are present in society today. The author's primary goal is to illustrate the potential inequities which could result from allowing DRGs to force allocation of health resources without any reference to social responsibility issues.

Regulating Heart And Liver Transplantation, George J. Annas

Faculty Scholarship

Organ transplantation has been a favorite topic of health lawyers since its inception. Organ procurement was addressed with the adoption of the Uniform Anatomical Gift Act in all fifty states, and "brain death" has been recognized both judicially and legislatively across the United States. Nonetheless, it is now apparent that the major problems in organ transplantation are not legal in nature, and thus neither are the solutions. Heart and liver transplants are extreme and expensive medical interventions that few individuals can afford and few hospitals can offer. In an era of economic scarcity, how (if at all) should organ transplant …

Regulating Heart And Liver Transplants In Massachusetts: An Overview Of The Report Of The Task Force On Organ Transplantation, George J. Annas

Faculty Scholarship

Organ transplantation has been a favorite topic of health lawyers since its inception. Organ procurement was addressed with the adoption of the Uniform Anatomical Gift Act in all fifty states, and "brain death" has been recognized both judicially and legislatively across the country. Nonetheless, it is now apparent that the major problems in organ transplantation are not legal and thus neither are their solutions. Heart and liver transplants are extreme and expensive interventions that few individuals can afford and few hospitals can offer. In an era of economic scarcity, how (if at all) should organ transplant procedures and other extreme …

Competence To Refuse Medical Treatment: Autonomy Vs. Paternalism, George J. Annas, Joan E. Densberger

Faculty Scholarship

The right to refuse medical treatment is universally recognized as a fundamental principle of liberty. Nonetheless, the right is often infringed upon by paternalistic physicians who either use too narrow a definition of competence, or misunderstand or ignore the patient's liberty interest in freedom from coerced medical interventions. A careful consideration of competence in the medical care setting leads to a conclusion that it can best be assessed by determining the patient's ability to understand the information necessary to provide informed consent to treatment. If a patient has this capacity, both his consent and refusal must be honored. Placing competence …

Refusal Of Lifesaving Treatment For Minors, George J. Annas

Faculty Scholarship

I feel very comfortable talking about human rights, civil rights, the role of individual privacy, autonomy, and dignity in making decisions about oneself. Yesterday's topics concerning adults and privacy, however, were much easier than today's, which deal with children. It's not difficult to argue for the right of competent adults, whether it be in Texas' or California,2 to make their own decisions. As much as we may or may not agree with their decisions, at least arguing that -competent individuals like Dax Cowart and Elizabeth Bouvia have a right to make their own decisions makes a lot of sense; the …

Biological Monitoring: The Employer's Dilemma, Frances H. Miller

Faculty Scholarship

The industrial workplace contains many potential health hazards that not only can cause great harm to workers, but also can destroy the employers’ economic stability. Often these hazards are documented and dealt with, but frequently they are unknown. When health-conscious employers monitor the physical well-being of their employees in an effort to avoid the terrible personal and economic costs these hazards can produce, they may be supplying their employees with the documentation necessary to recover financially for their industrial illnesses.

This Article analyzes this dilemma confronting employers. It describes the many factors employers must consider when deciding whether to institute …

In Vitro Fertilization And Embryo Transfer: Medicolegal Aspects Of A New Technique To Create A Family, George J. Annas, Sherman Elias

Faculty Scholarship

IVF and ET conjure up a variety of images, from "test tube babies" to Steven Spielberg's extraterrestrial. Indeed, it is sometimes difficult to separate science fiction from scientific reality. Nonetheless, the extracorporeal fertilization of a human egg followed by transfer to a human uterus and birth of a child, has been repeated in a number of countries around the world. In vitro fertilization (IVF) and embryo transfer (ET) are now reality.' Most of us applauded this new technology along with the parents of the resulting children. These infertile couples were able, with the help of IVF, to have their own …

The Right To Refuse Treatment: A Model Act, George J. Annas

Faculty Scholarship

Although the right to refuse medical treatment is universally recognized as a fundamental principle of liberty, this right is not always honored. A refusal can be thwarted either because a patient is unable to competently communicate or because providers insist on continuing treatment. To help enhance the patient's right to refuse treatment, many states have enacted so-called "living will" or "natural death" statutes. We believe the time has come to move beyond these current legislative models, and we therefore propose a Model Act that clearly enunciates an individual's right to refuse treatment, does not limit its exercise to the terminally …

Mandatory Pku Screening: The Other Side Of The Looking Glass, George J. Annas

Faculty Scholarship

The challenge that PKU screening programs face is to be effective without sacrificing individual liberty. Most states have assumed that this is impossible, and have enacted mandatory PKU screening tests. It now appears that in fact voluntary screening for PKU can be effective. Accordingly, it seems appropriate to reexamine existing mandatory screening statutes to determine if we can replace government coercion with voluntary informed consent. Focus should be placed on the proper role of the government in screening, and on improving the consent process, and not on those few couples who withhold consent.

The Emerging Stowaway: Patients' Rights In The 1980s, George J. Annas

Faculty Scholarship

At one point in Edgar Allan Poe's Narrative of Arthur Gordon Pyr of Nantucket, Pym, who has stowed away in the hold of a whaling vessel, believes he has been abandoned and that the hold will be his tomb. He expressed sensations of "extreme horror and dismay," and "the most gloomy imaginings, in which the dreadful deaths of thirst, famine, suffocation, and premature interment, crowded in as the prominent disasters to be encountered."

Report On The National Commission: Good As Gold, George J. Annas

Faculty Scholarship

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the Commission's researcher-dominated composition which permitted it to assume that (1) research is good; (2) experimentation is almost never harmful to subjects; and (3) researcher-dominated IRBs can adequately protect the Interests of human subjects. The successor Presidential Commission can learn much by reexamining these premises.

The Case For Medical Licensure, George J. Annas

Faculty Scholarship

Locke et al. argue elsewhere in this issue that medical licensure should be abolished. Their reasoning is direct and seductive - but their free market cure is worse than the disease they describe. Their major premise, for example, is simply wrong: "Any governmental action that violates individual rights is improper." For this notion they cite the ultraconservative novelist Ayn Rand who talks about things that are "right" for humans to do. But there are two confusions: (I) rights do not exist in a vacuum; in an interdependent society the rights of individuals must sometimes be balanced against the rights of …

How To Make The Massachusetts Patients' Bill Of Rights Work, George J. Annas

Faculty Scholarship

The movement for enhanced patients' rights is based on two premises: (I) citizens possess certain rights that are not automatically forfeited by entering into a relationship with a physician or health care facility; and (2) most physicians and health care facilities fail to recognize these rights, fall to provide for their protection or assertion, and limit their exercise without recourse.

The primary argument against patients' rights is that patients have "needs" and defining these needs in terms of rights leads to the creation of an unhealthy adversary relationship.' It is not, however, the creation of rights, but the disregard of …

Fathers Anonymous: Beyond The Best Interests Of The Sperm Donor, George J. Annas

Faculty Scholarship

Alex Haley concludes his international best seller, Roots, with the burial of his father in Little Rock, Arkansas. Walking away from the graveside he ponders the past generations, observing "I feel that they do watch and guide." The book inspired whole industries devoted to the development of family trees, and locating one's "roots" has become somewhat of an obsession with many. Because of the current secrecy surrounding the practice of Artificial Insemination Donor (AID), there are an estimated 250,000 children conceived by AID (at the rate of 6-10,000 annually in the United States) who will never be able to find …

The Care Of Private Patients In Teaching Hospitals: Legal Implications, George J. Annas

Faculty Scholarship

In Herman Melville's novel Moby Dick Ishmael searches for knowledge in diverse ways; he views the world not only through his senses but symbolically and metaphorically. At one point, he is tied to the pagan harpooner Queequeg by a "monkey-rope," and it is his duty to use this rope to pull Queequeg free from the sharks surrounding the dead whale that Queequeg is butchering when Queequeg slips from his perch atop the whale. Should he fail, Queequeg's weight will pull them both into the shark-filled waters. Ishmael ponders: "I seemed distinctly to perceive that my own individuality was now merged …

Reconciling Quinlan And Saikewicz: Decision Making For The Terminally Ill Incompetent, George J. Annas

Faculty Scholarship

One of the most perplexing problems in the medicolegal field concerns the criteria on which decisions not to treat terminally ill incompetent patients should be made. These decisions traditionally have been made by physicians in hospitals-sometimes with the assistance of the patient's family-on the basis of their perceptions of the patient's "best interests." Recently, two state supreme courts have ruled on this question. The New Jersey Supreme Court, in the Quinlan case, developed a medical prognosis criterion, and permitted the patient's guardian, family, and physicians to apply it with the concurrence of a hospital "ethics committee." The Massachusetts Supreme Judicial …

Where Are The Health Lawyers When We Need Them, George J. Annas

Faculty Scholarship

A momentous event in the field of health law occurred in April of 1978: the first national meeting of teachers of health law was held at Boston University. Of sixty individuals invited, almost all of whom teach health law as a full-time profession in various graduate schools, forty-five participated in the two-day workshop. While that response alone may have revealed the answer, the first topic on the agenda was: "Is health law a discipline?"

Judges At The Bedside: The Case Of Joseph Saikewicz, George J. Annas

Faculty Scholarship

In what may prove to be the most controversial medicolegal decision of the year, the Massachusetts Supreme Judicial Court has ruled that, in certain cases, courts are the proper forum in which life-sustaining medical decisions should be made.1 The controversy goes deep. It involves questions of who should make life-prolonging decisions, in what forum, and on what criteria. Until the last few years, these questions arose almost exclusively in the context of Jehovah's Witnesses cases - cases in which life-saving blood transfusions were being refused for religious reasons. But with society's increasing consciousness about the way people die in hospitals, …

The Rights Of The Employee As Patient, Frances H. Miller

Faculty Scholarship

No abstract provided.