Judges, like lawyers, love to make disclaimers. So, at the outset, I disclaim any expertise in medicine or bioethics. My views are those of a generalist, a judge who has been required to decide cases involving bioethical questions such as the termination of medical treatment.

As Chief Judge Wachtler has explained, the New York Court of Appeals, like the Supreme Court of Missouri in Cruzan, has decided to require clear and convincing evidence before permitting the termination of life-sustaining treatment for an incompetent patient who is not terminally ill. Other courts, including the New Jersey Supreme Court, have reached a different conclusion.

It is not my purpose today to persuade you that the position of our court is correct. Instead, I propose to look at the Cruzan case to see what it does and does not tell us about the identity of the decision-maker and the standard for decision-making in the termination-of-medical-treatment cases.

International guidelines regarding ethics, and in particular the ethics of clinical research, are problematic on two broad levels. First, by asserting their universality, “international” guidelines obscure real and legitimate crosscultural differences in ethical expectations. International guidelines seek to make homogeneous something which is not necessarily so. Second, existing guidelines are ambiguous about their objectives and purposes. On the one hand, guidelines are structured as a set of goals, largely aspirational in language and content. But on the other hand, such guidelines also suggest a normative function, providing a set of standards by which to judge and, if appropriate, sanction investigators’ conduct.

These criticisms are not intended to argue that international guidelines are useless. Nor are they intended to question the good faith under which such guidelines are developed. Rather, we wish to suggest that the role of present international guidelines is somewhat more limited than is ordinarily appreciated.

With the identification of HIV as the etiological agent responsible for AIDS in 1984, it became clear that an understanding of the dimensions of the epidemic would require more than a careful detailing of the incidence and prevalence of overt symptoms of AIDS. To enable public health authorities to target and evaluate preventative interventions and plan for the health care services that would be required in the future as the infected progressed to symptomatic conditions, knowledge of the incidence and prevalence of HIV infection was critically needed.

This paper discusses the obligation of acute care hospitals and emergency services to treat patients. Since care rendered in these settings is, of necessity, provided by health care professionals, not buildings or programs, the obligation may be twofold. First, are there obligations for hospitals and emergency services to offer treatment? Second, do health care professionals practicing in these settings have an independent obligation to treat? How has the Supreme Court decision in Cruzan affected these obligations?

The tradition in this country has been that private hospitals had no obligation to treat patients, as opposed to public hospitals which were frequently set up for the very purpose of treating patients who had no other access to care. Over the years, statutes and case law have limited the rights of private hospitals and physicians to refuse to treat patients.

Just over a year has elapsed since the decision of the Supreme Court of the United States in Cruzan. In the year prior to and since the decision there have been a substantial number of articles in the medical literature that have discussed the possible impacts of the decision on medical care along with suggestions as to how to avoid the more onerous consequences. These analyses are constrained by the lack of any direct measurements, an activity that is itself complicated by other events such as the publicity surrounding episodes of assisted suicide and so-called mercy killing. In this paper we will limit our focus to how the decision in Cruzan is likely to affect the doctor-patient relationship, especially in the critical activities surrounding decision-making about the use of life sustaining treatments.

“All things considered, I chose what was best for my children, or what I thought was best…” confessed Jean- Jacques Rousseau in 1782. What more can one expect from a parent or a professional entrusted with decisions about children? What Rousseau thought was “best” for each of his five infants, however, was to dispatch them to foundling homes in Paris, without even keeping a record of their birthdates, thus leaving them to an unknown but probably dismal fate.

Acting from moral and often legal obligations to protect vulnerable persons from harm and to enhance their welfare, adults daily make decisions about and for children. Professionals and policy makers fulfill their social responsibilities by creating and implementing policies and practices that enable children's caregivers to fulfill these same goals.

We presently are not really leaving withdrawal of treatment decisions to families and there are good reasons why we ought not to do so. To see why this is, we need to focus on what is special about PVS cases as opposed to other kinds of medical cases in which we are forced to make life and death decisions.

One thing which is very special about PVS is the fact that it is a condition which intuitively pushes us to rethink, once again, society's definition of “death.” We have already changed our definitions of death to include situations in which respiration and circulation continue but the “whole brain” is dead. Defining death to include irreversible PVS would merely require extending the definition to include situations where the brain stem is functioning but the neocortex is dead. There are, of course, obstacles to overcome in extending the definition in that fashion.

Lilienfeld and Lilienfeld have defined epidemiology as “the study of the distribution of a disease or physiological condition in human populations and of the factors that influence this distribution.” Epidemiology is an eclectic discipline, utilizing statistics, sociology, and biology of the study of disease populations. Epidemiological studies can help explain the etiology of a specific disease; they can evaluate the consistency of epidemiologic data with etiological hypotheses and provide a basis for developing or evaluating preventive procedures and public health practices.

The consultation for the Development of International Guidelines for Epidemiological Research and Ethical Review Procedures assembled in Geneva in November 1990 offered basic principles that should apply to epidemiological and clinical research. The principles provide the basis for discussion here.

Providing protection for the rights and welfare of two categories of research subjects in epidemiologic research must be a matter of serious concern to those who design, conduct and disseminate findings of epidemiological research.

I want to approach this difficult topic not from the professional perspective of a lawyer, but rather as the person I am in multiple relationships: wife, mother, step-mother, daughter, and step-daughter. I would suggest to you that none of us can avoid thinking about the role of families in making decisions for incompetent patients without viewing the questions that arise through lenses created by the roles we play in multiple relationships. I would also suggest to you that none of us can avoid thinking about the possibility of becoming incompetent ourselves without thinking about the relationships we have with our families.

My remarks here will be addressed primarily to the Cruzan decision, so they will be most obviously applicable to patients in a persistent vegetative state. However, I intend for my reflections to apply to decision-making about all incompetent adult patients.

The HIV epidemic has led to a reassessment of attitudes regarding public access to new therapeutic agents for the treatment of life-threatening and severely debilitating diseases. People with AIDS and their advocates have relentlessly attacked the process by which new drugs are developed and approved for marketing in this country, a process characterized as overly conservative, risk-averse, and paternalistic. In response to growing pressure to accelerate access to important new therapeutic agents, the Food and Drug Administration (FDA) has issued several bold initiatives designed to facilitate the development of experimental drugs used in the treatment of serious or immediately life-threatening diseases.

The clinical testing and regulatory review of new therapeutic agents in the United States are lengthy processes. A recent analysis of new chemical entities (NCE) approved by the FDA in 1987,1988, and 1989 has revealed that, on average, the clinical development phase for new drugs exceeds five years (63 months).

Here's what was sitting on my desk on my first day of work for Senator Jack Danforth last summer:

August 19

Liz-

Here is something you can start on when I am in Wyoming. Maybe you could begin pulling together some thoughts and material. Perhaps someone at YDS could give you some help. However, please don't attribute any conclusions to me as I have none.

What are the ethics of extending the length of life?

We cannot artificially end life (thou shalt not kill), but how about artificially extending life? Is that always good, sometimes good?

Is it good to extend the life of a senile 90 year old who wears diapers? How about “neonatal care”—for a baby who would otherwise die? What's the difference in these two cases, or should we have a difference?

In ethics, is keeping people alive the highest good? Should our priority be to keep people breathing?

Is it “playing God” to make distinctions on the basis of quality of life? Do we owe a lesser degree of care to the comatose patient than someone else?

In Cruzan, the Supreme Court held that the refusal of treatment is a constitutionally protected right and that the methods for permitting its exercise should be crafted by the laboratory of the states. In June 1990, when the court ruled, there already existed a large and complex body of law concerned with the refusal of treatment which differed, sometimes considerably, from state to state. Generally, withholding or withdrawing life-sustaining treatment has been accepted by the states, but different systems of justification have been used.

Competent people are able to make decisions to refuse any form of medical treatment, regardless of their medical condition; competent people can also prepare written instructions describing the medical treatment they would want to receive in the future if incompetent, which have been endorsed by both state courts and legislatures.

Three years ago I first surveyed state court decisions and laws governing the withholding or withdrawal of medical treatment. The decision of the United States Supreme Court in Cruzan v. Director, Missouri Department of Health on June 25, 1990, makes it timely to review again state law developments because a majority of the Court announced in Cruzan that it will leave to the states the question of what legal requirements may be imposed on decisions to discontinue treatment for incompetent patients. Justice Rehnquist, writing for the majority, explained that the Court's deference to state decision-making is grounded in the fact that “state courts have available to them for decision a number of sources—state constitution, statutes, and common law—which are not available to US.” Although the opinion makes clear that Missouri might have authorized the family of Nancy Cruzan to decide to terminate medical treatment for her, a majority of the Supreme Court refrained from holding that Missouri is constitutionally required to do so.

For a dozen years, my clinical practice has been largely with dying patients, my academic pursuits have focused on medical ethics, and my public service has been mostly at the interface of medicine and law. One would think that I would have “done the right thing” long ago and signed a living will. I have not. This essay is meant to illuminate my reasons. Some of my reasons may apply to others, and I will also mention some concerns that affect others but not me. However, I do not oppose the growth and development of advance directives. Rather, I hope to open the public and professional discussion of how to make decisions for incompetent adults in order to include more varieties of formal and informal advance directives and to force policy-makers to consider how to make decisions for incompetent adults who have no advance directives.

As a physician, I do use advance directives, both formal and informal, with many patients in all of my clinical settings.

This is the first in a projected series of periodic reports on international legal developments relating to reproductive health. It follows an introductory essay on abortion law developments in the industrialized world, which appeared in the Winter 1990 issue of Law, Medicine & Health Care. The major focus of this report is again abortion, the reproductive health issue with the highest international legal profile. Like its predecessor, it discusses the consequences of the withering away of Communism in Eastern Europe—in this case Czechoslovakia, the German Democratic Republic, and Poland—as well as the effects of major liberalization of abortion law in Belgium and Canada and the approval by France of use of the abortion-inducing drug RU-486.

Nationally, the number of hospital ethics committees grew dramatically during the 1980s. The motivation for establishing such committees, however, was not only internal but included court cases, federal regulations and a Presidential Commission report urging the establishment of such committees by hospitals.

While each of these external forces added to the pressures for hospitals to establish their own ethics committees, the establishment of these committees was voluntary in every state until 1987 when the Maryland Patient Care Advisory Committee Act became effective. The Act requires all hospitals within Maryland to establish their own patient care advisory committees or ethics committees, as most hospitals refer to them. Specifically, the Act provides that at the request of a petitioner, these committees must offer advice in cases involving individuals with life-threatening conditions. The committee must consist of at least four members, including a physician, a nurse, a social worker, and a hospital's chief executive officer or designee.