LAW AND BIOETHICS

Bioethics began as, and remains, an interdisciplinary field. If developments in biology and medicine have fueled the bioethics train and philosophy has laid down the tracks on which it has run, then law has been the engineer at the controls of the locomotive and statutes and court decisions have thrown the switches that guided the train through the rail yards. Law's influence on bioethics has been so pronounced as to be unmistakable, yet so pervasive as sometimes to be unnoticed.

It might be argued that law's role was pronounced for purely historical reasons: Bioethics began as an American phenomenon and hence was shaped by certain aspects of American culture. Lacking an established church or a single heritage of values, though committed to the rule of law and to the equality of all persons, Americans have a habit of turning to courts to resolve moral conflicts. Moreover, other features of the terrain also indicated a major role for the law. Bioethics frequently presents central civic issues, among them these: When does a human entity first become (or cease being) a legal person? What conduct of healthcare professionals treating incurably ill patients would constitute murder? May parents be paid for transferring to other persons the rights of custody and control over their children? Does the prospect of gaining knowledge of potential benefit to the community ever justify using people without their consent or even their knowledge?

Dependence on the legal system to settle many ethical and social issues generated by medicine and the life sciences does more than merely provide a means for resolving disputes. Reliance on the legal system denotes that an issue should be understood as having two opposing sides that will do battle for their respective rights to act in a particular fashion or to restrain the other side from acting in a contrary fashion. Moreover, as a means of discovering and articulating principles, the law favors certain implicit and explicit values.

The relationship of law and bioethics has not, however, been unidirectional: Bioethics has also affected the law. While much of law is concerned with commerce and institutions, both public and private, bioethics is essentially about people and about the fundamental choices that determine and even define their lives. If the law has brought to bioethical cases an attention to rights and procedure, bioethics has enriched legal analysis with life-and-death dramas. It would strain the point to say that medicine saved the law, as Stephen Toulmin observed medicine did for philosophy. But the ethical dilemmas arising from medicine and its associated scientific disciplines have helped to humanize the law, providing a setting in which the central struggles of our times—of individual rights and the collective good, of liberty as against equity and equality, of justice and fairness, of personal wishes versus expert judgment or the will of the majority—are played out with unparalleled urgency and vitality. When the question is whether a life is worth living, for example, the answer is consequential. And when legal institutions falter in answering such questions, then lawyers and others are reminded that perfect legal solutions may not exist for all bioethical dilemmas. Bioethics raises fundamental challenges for theorists as well as practitioners of the law about the harm that society may impose upon a minority in order to uphold values believed to be of fundamental importance to the majority, or the limits of the law as a guide to human conduct. Yet the focus of this essay is not the theoretical connection between morality and law, but rather the law as a practical force in shaping and defining bioethics.

What Is the Law?

SOURCES OF LAW. The term law carries a number of meanings. In ordinary speech, it usually refers to specific criminal or regulatory provisions ("It's against the law to …"). This usage also reflects the common equation of law with statutes, denoting not just criminal statutes but also those governing civil or procedural matters, such as the ownership of property or how one is called for jury duty. A fuller understanding of the law would emphasize other important sources. Of particular prominence today are the detailed and voluminous regulations issued by governmental departments and administrative agencies to implement the powers and carry out the duties conferred on them by statutes. Although statutes are sometimes quite detailed, many areas of human activity (especially of an industrial or commercial nature) are so complex that the legislature must almost of necessity confine itself to framing the basic legal structure, while delegating the task of supplying all the details to those with greater time and expertise at the administrative level, subject to various degrees of public, executive, legislative, and judicial oversight.

Especially in countries, including the United States, whose legal systems are derived from the English model, judicial decisions are a source of law at least as important as statutes. In some decisions, judges interpret statutes and hence give meaning and shape to them; while in others, judges decide issues not directly addressed by statutes and effectively make new law. At one time, when statutory rules covered only a small portion of human affairs, most of English law consisted of judicial resolution of individual disputes, collectively known as "the common law." To this day, many areas of law have a strong common-law flavor, which is constantly reinforced and renewed by judges' decisions about novel issues. Even in countries with civil-law systems based on Roman law or the Napoleonic Code, judges participate in the crafting of the law by their interpretation of code provisions.

Finally, in legal systems that follow the model of the United States, in which all activities of the government— including making and interpreting the law—are subject to limits specified in a constitution, no statement of the law would be complete without reference to the text of that supreme law, as well as the authoritative interpretations of its provisions by the courts.

Even these sources—statutes, regulations, judicial decisions, and the constitutions—do not exhaust the meaning of the law, which also connotes the legal system, the institutions, and the processes through which the law is applied. In this sense, the law encompasses the processes and rules of courts and administrative bodies (for example, on admission of evidence), as well as the more informal standards or practices that are reflected in the action of those lawapplying people and institutions (such as public prosecutors or bureaucrats) who have wide discretion in administering statutes and regulations. Within their sphere of authority, the law is what they say it is. Indeed, to the extent they are not expressly forbidden, the customs and practices of people in any field may properly be described as part of the law, though those customs and practices may formally be denominated law only when explicitly incorporated into a judicial opinion, statute, or regulation.

Seen in this way, the law is a basic framework for society; it is a system not only for promulgating official policies and procedures and for administrating prosecutorial, judicial, and regulatory affairs but also for providing explicit or implicit sanction for the private arrangements through which activities and relationships are ordered. Of course, many people would not identify the law as the source for the way they conduct their affairs. Instead, they would point to the influence of family and community customs or values, as well as to explicit moral or religious teachings. But as members of society, they must still operate within the law; this means that if their private arrangements run afoul of the expectations of society as embodied in the law, these arrangements may be limited or nullified. For example, in a number of U.S. jurisdictions, legislatures or judges have declared contracts for women to bear children for couples (so-called surrogate motherhood) to be null and void, as against public policy, even though a purported contract is freely and knowingly agreed to by all parties.

The existence of such private ordering as an important but often overlooked source of lawmaking also serves as a reminder that even in a society, such as the United States, with a high proportion of lawyers, lawmaking is not restricted to lawyers. From the local to the national level, many members of the legislative and executive branches of government are not lawyers; indeed, the federal constitution does not even require that judges be legally trained. Law is one of the three traditional learned professions (along with medicine and the clergy). Its members are licensed by the state and admitted "as officers of the court" to practice "at the bar of justice." Accordingly, like physicians, they are governed by ethical standards articulated by their profession through its associations as well as through the decisions of judges passing on cases of alleged transgression of professional obligations.

Around the world, most legal education occurs in schools affiliated with universities. Characterizing legal education in the early twentieth century as akin to a trade school, Thorstein Veblen opined that "the law school belongs in the modern university no more than a school of fencing or dancing" (p. 211); but this complaint is no longer justified, if indeed it ever was. Today, schools provide much more than mere vocational training, and scholarship is not limited to exegesis of doctrine; it encompasses empirical, normative, and theoretical work. Nonetheless, the law is a practical field, not simply one of the liberal arts and sciences.

DIVISIONS OF THE LAW. Traditionally, for purposes of basic study and classification, law has been divided along such doctrinal lines as tort law, criminal law, contract law, constitutional law, equitable remedies, property law, wills and trusts, and civil and criminal procedure. Each of these areas is characterized by prototypical relationships among parties and a set of analytic and practical devices for structuring those relationships and determining the outcomes of disputes. In recent years, legal scholarship has taken on several additional layers.

One is an enrichment of the tools brought to the law's tasks by combining with another discipline: legal anthropology, law and economics, legal history, law and literature, law and philosophy, law and psychology or psychoanalysis, sociology of law, and law and religion, to mention prominent examples. Each of these combined subdisciplines has not only a methodology but also its own theories and assumptions. Furthermore, additional schools of thought have arisen—such as legal realism, critical legal studies, feminism, and critical race studies—that provide perspectives on the law by combining the tools of several disciplines and a set of attitudes toward legal, social, economic, and personal relationships. Plainly, a person working in an interdisciplinary field may bring one of the analytic perspectives to bear—for instance, a feminist approach to legal history or a legal-realist perspective on law and economics.

A third way of dividing the domain of law is by focusing on its application to specialized types of personal, commercial, institutional, and sociopolitical activities. (The range of specialized areas of the law seems virtually limitless; attorneys now practice antitrust law, art law, bankruptcy law, civil-rights law, commercial law, education law, employment and labor law, entertainment law, family law, insurance law, intellectual-property law, juvenile and dependency law, media and broadcast law, mental-health law, probate law, public and private international law, regulated industries law, sports law, securities law, and even space law, to name a few.) Whether from an academic or a practice vantage point, specialized fields of law usually link traditional doctrinal categories with information and methods derived from the disciplinary and analytic approaches just described. For example, people working in family law will draw not only on legal doctrines from remedies, from property law, from wills and trusts, and from criminal and civil law and procedure, but also on psychological, sociological, or feminist analyses and perspectives; while those pursuing antitrust law will draw not only on various aspects of business law and criminal and civil law but also on law and economics studies and perhaps historical and sociological analysis as well.

HEALTH LAW. Traditionally, medicine and law intersected in civil or criminal cases in which proof of medical facts was at issue. From the medical side, those involved were usually pathologists, who became specialists in "forensic medicine," as the field was known to prosecutors and criminal-defense attorneys; on the legal side, torts specialists who handled a large proportion of malpractice cases (and some of whom held degrees in both law and medicine) described their expertise as encompassing "medical law." With the tremendous growth in healthcare and research beginning in the mid-1960s, healthcare law—or more simply health law— emerged as a new field that includes these areas and more. It is one of the fastest-growing, most diverse, and most exciting legal specialties.

Health law draws on practically the entire corpus of traditional doctrinal fields—civil, criminal, constitutional, property, and procedural—as well as many other specialized areas, such as labor, insurance, antitrust, and government regulation. Practitioners represent hospitals and other healthcare providers; academic research centers; physicians, nurses, and other healthcare professionals and nonprofessional employees; insurance carriers and employers that provide health insurance as an employee benefit; manufacturers and distributors of drugs and medical devices; patients and their families; and governmental departments and agencies that finance and regulate the individuals and institutions providing healthcare. Although cases involving ethical dilemmas are the ones that draw public attention, they are the exception for most health lawyers, who are more likely to spend their time drafting contracts for the purchase of goods and services; bargaining about insurance reimbursement; preparing staff bylaws, checking professional peer activities, or handling other issues that arise in accreditation, credentialing, or certification of practitioners or institutions; negotiating with government agents about licensing, taxation, and environmental controls; or litigating a case of professional malpractice (Macdonald et al.).

The Impact of Law on Bioethics

The relationship of law and bioethics is complex and multifaceted. One need not share the view of a leading legal commentator—"American law, not philosophy or medicine, is primarily responsible for the agenda, development, and current state of American bioethics" (Annas, 1993,p. 3)—to conclude that the law has strongly influenced the methodology of bioethics, the central focus of bioethics, and the values of bioethics. "And—to the considerable extent that bioethics is an American invention and export—the influence of American law has been felt even in societies in which legal institutions play a less pronounced role than they do in the United States" (Capron, p. 43). Law's role in shaping bioethics has at least five facets.

FAMOUS LEGAL CASES. Notable cases have played a major role not merely in the development of bioethics but also in making it, by the 1990s, a prominent part of private reflection and public discourse. Difficult ethical issues are nothing new to the health professions. Yet until recently, issues were examined largely behind closed doors by physicians and nurses and an occasional theologian. In democratic societies, legal proceedings are usually open (though sometimes parties are permitted to use fictitious names, to help preserve their privacy). Consequently, the media are able not merely to report about a difficult decision that must be taken but also to put a human face on it by recounting the drama as it unfolds in the hearing room.

And bioethics cases are often very dramatic. A familiar example: As Karen Quinlan's parents argued during 1975–1976 in the New Jersey courts for authority to order her ventilator turned off, her photograph appeared so often in the media that it was probably more familiar to most Americans than the faces of their local members of Congress. Likewise, bioethical breaches—particularly scandalous ones, such as the Nazi physicians' experiments on concentration camp prisoners and the Tuskeegee syphilis study—not only generate landmark judicial rulings but also provoke adoption of new statutory or administrative law.

METHODOLOGY. Related to the addressing of bioethical cases through the law is a second facet, the law's largely inductive methodology. This method is especially associated with the common law, the process through which judges render decisions specific to the facts of the individual cases before them that are grounded in, or justified by, the decisions in prior cases whose facts are sufficiently analogous. Not only do judges often apply the same methodology when interpreting statutes, but legislatures, in drafting statutes, usually operate concretely and incrementally, building on court decisions and existing legislation (or borrowing from other jurisdictions) rather than attempting to operationalize grand principles. The law's fact-based, inductive method provides a counterpoint to the "principlism" that characterizes much philosophically oriented analysis in bioethics. Of course, this approach is not unique to the law, but it reinforces other case-based traditions in ethics, such as casuistry and Jewish ethics.

PROCEDURAL EMPHASIS. Third, recognizing that midlevel ethical principles such as autonomy, beneficence, justice, and nonmaleficence cannot solve most bioethical dilemmas (which arise precisely when conflict occurs among these unranked principles), and that pluralistic societies do not necessarily hold enough moral views in common to agree upon the correct resolution of most controversies, many bioethicists have welcomed "a procedural ethic, based on respect of the freedom of the moral agents involved, even without establishing the correctness of any particular moral sense" (Engelhardt, p. 45). This emphasis on procedure is familiar to lawyers, though the suggestion that bioethics should concentrate on acceptable decision-making processes rather than substantive rules draws objections from some legal scholars who see in proceduralism the risk of a slide into "the arbitrary exercise of power" (Annas, 1988, p. xiii).

Even when they have mandated that procedures be followed, the courts have not insisted that bioethical disagreements outside court employ all the procedural niceties that attach to judicial proceedings. Indeed, judges, legislators, and administrators alike have not always been very clear about the mandate and membership, much less the process, of institutional committees to make judgments about medical treatment and research. For example, in its landmark Quinlan decision, the New Jersey Supreme Court held that the guardians of unconscious patients could order lifesustaining treatment forgone with the agreement of the treating physician, provided a multiprofessional committee at the hospital concurred; yet it said nothing about how that committee should gather, hear, or evaluate evidence or otherwise reach conclusions (In re Quinlan, 1976).

RIGHTS ORIENTATION. The issues in bioethics are some of the most sensitive and most divisive confronted by our society, not least because of the rapid development of the life sciences. In both the laboratory and the clinic, novel problems are constantly generated by new capabilities for organ transplantation and mechanical replacement, for genetic diagnosis and therapy, for assisting reproduction, for sustaining life, for modifying human behavior, and for myriad other means of altering nature; such problems also arise out of major changes in the way health services are organized and financed. These developments and changes challenge existing social and professional norms; where those challenges are substantial and intractable, the people involved not infrequently turn to courts, legislatures, or executive agencies to protect their rights. "The concept of rights … has its most natural use when a political society is divided, and appeals to cooperation or a common goal are pointless" (Dworkin, 1977, p. 184).

Concern over abuses of patients and research subjects has been a major theme in bioethics, reinforced repeatedly by instances in which healthcare professionals and institutions have acted—sometimes from good motives and occasionally not—to the detriment of people in their care. The law has offered bioethics not just a procedural response but also a long tradition of protecting people from harm by assertion of their rights; indeed, a rights orientation seems inherent in the law's perspective on the relationship of the healthcare system to patients and research subjects.

Certain risks to patients arise from the imbalance inherent in this relationship—the vulnerability and dependence that illness creates, physicians' superior knowledge and technical mastery, and the way the organization of healthcare enhances professionals' power and prestige. From ancient times, medical ethics proclaimed the duties of beneficence and fidelity to patients' interests in order to guard against harm to patients. Yet, as bioethicists have pointed out from the first, this traditional view of medical ethics is problematic because physicians not only promised to serve their patients' interests but often took it upon themselves to define those interests. Lawyers aided this assault on medical paternalism with concepts borrowed from civil-rights law, such as political liberty and equality of treatment. From the 1960s onward, bioethicists adopting this stance "had much in common with the new roster of rights agitators" for consumers, racial and sexual minorities, and women (Rothman, p. 245).

The increase in the rights orientation coincided with the increasing effectiveness of medical interventions. Armed with wonder drugs, high-tech surgery, and new methods of resuscitation and intensive care, physicians saw their power to influence their patients' futures increase dramatically from the middle of the twentieth century; and that power became the subject of disputes concerning how it was to be distributed in the physician–patient relationship. Legal commentators suggested—and most bioethicists embraced—a reformulation of that relationship in terms of patients' rights (Annas and Healy). The dominance of the rights orientation dismays many healthcare professionals, who lament the adversarial tone they feel law has introduced into the practice of medicine. There may be a legitimate complaint here, but physicians have historically denied that they are making anything but medical decisions for patients. It has taken bioethicists to point out that once alternatives become available, the choice between them is usually based on value judgments, not medical judgments, and doctors have no special expertise that justifies their values taking precedence over patients' values. Rights are crucial to dealing with power inequality, even where one might prefer to conceive of relationships in terms of caring and connection. This tension remains a recurring theme in law and bioethics.

Although the incorporation of such central legal doctrines as informed consent into the core of bioethics can hardly be doubted, the transformative effects of law on medical practice are less clear. Commentators such as George Annas, who take a patients' rights approach, find many instances where those rights are still abused (1988); whereas scholars such as Jay Katz, who look at physicians' behavior, emphasize that powerful factors in physicians' training and psychology have prevented them from adopting a stance of open discussion and shared decision making. At the same time, other critics argue that the authority the law took from physicians is often transferred to lawyers and judges, not to patients; and that moreover, by replacing professional discretion with legal rules, the law has given physicians the unintended message that they need not exercise ethical judgment (Hyman). Even if physicians do not react in this fashion, the law's inclination to view relationships in terms of rights changes the way bioethical issues are analyzed and potentially displaces other forms of moral discourse traditionally associated with medicine. For example, by emphasizing what one has the right to do without helping to define what is the right thing to do, the law may have undermined the specifically moral aspects of bioethics (Schneider, 1994). "[N]othing but confusion of thought can result," as Justice Oliver Wendell Holmes observed, "from assuming that the rights of man in a moral sense are equally rights in the sense of the Constitution and the law" (p. 172).

SPECIFIC VALUES. Besides leading toward a rights orientation, the reliance upon the legal system imports specific values. These values are not unique to the legal system, though they tend to be associated with it, nor are they controversial, though they are not without consequence. That is, when one of these values is given preference in the resolution of a problem, other values, such as those that may be favored by medicine or by other philosophical systems, are likely to be overridden. The values usually associated with the law include justice, as opposed to progress or efficiency; equality, as opposed to inherent differences or measures of quality; due process, as opposed to scientific proof; and individual self-determination over one's life and body, as opposed to beneficence, psychological interdependence, or communal welfare. The law's values are generally those of liberal society: personal autonomy within a setting of ordered liberty in which individuals have wide but not unlimited freedom. Especially in pluralistic democracies, the law sets boundaries on the enforcement of majoritarian morality, thereby protecting many individual choices from interference.

Not all liberal societies treat the values involved in the same way. For example, although revolutions in France and the United States in the late eighteenth century drew on the same sources in articulating basic rights, the Declaration of the Rights of Man and the Citizen in France in 1789— unlike the Declaration of Independence in the United States in 1776—emphasized that individuals have duties as well as rights (Glendon). This difference between the American and European views of rights, which persists to this day, has important implications as bioethicists attempt to address such issues as self-risking behavior and limits on the allocation of scarce community resources to healthcare.

Law and Bioethics as a Field

As a field of study, law and bioethics can be viewed from several perspectives. First, from the vantage point of a nonlawyer doing bioethics—whether at a policy level or in individual clinical situations—one needs at least some understanding of the law and legal institutions. Moreover, institutional ethics committees usually include at least one lawyer, who can provide analytic abilities as well as expertise on statutory, regulatory, and case law.

Second, "law and bioethics" is a subject of increasing interest to students, scholars, and practitioners of law. In one view, law and bioethics can be seen as a subset of health law that deals with medical decision making, genetic and reproductive technology, human subjects research, and the like. In fact, health-law casebooks today typically include chapters or sections on bioethics. But this view does not fully capture the way in which bioethics is generally conceived. By the early 1960s, long before health law emerged as a separate field, courses dealing with bioethics were being taught at American law schools, although the first casebook with the title Cases, Materials, and Problems in Bioethics and Law was not published until 1981 (Shapiro and Spece). That volume, like other legal books dealing with bioethical issues, not only describes "the new biology" and recounts the dilemmas engendered by modern medicine and bioetechnology; it also discusses ethical theories and concepts, such as proportionality and personhood, that have crept from ethics into legal opinions. Nonetheless, law and bioethics is not just a subset of law and philosophy (or law and religion), since attention is usually focused on philosophical concepts not for their own sake but as they relate to understanding society's appropriate responses to technical developments that deeply affect people's lives and relationships. Most of the text of such books is drawn from reports of medical and scientific developments and from the rich array of relevant cases, statutes, and regulations, as well as commentaries about them (Capron and Michel).

In addition to academic attention, law and bioethics has been examined through commissions established by national and state governments through statutes and executive orders. These bodies have advanced bioethical analysis and promulgated legislative and administrative proposals (U.S. Congress).

Although people looking at the topic "law and bioethics" from the perspective of the latter field are likely to view it as a legitimate area of scholarship and practice, it is largely unrecognized among lawyers at large, who treat it neither as one of the distinctive "law and …" interdisciplinary fields nor as a distinct special application of law ("bioethics law") akin to employment law, sports law, and the like. The Association of American Law Schools does not categorize courses or teachers under such a heading, nor does the Index to Legal Periodicals, despite the existence in law journals of bioethics symposia as far back as the late 1960s (Capron and Michel). The literature of law and bioethics is not found only in law reviews or, for that matter, in scholarly journals of other disciplines such as philosophy. It also appears in medical and health-policy journals and in bioethics publications, such as the Hastings Center Report, the Kennedy Institute of Ethics Journal, and the Journal of Law, Medicine, and Ethics.

One important aspect of legal scholarship that can legitimately be said to be part of the "law and bioethics" literature is abortion. Recent treatments of this subject have been enriched by feminist legal analysis, which itself is greatly influenced by theorists such as Carol Gilligan and Nel Noddings, whose work concerns moral development and the different ways in which women and men may resolve moral dilemmas. This influence is perceptible not only in subjects dealing directly with women, such as abortion, maternal-fetal issues, and reproductive technology, but also in less obvious places such as analyses of ethics committees. Since feminist analysis emphasizes relationships and nurturance, it is not surprising to see that as the literature of law and bioethics moves beyond the rights orientation, feminist insights become important in developing a better legal understanding of the relationship between patients and health caregivers (Capron and Michel).

Conclusion

Scholars differ on the precise influence the law has had in shaping the content, methods, and focus of the interdisciplinary field of bioethics, but all would agree that the influence has been significant. Both those who applaud and those who bemoan the law's influence seem to agree that the law has done more than merely allow the enforcement of, or provide redress for breach of, existing moral rights possessed by participants in the healthcare system. Rather, the law has— through its orientation toward rights and through the values implicit in the processes it has fostered—established new rights and preferred certain values over others. On the positive side, this has helped promote the autonomy of patients and subjects, the openness of the processes by which decisions are reached, and equality of respect and concern for all participants. On the negative side, it has diminished the sense of community and of duties that attach to rights, while increasing many providers' sense of adversariness in their relationship to patients.

In a society in which ethical standards were sufficiently complete to address even novel technical problems, widely enough shared to be accepted without question by all or nearly all persons, and consistent and coherent enough never to lead to uncertain or contradictory results, bioethics might operate with little reference to the law. As Grant Gilmore observed, "A reasonably just society will reflect its values in a reasonably just law. The better the society, the less law there will be. In Heaven there will be no law and the lion will lie down with the lamb" (p. 1044). Until that time, the law will continue to play a large role in bioethics—not only providing a relatively neutral means through which troubling issues can be addressed and contended points resolved in a manner that is socially sanctioned, but also shaping bioethics through its concerns for justice and fair procedures, equality, and personal self-determination.

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SEE ALSO: Animal Research: Law and Policy; Death, Definition and Determination of: Legal Issues in Pronouncing Death; Disability: Legal Issues; Environmental Policy and Law; Human Rights; Informed Consent: Legal and Ethical Issues of Consent to Healthcare; Insanity and the Insanity Defense; Maternal-Fetal Relationship: Legal and Regulatory Issues; Medical Futility; Organ Tissue and Procurement: Ethical and Legal Issues Regarding Living Donors; Public Health Law; Right to Die: Policy and Law

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