The birth of Siamese twins to a Danville, Illinois physician and his wife on May 5,1981, renewed the recurrent debate on the morality, ethics, and legality of euthanasia for severely defective newborns. The twins, Jeff and Scott Mueller, were joined below the waist and shared the lower part of their digestive tract and three legs. Later studies revealed internal anomalies as well. At birth they were in critical condition, suffering from respiratory distress, and were not expected to survive more than a few days.

A note written by a nurse, and countersigned by Dr. Petra Warren, reading “do not feed in accordance with parents’ wishes” was entered on their hospital chart. Several nurses disobeyed the order and fed the infants. As the twins continued to live, against expectations, word of their birth spread. An anonymous caller informed the Illinois Department of Children and Family Services that they were being starved to death.

New causes of action in tort law do not simply emerge, fully grown, like Athena from the head of Zeus. They develop as a result of a struggle between older case law on the one hand and the need to respond to an emerging problem on the other. This metamorphosis can be seen in many areas of jurisprudence, but most notably in the fields of products liability and medical malpractice litigation.

The explosion in products liability litigation, for example, is linked in part to the vastly increased proliferation of a variety of consumer goods and to new forms of marketing mechanisms for selling these goods, so that consumers are exposed to a wider range of risks. Medical malpractice litigation in the “wrongful life” area similarly reflects not only a change in social values toward abortion, but also changes in the perceived ability of medicine to detect and predict defects in the unborn fetus or the likelihood of such defects based upon the genetic history of the potential parents.

The question of how and when a novel medical procedure becomes accepted as standard practice has important legal implications. It may in certain situations be determinative of whether third-party reimbursement is available for such procedures. It may also affect the standard used in determining a physician’s liability for negligence. This article discusses several innovative medical procedures and the process of their acceptance by the medical community. It will be seen that none of these examples effectively delineates the process by which an innovative procedure becomes the accepted standard of care. Finally, the article suggests a system based upon consensus among recognized medical experts, and recommends that this system supplant the traditional cost-benefit analysis which is currently used to determine the accepted standard of care.

No formal mechanism currently exists for the introduction of innovative medical technologies, in contrast to the complicated procedures developed for the orderly introduction of new drugs into the marketplace.

During the past few years, health care professions haw received strong criticism for seemingly ethically wrong or inhumane practices. The Tuskegee syphilis study, experimentation on mentally retarded persons at Willow-brook, forced sterilizations of retarded individuals, and alleged malpractice and Medicaid abuses are a few examples of those instances that have received publicity. Incidents such as these, coupled with the development of an aggressive consumerism and with escalating scientific technological advances, haw created an urgent and widespread concern about medical ethics or bioethics. The Hastings Institute, two presidentially appointed commissions on issues in medical ethics, and the introduction of ethics courses in the curricula of medical and nursing schools are responses to ethical concerns in health care.

Although numerous texts and articles on specific bioethical issues haw been published in recent years, troubling questions remain about the normative ethics that form the foundation of responses to these issues.

Generic drugs that have not been specifically approved by the Food and Drug Administration (FDA) are today being marketed, and considerable legal controversy surrounds the issue of whether the FDA can require premarketing approval of generic copy drugs (“me-toos”).

Prescribers and dispensers of drugs cannot blindly assume that every drug on the market has been approved by the FDA, and that it will be safe and effective, as can be seen from the following incident. In September 1981, in an unprecedented action, an Ohio grand jury indicted a pharmacist for manslaughter in the death of a woman to whom he sold a furosemide product unapproved by the Food and Drug Administration. The woman died of congestive heart failure and the grand jury found probable cause that the death was caused by the diuretic. The drug was dispensed despite a March 30,1979,news release from the Department of Health, Education and Welfare warning that unapproved furosemide tablets were being marketed and that these drugs might be ineffective and could possibly be harmful.

At one point in Edgar Allan Poe’s Narrative of Arthur Gordon Pym 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 imagining, in which the dreadful deaths of thirst, famine, suffocation, and premature interment, crowded in as the prominent disasters to be encountered.”

It is probably uncommon for hospitalized patients to feel as gloomy as Pym. Nevertheless, installed in a strange institution, separated from friends and family, forced to wear a degrading costume, confined to bed, and attended to by a variety of strangers who may or may not keep the patient informed of what they are doing, the average patient is intimidated and disoriented. Such an environment encourages dependence and discourages the assertion of individual rights.

As the physician-director of Boston’s Beth Israel Hospital has warned: “today’s hospital stands increasingly to become a jungle, whose pathways to the uninitiated are poorly marked and fraught with danger. . . .”