"The Hopkins Mongol Case": The Dawn of the Bioethics Movement

The 1971 Hopkins case was one of several deaths at that hospital involving infants with Down syndrome and treatable medical problems, including an essentially identical case involving duodenal atresia a few years earlier. In the earlier case, Dr Robert E. Cooke, Pediatrician-in-Chief at Johns Hopkins, intervened over the strenuous objection of two colleagues, who were directly involved in the care of the infant: Dr Mary Ellen Avery, a leader in American neonatology, and Dr David Clark, a leading pediatric neurologist. Cooke had a personal interest in the care of children with disabilities, having raised two children with Cri du Chat syndrome, and had a close relationship with the Kennedy family, with long-term service as Chair of the Scientific Advisory Committee of the Joseph P. Kennedy Jr Foundation.

Cooke had reported the previous case to child protective services, seeking appointment of a guardian-ad-litem who could consent to the surgery, but was rebuffed by the judge, who held that the parents had legal authority to make health care decisions for their child, notwithstanding evolving legal standards of abuse and neglect that included withholding necessary medical treatment. Cooke’s action infuriated Avery and Clark, leading Clark to resign his position. Thus, when the 1971 case emerged, Cooke was constrained in his ability to intercede.

Many residents and nurses involved in the infant’s care were uncomfortable with the plan, with nearly daily meetings in Cooke’s office including residents, attending physicians, nurses, clergy, and others. One outcome of these meetings was the formation of an informal ethics committee to provide a forum for discussion and advice on future cases. Similar committees had been described to review abortion cases and allocation of dialysis machines,⁵  but the Hopkins committee, called the “God Committee” by some,⁶  was the first created to address a wider range of clinical ethical controversies.

Shortly after the death of the Hopkins infant, Cooke met with Eunice Kennedy Shriver and Sargent Shriver at a meeting of the Kennedy Foundation advisory board and proposed making a movie about the case. The resulting film, “Who Shall Survive: One of the Choices on Our Conscience” premiered in October 1971 at the newly opened Kennedy Center in Washington, DC, with extensive discussion by distinguished panelists. The film attracted extensive national media coverage and led to numerous publications in scholarly journals and the lay press. More than any case up to that time, it brought the issues of end-of-life decisions involving infants with disabilities out of the hospital closet to international attention.

The Kennedy Foundation, which had previously concentrated its resources on scientific and clinical research and training in developmental disabilities, began to focus on research and training in bioethics. Under the influence of Cooke and President John F. Kennedy, the National Institute of Child Health and Human Development had opened in 1962, providing federal resources for research involving children and developmental disabilities, allowing the Kennedy Foundation to reduce its commitment to scientific research. This allowed the Foundation to shift their resources to bioethics, leading to the creation of influential bioethics centers at Georgetown and Harvard Universities and, subsequently, the University of Wisconsin–Madison.

The opportunity to work with the Shrivers led me to change my career plans from an imminent fellowship in pediatric pharmacology to a Kennedy-sponsored fellowship at their Program in Law, Medicine, and Ethics at Harvard, where I met John Robertson, a budding health lawyer. Robertson and I quickly became close friends and, with Kennedy Foundation support, established a bioethics program at the University of Wisconsin–Madison, where we soon recruited Dan Wikler, a budding philosopher with no previous plan to devote his career to bioethics, to form the first program of its kind, with a physician, philosopher, and lawyer, in tenure track positions in a medical school. Robertson and I published a series of articles on legal and ethical issues in passive euthanasia of “defective newborns,” as they were called at the time, including a conceptual rationale for the use of ethics committees as the preferred approach for decision-making in such cases.⁷  Wikler went on to become an international leader in bioethics, establishing a bioethics program at the World Health Organization, and played a lead role in creating what later became the American Society of Bioethics and Humanities. Robertson also became a prominent figure in health law and bioethics, and the Wisconsin bioethics program grew to 8 tenured faculty positions, producing another generation of leaders in bioethics.

Part of the profusion of scholarly work after the Hopkins case included empirical studies of the extent of the practice of withholding life-saving treatment from infants with Down syndrome and other congenital malformations, particularly spina bifida. This included 2 studies in which researchers demonstrated that the majority of pediatricians and pediatric surgeons either agreed with the way the Hopkins case was managed or at least stated that they would not report such a case to child protective services.^8,9 

This approach was supported by the courts, including the 1978 Philip Becker case¹⁰  in which the California Supreme Court upheld the right of the biological parents to refuse needed repair of a life-threatening ventricular septal defect from a 9-year-old boy with Down syndrome. The parents argued that although Philip was happy at the time, his future well-being would be in jeopardy when his parents died. This claim seemed implausible because Philip had never met his biological parents, who gave him up soon after birth to be raised by foster parents. He was by all accounts a happy child, and the court’s decision seemed not to be in his interests, in addition to being inconsistent with medical neglect laws.

“Baby Doe” was an infant born in 1982 in Bloomington, Indiana, with Down syndrome and esophageal atresia, whose parents declined consent for surgery, a decision upheld by the Indiana Supreme Court. Thus, by the mid-1980s, there was a consistent theme of physicians supporting parents who refused to consent to life-saving treating of children with Down syndrome, and 2 state supreme courts upheld these decisions. The system seemed to be interpreting medical neglect statutes as if they did not apply to infants with disabilities.

Laws are not written until they are first broken. In a society in which nothing had ever been stolen, there would be no law against stealing, until something was stolen (paraphrased from Romans 5:13). Increasing criticism of the Hopkins and Baby Doe cases, without an effective response from the medical profession or the courts, made it inevitable that a legislature or executive branch of government would step in. This occurred after the Indiana case, when President Reagan promulgated a set of rules requiring health care providers to report discrimination on the basis of handicap to a federal hotline, resulting in dispatch of a “flying Baby Doe squad,” whose assignment was to ensure that medically effective treatment was provided to infants with disabilities.¹¹ 

The rules were challenged on legal and principled grounds and were reissued in final form in 1985. The central conceptual problem was the requirement that medically beneficial treatment should not be withheld from handicapped infants solely on the basis of their present or anticipated disability.^12,13  The predicted and actual result of this requirement was that a longstanding and widespread problem of undertreatment, withholding medically beneficial treatment from infants with excellent prospects for long happy lives, was replaced with a problem of overtreatment, aggressive use of medical interventions on infants with little or no prospect for long or meaningful lives.¹¹ 

In cases in which there is virtual unanimity, among parents and providers, that allowing natural death to occur is in the best interest of the infant, the rationale is commonly driven by agreement that the infant’s cognitive (or other) disabilities create burdens that outweigh the benefits or that the infant is so disabled as to not to be able to experience any benefits.¹⁴ 

The simplest example is an infant with anencephaly, dependent on medical technology such as mechanical ventilation, in which virtually all involved agree that such treatment, although medically effective, does not serve any plausible interest of the infant because s/he is incapable of experiencing or enjoying even the most primitive pleasures of existence (ie, the infant is so profoundly disabled as to render life-sustaining treatment inappropriate).

The anencephaly case seems like too obvious an example, but a court in Fairfax, Virginia, considering a case involving an anencephalic infant named Baby K, ordered continuation of life support, including long-term mechanical ventilation, for over 2 years, including in its rationale a reference to the Baby Doe regulations.¹⁵  This decision was based primarily on the federal “Emergency Medical Treatment and Active Labor Act,” a federal law requiring stabilization of patients experiencing a medical emergency, but the court also ruled that federal law prohibited discrimination based on disability.^16,17 

It is beside the point that the Baby Doe regulations allowed an exception for children who were in a state of perpetual coma, which would have applied to Baby K, because even this exception proved overly restrictive. The 1986 case of Lance Steinhaus in Minneapolis illustrated the problem. Lance was in a persistent vegetative state resulting from child abuse. His mother, who was not involved in the abuse, asked that that a do not resuscitate order be written. A prolife attorney argued successfully that the do not resuscitate order would have violated the Baby Doe regulations because it was based on an intellectual handicap, and the exception for perpetual coma did not apply because the persistent vegetative state was characterized by sleep-wake cycles, thus making the coma not “perpetual.”¹⁸ 

These and other problems with the Baby Doe regulations led the American Academy of Pediatrics, led by its newly formed Committee on Bioethics, on which I served, to suggest that the substantive role of handicap, or disability, be replaced by a process that would be more likely to lead to ethically defensible outcomes; namely, ethics committees, or as they were called at the time, infant care review committees.¹⁹ 

Ethics committees were starting to form before the American Academy of Pediatrics recommendation, but the placement of that recommendation in the revised Baby Doe regulations provided a stimulus for their expansion and ultimately the present situation. They are now required by the Joint Commission on Accreditation of Hospitals, not just for cases involving infants with disabilities but the entire range of ethical controversies that arise in a modern hospital involving patients of all ages. It is plausible that ethics committees would have evolved anyway, but there is a line that can be drawn from the ethics committee formed at Hopkins, rationalized by our 1976 paper,⁷  to their role today.

The prediction that the rationale for the correction of the problem of undertreatment, namely, the substantive principle that disability could not be a justification for withholding life-sustaining treatment, would lead to overtreatment was confirmed by a series of publications after the promulgation of the Baby Doe regulations, showing that pediatricians were now aggressively treating infants, contrary to the physicians’ assessment of what was in the patient’s interests, based primarily on their false belief that the Baby Doe regulations required them to do so.^20,21  The practice of overtreatment reached a nadir in a Wisconsin appellate court decision, Montalvo v Borovec, in which the court held that a parent may never authorize withholding of life-sustaining treatment from a child who is not in a persistent vegetative state.²² 

This influence of the Baby Doe regulations occurred despite the fact that the regulations imposed no direct legal obligations on doctors, hospitals, or parents. In their final form, the regulations were pursuant to a child abuse funding statute, requiring states, as a condition of receiving federal funding for child abuse programs, to have procedures in place to respond to reports of alleged discrimination on the basis of handicap.²³  The penalties for noncompliance were limited to withholding of funds to states, but numerous physicians, often misled by hospital attorneys, believed the regulations created risks of civil or even criminal liability.²⁴  A 1985 report by the Department of Health and Human Services Inspector General found all states to be in compliance, despite the widespread practice of withholding life-sustaining treatment from infants when such withholding was deemed by the health care providers to be in the interest of the infant.²⁵ 

In addition to false claims that the Baby Doe regulations required overtreatment, physicians and lawyers were also affected by exaggerated fears of civil or criminal liability from malpractice suits or charges brought by aggrieved families, district attorneys, or attorneys general. Pope, a leading scholar on this topic, has concluded that these risks are overstated, as “actions for damages only succeed where the provider’s conduct is outrageous,” and that “surrogates cannot establish outrageous conduct by pointing to the unilateral withdrawal of LSMT [life-sustaining medical treatment] itself, but only by demonstrating that the manner in which it was withdrawn was outrageous.”²⁶ 

The cases of overtreatment, like the cases of undertreatment, were the result of decisions being made on grounds other than the best interests of the child. Undertreatment was driven by claims by Duff and others that the interests of the family as a whole, as judged by the parents, should take precedence over the interests of the affected infant.^27,28  Overtreatment was driven by the problematic assertion that disability should play no role in treatment decisions and concerns, usually false, that the Baby Doe regulations required such treatment, or that even the extremely low risk of liability justified imposing interventions that were not in the interests of the child.

The American Academy of Pediatrics, led by its Committee on Bioethics, eventually issued a policy statement recommending that treatment decisions be based on the best interests of the child, as best those could be determined, with reliance on ethics committees as a procedural mechanism for resolving disputes.¹⁹ 

The current consensus that the best interest of the child should be the guiding principle in treatment decisions hardly requires discussion today. But that was not the case at the time the Hopkins baby lived and died, or for thousands of years of recorded history before that, when the guiding principle was that the preferences and interests of the parents should have priority.

In the 1970s and 1980s, a transformation occurred in the treatment of infants with disabilities. A centuries-old tradition of fatal neglect, widely supported by contemporary pediatricians, was reversed. The pivotal cases involved infants with Down syndrome and associated treatable medical problems. The first of these to be brought to wide public discussion was the Hopkins case.

Today it is a cliché to state that the best interests of the child should be the guiding principle in pediatric treatment decisions, but this was not the prevailing view in the 1960s and 1970s, when the Hopkins case burst into national awareness, a case that played an important role in the subsequent growth of the modern bioethics movement, ethics committees, and recognition of the best interests of the child as a basis for treatment decisions.

As stated earlier, it would be foolish to claim that none of these changes would have occurred were it not for the Hopkins case. Post hoc non est propter hoc. But a line can be drawn from that case, and the individuals at the center of it, to a dramatic shift in opinion and medical practice involving infants with disabilities, based on reflection and analysis of the central ethical and legal principles, and a coherent argument for changing the way that decisions should be made.

Eunice Kennedy Shriver loved to talk about the many things we have learned from children and adults with Down syndrome. The Hopkins baby, in his short life, had a major influence on my career and others, and those careers affected the lives of many other professionals, families, and children.