The current set of federal regulations about how to treat extremely ill, premature, or terminally ill infants <1 year of age, widely known as the “Baby Doe” rules, went into effect 20 years ago.1 They are amendments to the Child Abuse and Protection and Treatment Act, which are federal funding requirements for states to receive grants.2 Many neonatologists and other pediatricians reported that these rules immediately altered standards of care and limited clinicians’ and parents’ abilities to select individualized treatment plans and act in the best interests of infants.3,4 Their criticisms were akin to those of the courts5 in rejecting an earlier and similar set of Baby Doe regulations6 based on a Reagan-Administration interpretation of civil rights law.7
Yet, 20 years later these Baby Doe rules1 still stand, and so does the perceived support of them by the American Academy of Pediatrics because of comments by its leadership and Committee on Bioethics.8,9 These rules are inconsistent with other AAP guidelines recommending individualized decision-making by clinicians and families for seriously ill children based on the best-interests standard, or so I will argue.10,11 The choice between the Baby Doe rules and the best-interests standard is important, as a recent case conference may show. A family was faced with a decision about how to respond compassionately to their extremely premature and severely impaired newborn. In attendance were members of the parents’ extended family, including an aunt who was a hospice nurse and a cousin who was an adult pulmonologist. These 2 family members had extensive experience in caring for dying adults. The entire family agreed that given the infant’s poor prognosis and suffering intrinsic to his illness and treatments, it was in his best interest to have comfort care and to forgo aggressive life-sustaining treatments. The 3 neonatologists present also agreed that this plan would be in the infants’ best interest but said that they were constrained by the Baby Doe rules and would have to continue maximal treatments because the treatments for the infant’s condition were not virtually futile in terms of survival, he was not dying, and the infant was not in a chronic and irreversible coma. The hospice nurse and pulmonologist were shocked that the best-interests standard could not be used for infants in the way it was routinely used for incompetent adults lacking advance directives.12
The AAP Committee on Bioethics writing on the Baby Doe regulations in 19968 would probably say that the 3 neonatologists misunderstand these rules. The committee holds that many neonatologists have misunderstood these regulations, and they use a survey conducted by my colleagues and me3,4 as evidence of this. The committee claims that the Baby Doe rules allow considerable discretion and are consistent with individualized decision-making by clinicians and parents using the best-interests standard.8 This view is considered and rejected because these rules thwart individualized decision-making using the best-interests standard for infants, or so I will try to show.
The best-interests standard is a moral and legal standard for guiding decisions for persons lacking decision-making capacity and who have not left advance directives; it should be used by guardians, judges, clinicians, or other responsible persons for making decisions for the incompetent person by assessing the net benefits and burdens and selecting the best available options for the incompetent person.13
After discussing the background of the Baby Doe regulations, I consider why the AAP should reconsider its perceived support for these rules and why the 1996 AAP Committee on Bioethics8 is incorrect in stating that many neonatologists have misunderstood these regulations. I will argue that consistency requires the AAP to choose between its apparent endorsement of the current Baby Doe regulations and other AAP recommendations favoring decision-making that is individualized, made jointly by physicians and parents, and based on a child’s best interest.10,11
BACKGROUND
There have been 2 sets of Baby Doe rules, both similar in their language and purpose. The first set of Baby Doe rules was based on section 504 of the Rehabilitation Act of 1973.6,7 The Reagan Administration was responding to the death of an infant called Baby Doe, with a tracheoesophageal fistula, trisomy 21, and other problems; the parents, under the advice of some physicians, had decided not to repair the fistula. The Indiana courts supported the family’s decision, but while an appeal was being made to the US Supreme Court, the infant died. The legal theory behind the first set of Baby Doe rules was that nontreatment could only be justified if 1 of 3 stated exceptions existed; otherwise, nontreatment was discriminatory and violated the infant’s civil rights. (Baby Doe died in 1982; as more has been learned about trisomy 21, there has been greater agreement about the duty to provide life-saving treatments for infants with this condition.)
The birth of another infant known as Baby Jane Doe on October 11, 1983 in New York tested this legal theory. Infant Jane had spina bifida, hydrocephalus, kidney damage, and microcephaly. The parents were told that the infant would be severely retarded and paralyzed below the lesion and suffer from frequent kidney and bladder infections. Doctors disagreed about whether aggressive treatment was appropriate and whether it was in the best interest of this child to have corrective surgery. The parents, deciding it was in their child’s best interest to be provided palliative care, declined surgery. A legal battle ensued that went to the US Supreme Court, testing the first set of Baby Doe rules.
The US Supreme Court in Bowen v American Hospital Association5 rejected the Reagan-Administration interpretation of the civil rights law that generated the first set of Baby Doe rules and went on to offer a stinging criticism of the purposes behind these regulations. The Bowen Court viewed these rules as unnecessary to protect the rights of disabled infants and as interfering with parental rights to consent or refuse treatment based on what they deemed to be in their infants’ best interest. The court also viewed these regulations as naive in their approach to medical decision-making, because the degree of disability is relevant to making good life-sustaining medical treatment decisions. The court concluded that these rules represented an unwarranted attempt to influence standards of care and that “no evidence of discrimination or discriminatory care was given.”5 The court also endorsed the best interests of the child standard when it agreed with the Appellate Division ruling that “concerned and loving parents had chosen one appropriate medical course over another and made an informed decision in the best interests of the infant.”5 Other courts have also endorsed this standard. For example, the Appeals Court in Maryland recently stated: “we have long stressed that the ‘best interest of the child’ is the overriding concern of this court in matters relating to children.”14 Recently, the Supreme Court of Texas, in Miller v HCA, held that parents have the right to consent to or refuse treatments for infants and that other than in an emergency, a court order must be obtained to overrule parental refusals. The Miller Court’s reasons were that allowing parents to have the primary responsibility would promote the best interests, welfare, and safety of children, given the various circumstances and options that shape complex medical decision-making.15
As this legal challenge to the first set of Baby Doe rules proceeded, it became clear to the Reagan Administration that the courts were rejecting its interpretation of the civil rights law on which they had based these regulations. In response, Congress adopted a similar set of Baby Doe rules as amendments to the child abuse and neglect funding requirements for states.1 These funding requirements are technically optional, although most states adopted them. The second set of Baby Doe rules went into effect in 1985, but unlike the first set, they have not been tested in the courts and are still in effect. Support from some members of the AAP leadership for these rules may have helped its passage.9
SHOULD THE AAP SUPPORT THE BABY DOE REGULATIONS?
The AAP has been a leader in addressing how to extend compassionate help to children and their families who must choose between providing palliative care and aggressive life-support interventions. The AAP Committee on Fetus and Newborn, for example, states: “The medical treatment of infants should be based on what is in their best interest. However, because the infant’s ‘best interest’ is not always clear, parents and health care givers are often faced with difficult treatment decisions when faced with the situation of a severely ill, extremely premature, or terminally ill infant.”10(p362) Their recommendations for individualized decision-making using the best-interests standard are widely supported in the pediatric literature3,4 and in other AAP policies.11 These guidelines are also consistent with established principles of care for incompetent adults.12,16
The 1996 AAP Committee on Bioethics, in “Ethics and the Care of Critically Ill Infants and Children,” also agrees that decision-making for all children regardless of age should be individualized and made by the guardians and physicians based on what is best for the infants.8 They argue that this policy is consistent with the Baby Doe regulations1 and that those who think otherwise misunderstand these requirements. This committee claims that the mistake is evident from the responses of neonatologists and other pediatricians who answered a survey conducted by my colleagues and me shortly after the current rules went into effect.3,4 This committee’s view is similar to some members of the AAP leadership, who also hold that, properly understood, the Baby Doe regulations do not restrict doctors and families from using reasonable medical judgment, selecting individualized treatment plans, and serving the best interests of infants.8,9 I will argue that this benign interpretation cannot be supported by the language or purposes of the Baby Doe rules, and thus it is incompatible with the sort of individualized decision-making and use of the best-interests standard advocated by the AAP in other publications.10,11
ARE THE BABY DOE RULES MISUNDERSTOOD?
The 1996 AAP Committee on Bioethics states:
“[T]he actual language of the 1984 Child Abuse Amendments may permit more physician discretion than some realize. Although the law mandates provision of LSMT [life-sustaining medical treatment] to most seriously ill infants, it does provide for exceptions in the case of permanent unconsciousness, ‘futile’ treatment, and ‘virtually futile’ therapy that imposes excessive burdens on the infant. Physicians, with parental agreement, may even forgo giving hydration and nutrition when they think these measures are not ‘appropriate.’ (Quoted words and phrases come directly from the law.)”8(p149)
Although the members of the Committee on Bioethics are correct that the “quoted words and phrases come directly from the law,” each is taken out of context. When taken in context, the meaning of the Baby Doe rules reflects the understanding criticized by the Supreme Court in Bowen v American Hospital Association5 and by many neonatologists and other AAP pediatricians3,4 but applauded by right-to-life advocates such as President Reagan17 and his Surgeon General for the US Public Health Service, C. Everett Koop.18
“Permanent Unconsciousness” or “Irreversibly Comatose in Context”
The Committee on Bioethics states that there is no need to provide treatment when infants are permanently unconscious. The actual language of the first exception is that treatment need not be provided if “[t]he infant is chronically and irreversibly comatose”1(p14887) (see Appendix 1). This exception is the one and only quality-of-life consideration permitted in these rules. Yet many neonatologists and other pediatricians responded that this was insufficient for individualized and compassionate decisions using the best-interests standard.3,4
“Futile” in Context
The Committee on Bioethics states that there is no need to provide futile treatments. Futile means “useless for something,” and the rules carefully qualify how doctors and families must understand futility in caring for infants. The second exception states: “The provision of such treatment would merely prolong dying, not be effective in ameliorating or correcting all of the infant’s life-threatening conditions, or otherwise be futile in terms of the survival of the infant.”1(p14887) It is clearly stated that “futile” means “futile in terms of survival of the infant”1 (see Appendix 1). The second clause offers little discretion because, taken in context, “ameliorating or correcting all of the infants’ life-threatening conditions” must be assessed in terms of whether it would “merely prolong dying” (the first clause) or “otherwise be futile in terms of survival” (the third clause). The Reagan Administration did not want to leave it up to doctors and families to decide what was appropriate, useless, reasonable, or futile for what they called “handicapped” infants such as Baby Doe.17,18 Ronald Reagan wrote: “[T]he real issue is whether to affirm and protect the sanctity of all human life, or to embrace a social ethic where some human lives are valued and others are not. As a nation we must choose between the sanctity of life ethic and the ‘quality of life ethic.’”17(p355) In the end, the Baby Doe rules the Reagan Administration crafted allowed the one and only one quality-of-life consideration, namely, permitting interventions to be withheld or withdrawn for chronic and irreversible coma (the first exception); however, in the second exception, futility must be strictly understood in terms of whether the intervention would merely prolong dying. As we shall see, this is also true of the third exception relating to what is virtually futile.
“Virtually Futile” in Context
The Committee on Bioethics states that exceptions to maximal life-support treatments may be made when the interventions would be a “′virtually futile’ therapy that imposes excessive burdens on the infant.”8(p149) The actual language of the third exception is: “The provision of such treatment would be virtually futile in terms of the survival of the infant and the treatment itself under such circumstances would be inhumane”1(p14887) (see Appendix 1). The Committee on Bioethics is incorrect that this exception gives doctors the discretion to stop “burdensome” or “inhumane” treatments that they, using reasonable medical judgment, regard to be virtually futile. Rather, this exception requires considerations of what is inhumane only when treatment would be “virtually futile in terms of survival.” What is useful or virtually futile for one purpose, such as comfort care, may not be virtually futile to prolong biological life. Thus, the Baby Doe rules are far more restrictive than the interpretation of them offered by the 1996 Committee on Bioethics and other members of the AAP leadership suggest.8,9 The implausibility of the Committee on Bioethics’ interpretation should, once again, be evident from the purposes of the Baby Doe regulations. President Reagan17 and Surgeon General Koop18 stated that their goals in framing the Baby Doe rules were to restrict what doctors and parents could regard as appropriate, reasonable, and virtually futile in cases such as those of Baby Doe and Baby Jane Doe. The Reagan Administration, as noted, did not want to allow parents and their physicians to use quality-of-life judgments other than chronic and irreversible coma to decide if treatment in such cases were futile or inhumane.1,17,18
“Appropriate” and “Nutrition, Hydration, and Medication” in Context
The Committee on Bioethics states: “Physicians, with parental agreement, may even forgo giving hydration and nutrition when they think these measures are not ‘appropriate.’”8(p149) This interpretation cannot be supported by the text of the Baby Doe rules, which states that appropriate nutrition, hydration, and medication must always be given (see Appendix 1). “Appropriate” is a strong value word that can mean what is appropriate for a particular condition (eg, it is appropriate to give antibiotics for meningitis) or what is appropriate treatment for a particular patient. Traditional medical judgment and other publications by the AAP determine the usefulness or benefits of a proposed treatment for a particular patient. Parents and physicians may decide that it is not appropriate to give antibiotics to an infant with anencephaly who has meningitis. The complaint from neonatologists and many AAP pediatricians was that, at certain times, it is appropriate to withhold or withdraw certain hydration, nutrition, or medications based on traditional medical judgment using individualized decisions and the best-interests standard to decide what is appropriate.3,4
The plain language of the Baby Doe rules, however, reflects the Reagan-Administration view that judges, clinicians, and parents must never withdraw or withhold medication, nutrition, or hydration from infants1 (see Appendix 1). Reagan wanted a policy to clarify that federal law did not permit federally funded hospitals to starve infants or use quality-of-life consideration in deciding what interventions were futile or virtually futile.17 Reagan saw the issue as related to the abortion debate and wrote that “[l]ate-term abortions, especially when the baby survives, but is then killed by starvation, neglect, or suffocation, show, once again the link between abortion and infanticide.”17(p357) He wanted to ensure that institutions would not allow the withholding or withdrawing of hydration or nutrition as in the case of Baby Doe and that the mistakes of the past would not be repeated: “The judge let Baby Doe starve and die, and the Indiana Supreme Court sanctioned his decision.”17(p354) Koop, his Surgeon General, also took this view.18 He wrote that the decisions to withhold nutrition and fluids from Baby Doe “shocked me because in medicine, nutrition and fluids are life itself” and that all patients, including “Granny Doe” should be protected. “In any case, I would want ‘Granny Doe’ to receive whatever treatment is indicated. That does not mean prolonging the act of dying. But it does at least mean providing her with the nutrition and fluids needed to sustain life at its most basic level.”18(p3) The Baby Doe rules reflect the position articulated by Reagan and Koop exactly.
“Reasonable Medical Judgment” in Context
Robert Haggerty, MD, was the AAP’s president when the Baby Doe regulations were passed. He was quoted as saying: “It would appear that the final rule reaffirms the role of reasonable medical judgment and that decisions should be made in the best interests of infants.”9(p6) It is clear that the words “reasonable medical judgment” appear in the Baby Doe regulations (see Appendix 1). This does not mean, however, that this rule permits parents and physicians to decide on their own what is reasonable (see Appendix 1). The Baby Doe rules make it clear that doctors’ use of reasonable medical judgment is restricted to applying these exceptions.17–19 They limit the use of reasonable medical judgment to assessing whether infants are dying or chronically and irreversibly comatose or what medications or other procedures are needed to sustain life.
THE BABY DOE RULES ARE MISTAKEN
In a survey conducted by me and my colleagues shortly after the second set of Baby Doe rules was adopted,3,4 we found that the reasons given by the neonatologists and other AAP pediatricians who criticized these rules mirrored those of the New York Appeals Court and US Supreme Court in rejecting the first set of Baby Doe regulations.4 The clinicians responded that the Baby Doe regulations were unnecessary to protect the rights of disabled infants, offered inadequate consideration of the infants’ suffering, and interfered with parental rights to select the action that was in the best interests of their children. The neonatologists, in responding to 3 hypothetical but common cases discussed in pediatric literature as paradigms for withholding or withdrawing life-saving treatment, agreed (76–96%) about what would be considered in the child’s best interest using good medical judgment. However, in some cases, up to one third of respondents perceived a conflict between obligations to act in the child’s best interests and the legal requirements under the Baby Doe rules.1 Thus, the clinicians’ views for criticizing the current Baby Doe rules were similar to those of the New York Appellate and US Supreme Courts for rejecting the first set of Baby Doe regulations in the Bowen v American Hospital Association decision.5 They agreed that these rules limit clinicians’ discretion and parents’ ability to act in the best interests of the infants in deciding whether they should receive comfort care or aggressive life-saving treatments.
I have argued that the words “futile,” “virtually futile,” “appropriate,” “inhumane,” and “reasonable medical judgment” are taken out of context by the Committee on Bioethics and the AAP leadership supporting the Baby Doe rules. Consequently, these rules do not allow the sort of discretion that they claim.8,9 Rather, the correct interpreters of these rules may be the right-to-life advocates,9,17,18 who applauded the rules and of the courts5; it was neonatologists and other pediatricians who criticized the rules.3,4 Agreement among members of the US Supreme Court, neonatologists, and other pediatricians about the detrimental effects of both sets of Baby Doe regulations should cause the AAP Committee on Bioethics to reconsider whether they are correct about the 1984 Child Abuse Amendments being misunderstood. The Baby Doe rules are only consistent with the best-interests standard if it is assumed, as it was by Reagan and Koop, that maximally supporting infants with any degree of conscious life who are not dying is always in their best interest.
The 2 sets of Baby Doe rules1,6 single out 1 group, infants <1 year old, for a set of rules that most adults would not tolerate for themselves. Adults, facing a choice between prolonging life and preventing a life of minimal or no consciousness or of pain and suffering, sometimes believe that there are worse things than dying.16 This attitude is reflected in the first priority of palliative care as the relief of pain and suffering.12 In contrast to the Baby Doe rules, the more-established best-interests standard applies to all persons lacking decision-making capacity or competency.
The Baby Doe rules1 are incompatible with other AAP recommendations9,10 about using the best-interests standard for decision-making for children and about compassionate and individualized end-of-life care. Thus, consistency requires that the AAP choose between them. In my view, the choice is clear, and the AAP should withdraw its apparent support for the Baby Doe rules. If we agree that it is wrong to do to others what we would not want for ourselves and that we would not want an Infant Doe–like policy for ourselves as adults,11,14 then we should not adopt such a policy for infants <1 year old and should work to retire the Baby Doe rules.
APPENDIX 1
The current Baby Doe rules were enacted in 1984 and went into effect in 1985. They are funding requirements for states to receive child abuse funds, regulated by the states, and technically optional. They are untested by the courts. The key portion states:
[The withholding of medically indicated treatment is] the failure to respond to the infant’s life-threatening conditions by providing treatment (including appropriate nutrition, hydration, and medication) which, in the treating physician’s (or physicians’) reasonable medical judgment, will be most likely to be effective in ameliorating or correcting all such conditions, except that the term does not include the failure to provide treatment (other than appropriate nutrition, hydration, or medication) to an infant when, in the treating physician’s (or physicians’) reasonable medical judgment any of the following circumstances apply: (i) The infant is chronically and irreversibly comatose; (ii) The provision of such treatment would merely prolong dying, not be effective in ameliorating or correcting all of the infant’s life-threatening conditions, or otherwise be futile in terms of the survival of the infant; or (iii) The provision of such treatment would be virtually futile in terms of the survival of the infant and the treatment itself under such circumstances would be inhumane [US Department of Health and Human Services, 1985:1340.15(B)2p14887–14888].
Footnotes
- Address correspondence to Loretta M. Kopelman, PhD, Department of Medical Humanities, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC 27858. E-mail: kopelmanlo{at}mail.ecu.edu
No conflict of interest declared.
REFERENCES
- Copyright © 2005 by the American Academy of Pediatrics
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