In this month's Pediatrics electronic pages, Dr Sayeed1 does the neonatology community an important service by calling our attention to the Born-Alive Infants Protection Act of 2002 and its implications for the clinical standards and ethics of neonatal practice. This new federal legislation goes beyond the Baby Doe rule from 1984,2,3 which technically required reporting of cases in which infants were allowed to die without one of the stipulated exceptions applying. As Sayeed reports, the Born-Alive Infants Protection Act has been interpreted by the Secretary of the US Department of Health and Human Services to mean that the department “will investigate all circumstances where individuals and entities are reported to be withholding medical care from an infant born alive in potential violation of federal statutes for which we are responsible.”1 The strategy seems to be to continue that envisaged (but never really enforced) under the Baby Doe rule: to respond to reports rather than seek to directly regulate the practice of neonatology, a regulatory function traditionally left to the states in our federal system of self-government. Sayeed's summary of the law's potential effect invokes a vivid and apt metaphor: “the current administration's resurrection of recently quiescent oversight of the treatment of imperiled newborns agitates the legal fault line that physicians walk along when caring for these infants.”1
Sayeed raises a number of serious ethical concerns about this new law, and he should be saluted for doing so. Sayeed is entirely correct to point out that the law may be more substantive and serious in its effect on clinical practice in neonatology than the American Academy of Pediatrics seems to think, based on the opinion that Sayeed quotes. I will address some of the major concerns that he has identified.
Sayeed reads the new legislation and the memorandum from the Centers for Medicare and Medicaid Services as requiring, under the Emergency Medical Treatment and Active Labor Act, that any infant born alive (as defined in the new law) must, as a matter of legal obligation, be assessed and, if judged reliably to be in an emergency condition, provided treatment to stabilize the medical emergency. Sayeed points out that the Centers for Medicare and Medicaid Services memorandum does not define a medical emergency, but this definition is already well understood in medicine: a life-threatening or health-threatening condition that must be treated immediately to prevent imminent death or serious loss of health, respectively, as a consequence of which there is no time for informed consent either from the patient directly (in the case of competent adults) or from the duly authorized surrogate decision-maker(s) (parents in the case of minor children). Physicians have all of the ethical and legal authority they need to intervene in medical emergencies, in the absence of a valid advance directive, such as by an out-of-hospital do-not-resuscitate order. Sayeed misunderstands the recent Miller case in Texas, which is represented as “paternalistic” in that it “discounts the importance of obtaining parental consent” in life-threatening medical emergencies.1 The use of “paternalistic” implies that parental autonomy in the form of a refusal of treatment of such an emergency can override the physician's obligation to treat, a line of reasoning that the Texas Supreme Court does not accept.4 In Texas, physicians have an independent obligation to treat the life-threatening conditions of minor children, and no consent from anyone is required. This line of reasoning is ethically sound: pediatricians have independent fiduciary obligations to protect and promote the health-related interests of their patients.5
Sayeed also suggests that failure to resuscitate a newborn reliably judged to be at 21 weeks' gestational age (presumably by quality obstetric ultrasound examination) could be construed as a violation of the new law. The Emergency Medical Treatment and Active Labor Act and the Baby Doe amendment, the federal statutes for the enforcement of which the US Department of Health and Human Services is responsible, do not envision an obligation to provide treatment that is futile in terms of survival. The Baby Doe rule explicitly uses this language, reflecting the basic logic of obligations: they do not exist when it has become impossible to fulfill them. This moral logic is captured in the well-known rule in ethical theory, ought implies can, and its corollary: if something is impossible, there is no obligation to attempt it. Sayeed is right on target to emphasize that the new law is surely meant to be intrusive, but (even) the law is not absurd in its requirements.
Sayeed also raises concerns about the treatment of infants “at the soft margins of viability,”1 a crucial phrase that is left undefined. Presumably, Sayeed means to include infants in the 22- to 23-completed-weeks gestational age. In this patient population there is a small, nontrivial percent of survivors. Of survivors, more have significant neurologic impairments (a clinical category not consistently defined in the literature) than do not. Most of these infants die or survive with such impairments.
For infants in this population, Sayeed notes that “futility is clearly a matter of therapeutic debate.”1 Recent data from the Vermont Oxford Network on outcomes for this population help to explain why, especially the comment of the authors that neonatologists are engaged in a “large uncontrolled experiment.”6 Whenever futility is invoked as the clinical ethical justification for limiting life-sustaining treatment, the sense in which “futility” is being invoked must be specified, because there is more than one concept of futility.7,8
The Baby Doe rule might be helpful here. As one basis for an exception to the obligation to treat, the Baby Doe rule invokes the concept that life-sustaining treatment has become “virtually futile in terms of survival and inhumane.”2 This concept of futility may have important application to clinical reasoning about life-sustaining treatment at the limits of viability, in cases in which treatment is becoming progressively less effective for one or several but not all of the infant's life-threatening conditions and the iatrogenic burden is mounting to the point at which the child's interactive capacity has been or is about to be eliminated. Such treatment should count as “virtually futile in terms of survival and inhumane.” McCormick,9 in what is now regarded as one of the classic articles of bioethics literature, also argued that, when an infant is overwhelmed by the struggle to survive, the Judeo-Christian tradition does not require that life-sustaining treatment be continued.
Finally, Sayeed notes that physicians “believe ethical duty requires frank discussions about quality-of-life considerations when reviewing treatment options with parents” of infants at the limits of viability.1 The concept of quality of life has long been invoked in neonatal ethics10 but without the precise meaning that it has in the social sciences: the ability to engage in life tasks and derive satisfaction from doing so. To have life tasks, to gain satisfaction from engaging in them, and to have values on the basis of which one can judge whether the extent of one's satisfaction is sufficient and therefore makes one's life worth living require sophisticated cognitive and affective functions, which infants have not yet developed. The concept of quality of life, therefore, has no meaningful application in neonatal ethics. Therefore, invoking futility in terms of quality of life, or qualitative futility,11 which Sayeed seems to do, has no place in neonatal ethics. Quality-of-life futility judgments are also clearly excluded as valid exceptions in the Baby Doe rule to the physician's obligation to provide life-sustaining treatment. Even if quality-of-life futility could be meaningfully invoked in neonatal ethics, it is not at all clear that children with significant impairments who were born prematurely report a lower quality of life than unaffected children.12
It is possible to mount a challenge to this line of argument from the perspective of justice. Justice requires that the distribution of benefits and burdens of a medical intervention in a population be fair. The distribution of clinical benefits and burdens is skewed for this population of infants. Only a very small percentage experience an unalloyed clinical benefit (intact survival), whereas many more experience significant clinical burden (death or survival with significant, often irreversible impairment) without any opportunity to experience potentially compensating clinical benefit. The conditions of justice as fairness are therefore violated, calling into question the justice of the Baby Doe rules and practice standards based on them.13
The discipline of ethics requires us to go where the arguments take us, even and especially when we might not like where they go.14 For neonatal ethics at the limits of viability, the narrow focus of both the older and the most recent federal legislation and regulations on futility in terms of survival and the exclusion by them of quality-of-life futility are well supported by ethical argument that focuses on the clinical application of relevant concepts of futility.
This narrow focus can, indeed, be challenged from the perspective of justice. The justice-based approach to neonatal ethics at the limits of viability, however, must wrestle with its own serious challenge: the skewed distribution of benefits and burdens can be remedied but only by letting mortality rise as a way to reduce morbidity. From the perspective of justice, not every reduction in mortality from critical care intervention is worth the resulting morbidity in a population of patients. The challenge arises because letting mortality rise will mean that some infants who would otherwise have survived intact will have been allowed to die. Whether neonatal ethics at the limits of viability should embrace a justice-based approach remains a topic for further serious investigation.
- Accepted August 3, 2005.
- Address correspondence to Laurence B. McCullough, PhD, Center for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Houston, TX 77030. E-mail:
No conflict of interest declared.
- ↵Sayeed SA. Baby Doe redux? The Department of Health and Human Services and the Born-Alive Infants Protection Act of 2002: a cautionary note on normative neonatal practice. Pediatrics.2005;116 (4). Available at: www.pediatrics.org/cgi/content/full/116/4/e576–e585
- ↵Nondiscrimination on the basis of handicap; procedures and guidelines relating to health care for handicapped infants—HHS. Final rules. Fed Regist.1985;50 :14879– 14892
- ↵Kopelman LK. Are the 21-year-old Baby Doe rules misunderstood or mistaken? Pediatrics.2005;115 :797– 802
- ↵Miller v HCA, Inc., 118 S.W. 3d 758, 771 (Tex. 2003)
- ↵American Academy of Pediatrics, Committee on Bioethics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics.1995;95 :314– 317
- ↵Lucey JF, Rowan CA, Shiono P, et al. Fetal infants: the fate of 4172 infants with birth weights of 401 to 500 grams—the Vermont Oxford Network experience (1996–2000). Pediatrics.2004;113 :1559– 1565
- ↵McGraw MP, Perlman J, Chervenak FA, McCullough LB. Clinical concepts of futility and ethically justified limits on neonatal care: a case presentation of an infant with Apgar scores of zero at one, five, and ten minutes. Am J Perinatol.2005; In press
- ↵Shaw A. Defining the quality of life. Hastings Cent Rep.1977;7(5) :11
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