Sadath Sayeed

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

The Born-Alive Infants Protection Act (BAIPA), passed by Congress in 2002, has attracted little publicity. Its purposes were, in part, “to repudiate the flawed notion that a child’s entitlement to the protections of the law is dependent on whether that child’s mother or others want him or her.” Understood as antiabortion rhetoric, the bill raised little concern among physicians at the time of legislative hearings and passed in both Houses by overwhelming majorities, hardly suggesting contentious legislation. After its signing into law, the Neonatal Resuscitation Program (NRP) Steering Committee issued an opinion stating that “[BAIPA] should not in any way affect the approach that physicians currently follow with respect to the extremely premature infant.” This interpretation of the law, however, may have been short sighted. In April 2005, the US Department of Health and Human Services (DHHS) brought life to the BAIPA, announcing: “As a matter of law and policy, [DHHS] 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.” The agency issued instructions to state officials on how the definitional provision within the BAIPA interacts with the Emergency Medical Treatment and Labor Act (EMTALA) and the Child Abuse Prevention and Treatment Act (CAPTA). These interagency memoranda potentially resurrect dormant governmental oversight of newborn-treatment decisions and thus may have influence over normative neonatal practice. Under the BAIPA, the DHHS interprets EMTALA to protect all “born-alive” infants; hospitals and physicians violating regulatory requirements face agency-sanctioned monetary penalties or a “private right of action by any individual harmed as a direct result.” According to its memorandum, the DHHS will investigate allegations of EMTALA violations whenever it finds evidence that a newborn was not provided with at least a medical screening examination under circumstances in which a “prudent layperson observer” could conclude from the infant’s “appearance or behavior” that it was “suffering from an emergency medical condition.” The memorandum fails to clarify which observers qualify as prudent, what infant appearance or behavior is relevant, or what defines an emergency medical condition. Because these evaluative criteria are not constrained by reference to relevant standards of medical care, the agency arguably substitutes a nonprofessional’s presumed sagacious assessment of survivability for reasonable medical judgment. Indeed, under a straightforward reading of the instruction, a family member could conceivably trigger an investigation after observing a relative deliver a 20-week fetus who maintains a heartbeat for an hour before its death. Most physicians would not consider this an emergency medical condition and, rather than perform a screening examination, would provide comfort for the newborn and support for the family. The guideline, however, does not state that professional acumen trumps the layperson’s observations in these instances; thus, physicians are left unclear about whether screening examinations are required for all newborns regardless of a priori, reasoned considerations of survivability. In this context, the NRP Steering Committee opinion states that “at the time of delivery… the medical condition and prognosis of the newly born infant should be assessed. At that point decisions about withholding or discontinuing medical treatment that is considered futile may be considered by… providers in conjunction with the parents acting in the best interest of their child.” However, most pediatricians skilled in screening and resuscitation are not currently called on to perform this function when the gestational age of a nonviable fetus is reasonably certain before delivery. If under the law screening is now required at any gestational age, professional procedure immediately after previable births may need modification. More worrisome, threatened aggressive investigations of alleged EMTALA violations at the soft edges of viability, where futility remains a matter of debate, jeopardize the normative ethical practice of offering discretionary palliative care. The DHHS sent its other instruction to state child protective services agencies responsible for implementing CAPTA regulations; it reiterates the limited situations in which physicians may withhold medical treatment from infants and reemphasizes the local role of “individuals within health care facilities” to notify authorities of suspected infractions. Its real import, however, is insistence on local execution of legal remedies to prevent nontreatment decisions deemed impermissible by the 1984 Baby Doe rules. Because this new directive encourages governmental oversight of treatment decisions involving imperiled newborns, a period of benign regulatory neglect seems to be over. The federal CAPTA rules arguably remove quality-of-life considerations from the decision-making calculus and therefore may conflict with the best-interests paradigm advocated by the American Academy of Pediatrics and NRP. How courts will respond to the DHHS interpretation of EMTALA and CAPTA under the BAIPA remains unclear. Federal courts have yet to authoritatively examine alleged EMTALA violations involving newborn treatment decisions at the limits of viability. The Wisconsin Supreme Court has permitted an EMTALA claim to go to trial where physicians allegedly did not screen or resuscitate a 22-week newborn delivered in an emergency department, and a lower appellate court has relied on CAPTA to hold that parents do not possess the right to choose against resuscitating an extremely premature newborn. The Texas Supreme Court recently granted physicians the paternalistic prerogative to resuscitate imperiled newborns without attention to parental preference under a common law doctrine of “emergent circumstances.” These judicial decisions undermine the ethical discretion parents are typically afforded in decision-making before and after delivery in these morally complex situations. The DHHS interpretation of the BAIPA may encourage jurisdictional creep of these kinds of pronouncements as the agency seeks to expand legal protections for born-alive infants. The US Supreme Court has stated that “courts must presume that a legislature says in a statute what it means and means in a statute what it says there”; thus, judges interpret law by analyzing “concrete statutory language, not by reference to abstract notions of generalized legislative intent.” The BAIPA indiscriminately defines “born alive” to include an infant “at any stage of development… regardless of whether the expulsion or extraction occurs as a result of natural or induced labor, cesarean section, or induced abortion,” and it makes no reference to standards of care or best interests, nor does it specifically protect a parent’s decision-making authority. Under the law’s strict logic, an 18-week miscarried fetus with a detectable heart beat after delivery is entitled to the full protections of the law as determined by “any Act of Congress, or any ruling, regulation, or interpretation of the various administrative bureaus and agencies.” Before concluding that the BAIPA would not affect normative neonatal practice, the NRP Steering Committee should have analyzed the act’s actual statutory language and avoided relying heavily on imprecise legislative intent. The BAIPA’s congressional sponsors did claim that the law “will not mandate medical treatment where none is currently indicated,” but such political rhetoric is often not sufficient to render law innocuous years after separation from its legislative history. Besides, nowhere in the House record does the majority explicitly acknowledge that discretion to decide the fate of imperiled newborns invests in parents, in consultation with physicians; indeed, the bill’s stated purpose was to repudiate that notion. At best, legislators recognized that physicians disagree about the efficacy of resuscitating at the limits of viability, and therefore the current standard of care permits doctors to deem resuscitation a futile endeavor. However, judges may resist characterizing resuscitation as futile, given its poor analytical fit, and substantial public-policy concerns regarding discrimination against future disabled individuals could easily tip a court to preserve incipient, at least, physiologic life under the BAIPA’s all-encompassing definition of born alive.

The OHRP and SUPPORT

A group of medical ethicists and pediatricians asks for reconsideration of the recent Office for Human Research Protections decision about informed consent in SUPPORT.

Impact of ethics and economics on end-of-life decisions in an Indian neonatal unit.

OBJECTIVE: The aim of this article was to describe how providers in an Indian NICU reach life-or-death treatment decisions. METHODS: Qualitative in-depth interviews, field observations, and document analysis were conducted at an Indian nonprofit private tertiary institution that provided advanced neonatal care under conditions of resource scarcity. RESULTS: Compared with American and European units with similar technical capabilities, the unit studied maintained a much higher threshold for treatment initiation and continuation (range: 28–32 completed gestational weeks). We observed that complex, interrelated socioeconomic reasons influenced specific treatment decisions. Providers desired to protect families and avoid a broad range of perceived harms: they were reluctant to risk outcomes with chronic disability; they openly factored scarcity of institutional resources; they were sensitive to local, culturally entrenched intrafamilial dynamics; they placed higher regard for “precious” infants; and they felt relatively powerless to prevent gender discrimination. Formal or regulatory guidelines were either lacking or not controlling. CONCLUSIONS: In a tertiary-level academic Indian NICU, multiple factors external to predicted clinical survival of a preterm newborn influence treatment decisions. Providers adjust their decisions about withdrawing or withholding treatment on the basis of pragmatic considerations. Numerous issues related to resource scarcity are relevant, and providers prioritize outcomes that affect stakeholders other than the newborn. These findings may have implications for initiatives that seek to improve global neonatal health.

Differing Attitudes Toward Fetal Care by Pediatric and Maternal-Fetal Medicine Specialists

OBJECTIVES: The expansion of pediatric-based fetal care raises questions regarding pediatric specialists’ involvement in pregnancies when maternal conditions may affect pediatric outcomes. For several such conditions, we compared pediatric and obstetric specialists’ attitudes regarding whether and when pediatrics consultation should be offered and their views about seeking court authorization to override maternal refusal of physician recommendations. METHODS: We used a mail survey of 434 maternal-fetal medicine specialists (MFMs) and fetal care pediatric specialists (FCPs) (response rate: MFM, 60.9%; FCP, 54.2%). RESULTS: FCPs were more likely than MFMs to indicate that pediatric counseling should occur before decisions regarding continuing or interrupting pregnancies complicated by maternal alcohol abuse (FCP versus MFM: 63% vs 36%), cocaine abuse (FCP versus MFM: 60% vs 32%), use of seizure medications (FCP versus MFM: 62% vs 33%), and diabetes (FCP versus MFM: 56% vs 27%) (all P < .001). For all conditions, MFMs were more than twice as likely as FCPs to think that no pediatric specialist consultation was ever necessary. FCPs were more likely to agree that seeking court interventions was appropriate for maternal refusal to enter a program to discontinue cocaine use (FCP versus MFM: 72% vs 33%), refusal of azidothymidine to prevent perinatal HIV transmission (80% vs 41%), and refusal of percutaneous transfusion for fetal anemia (62% vs 28%) (all P < .001). CONCLUSIONS: Pediatric and obstetric specialists differ considerably regarding pediatric specialists’ role in prenatal care for maternal conditions, and regarding whether to seek judicial intervention for maternal refusal of recommended treatment.

End-of-life decisions as bedside rationing. An ethical analysis of life support restrictions in an Indian neonatal unit

Introduction Hundreds of thousands of premature neonates born in low-income countries are implicitly denied treatment each year. Studies from India show that treatment is rationed even for neonates born at 32 gestational age weeks (GAW), and multiple external factors influence treatment decisions. Is withholding of life-saving treatment for children born between 28 and 32 GAW acceptable from an ethical perspective? Method A seven-step impartial ethical analysis, including outcome analysis of four accepted priority criteria: severity of disease, treatment effect, cost effectiveness and evidence for neonates born at 28 and 32 GAW. Results The ethical analysis sketches out two possibilities: (a) It is not ethically permissible to limit treatment to neonates below 32 GAW when assigning high weight to health maximisation and overall health equality. Neonates below 32 GAW score high on severity of disease and efficiency and cost-effectiveness of treatment if one gives full weight to early years of a newborn life. It is in the childs best interest to be treated. (b) It can be considered ethically permissible if high weight is assigned to reducing inequality of welfare and maximising overall welfare and/or not granting full weight to early years of newborns is considered acceptable. From an equity-motivated health and welfare perspective, we would not accept (b), as it relies on accepting the lack of proper welfare policies for the poor and disabled in India. Conclusion Explicit priority processes in India for financing neonatal care are needed. If premature neonates are perceived as worth less than other patient groups, the reasons should be explored among a broad range of stakeholders.

Does professional orientation predict ethical sensitivities? Attitudes of paediatric and obstetric specialists toward fetuses, pregnant women and pregnancy termination

Background To determine (1) whether fetal care paediatric (FCP) and maternal–fetal medicine (MFM) specialists harbour differing attitudes about pregnancy termination for congenital fetal conditions, their perceived responsibilities to pregnant women and fetuses, and the fetus as a patient and (2) whether self-perceived primary responsibilities to fetuses and women and views about the fetus as a patient are associated with attitudes about clinical care. Methods Mail survey of 434 MFM and FCP specialists (response rates 60.9% and 54.2%, respectively). Results MFMs were more likely than FCPs to disagree with these statements (all p values<0.005): (1) ‘the presence of a fetal abnormality is not an appropriate reason for a couple to consider pregnancy termination’ (MFM : FCP—78.4% vs 63.5%); (2) ‘the effects that a child born with disabilities might have on marital and family relationships is not an appropriate reason for a couple to consider pregnancy termination’ (MFM : FCP—80.5% vs 70.2%); and (3) ‘the cost of healthcare for the future child is not an appropriate reason for a couple to consider pregnancy termination’ (MFM : FCP—73.5% vs 55.9%). 65% MFMs versus 47% FCPs disagreed that their professional responsibility is to focus primarily on fetal well-being (p<0.01). Specialists did not differ regarding the fetus as a separate patient. Responses about self-perceived responsibility to focus on fetal well-being were associated with clinical practice attitudes. Conclusions Independent of demographic and sociopolitical characteristics, FCPs and MFMs possess divergent ethical sensitivities regarding pregnancy termination, pregnant women and fetuses, which may influence clinical care.

Ethics and professionalism education during neonatal–perinatal fellowship training in the United States

Objective:The objectives of this study were to determine the perceived adequacy of ethics and professionalism education for neonatal–perinatal fellows in the United States, and to measure confidence of fellows and recent graduates when navigating ethical issues.Study Design:Neonatal–Perinatal Fellowship Directors, fellows and recent graduates were surveyed regarding the quality and type of such education during training, and perceived confidence of fellows/graduates in confronting ethical dilemmas.Result:Forty-six of 97 Directors (47%) and 82 of 444 fellows/graduates (18%) completed the surveys. Over 97% of respondents agreed that ethics training is ‘important/very important’. Only 63% of Directors and 37% of fellows/graduates rated ethics education as ‘excellent/very good’ (P=0.004). While 96% of Directors reported teaching of ethics, only 70% of fellows/graduates reported such teaching (P<0.001). Teaching methods and their perceived effectiveness varied widely.Conclusion:Training in ethics and professionalism for fellows is important, yet currently insufficient; a more standardized curriculum may be beneficial to ensure that trainees achieve competency.

Assessing the modified youngest-first principle and the idea of non-persons at the bedside: a clinical perspective.

I commend Kerstein and Bognar (2010) for critiquing a framework that purports to provide an ethical basis for the allocation of scarce resources in health care centered on the assessment of “complete lives” (Persad, Wertheimer, and Emanuel 2009). Of particular interest to a clinician active in the field of newborn medicine is an idea like the “modified youngest-first principle” (Kerstein and Bognar 2010). I agree with the authors that the root moral claims substantiating this principle need further elaboration. Reference to a rather unimpressive set of empirical data does next to no work, even when coupled to Dworkin’s plausible intuition about the quality and quantity of moral loss at different stages of human development (Persad et al., 2009). To their credit, the authors acknowledge numerous potential problems in assigning weight to notions like prior investment and quality of life, and they also admit uncertainty about how current individual human capacity ought to be weighed against numerous future human potentials. In their concluding remarks, they suggest a possible foundation on which to prioritize the interests of “persons” by asserting that “by virtue of possessing. . . capacities beings have special worth or dignity.” (Kerstein and Bognar 2010) This is not a novel suggestion. (Harris, 1999) As a principle it may help capture what is likely a broadly felt intuition in the following kind of case: if we could only extend the life of a 4-month or a 20-year old for one day, we really ought to save the latter. There is a compelling logic in the idea that if one cannot value one’s own existence, it cannot harm that being (though it may harm others) to cease to exist (Harris, 1999).

Perspectives on anticipated quality-of-life and recommendations for neonatal intensive care: a survey of neonatal providers

Abstract Objective: Explore associations between neonatal providers’ perspectives on survival, quality of life (QOL) and treatment recommendations. Methods: Providers attending a workshop on neonatal viability were surveyed about survival, perceived QOL and treatment recommendations for marginally viable infants. We assessed associations between estimated survival and perceived QOL and treatment recommendations. Results: In the 44 included surveys, estimates of survival and QOL varied widely. Maximum care was recommended 80% of the time when anticipated QOL was high, versus 20% when anticipated QOL was low (p < 0.001). Adjusted for confounders, odds of recommending maximum intervention were 4.4 times higher when anticipated QOL was high (95% CI 1.9 – 10.2, p = 0.001). Conclusions: The perspectives of practitioners who provide care to critically ill neonates regarding potential survival and QOL vary dramatically and are associated with the treatments those practitioners recommend. Practitioners should take care to avoid basing treatment recommendations on their own perspectives if they are not well aligned with those of the parents.

Leveraging Opportunities for Critical Care in Resource-Limited Settings

The authors report no relationships that could be construed as a conflict of interest. From the *Division of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; yCenter for Global Health, Massachusetts General Hospital, Boston, MA, USA; zDepartment of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; xSeed Global Health, Boston, MA, USA; and the kDivision of Newborn Medicine, Department of Medicine, Boston Children’s Hospital, Boston, MA, USA. Correspondence: V. B. Kerry (vbk@ seedglobalhealth.org).