Ethical Issues in the Perinatal Period




Despite great advances in perinatal medicine, not all newborns born alive can stay alive or survive without experiencing severe—perhaps even devastating—physical and mental problems. This is particularly true for extremely preterm infants (approximately 24 to 27 weeks’ gestation), who have a survival rate of approximately 75%. Thus, many extremely low-birth-weight infants can and do survive despite being born much too soon, although they often experience significant long-term problems such as chronic lung disease, short gut syndrome, neurologic and cognitive abnormalities, poor growth, blindness, and chronic illness.


In at least some of these cases, physicians, nurses, or parents raise questions about whether initial or continued aggressive treatment is ethically correct, who should make these decisions, and what criteria they should use. These questions have been publicly asked and answered in a variety of ways since 1973 when Duff and Campbell acknowledged that they, their neonatal intensive care unit (NICU) staff, and the involved parents allowed some infants to die because of their poor chances of survival or of having a reasonable quality of life. No single standard of care exists in this area, and indeed one commentator has noted that this area of bioethics remains “as intractable today as it was 30 years ago, when it began to be publicly discussed.” Studies have shown what clinical experience and common sense posit: physicians’ practices regarding the use or withholding of resuscitative therapy in the NICU are not consistent.


This chapter explores some answers to these enduring and fundamental questions by presenting and commenting on an actual case. In doing so, it considers the most pressing questions and dominant myths about forgoing treatment of newborns and briefly explains why the myths should be discarded by ethical and humane practitioners of neonatal medicine. These myths deserve attention because they are both widely held and dangerous to the interests of infants, parents, and medicine. Unnecessary legalism, improper disenfranchisement of parents, simplistic reliance on a single popular standard of questionable meaning, and rejection of quality-of-life considerations are still the deepest and most insidious traps into which physicians and nurses caring for newborns fall.



This case report is based on four articles published in the Houston Chronicle on January 6, 1998 (Section A, p. 9 ), January 17, 1998 (Section A, p. 1 ), January 31, 1998 (Section A, p. 29 ), and April 18, 1998 (Section A, p. 36 ). Unless otherwise indicated, all direct quotes are taken from these articles.


The Case


Mark and Karla Miller filed a negligence lawsuit against a hospital, Women’s Hospital of Texas, and the company that owns the hospital, Columbia/HCA Healthcare Corporation, following the premature birth of their daughter, Sydney. She was born at 23 weeks’ gestation and weighed 615 g. The parents claimed that the hospital had “callously ignored the couple’s request not to artificially prolong the child’s life at birth” and that resuscitating such an underdeveloped baby amounted to “medical experimentation on humans.” They also accused the hospital of being motivated to impose treatment to collect the large revenues that would thereby be generated.


Mrs. Miller had developed chorioamnionitis, and she was hospitalized. “With her own life in potential danger, she and her husband agreed with the doctor to induce labor.” They were notified about the “uncertain odds of survival in such a young pregnancy” and the “baby’s unlikely prospects for survival so early in pregnancy.” After “much agonizing,” they decided to have the baby delivered (following induction) but “to let nature take its course.” According to the parents’ lawyer, they saw it as “God’s will” if the newborn had “not developed to the extent that it could survive without artificial means”; they wanted no “special heroics” performed. The parents claimed they had repeatedly requested that doctors not resuscitate the newborn if she had not developed adequately to sustain life on her own.


Although the obstetrician and neonatologist agreed with the parents that comfort care was a very reasonable option, the hospital administrator of the NICU allegedly told the father that the hospital had a policy requiring resuscitation of any infant that weighed more than 500 g, although she was never able to produce a written policy to this effect. She also allegedly informed the father that “his only option would be to take his wife to another hospital, which he could not risk because of her condition.” When the father said he would be in the delivery room and would stop physicians from performing resuscitation, this administrator said police would be called to remove him from the premises.


The hospital disputed the parents’ version of the facts and claimed it had an ethical and legal obligation to keep the baby alive. It denied that treatment decisions were related to financial considerations, that its administrator had made any threats or statement to the father as he had alleged, and that it had any responsibility for medical decisions that were made by the physicians and family involved. It claimed that the attending physicians had drafted a “birth plan” with the parents’ full consent and produced several consent forms signed by the father for medical services.


Furthermore, the father allegedly never questioned the physician’s actions to keep the child alive either in the delivery room or later. The hospital also asserted that the physicians honored the parents’ decision not to restart the infant’s heart if she went into arrest. However, she had a heartbeat when born, although her “lungs and other vital organs” were not working at birth, and received vigorous treatment.


Sydney was born with her eyelids fused shut and is legally blind. She remained hospitalized for nearly a year at a cost of about $1 million. She is severely brain damaged and requires extensive care, because she is almost totally incapacitated. Her mother ended her career as an equities fund broker to care for her daughter full time because the family could not afford the $200,000 annual cost of professional care.


Eleven days after the start of the trial and after 2 days of deliberations, the jury returned a $42.9 million verdict against the hospital and Columbia/HCA by a vote of 10 to 2: $29.4 million for the costs of the child’s past and future medical care and $13.5 million in punitive damages. Pretrial interest of $22.4 million on the damages awarded made the total verdict worth $65.3 million. The parents’ lawyer stated that the key issue was “who will make the basic medical decisions—families or medical specialists who do not have to live with the consequences.” One juror reported that he and other jurors believed the Millers rather than the hospital and that there was evidence that indicated “arrogance” on the part of the hospital and Columbia/HCA.


Defense witnesses had testified that the care delivered to both the mother and infant met the applicable standard of care and that “the newborn’s condition was adequate enough to require them to try to sustain life.” These witnesses also stated that denying “proper care could subject the doctors to penalties and sanctions, or even suit alleging negligence.”


The case generated considerable attention, and one can read the large punitive damage award as a clear signal by the jury that it supported the parents in this case and disapproved of the actions of the hospital. In the end, however, the Millers did not receive any compensation because the verdict was overturned on appeal, with the Texas Supreme Court creating an “emergent circumstances” exception whereby a physician in Texas may resuscitate an infant in the delivery room without first obtaining parental consent. The sharp difference between the opinion of the jury and the reasoning of the court raise a number of important ethical questions.




Discussion


Is there a legal and ethical obligation to resuscitate all newborns and continue providing treatment until a child is imminently dying?


Some, perhaps many, physicians and nurses believe that no choice exists but to resuscitate every newborn infant in the delivery room, no matter how small, and continue aggressive medical treatment in the NICU until he or she is headed inevitably and imminently toward death. Once the infant has shown itself to be close to death despite aggressive medical management, then and only then can physicians and parents choose to withhold or withdraw life-sustaining treatment.


First, it is incorrect to claim either that all infants are in fact resuscitated at birth or that the standard of care requires that they be resuscitated. In one cross-cultural study of neonatal deaths, 29 of the 183 neonatal deaths (16%) occurred in infants who received comfort care instead of cardiopulmonary resuscitation at delivery. Other articles in the medical literature support the position that resuscitation in the delivery room is not professionally and ethically required in all cases. In addition, the Neonatal Resuscitation Program, created jointly by the American Academy of Pediatrics and the American Heart Association, specifically recognizes that there are situations in which it is ethical not to initiate resuscitation.


Second, it is false to claim on the merits that a strict ethical and legal obligation exists to resuscitate every newborn regardless of his or her condition, prognosis, or parental desires about resuscitation. For example, if prenatal testing and ultrasonography had unambiguously detected anencephaly, the parents had given their informed consent to nontreatment, and this condition was clearly present at birth, no obligation to resuscitate such an infant would exist because of his or her permanent unconsciousness, the nature of the anomaly, and the reasonableness of the parents’ determination of what they feel is in the best interests of the child.


In other words, there may be cases in which enough can be known about a child’s diagnosis and prognosis before birth that a parental decision to decline aggressive resuscitation is morally justified and within the bounds of parental discretion. Such cases are likely to involve an infant with one of the following diagnoses: confirmed gestational age of less than 23 weeks or a birth weight of less than 400 g, anencephaly, and confirmed lethal genetic disorder or malformation.


On the other hand, an extremely premature infant can be born alive with no prenatal indication of any specific anomaly or disease, and his or her medical condition and prognosis might be so uncertain that the attending physicians cannot honestly assess the particular child’s prospects for survival and outcome at birth. In this situation or a similar one, the physicians and nurses could conclude that they were under an ethical obligation to resuscitate the child initially because of uncertainty about his or her true diagnosis and prognosis. If this is the case, however, they would also be obligated promptly to ascertain more accurately the particular child’s medical condition and the prospects for a life not characterized by excessive pain, burdensome interventions, or inability to consciously interact with others.


From this point of view, the absence of reasonably accurate medical information at birth needed to ground the value judgment that must inevitably be made about forgoing treatment renders a parental decision against initial resuscitation uninformed, poorly (if at all) justified, and not prima facie morally binding on the health care providers. Even assuming the validity of this rationale, it still remains true that after more clinical information has been gathered and more deliberation has occurred, the physicians, nurses, and hospital should then respect parental decisions to forgo further treatment in appropriate cases.


The father in the Miller case testified that both the obstetrician and the neonatologist were bleak about the future prospects for their child. The Millers were told that the hospital had “never had such a premature infant live and that anything they did to sustain the infant’s life would be guesswork.” The Neonatal Resuscitation Program explicitly recognizes that parents have the primary role in determining what is in the best interests of their child. Their decision, however, must be based on the best information available, which may not be obtainable until after delivery. In general, infants who will die tend to declare themselves early, although this period has grown increasingly longer, from 2 to 3 days in the early 1990s to 10 days in 2001. Waiting a few days to reflect on forgoing treatment may generate more clinical information and greater predictability about the child’s diagnosis and prognosis.


Whatever the merits of this brief moral analysis, it is a myth that the law requires all infants to receive aggressive resuscitation and treatment until they are imminently dying. The ultimate source of this myth is the so-called “Baby Doe” law, the Child Abuse Amendments of 1984. These amendments to the Child Abuse Prevention and Treatment Act (CAPTA) and the implementing regulations issued by the Department of Health and Human Services (DHHS) constitute the Baby Doe laws that are currently in effect in the United States. These laws require each state to establish certain procedures for reporting alleged instances of “medical neglect,” including the withholding of “medically indicated treatment,” to local child protective services and for investigating such reports— if the state wishes to receive federal child abuse prevention grants. On their face, the DHHS regulations permit treatment to be forgone only in very limited circumstances.


Many physicians are under the impression that the Baby Doe law directly imposes on them certain duties to care for newborns and that they will suffer federal penalties if they fail to do so. These laws, however, do not apply directly to physicians or parents of critically ill newborns; they only require states receiving federal funds to do certain things. The obligation of individual medical professionals to report instances of child abuse or neglect, including medical neglect, arises out of the law of an individual state, not the federal Baby Doe law. The substantive legal standards applicable to a determination of whether a particular decision by a physician and parents to forgo life-sustaining treatment of a newborn as unacceptable are established by state law, not by the Baby Doe law.


State law typically does not contain explicit or detailed standards for determining when treatment is being improperly withheld or withdrawn from a child. California, for example, requires physicians and other licensed providers to report as child neglect parental refusals of “adequate medical care,” but not when the parents have made an “informed and appropriate medical decision” after consulting with a physician who has actually examined the child. Because there is no statutory definition of “informed and appropriate medical decision,” the practical meaning of the term is left to clinicians, who must decide whether an “inappropriate” medical decision has been made and consequently whether they are going to make a report to child protective services.


The legacy of the Baby Doe law has been mixed. Shortly after its passage, one veteran clinician lamented that the Baby Doe law was “usually taken as a mandate to rescue many infants by the application of available technology, even though families and their health and other advisors often hold that quality of life and other considerations, including staggering costs and low benefits, clearly support a different choice.”


He accused an influential portion of the medical profession of helping the federal government to create “a law, which, chiefly on ideological or biological grounds, often mandates treatment that careful reflection by those most intimately involved finds inappropriate.”


In addition, at least one court has interpreted CAPTA to mean that resuscitation is required even for a 23-week infant. In Montalvo v Borkovec, a negligence suit was brought by the parents of Emanuel Vila against the obstetrician and neonatologist for resuscitating him after he was born at 23 weeks weighing 679 g. The parents claimed that they were not sufficiently informed of the risk of disability to Emanuel and therefore the consent for his birth (via cesarean section) and resuscitation was not informed. The Court of Appeals of Wisconsin, however, sharply disagreed that informed consent was necessary:



First, requiring the informed consent process here presumes that a right to decide not to resuscitate the newly born child or to withhold life-sustaining medical care actually existed. This premise is faulty.


The court went on to interpret CAPTA to mean that, under these circumstances, the parents “did not have the right to withhold or withdraw immediate postnatal care from him.” As a state appellate court decision, it may not have much impact outside of Wisconsin. Nevertheless, if similar reasoning is adopted by the courts, it would effectively remove decision making from the parent-physician dyad.


Not only have legal cases addressed the issue, but legislation was passed in 2002 that has led to some confusion with respect to the treatment of extremely premature or disabled infants. The Born-Alive Infants Protection Act, Public Law No. 107-207, was passed by Congress in 2002. The law states that infants who are born alive, no matter what the circumstances or stage of development, are “persons who are entitled to the protections of the law.” The Neonatal Resuscitation Program Steering Committee does not believe that the law should “in any way affect the approach that physicians currently follow with respect to the extremely premature infant.” There are concerns, however, that the law may “potentially resurrect dormant governmental oversight of newborn-treatment decisions and thus may have influence over normative neonatal practice.”


Parents of extremely sick newborns such as those in the Miller and Montalvo cases often want no “special heroics” (a vague and ambiguous phrase that always needs specific interpretation and explanation) even at birth because they are afraid that once the physicians start to treat, they will refuse to stop until the child is literally a few minutes or hours from death. Ultimately, however, careful attention to the humane and compassionate treatment of disabled and severely ill newborns is the caregiver’s primary ethical duty. To the extent that excessive fear of legal liabilities in the past has led physicians to overtreat infants with very poor prognoses and thereby cause them (and others) suffering with no corresponding benefit, or to disenfranchise parents from giving informed consent to the treatment of their infants because “the law” has made the decision for them, we all have been done a profound disservice, most especially the infants who are supposed to be the ones served by the physicians who care for them.


Should physicians or hospitals, rather than parents, make decisions to forgo resuscitation or treatment of an extremely low-birth-weight newborn?


Parents of severely ill newborns are frequently disenfranchised, in whole or in part, from participating in the decisions pertaining to their child’s medical treatment. There are a number of reasons for this phenomenon. First, as discussed earlier, physicians are intimidated by what they often misunderstand to be the legal restrictions on forgoing treatment of a newborn. In fairness, they also are probably genuinely puzzled about the ethics of the matter. As a result, though, they have serious trouble identifying the legal and ethical boundaries of medical and parental discretion in deciding to let a newborn die by forgoing life-sustaining treatment. Peremptorily ignoring parental requests to consider forgoing treatment or adopting a policy of never forgoing treatment before a child’s death is inevitable and imminent eliminates the need to confront and practically resolve the underlying ethical issue.


Second, at least some physicians simply consider themselves to be best qualified and solely responsible for determining the medical fate of their infant patients. Indeed, in one survey of neonatologists only about one third responded that parental preference would influence their decision on delivery room resuscitation.


Third, many physicians and nurses assume that parents of severely ill newborns are so influenced by anxiety, grief, and guilt that they could not possibly make good decisions about their child’s fate. They may even distrust the motives and character of any parent who wants anything other than full, aggressive treatment. Finally, physicians and nurses commonly experience serious difficulty both coping with the inherent uncertainty of their diagnoses and prognoses and trying to explain this uncertainty to parents.


Whatever its causes, routine disqualification of parents from participating in the medical treatment plans for their newborns is wrong. Parents have rather broad legal and moral authority to give or withhold their consent to treatment of their children, although this authority is certainly not unlimited. The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research rightly notes that there is a presumption, strong but rebuttable, that parents are the appropriate decision makers for their infants. Traditional law concerning the family, buttressed by the emerging constitutional right of privacy, protects a substantial role for parental discretion for parents.


Similarly, the U.S. Supreme Court has affirmed that the “decision to provide or withhold medically indicated treatment is, except in highly unusual circumstances, made by the parents or legal guardian.”


Parents have unique natural bonds of love for and loyalty to a child. The child is their flesh and blood and exists in a family they have created. Of course, not all parents treat their children properly, and they can make unacceptably poor decisions about treatment in some cases. Nevertheless, in the absence of strong evidence to the contrary, one must assume that the parents are the proper decision makers. Furthermore, there is no assurance that strangers—be they physicians, nurses, judges, or lawyers—who have no bonds of love or loyalty to a child, will make a better decision about treatment than the parents.


Assuming it is true that the Millers had repeatedly requested that physicians not resuscitate their child if she had not developed adequately to sustain her own life and that the hospital (and presumably the attending physicians and nurses as well) “callously disregarded the couple’s request,” then the health care providers improperly ignored the parents’ presumptive moral and legal authority to make medical decisions for their child. Even if the providers conscientiously disagree with the parents, they have the obligation to express the factual and moral grounds for their disagreement clearly and plainly. More important, they are obliged to disclose whether and under what circumstances they will honor parental decisions to refuse treatment. Even though ultimately overturned, the jury’s verdict should serve as a stern warning to physicians, nurses, and hospitals that ignoring parental wishes, particularly in an arrogant and peremptory manner, does not sit well with the public and may carry legal consequences.


One important principle of pediatric ethics is that physicians, nurses, and other clinicians do have independent ethical obligations to the child. Clinicians are not just the tools of the parents’ wishes; they are moral agents who bear responsibility for the child as well. The medical team, together with the child’s parents, should be deciding how best to care for a severely ill newborn. Clinicians should provide parents with honest and accurate disclosure of both the child’s medical diagnosis and prognosis (with any attendant uncertainty) and their own carefully thought out recommendation for a plan of action in light of relevant ethical, medical, and legal considerations. But they may not simply ignore the parents. The jury’s verdict in the Miller case shows that members of the public will not automatically defer to the clinicians or hospital and permit them to act arrogantly toward parents who, quite literally, have to live with the consequences of all the medical decisions that are made on behalf of their children.


Sep 29, 2019 | Posted by in PEDIATRICS | Comments Off on Ethical Issues in the Perinatal Period

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