Although the focus of this chapter is on the U.S. legal system, the rate of medical malpractice litigation has been increasing internationally at a dramatic rate. Many European countries have seen double-digit (Great Britain >50%) and triple-digit (Germany and Italy >200%-500%) percentage increases in the number of cases presumed “malpractice or bad health care.”28 Clinicians across the globe must be aware of the legal environment particular to the country in which they practice. The case of Vo v Superior Court83 is illustrative. This Arizona case involved a woman who was shot in the head during a drive-by shooting on the freeway. The woman and her 23-week fetus died as a result of the shooting. The prosecutor subsequently charged Nghia Hugh Vo with two counts of murder. The Arizona Court of Appeals considered the propriety and legality of charging Vo with two counts of murder. The court stated that when the legislature created the murder statutes, it did not intend to include a fetus in the definition of a person or human being. The court concluded that the unlawful killing of a fetus could not be murder. Then the court stated that if the legislature intended to include a fetus in the definition of a person, it was the responsibility of the legislature to change the homicide statute. Shortly after the Vo opinion, the Arizona legislature amended the manslaughter statute to include “[k]nowingly or recklessly causing the death of an unborn child by any physical injury to the mother.”13 Several of the cases cited in this chapter mention the holdings of various state and federal appellate courts, and several US Supreme Court decisions are also discussed. How does a case get to an appellate court or to the US Supreme Court? Various rules determine which court hears a dispute and which appellate court has the jurisdiction to review the decisions of the lower courts. Most of the cases discussed in this chapter would be adjudicated in the state court system. The general hierarchies of the federal and state court systems are depicted in Figure 5-1. In holding attending physicians liable for the acts of others, courts tend to rely on three different theories of liability. An early theory of attending liability was known as the “captain of the ship doctrine.” Physicians, particularly surgeons, were assumed to be similar to naval captains and to have complete control over the operating room (the “ship”) and all the medical personnel (the “crew”) within. With this control came responsibility for all negligent actions performed by anyone under the surgeon’s “command.”63 Most courts now recognize the increasing complexity of health care provision and have rejected the captain of the ship doctrine as “an antiquated doctrine that fails to reflect the emergence of hospitals as modern health care facilities.”49 The attending physician can also be held liable for providing “negligent supervision.” For supervisees under his or her charge, the attending physician is responsible for providing adequate training and supervision. The attending physician must be readily available and promptly respond to requests for assistance. This responsibility was underscored in a 2004 obstetric malpractice case in which the attending anesthesiologist was not immediately available for an emergency cesarean section, and the fetus allegedly suffered as a result. The case was settled for $35 million.14 Finally, in many cases, an attending physician becomes liable for the actions of supervisees by the creation of a physician-patient relationship that flows from the patient through the supervisee to the attending physician. In a case in New York, a patient was seen by a nurse practitioner in an emergency department, and the nurse practitioner misdiagnosed the condition. The attending physician discussed the patient with the nurse practitioner and signed the chart, but did not personally examine or speak with the patient. The court, interpreting New York’s law regarding nurse practitioners, held that “the ultimate responsibility for diagnosis and treatment rests with the physician.”66 Residents who have completed their first year of training are eligible to be licensed to practice medicine without supervision. Because of this fact and the expectation of appropriate supervision, most states treat residents as physicians rather than students and hold them to “the same standard of care as physicians who have completed their residency in the same field of medicine.”15 Nevertheless, because trainees are thought to be agents of the hospitals in which they work, often have limited financial resources from which to pay a judgment against them, and always have an attending physician assigned to the patients they are caring for, the institution and the attending physician are almost always named in the lawsuit as well. Neonatologists must be very careful about appropriately supervising residents and fellows. In some cases, inexperienced trainees are responsible for caring for some of the sicker patients in the NICU. From a legal standpoint, the supervising neonatologist must remain involved in the care of these patients and provide an appropriate level of oversight. The level of supervision would vary based on a variety of factors, including the condition of the patient, the likelihood of major changes in that condition, and the experience and skill of the resident providing the care. Failure to provide appropriate supervision can result in liability for negligent supervision.45 Many NICUs now employ physician assistants (PAs). A PA is a health care professional who may practice medicine only with physician supervision. A certified PA is a health care professional who has completed training and passed a national certification examination. The scope of practice of PAs is governed by state law and varies from state to state. In many states, PAs are authorized to prescribe medications. Physician assistants can contribute greatly to the care of neonates, and some centers that have found it difficult to recruit an adequate number of NNPs have found PAs to be an “untapped resource for the NICU.”67 It is important, however, for physicians to determine the scope of practice for PAs in their individual state for two reasons. First, there is increased potential malpractice liability for the supervising physician when PAs exceed their scope of practice. Second, physicians may risk loss of their licenses if they are “found to have condoned the unauthorized practice of medicine by a nurse or other health care professional for whose conduct [they are] responsible.”17 There has been a rapid increase in recent years in the number of advanced practice neonatal nurses (APNNs) in the United States. An APNN is a registered nurse who has completed a master’s degree in advanced nursing practice and, in most cases, has passed a national certifying examination. Advanced practice nurses are regulated at the state level, and educational requirements can vary. Most states require a graduate degree, generally a master’s, for authorization to practice at the advanced practice level, and 45 states require national certification.56 Additionally, the National Association of Neonatal Nurses supports a “future goal” of having all APNNs be prepared through a Doctor of Nursing Practice.57 APNNs have played an invaluable role in improving health care for neonates in various settings ranging from urban academic centers to small rural hospitals. Under certain circumstances, there can also be additional liability for the physician. • A neonatologist should supervise an APNN in the NICU. • The APNN should collaborate and consult with other health care professionals. • The APNN should be certified by a nationally recognized organization and should maintain that certification. • The APNN should participate in continuing education. • The APNN should comply with hospital policy regarding credentialing and recredentialing.10 One critical issue concerning APNNs is the liability of the supervising physician. In some states, NNPs are licensed to practice independently and require no supervision under the law. If an NNP is hired by a hospital as an independent contractor with his or her own privileges, the physician does not employ the NNP. In these situations, when the NNP and physician are interacting in the management of an infant, the physician is acting the same as when consulting with any other provider, with similar liability. Medical malpractice litigation can be contentious and acrimonious. It is a pervasive issue that appears with great regularity in the popular press. Many books have been dedicated to the subject of medical malpractice. In his 2011 State of the Union Address, President Obama voiced support for “medical malpractice reform to rein in frivolous lawsuits.”77 This section is largely limited to a discussion of malpractice in neonatal-perinatal medicine (Box 5-1). “The duty of care owed to an individual, for purposes of a claim of medical malpractice, is based primarily on the existence of the physician-patient relationship.”73 To proceed with a negligence case, the plaintiff must show that the defendant had a duty to the plaintiff. This has been described as a “threshold issue.” Does the defendant owe a duty to the injured party? If there is no duty, no claim of negligence can be sustained. Does a physician caring for a pregnant woman have a duty to the newborn even after the infant is born and being cared for by another physician? In Nold v Binyon,59 a woman tested positive for hepatitis B. Her newborn did not receive hepatitis B immunoglobulin or the hepatitis B vaccine, and the infant subsequently became a chronic carrier for hepatitis B. The trial court ruled, and the Kansas Supreme Court agreed, that the delivering physician had a duty to inform the woman of her hepatitis B status. The Supreme Court stated, “A physician who has a doctor-patient relationship with a pregnant woman who intends to carry her fetus to term and deliver a healthy baby also has a doctor-patient relationship with the fetus.” In Sterling v Johns Hopkins,73 a woman was admitted at approximately 32 to 33 weeks’ gestation to a hospital, and she developed severe preeclampsia and suspected HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome. The treating physician called the emergency transport service to arrange transport to Johns Hopkins because the receiving hospital had an NICU that could potentially care for a premature infant. The receiving physician spoke with the referring physician on the telephone. The woman became unresponsive during the transport. She experienced an intracranial bleed and later died. With changes in technology, there has been a rapid increase in the use of telemedicine, which is defined by the American Telemedicine Association as “the use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.”12 A number of legal issues have arisen with respect to telemedicine, and the law has not been able to keep pace with the technology. Many of these issues have to do with licensure, credentialing, and reimbursement as well as liability. For example, a physician based in state A who cares for a patient via telemedicine located in state B may be found to be practicing without a license and subject to disciplinary action in state A as well as medically liable in state B. Some states have created special laws or offer limited telemedicine licenses. Other states have specific regulations about the care provided. Colorado, for example, requires that “Any health benefits provided through telemedicine shall meet the same standard of care as for in-person care.”23 Additionally, many malpractice insurance policies specifically exclude telemedicine coverage. There is little question that telemedicine has significant potential to improve quality and access to care for patients, especially in underserved areas. Given the legal risks, however, it is important to seek legal counsel and be aware of relevant laws and regulations. Prenatal consultations might or might not give rise to a duty between the neonatologist and the pregnant woman and her child. Among the determining factors, courts seem to evaluate the formality of the consultation and the presence or absence of contact between the parties. In Hill v Kokosky,37 an obstetrician informally consulted with a neonatologist. The plaintiff had been admitted to the hospital at 22 weeks’ gestation with a diagnosis of incompetent cervix. The two physicians informally discussed the case over the telephone. The obstetrician discussed the case in the abstract, and the neonatologist tended to agree with the obstetrician’s management. There was no referral or formal consultation. From the record, it seemed that the neonatologist did not review the chart, speak with the mother, or even know the mother’s name. The infant was born 2 weeks later and developed severe cerebral palsy. What is the duty that is owed? The duty is to provide reasonable care under the circumstances. Although generalists are held to a standard of “same or similar community,” specialists and subspecialists, such as neonatologists, NNPs, and perinatologists, are generally held to the higher national standard of care.60 An expert witness from a different state can testify about the national standard of care for a neonatologist. In these cases, the neonatologist’s care is not being compared with the care provided in a similar community; the care is evaluated in light of national standards. A typical case is a brachial plexus injury after birth. In Knapp v Northeastern Ohio Obstetricians,46 a mother alleged that her infant’s brachial plexus injury was the result of excessive traction applied by the obstetrician. The trial court found, and the appellate court affirmed, that the evidence did not support the mother’s allegations. The court concluded that the obstetrician had not breached the standard of care. Retinopathy of prematurity (ROP) is another common source of negligence cases involving newborns. In Brownsville Pediatric Associates v Reyes,20 a pediatrician was found liable for substandard ventilator management. The expert witness testified that the child’s resulting brain damage and ROP were related to hyperventilation and hyperoxia. The plaintiff was awarded $8 million, and the defendant’s appeal was denied. Another ROP case34 dealt with the responsibility of the neonatologist, the pediatricians, the pediatric ophthalmologist, and the parents when 29-week gestation twins missed their follow-up appointments for ROP evaluation. The twins became legally blind. In this case, the neonatologist apparently provided all necessary referrals and documentation, and she was not named in the resulting suit. In tort proceedings other than medical malpractice, a person with common knowledge generally knows and understands “due care.” If someone is walking down the street with closed eyes and bumps into someone else and injures the other person, a lay juror does not need an expert witness. The lay juror understands that one should not walk down the street with closed eyes because someone else could be injured as a result. In medical malpractice cases, however, the lay juror generally does not have a grasp of “reasonable care under the circumstances.” This is one of the roles of the expert witness. To serve as an expert witness, an individual must have specific knowledge and training that qualifies him or her to serve in this capacity. The Rhode Island statute,68 for example, states “only those persons who by knowledge, skill, experience, training, or education qualify as experts in the field of the alleged malpractice.” Expert witness testimony is often required in neonatal-perinatal malpractice cases. Expert witnesses were used in the 2000 Pennsylvania case, Sonlin v Abington Memorial Hospital.71 In this case, a premature infant girl who was born at approximately 34 weeks’ gestation had an umbilical line. The infant developed vascular compromise in her left leg, which resulted in a thrombus that required amputation of the extremity. The plaintiff maintained that the neonatologist did not recognize the thrombus and that he did not institute corrective action in a timely fashion. In the Louisiana case, Hubbard v State,39 a full-term newborn was admitted with meconium aspiration and hypoglycemia. A peripheral intravenous infusion of 10% dextrose in water was ordered. After a change was made in the intravenous fluid, it was noted that the infant’s hand became red and swollen, and the infant became lethargic. His blood glucose was 450 mg/dL. Because of an error, the infant had received 50% dextrose in water instead of the 10% dextrose in water that was ordered. The infant sustained third-degree burns that left permanent disfigurement of the hand, and a computed tomography scan showed a “possible venous thrombosis of the transverse and sagittal sinus.” By the time this case reached the Louisiana Appellate Court, the child was almost 8 years old. In the interim, the child had been found to have Russell-Silver syndrome, a condition known to be associated with developmental impairment. The expert witnesses were extensively questioned about whether the dehydration and possible venous thrombosis contributed to the child’s observed mental delays. Unbiased and truthful expert witnesses are an important component of the American tort system. An American Academy of Pediatrics policy statement describes professional expectations for expert witnesses, including “thorough, fair, objective, and impartial” testimony provided for reasonable compensation.11 Additionally, the experts must base their opinions on “sound scientific principles.”
Legal Issues in Neonatal-Perinatal Medicine
General Legal Principles
Legislative Law and Case Law
General Structure of the Federal and State Court Systems
Supervision of Others
Theories of Liability for Attending Physicians
Residents and Fellows
Physician Assistants
Advanced Practice Neonatal Nurses
Malpractice
Duty
Telephone Advice
Telemedicine
Prenatal Consultation
Breach
Standard of Care
Role of the Expert Witness
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