Legal Issues in Neonatal-Perinatal Medicine


Clinicians, especially clinicians working in the intensive care unit environment, are accustomed to a modicum of predictability. Treatment plans are generally based on years of clinical experience coupled with robust dialogue with one's colleagues. How should physicians react to the $21 million “wrongful birth” verdict against a geneticist who missed the diagnosis of Smith-Lemli-Opitz syndrome? How does one prepare for the resuscitation of a 23-week-gestation infant knowing that some physicians have been sued for resuscitating such infants and others have been sued for failing to resuscitate them? Does the Born-Alive Infants Protection Act require that 22-week fetuses be given a trial of an endotracheal tube?

The medical profession tends to view the legal system with mistrust. The unfamiliar concepts and vocabulary coupled with the seemingly unpredictable nature of legal decision making can create an environment of confusion and apprehension. For various reasons, these concerns are particularly acute for neonatal-perinatal practitioners. Tremendous clinical and ethical uncertainty can surround the decision to resuscitate an extremely premature infant. Neonatologists are often asked to attend deliveries for premature infants at the limits of viability. Must the physician honor the parents’ requests? What if the parents request that their extremely premature infant not be resuscitated? What are the roles and duties of the perinatologist, the neonatologist, and the hospital administration? These questions are not obscure or theoretical. A $60 million verdict by one jury, subsequently overturned, accentuates the importance of a clinician's familiarity with the laws that affect clinical practice. In these cases, the legal system can seem capricious and arbitrary. When the stakes are so high, and there is a lack of applicable case law, it is understandable that clinicians are left in a quandary.

During residency and fellowship training and after training is completed, clinicians interact with the legal system. This interaction may be in the form of a contract with a new employer, a lease for office space, or as a defendant in a medical malpractice suit. This chapter focuses on more recent legal developments in neonatal-perinatal medicine that can affect the daily professional lives of individuals who work in high-risk maternal units, delivery rooms, and neonatal intensive care units (NICUs). Several complex issues are addressed: What are the legal ramifications of a neonatologist disregarding a parent's request to forgo delivery room resuscitation? What are a physician's liabilities when providing phone supervision of an ambulance transfer of a critically ill patient? What are the elements of a medical malpractice case?

Practicing clinicians must understand their rights, duties, and liabilities as physicians. They must understand the legal relationship that they have with their employers, the hospital, referring physicians, consultants, and neonatal nurse practitioners (NNPs), and physician assistants (PAs) they supervise.

This chapter also assists the clinician in understanding basic terms and concepts of medical law. A certain baseline vocabulary is necessary to discuss the relevant issues adequately. Terms and definitions are introduced throughout the chapter. Additionally, certain landmark cases are discussed. This chapter provides legal background so that the clinician has a more complete understanding of the legal principles, cases, and statutes that affect the daily practice of neonatal-perinatal medicine.

Although the focus of this chapter is on the US 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.” Clinicians across the globe must be aware of the legal environment particular to the country in which they practice.

Disclaimer

The authors of this chapter have attempted to provide a background or framework of law for the purpose of educating clinicians. Nothing contained in this chapter should be viewed as substantive legal advice. This chapter does not create an attorney-client relationship between the authors and any readers.

Laws generally vary from state to state in the United States. Federal laws may represent a separate body of rules that can affect a given practitioner.

Legal cases often hinge on very specific facts. Courts and juries make determinations based on the facts of a given case. A slight variation in circumstances, or the same facts argued by a different lawyer or in front of a different jury, can result in a completely different legal outcome. A practitioner should never assume that his or her situation is identical to the parties in another situation. Seasoned practitioners recognize that not all 27-week-gestation infants with respiratory distress syndrome have identical courses. Likewise, each legal situation has its own nuances that can determine a distinct outcome. Courts expend considerable effort to distinguish the facts when comparing one case with another.

The authors neither advocate for nor reject the judicial decisions and legislative actions described in this chapter. Readers should become familiar with the current laws that affect practice in their states. If readers have specific questions, they should consult with a qualified attorney.

General Legal Principles

Legislative Law and Case Law

Individuals unfamiliar with the US legal system may have difficulty understanding the distinction between case law and statutes. Generally, a significant portion of US law is based on the common law. These laws have roots in English law from the last few hundred years. In many ways, the common law provides the foundation for the US perspective on contracts, property, torts, criminal law, evidence, and many other legal disciplines.

The common law was created by judges who were generally evaluating disputes between parties. More recently, well-known cases such as Brown v Board of Education or Roe v Wade are examples of judicial decisions that became US law. These were cases that involved defined parties. The US Supreme Court made a determination, and the law was established.

In addition, many laws are created by elected legislative bodies, such as the US Congress or a state legislature. Often court opinions state that it is not the role of the judiciary to redefine or change the definition of laws that were created by a legislative body; rather, the legislature is generally responsible for changing a law.

The case of Vo v Superior Court 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 “knowingly or recklessly causing the death of an unborn child by any physical injury to the mother.”

The Vo case serves as an example of the dynamic balance between the two branches of government that create law. In this case, the judges stated that it was the responsibility of the legislature to change the definition of manslaughter. The legislature responded to this case by expanding the definition of manslaughter to include unlawful killing of a fetus. Although the Vo case has also been included in the acrimonious debate of fetal rights, it is presented here to elucidate the concept of legislative law as opposed to judicial law.

State Law and Federal Law

Another area of potential confusion is the differences between state laws and federal laws. Medicine is generally regulated at the state level, and consequently most clinicians find themselves in state court subjected to state laws. Significant restrictions exist that keep most cases out of federal court. A civil rights case, a dispute involving the Americans with Disabilities Act (ADA), or a malpractice case that occurred at a military hospital are three examples of cases that could be adjudicated in federal court. Unless a case meets narrow criteria to qualify for federal adjudication, most legal disputes involving perinatal or neonatal practitioners are tried in state court.

How do laws in one state affect clinical practice in another state? Practitioners may wonder how a Michigan court decision would affect a practitioner in Ohio or Nevada. Generally state court decisions are binding only in that state. If the Texas Supreme Court has ruled on an issue, the court's findings are viewed as state law in Texas, and the legislatures and courts of California, North Carolina, or Wyoming are not bound by the Texas court ruling. A state court's ruling could be persuasive in other states, but the conclusions of one state court are not generally viewed as binding on courts in other states.

This concept of one state's laws affecting another state also holds true for laws passed by state legislatures. If the California legislature passes a law concerning access to prenatal care, the law would have essentially no effect on citizens of Connecticut or Virginia. Issues such as the definition of “live birth” are treated differently by different state governments. Clinicians should be familiar with their applicable state laws before relying on case law or statutes cited in this chapter.

General Structure of the Federal and State Court Systems

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 Fig. 4.1 .

Fig. 4.1, Hierarchy of the federal and state court systems in the United States.

Supervision of Others

Theories of Liability for Attending Physicians

Attending neonatologists carry substantial responsibility. Generally, they bear ultimate medical responsibility for the neonates under their care. Practically speaking, it is impossible for one physician to provide all of the care for a sick newborn. Depending on the clinical setting, nurses, NNPs, PAs, respiratory therapists, social workers, residents, fellows, consultants, and many others all contribute greatly to patient care. The exact demarcation of responsibility and liability borne by attending physicians for these alternate providers is often difficult to determine.

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.” 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.”

Respondeat superior is a more accepted doctrine of physician liability for negligence of others under his or her control. Respondeat superior literally means “let the master answer.” Because an attending physician has a right of control over an NNP or resident, the negligence of that provider is imputed to the attending physician in certain circumstances. Under respondeat superior , the attending physician would be responsible if a resident negligently places umbilical lines or an endotracheal tube. The attending physician would not be liable, however, under respondeat superior if a bedside nurse was negligent in the observation or reporting of a significant intravenous infiltrate. Under the earlier “captain of the ship” doctrine, the attending physician may have been deemed to be responsible for the intravenous infiltrate.

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.

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.”

Residents and Fellows

During their postgraduate training, residents and fellows gain increasing experience and clinical skills under the supervision of attending physicians. Under the doctrine of respondeat superior , the educational institution and the attending physician are generally responsible for the medical care provided by residents and fellows.

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.” 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 for which they are caring, 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.

Physician Assistants

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.” 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.”

Advanced Practice Neonatal Nurses

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. Additionally, the National Association of Neonatal Nurses supports a “future goal” of having all APNNs be prepared through a Doctor of Nursing Practice. 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.

In neonatology, there are generally two recognized types of APNNs: clinical nurse specialist and neonatal nurse practitioners. The clinical nurse specialist is a registered nurse with a master's degree who has expertise in neonatal nursing. The NNP is a registered nurse with experience in neonatal nursing (many have completed a master's degree) and additional clinical training in the management of newborns. Neonatal nurse practitioners are allowed to assess, diagnose, and treat newborns independently or under the supervision of a physician.

The licensure and scope of practice of APNNs vary considerably from state to state. Each institution must have policies and procedures for granting privileges for APNNs. The American Academy of Pediatrics Policy Statement on Advanced Practice in Neonatal Nursing released in June 2003 recommends the following:

  • 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.

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.

In most instances, however, and in almost all NICU environments, APNNs are not hired as independent contractors but rather as employees of the physician or hospital. In these cases, the employer is vicariously liable for the acts of the employee. The NNP is often supervised by an attending neonatologist who bears ultimate responsibility for the patient, as discussed earlier.

Malpractice

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.” This section is largely limited to a discussion of malpractice in neonatal-perinatal medicine ( Box 4.1 ).

Box 4.1
Common Malpractice Suits in Neonatology

Delivery Room Management or Resuscitation

  • Poor neurologic outcome

  • Cerebral palsy: neonatologist named as codefendant with obstetrician-perinatologist

  • Neonatal encephalopathy: plaintiff alleges some component of injury occurred postnatally

Line Complications

  • Vascular accidents related to central venous lines

  • Loss of fingers or toes associated with central lines

  • Thrombus and complications from thrombus

Delay in Diagnosis or Treatment

  • Poor blood gases, prolonged hypotension

  • Delay in antibiotic administration

  • Congenital hip dislocation

  • Congenital heart disease

Transport Team

  • Medications or care provided by transport team (e.g., excessive heparin given)

Failure to Monitor Adequately

  • Blood glucose

  • Blood oxygen: either hypoxia (brain damage) or hyperoxia (retinopathy of prematurity)

  • Seizure

Malpractice is part of a broader area of law known as torts . Tort law largely deals with the duties and responsibilities that individuals have toward one another. Torts are generally divided into two groups: intentional torts and unintentional torts. Defamation, invasion of privacy, civil battery, and professional malpractice are all torts, but malpractice is a type of unintentional tort.

Negligence means that an individual's behavior has deviated from a standard of “due care.” Malpractice is considered a specific type of negligence. By some interpretations, malpractice is also considered a type of breach of contract with the patient, so the defendant is technically being accused of committing a tort and violating contract law.

Lawyers, accountants, physicians, and other professionals are held to a certain level of conduct. If one's professional conduct is substandard and a client, customer, or patient is harmed by this substandard conduct, a plaintiff may attempt to show that the practitioner has committed malpractice. To win a malpractice case, the plaintiff must show four critical elements: duty, breach, causation, and damages.

Duty

“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.” 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.

If a neonatologist has privileges only at hospital A, and the physician is called and refuses to attend a high-risk delivery at hospital B, the physician likely would have no professional relationship with the pregnant woman or her infant at hospital B. The neonatologist cannot breach his or her duty if no duty to the defendant exists. This concept of duty is separate from the moral or ethical obligation to provide care. A physician cannot be liable to a patient if there is no legal duty. Likewise, if NNP Smith is on call for the evening, and NNP Jones has left town with his family for a scheduled vacation, it would be difficult for an injured plaintiff to show that NNP Jones had a duty to attend a high-risk delivery while he was out of town.

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 , 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.”

Supervising Others

As discussed earlier, neonatologists are often asked to supervise the care provided by others. This supervisory role generally establishes a physician-patient relationship with any patient who is cared for by the supervised NNP or PA. In these cases, the physician has a duty to the patient even if the supervised NNP is providing all of the bedside care.

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