Defensive medicine has become a medical term of art. However, it can connote a thoughtful systematic approach to health care rather than the excessive ordering of investigatory studies because of anticipatory fear of litigation for malpractice. Medical malpractice lawsuits are based on the principle of negligence. Negligence implies some wrongful act of commission or omission (5). The essence of negligence is unreasonableness.

Due care is simply reasonable conduct (6). In order for negligence to be demonstrated in a courtroom, the injured person/plaintiff must demonstrate that (a) there was a legal duty owed to him; (b) there was a breach of that duty (a deviation from the accepted standard of care); (c) as a result of the duty and the breach thereof, damages or an injury occurred; and (d) the damages or injury can be determined to have been caused by, or shown to have flowed from, the care or lack of care provided by the health care provider and/or organization responsible for the environment in which the health care was provided.

Quality assurance and risk management aspects of medical care are relatively recent innovations designed to improve patient care and outcome; they are discussed in greater detail in the second section of this chapter. Quality assurance activities accept the legal and medical position that a health care provider owes a duty to the patient to provide reasonable medical care, consistent with available resources. There are inherent, irreducible risks in the delivery of medical care and treatment, and quality assurance and risk management assessments are designed to identify and limit the risks. There are always risks in a medical intervention, and there are always risks in not rendering a medical intervention. The balance of relative risks needs to be understood by both the health care provider and the patient and/or parent/guardian.

The duty to act is determined when the health care professional- or organization-patient relationship commences (7). A “duty” is a legal and ethical responsibility. There is no legal duty under most circumstances for a health care provider or institution to accept a patient for care unless they hold themselves out as providing emergency care or they are required to do so by law, regulation, or contract. If a medical center, hospital, or physician represents itself to the public as a source of emergency medical care and the community has come to expect such care, then a patient cannot be arbitrarily denied such services (8). Once a health care service is initiated, a health care provider/institution-patient relationship exists, a duty is created, and there is then a legal and moral obligation not to abandon the patient. Further, the care that is being provided must be adequate under the circumstances. A moral and legal obligation attaches, which precludes abandonment or “dumping” of the patient (9). A referring hospital transferring an infant to another institution for further care is not perceived as abandoning the patient, as long as the reason for transfer is medical and not financial. The senior medical person responsible for the transport, whether stationed at a hospital or directly providing patient care during transport, is deemed to be supervising the health care until the transport team transfers care to the clinical staff at the receiving referral medical facility. The transport team’s legal and ethical duty to the patient exceeds that of other parties, such as the referring or referral hospital.

The complexity of health care responsibility and liability increased rapidly during the 20th century. Public health
care facilities have existed since the Middle Ages. Commencing in the 13th century, the Hotel Dieu in Paris provided indigent care for many centuries. In the United States, city, municipal, state, and federal public hospitals provided care for those unable to obtain it elsewhere, and the physicians and hospitals were not held liable for the outcome of care that was provided free of charge. The doctrine of charitable immunity protected hospitals from legal liability if medical negligence occurred within their boundaries. However, an individual’s inability to pay for medical care no longer affects his or her ability to demand and receive services that are commensurate with those provided to patients who pay for their care directly or through third-party payment systems. Thus, providing care to patients who are unable to pay no longer protects a health care provider or medical institution from liability for negligence or malpractice. Physicians, other health providers, suppliers, and manufacturers of equipment, medical devices, and medicines can now all be sued for negligence and be held individually or jointly liable for their own actions, those that they supervise, and those that are performed by members of their health care team.

Recent advances in telephone-linked care (TLC) or “telemedicine” (see also Chapter 5) have initiated new questions regarding the practice of medicine across state lines (12). TLC has been applied as a supplement to direct patient care, to monitor patient progress, and as a service expander for specialized medical expertise and technology (e.g., the interpretation of neonatal radiologic or cardiologic films and tracings). Landwehr and associates (13) demonstrated the feasibility of telesonography for the interpretation of fetal anatomic scans from a remote location. Lewis and Moir (14) in Scotland and Landquist (15) in Finland demonstrated that telemedicine is an international technology.

TLC has been practiced for more than 30 years (in its simplest form, it includes giving advice over the telephone). In 1996 the U.S. Congress passed the Telecommunications Reform Act, which required a study of patient safety, efficacy, and the quality of services (16). The neonatologist has the opportunity to engage in “telehealth,” which includes consultation, transportation, and interpretation of radiographic, cardiologic, and other data, as well as professional education, community health education, public health, and administration of health services. The American Medical Association and American Telemedicine Association have urged medical specialty societies to develop appropriate practice standards. Managed care organizations have begun to embrace telemedicine. Louisiana, in 1995, became the first state to enact legislation dealing with telemedicine reimbursement (17) that specifies a certain reimbursement rate for physicians at the originating site and includes language prohibiting insurance carriers from discriminating against telemedicine as a medium for delivering health care services.

California in 1996 (18), Oklahoma in 1997 (19), Texas in 1997 (20), and Kentucky in 2000 (21) have also passed telemedicine legislation. However, at the present time, issues relating to cross-state licensure are perceived to be potential barriers to the expansion of telemedicine, especially now that reimbursement is possible. States license physicians and other health care providers within their boundaries, but the federal government has the authority to prepare national licensure standards as they relate to national programs such as Medicaid and Medicare. In the future, there may be alternative approaches to licensure (22). Regardless of the end result of the issues surrounding telemedicine, neonatologists increasingly cross state and international boundaries and need to appreciate that the laws of political jurisdictions other than their home state may significantly impact the manner in which they practice.

The U.S. Food and Drug Administration (FDA) has become involved in telehealth activities on the Internet.
Over the past few years, some Web sites have offered illegal drugs or prescription drugs based on questionnaires rather than a face-to-face examination by a licensed health care practitioner. Some offshore sites offer prescription drugs without any prescription or medical consultation. The FDA works with the U.S. National Association of Boards of Pharmacy, which created a program in 1999 called Verified Internet Pharmacy Practice Sites to provide the consumer with the ability to verify the safety of medications being sold over the Internet (23). A number of U.S. federal and state regulatory agencies are working together to address health-related consumer problems on the Internet. They include state health authorities, FDA, Justice Depart-ment, and Federal Trade Commission. The Federal Trade Commission plays a key oversight and enforcement role in Internet commerce.

Battery is a tort; it is an intentional and volitional act without consent which results in touching that causes harm (e.g., the touching of a patient’s body without consent). A technical battery can occur when there is no actual harm but touching occurred without consent. Patient care, even with a beneficial outcome but without informed consent, may be considered battery.

Plaintiffs may sue for an injury that occurred as a result of negligence or a tort (physical or mental harm), or both. Because the criminal court usually will not award monetary damages to the victim of a crime and because the standard of proof for conviction is “beyond a reasonable doubt” (quantitatively, this can be conceptualized as at least 95% certain), plaintiffs usually prefer to sue for injuries from a tort in civil court. In civil litigation, monetary damages may be awarded, and if the injury was determined to be egregious, punitive damages also can be assessed against the defendant. The standard of proof in civil litigation is the “preponderance of the evidence” or the “more likely than not” standard; it is a “superiority of weight” test that requires that for the plaintiff to be successful, 50.01% of the evidence must weigh in his or her favor (24). Thus, the preponderance of the evidence rule is a threshold test (25). In general, either the plaintiff proves that the damages were more likely to have been caused by the defendant agent than by any other source and is; therefore, entitled to full compensation, or he or she fails to meet the burden of proof and is entitled to nothing (26).

There are circumstances in which no expert witness is required to corroborate the findings of negligence. The doctrine of res ipsa loquitur essentially means that the thing speaks for itself. Under such circumstances, the negligence is inferred from the act itself, i.e., proof from circumstantial evidence. In the classic case Ybarra v Spangard, a patient was well prior to being anesthetized for an appendectomy, and when he woke up he had an injury to his arm (36). Clearly, he could not determine how his arm was injured; the operating room and recovery room staff either could not or would not explain the etiology of the injury. The court found for the injured plaintiff without the introduction of any expert witnesses because (a) the plaintiff had not done anything that in any way could have contributed to the injury, (b) the injury could not have occurred unless someone
was negligent, and (c) the instrumentalities (hospital staff and physicians) that allegedly caused the injury were at all times under the control of the defendant hospital.

Decision making in life and death situations is not easy. Advanced care planning efforts initially evolved in the care of the elderly (46). Advanced care planning, or contingency medical care planning, is no longer generally reserved for adults. The American Academy of Pediatrics Committee of Bioethics developed a policy statement about parental permission and informed consent (47). A distinction is made in this public policy statement and in case law in the United States between emergency medical treatment, life support efforts, and elective surgical procedures, such as circumcision or removing a kidney from one child to aid a sibling (48,49). Neonates need others to make decisions about their treatment and viability. Their treatment in a neonatal intensive care unit (NICU) is also never a series of leisurely scheduled elective procedures. There must be a designated person to whom the health care providers relate and who is held to render decisions about treatment. When potential conflicts in decision making are recognized, a conference among the concerned individuals, with representation from the hospital administration, may be a worthwhile endeavor to clarify who actually has the final decision-making authority. There may be times in the treatment of a patient when one person has to render an immediate decision, even if that decision is not a consensus. Decision-making issues are often confounded when the mother of the neonate is an adolescent herself and not wed to the father.

While all 50 states in the United States and the District of Columbia have passed legislation on advance directives, reinforcing the fact that adherence to such directives is mandatory rather than optional continues to be problematic (46). The majority of states do place restrictions on proxy decision making. If identification of the responsible party for decision making is not clear or keeps shifting, legal consultation, initiated by the health care providers, is recommended. Most jurisdictions have the ability to hold emergency judicial proceedings when an impasse has been reached and a medical decision must be made before irreversible damage or death to the patient occurs (42).