Handbook of Clinical Neurology, Vol. 118 (3rd series) Ethical and Legal Issues in Neurology J.L. Bernat and R. Beresford, Editors © 2013 Elsevier B.V. All rights reserved
Law, ethics, and the clinical neurologist LOIS MARGARET NORA* American Board of Medical Specialties, Chicago, IL,USA
INTRODUCTION The diagnosis of neurologic diseases and the treatment and care of patients with such diseases occur in a context that demands more of the clinical neurologist than excellent clinical knowledge and skills. The disciplines of law and ethics form part of this broader context and affect the day-to-day practice of the clinical neurologist. Neurologists should have a working knowledge of law and ethics and should understand both the interplay between these disciplines and their effect on medical practice. Even a cursory knowledge of law and medicine can render neurologists more capable in certain aspects of clinical care, reduce the incidence of risky behaviors, and enhance professionalism. Furthermore, this knowledge can enable neurologists to recognize ethical and legal issues, handle these issues appropriately, and work effectively with professionals in the disciplines of ethics and law. This chapter explores the intersection of law and ethics with each other and with the practice of neurology. The discussion focuses on these issues in the United States; some differences are likely to occur across nations in ways consistent with the laws, cultural norms, and values system of each nation. As will be noted, substantial state-to-state variations in laws exist as well. The chapter begins with descriptions of law and ethics and a discussion of how these disciplines intersect. It then presents examples of the ways in which ethical principles and concepts are embedded in law that the clinical neurologist encounters in neurologic practice. The chapter concludes by suggesting emerging issues at the ethical–legal interface in clinical neurology that may affect the activities of the practicing neurologist in the future.
LAW Law is a government’s formalized system of regulating behavior with rules and regulations that are supported by
judicially enforced remedies. In the United States, the federal and state governments share sovereignty over a given state’s territory. The federal government’s jurisdiction is theoretically limited to powers expressly provided in the United States Constitution. Some of these powers, including the regulation of interstate commerce and the taxing power, have profound implications for physicians on matters ranging from drug regulation to Medicare to privacy. A state government, on the other hand, theoretically has “police” powers to regulate any area of conduct that is not expressly taken away by the U.S. Constitution or its own laws. This power routinely affects physicians in all aspects of practice, from licensure to employment and contracts to liability and insurances. In the United States, the U.S. Constitution is the supreme law of the land. Where both the federal and state governments may properly exercise jurisdiction over a matter, the state government is free to act until the federal government acts. When the federal government imposes law upon matters within shared jurisdictions, the state is pre-empted from contradicting or frustrating the federal law. Each government has a separate body of law, and each body of law can be organized into three typical sources of law: legislatures develop statutory law; courts develop case law; and administrative bodies issue regulations. American jurisprudence is grounded in the British law which governed the country before its founding and which informed its founders. Our legal system inherited the common law, which included the right to a jury trial, as well as the case law system. In the case law system, a reviewing court clarifies the law in a decision which will then stand as precedent. The principle of stare decisis means that court precedents will govern future similar cases, ensuring that similar cases will be judged in the same way.
*Correspondence to: Lois Margaret Nora, M.D., J.D., M.B.A., President and Chief Executive Officer, American Board of Medical Specialties, 222 North LaSalle Street, Suite 1500, Chicago, IL 60601, USA. Tel: þ1-312-436-2628, E-mail: [email protected]
The importance of judge-made case law in the United States cannot be understated. In the United States the principle of judicial review, sometimes called “judicial supremacy,” maintains that the judicial branch of government has the final say on what the law is. This does not overturn the legislature’s ability to pass laws, but it enables the state and federal supreme courts to overturn legislation they determine contradicts their respective constitutions. Just as significant is the inherent necessity for courts consistently to clarify legal rights and duties in a modern society that is undergoing constant, accelerating evolution and complexity. Case law, for instance, has accommodated modernity with negligence and product liability law. The primary source of law is legislation. While courts can only make decisions on the facts of cases which reach them, the legislature is forward-looking and can regulate all matters within its constitutional mandate. It is inherently more flexible as well. Not hobbled by the principle of stare decisis, the legislature is free to reconsider and amend or abolish its laws. Also, unlike judges, legislators are free to consider any source of information that can inform them, not simply the judicial records and lawyers relevant to a given dispute. Legislatures often create administrative agencies to develop the rules and resolve disputes that fall within the legislature’s constitutional jurisdiction, but which require time and expertise the legislature cannot directly invest. An administrative agency will be created with enabling laws that delineate an agency’s power, provide standards to govern its discretion, establish means for citizens to comment upon proposed rules before enactment and petition for other rules, retain legislative power to veto new rules, and implement means for judicial review. Administrative agencies are frequently given judiciallike powers to regulate disputes and enforce their regulations. Administrative law judges will typically resolve these disputes under their government’s Administrative Procedure Act. As a practical matter, administrative law decisions will inform similar cases brought before the agency, but they have no precedential value as controlling law. Administrative judges’ decisions are subject to judicial review by a regular court, but their decisions are given great deference and will not be overturned unless a judge has clearly abused the judge’s discretion in an arbitrary and capricious manner. Examples of federal administrative agencies that impact neurology are the Center for Medicare and Medicaid Services, the Food and Drug Administration, and the Office for Human Research Protections. On the state level, two administrative agencies that neurologists encounter are their state insurance regulation agencies and state medical boards. Established by a state’s Medical Practice Act, the state medical board will license
physicians, investigate complaints about their behavior, and impose discipline that may include fines, remedial training, and limitations, suspensions, or removal from practice. Rules require enforcement, and the discussion so far has shown that the law is ultimately resolved and enforced in the courts. Litigants go to court to obtain remedies. “Litigants” can be the government or any individual or entity (including corporations, partnerships, associations) the governing law recognizes to be a “person” having the right to sue. Cases brought to court can be typed according to the rights and duties being enforced or by the remedies that are being sought. The first major distinction is between criminal and civil law. Criminal laws and the punishments for violating them are always codified in statutory law. Violations of criminal law frequently involve injuries against private persons, but the violation is essentially punished as a wrong committed against the greater body politic. The case is brought in the name of the “People,” the “State,” or the “United States”, and the government’s attorney for criminal matters, usually a county district attorney or the local U.S. attorney, prosecutes the case. To win a criminal conviction, the prosecuting attorney must either prove his or her case to a judge or jury “beyond a reasonable doubt,” or negotiate a guilty plea agreement through the defense attorney with the accused. There is no standard definition of “beyond a reasonable doubt,” but the sense of the term is “proof to a certainty”(Whitman, 2008). The universal element in criminal punishments is the judgment of “conviction.” Characterized by legal philosopher H.M. Hart as the “moral condemnation of the community,” the criminal conviction may have important collateral consequences even where there is no fine and the sentence is suspended (Hart, 1958). Collateral legal consequences may include the loss of various civil rights (e.g., carrying firearms, voting) and many privileges (e.g., federal contracting, practicing medicine). Civil law can be first distinguished from criminal law as being prosecuted by injured parties (or those legally entitled to act on their behalf), not public prosecutors, to achieve a recovery for injuries, and only rarely to impose punishment. Civil remedies also enjoy lower burdens of proof. Generally a party meets the burden of proof by a “preponderance of evidence,” which simply means that most of the evidence (even as low as 51% of certainty) favors its side. There are two forms of civil remedies: money damages and equitable relief. Money damages are usually sought in civil law suits. Civil money damages are available against defendants who have allegedly committed either torts or breaches of contract. Torts are breaches of legal duties that society has imposed upon everyone
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST 65 in the defendant’s position for the benefit of people in encountered as a type of negligence lawsuit. The elethe plaintiff’s position. Such duties may include the duty ments of negligence are modified in a medical negliof automobile drivers to take care while driving or the gence case and are discussed in further detail below. duty of neurologists to conform to the general standard The third category of torts is for strict liability torts. of medical care for patients. Breach of contract lawsuits This group of torts developed in the 20th century; they are for breaches of legal duties owed the plaintiff which are generally product liability cases where an unreasonthe defendant has imposed upon him- or herself by enterably dangerous product has caused personal injury to ing into a contract. another. In a product liability case, the product can be In a tort lawsuit, money damages are meant to restore unreasonably dangerous because it was defectively manthe plaintiff to the plaintiff’s status quo ante, meaning ufactured, defectively designed, or had inadequate the condition plaintiff enjoyed before the injury. If plainwarnings. Liability can be imposed for any defectively tiff suffers a continuing injury, the damages will include sold product (including pills, bandages, implants), and the present cash value of future injury. Compensable liability can be shared by any party that is in the chain damages include both economic (or “special”) damages of manufacture, distribution, and sale. The tortfeasor’s and general (or “hedonic”) damages. Economic damages mental state is irrelevant for establishing liability in a are those damages like lost earnings and medical bills products case, but if evidence does show willful or intenthat can be directly computed as money costs. General tional conduct, the tortfeasor is especially vulnerable to damages include damages such as pain, suffering, dispunitive awards. ability, disfigurement, and loss of society, which cannot In many cases, money damages are inadequate to be priced in the marketplace but will still be computed as remedy a situation. For example, a tortfeasor might a dollar amount as damages. pay money damages and then continue the behavior that Torts include a range of claims which are usually catled to the lawsuit. Historically, when parties could not egorized by the nature and extent of defendant’s fault as obtain an adequate remedy at law, they turned away well as the type of injury. Intentional torts include batfrom the law courts and money damages and went to tery, trespass to land and personal property, assault, the King’s Chancery with petitions for equity, or fairand libel. The plaintiff must prove that the defendant ness. This alternative source of civil remedies has intended the action which constituted the tort, not that evolved into modern equitable relief. plaintiff intended the harm. Damages are significantly Modern court systems usually enable the same judges different for intentional torts. If no damages are proved, to preside over both law and equity types of cases, but successful plaintiffs are still entitled to small, nominal several critical differences endure. First, to obtain equidamages. At the other extreme, if a defendant’s conduct table relief, a petitioner must demonstrate that there is is extremely malicious or proved to be a matter of no adequate remedy at law; i.e., money damages are repeated wrongdoing, the defendant may be liable to insufficient. Second, the petitioner must be worthy of punitive damages, which are computed not to compenreceiving this highly discretionary remedy. Third, the sate the plaintiff but both to punish the defendant and petitioner must persuade the issuing court that the to deter others from the same misconduct. desired decree will be effective in securing justice as well Negligence tort suits are usually brought for personal as being capable of effective enforcement. Fourth, equiinjuries and sometimes for injuries to property. The tort table remedies are essentially matters for the individual occurs when one fails to act as a reasonably prudent percourt judge’s discretion. Juries do not decide these matson would act in the same circumstances and one thereby ters. The judge’s discretion enjoys special deference on causes a reasonably foreseeable injury to another. “Negappeal, and, with the exception of rulings affecting conligence” suggests carelessness, but the proof of the menstitutional rights, no decree will be disturbed unless the tal element is simply the divergence between the judge has clearly abused his or her discretion. defendant’s action and the applicable standard of care. Equitable relief is most easily categorized by the form The plaintiff then needs to prove both that the negligent of relief. The simplest form of equitable relief is a action in fact caused an injury, and the injury must be declaratory judgment, which merely resolves disputes proved for damages. No nominal damages are awarded. over the rights and duties between parties under a disPunitive damages are rare, and are limited to cases where puted law, regulation, contract, or other legal relationrepeated wrongdoing or other evidence shows a conship. Injunctions are typically characterized by their scious indifference to danger. Insurance never covers mandates; prohibitory injunctions forbid some action, punitive awards just as it never covers liability for intenand mandatory injunctions require some action. Injunctional wrongdoing. tions are also characterized by their finality and duraWhile “medical malpractice” theoretically can fall tion. Permanent injunctions are issued at the end of into a number of tort categories, it is virtually always contested proceedings, and are permanent in duration
66 L.M. NORA but subject to ongoing revision and relitigation as facts generally applicable to members of their specialty in change. They may also be dissolved when the cause of their geographic location. The second special element contention becomes moot. Preliminary injunctions are is that the practitioner breached the standard of care issued during the course of litigation when one party perby violating this standard. Jurors and judges are unable suades the judge that it is likely to win on the merits and to assess these issues simply by relying upon their coman injunction is necessary to preserve the utility of a final mon experience. Expert witnesses are necessary, and order. They may be continued until the judge’s “final” appropriate experts will have the education, training, decision. Temporary restraining orders can be issued and experience that give them the same or greater overat the beginning of a case, for a very short period of time lapping expertise as the defendant. The defendant is set by statute, where the petitioner’s rights can be permaautomatically qualified to testify as an expert on the nently impaired before the court can consider both sides’ same matters. The applicable standard or duty of care presentations on the preliminary injunction. will be proved and substantiated by the same and varied The burden of proof for equitable relief will vary by materials that inform the medical professional in pracjurisdiction, the timing and type of imposition requested, tice. Medical knowledge, technical skills, elements of and the type of rights which are affected. Injunctions professional behavior, and ethics standards will be used against the future exercise of constitutionally protected to explain the experts’ opinions and to inform the jury. conduct are virtually impossible. Injunctions cannot be Expert evidence will also be required to resolve the issued which require the performance of personal serissue of whether the defendant’s negligence caused vices even if those services have been promised in a conplaintiff’s injury. Causation is a legally complex issue tract; both the constitutional prohibition of involuntary and is also factually complex in many cases. Many torts servitude and the difficulty of enforcement moot mancan be processed with a clearly proved analysis that “but datory relief, but a prohibition of competition by the for” some negligence an injury would not have occurred. breaching party that is limited in time and geography Where multiple factors in the medical analysis contribute can be imposed. to the plaintiff’s injury, the governing jurisdiction will Medical practitioners have found meaningful equitafrequently impose a test of whether the defendant’s negble remedies when the practitioner’s judgment on mediligence was a “substantial factor” causing or aggravatcal care for minors and disabled patients conflicts with ing the plaintiff’s injuries. the patients’ guardians. Declaratory and injunctive The law in most jurisdictions expressly relieves plainrelief may determine issues such as the termination of tiffs of the burden of proving causation in cases qualifyorgan support for a deceased patient, civil commitment ing for the doctrine of res ipsa loquitur, which is Latin for a mentally ill patient, blood transfusions for minors for “the thing speaks for itself.” In these cases the need during surgery, and other issues. While courts generally for expert testimony is unnecessary where the patient avoid matters of complex oversight, they have exercised experienced an injury that could only be caused by medsuch power when necessary to safeguard entire custoical negligence and the injury occurred while the patient dial populations of children, mentally ill, and criminalwas under the exclusive care and control of the medical ly convicted persons. These decrees frequently serve defendant. Classic examples of this include leaving a government-funded institutions that receive inadequate scissors inside a patient or amputating the wrong limb. resources and support from legislatures. There are various defenses to negligence torts, but Medical malpractice may include intentional torts special aspects of the medical malpractice case mitiand product liability torts. As a practical matter, medical gate their utility. Conservative jurisdictions provide the malpractice cases are virtually limited to allegations of defense of contributory negligence where any neglinegligence in lawsuits seeking money damages. Malgence by the plaintiff which contributed to plaintiff’s practice cases may also be associated with complaints injuries will defeat the entire claim against the defento state medical boards and may result in administrative dant. More liberal jurisdictions will use various defenses proceedings as well. of comparative negligence that will measure plaintiff’s The medical malpractice negligence case is a specialnegligent contribution to the injury and use it to reized tort with special elements. A negligence tort is the duce or defeat liability. The success of these defenses breach of the general standard of care which causes in the medical malpractice case, however, will frequently injury to the plaintiff. Medical negligence is the medical depend upon the medical practitioner’s ability to prove professional’s breach of the applicable medical standard that the patient was adequately instructed on how to of care which causes injury to the patient. avoid injury and care for self. The applicable medical standard of care is the first Similar problems arise with the defense of “assumpspecial element of the medical negligence lawsuit. Medtion of risk.” A plaintiff who knowingly assumes a risk ical practitioners are held to the standard of medical care cannot recover for injuries suffered from that risk. As
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST will be noted later in this chapter, a signed consent form does not automatically establish this defense. Neurologists may become involved in medical malpractice cases in many ways. They may become plaintiffs or defendants. Neurologists will serve as expert witnesses for both plaintiffs and defendants. Not to be underestimated are the occasions where neurologists will be subpoenaed as “occurrence witnesses” or “treating physicians” to establish the course of the plaintiff’s medical care and injuries. Neurologists are legally qualified to serve as expert witnesses in any legal proceeding on issues pertaining to their specialty. These proceedings may include anything from a medical malpractice suit to a workmen’s compensation lawsuit. The neurologist may serve willingly as a witness or be subpoenaed and compelled to give testimony as a treating physician. The neurologist should always be acquainted with the medical ethics standards promulgated for expert witnesses (American Academy of Neurology, 2005, 2009, Sect. 6.4).
ETHICS Ethics is the branch of philosophy that concerns itself with the good and evil nature (morality) of actions and seeks to guide behavior in a way that increases good actions in society. For the most part, the practice of ethics in the medical setting is a nonsectarian activity based on secular principles and beliefs. That being said, the religious beliefs of a particular patient influence ethical decision-making for that patient, religious tenets often inform ethical decision-making in hospitals and healthcare systems that have religious sponsorship, and the physician should be aware of his or her own belief system. A variety of guides to ethics within major faith traditions are available (Steinberg, 2003; Muramoto, 2008; O’Rourke and Boyle, 2011). A number of terms are used to describe subdisciplines within ethics. Biomedical ethics (bioethics) deals with the ethical implications of biology in patient care, research, and policy development. Neuroethics are the ethical, legal, and social policy implications of neurosciences, including clinical care and neuroscience research (Illes and Bird, 2006). Clinical ethics is a subset of bioethics. Bernat has defined clinical ethics as “the identification of morally correct actions and the resolution of ethical dilemmas in medical decision-making through the application of moral concepts and rules to medical situations” (Bernat, 2008, p. 5). Jonsen et al. (2010, p. 2) define clinical ethics as a structured approach to ethical questions in clinical medicine. Most of the ethical issues that the neurologist will encounter fall within the classification of clinical ethics, although some issues will extend beyond traditional medical situations.
Although the moral conduct and character of the physician have been the subject of discussion for centuries, the disciplines of bioethics, clinical ethics, and neuroethics have been defined and developed over the past 50 years (Pellegrino, 1993; Beauchamp and Childress, 2009). The development of these disciplines has been coincident with the emergence of new and effective medical treatments, the escalation of costs in medical care, the movement of U.S. society away from paternalistic practices generally and in healthcare particularly, and the exposure of ethical abuses in medicine and research. Ethical reasoning is usually grounded in one of two broad approaches: utilitarianism and deontology. Each approach analyzes the morality of an action and proposes an appropriate course of action from its unique perspective. The utilitarian approach focuses on the consequences of an act. The greater the number of positive consequences (e.g., happiness, health) that result from an action, the more “right” (moral) that action. Conversely, actions that result in negative consequences (unhappiness, disability, and poor health) are considered “wrong” (immoral). The second approach, deontology, considers a person’s duty and focuses on the intent and reasons behind an individual’s actions. Deontologists hold that persons have a duty to act in the manner in which they would like others to act toward them and in the manner in which society, in general, would choose to have people behave. A deontologic approach may lead to the conclusion that, if the intent behind an action is good, the action is morally acceptable even it produces negative consequences. Both the utilitarian and the deontologic approaches are used to develop solutions to specific problems and also to develop guidelines and rules of behavior. Many ethical arguments use a combination of the two approaches. In spite of the differences in approach, the conclusions of the two approaches often overlap and may even be the same. Other approaches to ethical decision-making include virtue-based ethics, narrative ethics, casuistry, and feminist ethics (Jonson and Toulmin, 1989; Pellegrino and Thomasma, 1993; Charon and Montello, 2002; Held, 2006). Each of these approaches can add depth to ethical analysis and decision-making. For the neurologist, virtue-based ethics, with its emphasis on the moral character of the physician, may be of particular interest. Virtue-based ethics focuses attention on the motivations behind and the behaviors that make up a physician’s practice of medicine. The virtuous physician is habitually disposed to act in conformity with virtues such as integrity, empathy, courage, temperance, and wisdom. Activities that enhance the physician’s virtuous behavior will result in greater good for the patient. The virtue framework is of particular value to the physician who is selfreflective and disposed to consider his or her personal behavior within an ethical construct.
Several systematic methods have been proposed for clinical ethics problem-solving. The method of principlism applies four ethical principles that have particular importance in clinical medicine – nonmaleficence, beneficence, respect for autonomy, and justice – and their related rules to the ethical question in an attempt to reach a well-reasoned decision that would be consistent across similar cases (Beauchamp and Childress, 2009). The principle of nonmaleficence requires that physicians do no harm to their patients. The principle of beneficence states the physician’s affirmative obligation to act for the good of the patient. The principle of respect for autonomy requires a physician to foster and honor an individual patient’s right of selfdetermination, whereas the principle of justice requires equitable distribution of society’s resources and like treatment of similar circumstances. Another approach to clinical ethics in decisionmaking was developed by Jonsen and colleagues (2010) and is referred to as the “four topics” model (or “four boxes” model). This approach provides a practical method for incorporating clinical data, organizing information, and evaluating an ethical problem in the patient care setting. The four topics are medical indications, patient preferences, quality of life, and contextual features; for each topic a number of questions and considerations are applied to the case at hand. The four topics model incorporates analysis of the ethics principles and rules as part of its evaluation of each topic. Many resources related to ethics are available to the neurologist, including several books focusing on ethical decision-making in the clinical setting (Bernat, 2008; Fletcher et al., 2005; Jonsen et al., 2010). Codes of ethics have been compiled by several key medical organizations, including the American Medical Association (AMA), the American Academy of Neurology (AAN), the American College of Physicians, many neurologic subspecialty societies, and the neurosurgical societies (American Academy of Neurology, 2009; Council on Ethical and Judicial Affairs, American Medical Association, 2010; Leonard et al., 2010; Snyder, 2012). Other helpful resources include the Physician Charter on Professionalism prepared by three medical organizations, the AAN Case-based Ethics Curriculum for Residents, opinions rendered by the Council on Ethical and Judicial Affairs of the AMA, and articles from the AAN Ethics, Law, and Humanities Committee (Ethics, Law and Humanities Committee, American Academy of Neurology, 2000; American Board of Internal Medicine Foundation, 2002).
INTERPLAY BETWEEN ETHICS AND LAW Ethics and law are distinct disciplines but exhibit substantial overlap and dynamic interplay, particularly in the arena of medical practice. The large degree of
overlap between ethics and law is related to three factors: the purpose of each discipline, the character of medicine as a traditional profession, and societal responses to past ethical abuses by physicians and scientists. As a discipline, ethics aims to consider the moral nature of actions and to increase the likelihood of behaviors that result in the greater good. The law is society’s mechanism for translating social values into enforceable rules. Hence, it is not surprising that there is substantial overlap in the content of the two disciplines, and both ethical and legal analyses frequently refer to materials in the other’s domain. This being said, there are also important distinctions between the disciplines. For example, whereas ethical statements may be important moral and professional guideposts, they are neither binding nor enforceable; in contrast, laws are both binding and enforceable. An action may be deemed moral but should still not be legalized; similarly, an action may be legal although many may still consider it to be immoral. Medicine is one of the traditional professions. Traditional professions, including medicine, are characterized by three features. First, the members of the profession have a specialized body of knowledge and a set of skills that are not generally available to a person who is not a member of the profession. Second, society invests in the profession and grants the profession special privileges. Examples of this investment in the United States include the substantial governmental support of medical education and the permission granted by patients to allow students to learn from their histories, examine their bodies, and participate in their care (Association of American Medical Colleges, 2011). Physicians have a great deal of freedom in their decisions about where and how to practice medicine, and the medical profession self-regulates. Third, in return for these privileges, members of the profession covenant with society that they will act in ways that serve the best interest of patients and society as opposed to self-interest and that they will accept expectations and limitations on their behavior so that they can best serve the patient and society. The special covenant between physicians and patients has been recognized since ancient times and is embodied in physician oaths and professional codes (Hippocrates, 2002; American Academy of Neurology, 2009; Maimonides; Council on Ethical and Judicial Affairs, American Medical Association, 2010; Snyder, 2012). At the same time, state and federal laws regulate medical practice. Regulatory bodies, such as state medical boards, monitor and discipline the profession. Physicians may be liable in civil and criminal courts if they violate laws or their professional duty of care. Some of the ethical expectations established by the profession (e.g., physicians should not be in an intimate relationship with patients) overlap with the rules and regulations (American Academy of Neurology, 2009, Sect. 4.1;
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST American Medical Association, 2010, Sect. 8.14–8.145, pp. 297–302; State of Ohio). Other professional ethical expectations do not. For example, the AMA Code and the AAN Ethics Code proscribe physician engagement in executions, but physician participation is not illegal (American Academy of Neurology, 2009, Sect. 7.4; American Medical Association, 2010, Sect. 2.06, pp. 23–32). The State of North Carolina Department of Corrections successfully sued the North Carolina Medical Board to prevent it from using disciplinary action to enforce its proscription against physicians’ participation in capital punishment (North Carolina Department of Corrections v. North Carolina Medical Board). The same ethics codes proscribe physician involvement in coercive interrogation, but these practices are legal within the parameters established by the military and law enforcement agencies (Rubenstein et al., 2005; Marks, 2007; Halpern et al., 2008). A third reason for the strong interplay between ethics and law is the intense reaction of society to human rights abuses by physicians and scientists. The most egregious example of such abuses was the participation of the medical community, including neurologists, in the extermination of hundreds of thousands of persons in Nazi Germany (Zeidman, 2011a, b). In the United States, examples of unethical behaviors extend into the 1970s and include experimentation on orphans, mentally retarded children, and socioeconomically disadvantaged pregnant women (Rothman, 1991). The Tuskegee study conducted over decades until 1972 did not treat rural black men for syphilis (or even inform them that a treatment was available) in the desire to observe the “natural course” of the illness (Reverby, 2000). It is worth noting that arguments in favor of these abuses often incorporated ethical arguments about acting for the greater good. As society later reflected upon and judged these abuses, new ethical codes, laws, and administrative regulations resulted; the Declaration of Geneva and the Nuremberg Code are two examples (Nuremberg Code; World Medical Association, 2006). New administrative agencies were created to prevent further abuses; one example in the United States is the Office for Human Research Protection. These abuses help to underscore the fact that physicians must remain ever vigilant and thoughtful about what constitutes ethical behavior. Although there is often congruence between actions that are legal and actions that are ethical, there is no guarantee that such congruence exists. In Nazi Germany, involuntary sterilization and euthanasia of mentally retarded persons, patients with schizophrenia, and persons with epilepsy were legal (Zeidman, 2011a, b). When some medical students and physicians, including neurologists, spoke out against these legal actions as inconsistent with the ethical
codes of medicine, they were punished, and several were killed (Zeidman, 2011b). However, patients survived because of those physicians who would not participate in legal actions that they found unethical.
ETHICS MANIFESTED IN LAW ^ EXAMPLES RELEVANT TO NEUROLOGY PRACTICE This section presents examples of ways in which the four ethical principles are reflected in statutory law, administrative regulations, and common law. Each issue is linked to a single ethical principle, although it is clear that multiple principles are in play. The purpose of this discussion is not to present an indepth analysis of each issue but rather to use the issue as an opportunity to explore the interplay between ethics and law and their influence on the everyday practice of the clinical neurologist.
Nonmaleficence The ethical principle of nonmaleficence refers to the physician’s responsibility not to harm his or her patient. Nonmaleficence is a prominent ethical principle that underlies laws about physicians’ involvement in voluntary active euthanasia and physician-assisted suicide. These topics are among the most highly charged subjects in end-of-life care and are of substantial interest to neurologists, ethicists, and lawyers. Nonmaleficence is also a core principle underlying a less charged but extremely common aspect of everyday neurologic practice: respect for patient privacy.
VOLUNTARY ACTIVE EUTHANASIA
AND PHYSICIAN-ASSISTED SUICIDE
Voluntary active euthanasia is the administration, by the physician, of a lethal agent (or the administration of a therapeutic agent at a lethal dose), with the intent to cause a patient’s death for the purpose of relieving intolerable, intractable, and incurable pain. Physicianassisted suicide is a physician’s active assistance in implementing a patient’s suicide plan, usually through prescribing drugs that will be used in the suicide and possibly providing instruction on their use for that purpose. Both practices must be distinguished from other end-oflife ethical-legal issues such as withdrawal of therapies after a request from a competent patient or surrogate acting in the patient’s behalf, withdrawal of nutrition and hydration, and unintended death linked to therapies primarily intended to control a patient’s symptoms. Voluntary active euthanasia and physician-assisted suicide provide insights into the various ways in which laws develop and in which criminal law may, or may not, be used to regulate physicians’ behavior.
Voluntary active euthanasia is practiced legally in several European countries (Bernat, 2008, pp. 207–209). Although some ethicists have advanced arguments in favor of the practice (including the argument that beneficence requires that physicians participate in this practice for certain patients), the ethics codes of the major medical organizations currently do not support the practice (Ethics and Humanities Subcommittee, 1998; American Medical Association, 2010, Sect. 2.21, pp. 109–111; Snyder, 2012, p. 85). Reasons for the prohibition of voluntary active euthanasia in codes of professional behavior include the goals of medicine, the possibility that the practice might be extended to unwilling persons, the potential for coercion of members of vulnerable populations, and the potential for reduced trust in the medical profession. Homicide is the legal term for the killing of one human being by another human being. Homicides are of two broad types: criminal and justified. Examples of justified homicide include self-defense or legal authorization to kill (as might apply to a soldier killing during battle). Criminal homicide includes murder and manslaughter. Murder is further categorized as first-degree, which involves premeditated intent to kill, and seconddegree, which does not involve premeditation. Manslaughter is a form of homicide in which there was no intent to kill but death occurred as a result of criminal negligence or of actions that reflected a reckless disregard for human life. According to these definitions, therefore, the act of voluntary active euthanasia is a criminal homicide fitting the category of murder. If voluntary active euthanasia were legalized, it would be considered justified homicide. Suicide is the intentional taking of one’s own life. Suicide is not a crime in any U.S. jurisdiction, although attempted suicide may result in involuntary hospitalization for psychiatric evaluation. On the other hand, assisting a person to commit suicide is a crime in many states. In physician-assisted suicide, the physician’s actions constitute a crucial link in the chain leading to the patient’s death, although the physician does not perform the direct act that results in the patient’s death and providing the prescription is not the immediate event before death. Two examples may be helpful. First, Dr. Jack Kevorkian, a Michigan pathologist, assisted in, by his count, more than 130 patient suicides. Kevorkian was roundly criticized by the medical and ethics communities for his “suicide-on-call” methods, which included limited prior relationship (in some cases, less than 24 hours) with the persons for whom he assisted suicide and failure to obtain psychiatric and pain medicine consultations before assisting the suicide of patients with depression and pain (Roscoe et al., 2000). Kevorkian was criminally prosecuted four times in Michigan for participating in these suicides, but he was not convicted. However, when
Kevorkian performed euthanasia on national television, injecting the lethal dose himself, a jury found him guilty of homicide (People v Kevorkian). The Kevorkian trials appear to highlight citizens’ ambivalence about legal intrusion into what they believe are their individual rights of decision-making and the ways in which this ambivalence can affect legal decisions through the court system, as well as a jury’s willingness to distinguish between a physician assisting in a suicide and the same physician taking a deliberate positive action that is, intentionally, the immediate cause of a patient’s death. Second, Dr. Timothy Quill, a New York internist, described his involvement in the physician-assisted suicide of his long-time patient “Diane” in a 1991 article published in the New England Journal of Medicine (Quill, 1991). Many aspects of this individual case, including Quill’s longstanding relationship with “Diane,” her unquestioned diagnosis of terminal cancer, and the reality of her suffering, contributed to a very different reception on the part of the ethical, legal, and medical communities than that received by Kevorkian’s cases. Although Quill’s actions were criticized by many, New York state prosecutors declined to file criminal charges for his actions. There appears to be a reluctance to prosecute and convict physicians in cases of assisted suicides (Ziegler, 2005). These cases stimulated the activity of state legislatures to develop laws about physicians’ involvement in assisted suicides. A number of states have explicitly banned physician assistance in suicides (Gostin, 1997; Patients’ Rights Council, 2011; Assisted Suicide Laws State by State). Three states, Oregon, Washington, and Vermont have passed physician-assisted suicide laws, and Montana’s state supreme court determined that a state statute allows physician-assisted suicide, although that court did not find that the state’s constitution included such a right (Baxter v. Montana, 2009). The Supreme Court of the United States determined that there is no constitutional right to physician-assisted suicide and has upheld the states’ rights to determine their own laws on this matter (Vacco v. Quill, 1997; Washington v. Glucksberg, 1997). Currently, physician-assisted suicide is legal in four states. In Oregon, Washington, and Vermont the process is legal as a result of voter-initiated legislation. For example, Oregon’s Death with Dignity Act (2011), Washington State Legislature (2008), the first physician assistedsuicide statute to be passed in the United States, incorporates a procedure for physician-assisted suicide with an abundance of procedural safeguards intended to prevent the abuses mentioned earlier. For example, the law applies only to Oregon residents; the patient must have a terminal illness with a life expectancy of less than 6 months; the patient must request, in writing, a prescription for a lethal dose of medication; there is a waiting period of 15 days; there is encouragement for the
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST appropriate use of palliative care; and there is no requirement that a physician participate. The Oregon law has been upheld in spite of challenges at both state and federal levels, including a conclusion by the Attorney General of the United States that the law violated the Controlled Substances Act (Gonzales v. Oregon). Unlike the other three states, in Montana the legality of physician-assisted suicide is not the result of a law created by the state legislature. In fact, legislative proposals both to legalize physician-assisted suicide and to outlaw the practice have failed to become law in spite of multiple attempts over the past 15 years. Instead, the conclusion regarding the legality of physician-assisted suicide was the result of a 2009 opinion of the Montana Supreme Court that the state’s living will law, entitled The Rights of the Terminally Ill Act, includes language that permits physician-assisted suicide (Baxter v. Montana, 2009). In addition to demonstrating the interplay between ethics and law, this history demonstrates the remarkable variability that exists among laws and legal process across the states. Practically, states become laboratories for social change, and the states’ legal differences that result from the U.S. federalist approach are tolerated and encouraged. Many of the other states are looking to the Oregon experiment with interest. Statistics about the Oregon experience are reported annually by the state (Oregon Public Health Division, 2012). These statistics and other sources provide information about the relatively low number of patients who have committed suicide, the number of patients who have obtained medication to permit a suicide but have opted not to act on the suicide, the apparent lack of coercion of the vulnerable, and the strength of the palliative medicine programs in the state. These facts inform the other states as the political and social debate about this practice continues. Physician-assisted suicide is an area in which ongoing ethical debate will continue to inform an active and relatively slow-moving legal process.
PRIVACY The obligation of physicians to respect patient privacy, including the embedded obligation to maintain patient confidentiality, was articulated in the Hippocratic Oath: “All that may come to me in the exercise of my profession or in daily commerce with men which ought not to be spread abroad, I will keep secret and will never reveal” (Hippocrates, 2002). Arguments supporting respect of privacy include the deontologic rationale (e.g., as a result of their special relationship, the physician will have special knowledge of the patient not available to the general public; hence, the physician should not
share this information) and the utilitarian rationale (e.g., it is important that patients make full disclosures to their physicians, but this will happen only if they are confident that the private aspects of their lives will remain private; hence, the physician should not share the information). Multiple ethical codes have underscored the patient’s right to privacy and the physician’s responsibility to conform his or her practices to respect this right (Council on Ethical and Judicial Affairs, American Medical Association, 2010, Sect. 5.04–5.1; AAN, 2009, Code of Professional Conduct, Sect. 2.3; Snyder, 2012, pp. 76–77, 81). Patients have a privacy interest in all information about themselves, including diagnosis, the results of laboratory studies, genetic information, financial history, and interaction with the healthcare system, as well as in the specific information that they personally convey to the physician. The electronic medical record, social media, and e-mail communication may improve the quality and coordination of healthcare but may also create challenges in maintaining the privacy of personal information. The potential harm from the disclosure of information, such as the results of genetic testing, prescription drug history, and hospitalizations, is substantial. Ethical obligations to respect privacy have been reflected in law for many years. A common mechanism used to enforce privacy expectations has been the civil court system. Although there is no single tort for breach of privacy, the common law has recognized persons’ interest in privacy and the duty of physicians, health systems, and other healthcare workers to maintain privacy and confidentiality. A plastic surgeon was found liable for the use of before- and after-surgery pictures without the consent of the patient (Vassilades v. Garfinckel’s, Brooks Bros., 1985). A hospital was found liable for overly broad disclosure of information about a surgeon’s positive human immunodeficiency virus (HIV) status (Estate of Behringer v. Medical Ctr., 1991). Both physicians and lawyers have been censured for ex parte conversations between defense counsel and a plaintiff’s treating physician without either the consent of the patient or a court order. Recent years have also seen a dramatic increase in health privacy laws developed through the federal and state legislatures. These laws have been stimulated by the types of new health information available, the potential of that information to be harmful to patients, the increasing ease with which sensitive information can be transmitted, and the concurrent difficulty in regaining privacy after it is lost. Two examples are helpful. First, the mapping of the human genome and the emergence of new tests for a host of genetic conditions led to substantial discussion about ethical concerns
including, but not limited to, privacy of the information and harms that might occur related to inappropriate disclosure (Annas et al., 1995; Parker and Lucassen, 2005). This contributed to the development of many statutory laws related to genetic information (Jones and Sarata, 2008; National Conference of State Legislatures, 2008). Although one might argue that genetic information is no more or less deserving of privacy than other health information, most states’ laws treat this information as deserving of special protection. Many of these laws relate to privacy and mandate specific consent at multiple points, including before testing, before obtaining the results of tests (to allow saving the results), and before disclosure of information to others. Some laws limit the use of genetic information by employers and insurers. Specific penalties for violation of the privacy of genetic information have also been incorporated into some laws. Second, in 1996 a federal law entitled the Health Insurance Portability and Accountability Act (HIPAA) included requirements to expand the use of electronic health records and to incorporate the use of national identifiers across the nation’s healthcare system. The Act also included regulations protecting the privacy of health information. These new rules have dramatically changed – in some ways for the better and in others for the worse – the patient experience in physicians’ offices and hospitals. HIPAA privacy forms are completed; hospital signs encourage the avoidance of clinical discussions in public areas; greater care is taken in de-identifying shared materials; family members can encounter difficulties in getting information about loved ones; and isolated patients who might previously have received clergy and volunteer visitors no longer do so. The requirements that physicians respect privacy and maintain confidentiality are not legal (or ethical) absolutes, however. In fact, this subject provides many examples of legal rules that balance a physician’s duty to protect patient privacy with society’s need to have information that may affect public health and safety. Various state laws mandate disclosure of gunshot wounds, suspected child abuse, suspected elder abuse, and sexually transmitted diseases; physicians must be aware of the mandatory reporting laws of their state. A seminal common-law decision held that mental health providers with knowledge of a potential for harm to an identified victim have an obligation to warn that victim (Tarasoff v. Regents of the University of California, 1976). For many years physicians have had the ethical responsibility to report colleagues’ incompetence and criminal activities; failure to comply with these rules (sometimes because of fear of being sued) have contributed to state laws mandating physicians’ disclosure of these situations, providing immunity from suit for good-faith reporting of such
situations and punishing nondisclosure with substantial fines (AAN, 2009, Code of Professional Conduct, Sect. 6.3; American Medical Association, 2010, Sect. 9.031; Snyder, 2012, p. 92; Delaware Medical Practice Act).
Beneficence Beneficence is the ethical duty of physicians to act in the patient’s best interest. Unlike nonmaleficence, which requires the physician to avoid actions that are harmful to a patient, the principle of beneficence creates an affirmative obligation for the physician to act in the patient’s best interest. Beneficence may involve actions to prevent harm or actions to accomplish good. Examples of a physician’s actions that are consistent with this obligation include advocating for a patient’s needs, caring for a difficult patient, seeing a patient outside usual office hours, and avoiding conflicts of interest. A physician must be constantly vigilant to ensure that beneficence does not devolve into a form of medical paternalism that is not respectful to patients or that disempowers them. In general, because the ethical obligation of beneficence requires physicians to act (as opposed to not acting), the ethical obligations are more robust than the legal requirements. However, some legal obligations are grounded in the ethical principle of beneficence. Often these legal obligations are articulated through the common-law lens of the physician’s duty of care to a patient. Occasionally, aspects of beneficence have been embodied in laws or regulations. Two examples of beneficence in the law are the expectations of a physician before unilaterally ending the patient–doctor relationship and the management of conflicts of interest.
ENDING A PATIENT–PHYSICIAN RELATIONSHIP Absent special circumstances or relationship, both a patient and a physician have substantial freedom to determine whether they will begin a professional relationship. Once the relationship has begun, however, the expectations for each party relative to ending the relationship are quite different. This difference relates in substantial part to the physician’s ethical duty to act in the patient’s best interest. When there is a mutual decision on the part of the patient and the physician to end a treatment relationship, no issue occurs. Additionally, a patient may unilaterally end the professional relationship with a physician at any time for any reason and without permission or notice. On the other hand, it is more complex for a physician unilaterally to end the relationship with a patient, particularly if the patient does not wish the relationship to end. Ethical statements note that the physician should attempt to salvage the relationship even with a difficult patient (Snyder, 2012, pp. 75–76). A patient should be dismissed
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST from a physician’s practice only for good reasons and after adequate notice and identification of an alternative care provider. Legally, if a physician does not properly release a patient from his or her practice, the physician may be found liable for patient abandonment. Patient abandonment is a tort claim of negligence of the medical malpractice type. To succeed in the claim, a plaintiff (the allegedly abandoned patient) must demonstrate that the physician had a duty (not to abandon the patient), that the physician breached that duty, and that the breach of the duty resulted in the patient sustaining some form of injury. The alleged injury would probably be some damage to the patient’s health because of the lack of continuing medical care. In addition to the potential for a negligence claim, a claim of patient abandonment can lead to investigation and disciplinary action by the medical board of the state in which the physician practices. Penalties for violating state medical acts can include censure, mandatory training, suspension, and loss of the license to practice medicine.
CONFLICT OF INTEREST One of the most important aspects of physician behavior that has received ethical review and legal intervention in recent years is conflict of interest. This topic provides an interesting example of legislative reaction, with the development of new laws, to the concern that ethical rules and physician self-regulation are not sufficient. A conflict of interest occurs when circumstances create the risk that a physician’s professional judgment or actions toward a patient (the physician’s primary interest) will be unduly influenced by those circumstances. When these circumstances involve money, there is a financial conflict of interest. Other common circumstances that create conflicts of interest include personal relationships, stock ownership, gifts, meals, desire for status, and feelings of obligation. For example, the medical literature demonstrates that physicians’ clinical practice behaviors are influenced by interactions with and gifts from pharmaceutic representatives (Chren and Landefeld, 1994; Wazana, 2000; Katz et al., 2003). The mere presence of a conflict of interest does not prove that an action is either ethically or legally wrong. However, conflicts are to be avoided whenever possible and must be managed when they exist so that no wrong-doing occurs. One goal in avoiding and managing conflicts of interest is to avoid any actual wrong-doing; a second goal is to avoid any public perception of wrongdoing that may result in patient discomfort or lack of trust in a physician or in the profession as a whole. In recent years, the medical profession has engaged in substantial discussions of the ethical issues involved in avoiding and managing conflicts of interest. Knowledge
of the potential impact of conflicts of interest has resulted in new approaches to physician behavior, including limitations on the receipt of meals, trips, and gifts from pharmaceutic companies, and disclosures of relationships that might create a conflict to employers, students, and patients. In a manner similar to other professional negligence cases, in the correct circumstances a plaintiff could successfully bring a negligence case against a physician if a conflict of interest led a physician to deviate from the standard of care and if that deviation caused an injury to a patient. However, this chapter will focus on the emergence of federal legislation designed to eliminate conflicts of interest in federal healthcare programs. In addition to the ethical principle of beneficence, this topic is heavily influenced by the ethical principle of justice and its emphasis on the appropriate allocation of societal resources. In 2011, the federal government of the United States spent $844 billion on three healthcare programs: Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) (Congressional Budget Office, 2012). Given the substantial amount of public monies spent on healthcare and the fact that this amount continues to increase much faster than the rate of inflation, there is interest in reducing healthcare costs. In years past, investigators have demonstrated that costs are increased in settings in which physicians refer patients to a facility in which the physician has an ownership interest (Mitchell, 1992; Swedlow et al., 1992). Hence, multiple pieces of federal legislation have been proposed, passed, and implemented to eliminate these conflicts of interest whenever possible. One group of such laws is the anti-kickback statutes. These laws are reminiscent of the longstanding ethical proscriptions against fee-splitting among physicians and providing financial incentives to patients for referrals (American Medical Association, 2010, Sect. 6.02–6.03). The anti-kickback statutes prohibit a physician (or other healthcare provider) from receiving a benefit in exchange for the referral of a patient for a test or procedure that will be paid for through a federal program (usually Medicare or Medicaid). Under these laws, outlawed benefits include monetary payment, forgiveness of a debt, gifts, reductions in payments for equipment leases, or other items of value (Bulleit and Krause, 1999). A second set of laws, known as the Stark laws, introduced between 1989 and 2007, restricts physicians from referring patients for tests or procedures that will be paid for through a federal program at a facility in which the physician has an ownership interest (Rogers, 2007; Sutton, 2011). Although this legislation has certain “safe harbors” that allow referral in some limited instances, over the years there has been a progressive limitation of these exceptions.
L.M. NORA mechanism. An emancipated minor is legally competent RESPECT FOR AUTONOMY for all medical decision-making. In addition, state laws Respect for autonomy is an ethical principle of great may grant minor patients legal competence for specific importance in clinical ethics, particularly in the United healthcare decisions, particularly in the areas of treatStates, where individual rights are a cultural foundation. ment of sexually transmitted diseases and reproductive Respect for autonomy requires a physician to foster decision-making. and respect an individual patient’s right of selfClinical competence, as the name implies, is a medical determination. In recent decades the amount of attention conclusion. Neurologists are often involved in the care paid to respect for patient autonomy has increased. Reaof patients for whom a question of clinical competence sons for this increase include impatience with paternalexists. Clinical competence implies that the patient can ism in general and medical paternalism in particular, understand information, formulate a decision, and comgenerational differences in respect for status-based municate that decision. Clinical competence may fluctuauthority, and the greater number of treatment options ate across time, on the basis of disease process, that must be considered. Informed medical decisionmedication, and even time of day. Assistive devices, making is a fundamental ethical doctrine grounded in including hearing aids, eyeglasses, false teeth, and comthe principle of respect for autonomy. Informed consent munication boards, may be helpful in maximizing a is a legal doctrine that is firmly based in the ethical docpatient’s ability to demonstrate clinical competence. trine of informed decision-making. The second element of informed consent is the provision of adequate information. In general, patients must be told what intervention is being proposed, why it is being Informed consent recommended, risks, potential side-effects of the proThe purpose of informed consent is to promote patient posed intervention, and alternatives to the intervention, autonomy through shared decision-making between the including doing nothing. But within these categories, what patient and the physician. The doctrine encompasses two information should the physician share? The professional important patient rights: to obtain information and to standard requires physicians to provide information about make a decision. Informed consent is relevant across the proposed intervention that other physicians in the same the spectrum of medical decision-making, from everyspecialty in the same community would provide. The readay decisions about compliance with a medication regisonable person standard requires the physician to provide men to profound decisions about end-of-life care. information about the proposed intervention that a reasonTo satisfy the legal requirement of informed consent, able person in the patient’s position would want disclosed. four requirements must be met. First, the patient must The majority of states have adopted the reasonable person be competent. Second, the patient must be given adestandard which places the patient, rather than the physiquate information on which to base a decision. Third, cian, at the center of the decision about how much and there must be no duress; the patient’s decision must what information is appropriate. be made voluntarily. Fourth, the patient must agree to The third element in the legal definition of informed the proposed intervention. This last element underscores consent is voluntariness. Coercion and duress, explicit or the fact that informed patients can refuse proposed implicit, invalidate consent. The fourth element, consent interventions and may rescind their prior agreement. by the patient to the proposed intervention, reminds In general, courts have upheld the rights of clinically us that the patient must affirmatively agree to the intercompetent adult persons to refuse medical interventions vention. Courts have accepted a variety of verbal, writeven if that refusal is likely to result in the patient’s ten, and behavioral actions on the part of a patient to death. Courts have also recognized the rights of “mature demonstrate consent. Formal consent documents are minors” – older teens who are not yet legally competent often presented to patients; the presence of these docubut who are clinically competent and able to demonstrate ments and the patient’s signature provide evidence of an a thoughtful and reasoned decision – to decline therapies informed consent process. However, these documents (In Re E.G., A Minor, 1989). do not, of themselves, prove that informed consent The determination of patient competence incorpowas obtained. In fact, courts have criticized consent docrates two parts: legal competence and clinical compeuments that appear cumbersome for an ordinary person tence, also called decisional capacity. Adult patients to decipher and consent documents that appear to be are considered legally competent unless they have been written to protect the physician rather than to inform formally declared incompetent via legal processes. the patient. In general, minor patients are not considered legally In emergency situations in which the patient cannot competent unless they have been emancipated via marprovide consent and no surrogate decision-maker riage, military service, or some other state-determined is immediately available, treatment should proceed.
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST Additional legal exceptions to informed consent include the patient’s waiver of consent and the physician’s therapeutic privilege exception, under which the physician determines that the treatment is so important and that the informed consent discussion will be so harmful to the patient that the treatment should take place in the absence of consent. Courts have proved suspicious of therapeutic privilege, however, particularly when the patient sustains injury from the prescribed therapy. The legal doctrine of informed consent has largely been developed via the common-law system. In situations in which no consent was obtained or in which fraud or misrepresentation was used to obtain consent, criminal charges of battery are possible. Plaintiffs may also sue for the intentional tort of battery in such cases. Intentional torts allow the assessment of punitive damages against a defendant who has been found liable; however, the usual absence of medical malpractice insurance coverage for intentional torts may make this claim less attractive. Most commonly, plaintiffs sue in a negligence action for failure of informed consent. To prevail in this claim, the plaintiff must demonstrate that the injury suffered was a known complication of the intervention, that the physician failed to obtain informed consent adequately, and that if the physician had provided the correct appropriate information the plaintiff would not have agreed to the intervention. These are fairly high barriers for a plaintiff to scale. When a patient is not competent to make medical decisions, a surrogate decision-maker becomes responsible for making such decisions on behalf of the patient. Legal documents, including living wills and durable power of attorney for healthcare, have been developed and adopted by the states (Emanuel and Emanuel, 1989; Commonwealth of Massachusetts Trial Court Law Libraries, 2012; Aging with Dignity). Other forms of advance directives are also used. These documents allow currently competent patients to identify their choice of a surrogate decision-maker should competence be lost; they also allow the patient to articulate values, preferences, and choices of care. A federal law requires that patients be asked about the presence of such advance directives when they are admitted to a hospital (Ulrich, 2001). Nevertheless, situations still occur in which an incompetent patient does not have an advance directive and has not identified a surrogate. In such situations, many states have laws that define a hierarchy of surrogates (Menikoff et al., 1992). The two common standards used in surrogate decision-making are the substituted judgment standard and the best interest standard. Substituted judgment requires the surrogate to stand in the shoes of the patient and make the decision that the patient would have made for himself or herself. The presence of advance directives makes the surrogate’s difficult
decision somewhat easier. The best interest standard, on the other hand, requires the surrogate to look at all of the facts and circumstances surrounding the case and to identify the course of action that, in the minds of most people in that jurisdiction, is in the best interest of the incompetent patient. Whenever possible, there is a preference for the substituted judgment standard because the resulting choice should most closely reflect what the patient’s own choices would have been.
Justice The ethical principle of justice embodies several concepts: fairness to persons within and across groups, similar treatment of similar situations, and the allocation of scarce resources across society in a manner that does not unduly enrich or unduly disadvantage certain persons or groups. In a healthcare environment characterized by finite resources and increasing costs, an increasing number of discussions have focused on resource allocation at the societal and the individual patient levels. The need to consider the appropriate allocation of healthcare resources is now explicitly incorporated into some statements of medical ethics, including that of the American College of Physicians (Snyder, 2012, pp. 89–90). There is substantial disagreement in U.S. society, and even in the medical profession, about how the principle of justice should be made operational. However, there are abundant examples of legislatively created social programs, laws, and administrative regulations that reflect an underlying concern with and a commitment to justice. This section presents examples of each. The Medicare and Medicaid health insurance programs are two examples of programs created by the federal legislature and devised, in part, because of concerns about social justice (Rowland and Lyons, 1996). The programs provide access to healthcare to many persons who would otherwise lack such access. The two programs also demonstrate two approaches to “fairness.” The Medicare program applies to all persons older than 65 years regardless of their financial status and to all individuals with end-stage renal disease regardless of age or financial status. The Medicaid program applies to all persons who meet state-defined means-testing that determines financial need. Over the past 50 years, organ donation has become a viable treatment option for patients with a variety of diseases. Justice issues have been incorporated into conversations about organ donation since its inception. The federal National Organ Transplant Act of 1984 funded the Organ and Transplantation Procurement Network. This network, operated by the United Network for Organ Sharing, has established mechanisms for the equitable procurement and distribution of organs. Justice concerns
also contributed to laws prohibiting the sale of human organs in the United States. Concerns about allowing organ sales included disproportionately advantaging the wealthy individuals who could purchase the organs and also the possibility that poor people might be coerced into selling organs. Sometimes legislative actions that create a more just society are in response to bad behavior on the part of individuals and healthcare institutions. The Emergency Medical Treatment and Active Labor Act requires emergency rooms to treat patients needing emergency care and women in active labor, regardless of their ability to pay. Prior to this Act, a number of patients suffered serious injury after being denied care in emergency rooms because they had no insurance or other source of payment. The Women’s Health Movement focused attention on research practices then in place, and often rooted in beneficence, that excluded women from participation in many federally funded research studies (Office of Research on Women’s Health). In response to this attention and to the concurrent recognition that members of minority groups were similarly excluded, the National Institutes of Health (NIH) developed administrative policy that encouraged the inclusion of women and members of minority groups in federally funded research studies. This policy was published in 1987 and increased the numbers of women and members of minority groups who were involved in research studies; it also resulted in research findings that demonstrated previously unrecognized gender and racial differences in disease process and response to treatments. Congress translated this administrative policy into federal law in the NIH Revitalization Act of 1993.
EMERGING ISSUES The United States is in the middle of a profound restructuring of its healthcare system. The practice of medicine is moving from individual physician and small-group practices to large groups of employed physicians. The focus of healthcare funders is turning away from payment for the care of an individual patient and toward payment to Accountable Care Organizations for the health of groups of patients. The next two decades will see increasing discussion about the allocation of scarce resources across society and the physician’s role in those decisions. One area that will receive attention within this broad context is healthcare at the end of life. There will be greater pressures on individuals and families to limit interventions that are clearly futile. It will be interesting to see what impact, if any, this issue will have on ethicallegal discussions of physician-assisted suicide. It is
important that physicians continue to be advocates for individual patients, even as they incorporate information about the cost and effectiveness of various treatments into their care of patients. One of the resources that will be in short supply during the next 20 years, as baby boomers continue to age, is the pool of physicians. With the emergence of concierge medical practices and the increasing interest in “cosmetic” neurology and neuroenhancement practices, neurologists will be called upon to make personal choices about their practice of neurology (Chatterjee, 2004; Ethics, Law and Humanities Committee, American Academy of Neurology, 2009). We can hope that these choices will be informed by the ethical precepts of our profession and that we will individually and as a profession continue to subordinate our individual interests, when necessary, to meet the needs of our patients and communities. As many of the issues presented in this chapter have demonstrated, a failure of physicians voluntarily to meet our ethical and professional obligations is likely to result in new laws and regulations compelling the profession to do so.
REFERENCES Aging with Dignity. Five Wishes. Available at: http://www. agingwithdignity.or/five-wishes-states.php (accessed November 2, 2012). American Academy of Neurology (2005). AAN Qualifications and Guidelines for the Physician Expert Witness. Available at: www.aan.com/globalaxon/assets/ 2687.pdf (accessed November 1, 2012). American Academy of Neurology (2009). Code of Professional Conduct. Available at: http://www.aan.com/index.cfm? axon¼redirect&&path¼/go/about/ethics/conduct (accessed October 28, 2012). American Board of Internal Medicine Foundation, American College of Physicians Foundation, European Federation of Internal Medicine (2002). Medical Professionalism in the New Millennium: A Physician Charter. Available at http://www.abimfoundation.or/Professionalsm/PhysicianCharter.aspx (accessed November 1, 2012). Annas G, Glantz LH, Rohe PA (1995). Drafting the Genetic Privacy Act: science, policy, and practical considerations. J Law Med Ethics 23: 360–366. Assisted Suicide Laws State by State. Available at: http:// www.euthanasia.com/bystate.html (accessed November 1, 2012). Association of American Medical Colleges (2011). What Does Medicare Have to Do with Graduate Medical Education? Available at: https://www.aamc.org/initiatives/gmefunding/factsheets/253372/medicare-gme.html (accessed October 31, 2012). Baxter v. Montana 354 Mont 234, 224 P.3d 1211 (2009). Beauchamp TL, Childress JF (2009). Principles of Biomedical Ethics. 6th edn. Oxford University Press, New York.
LAW, ETHICS, AND THE CLINICAL NEUROLOGIST Bernat J (2008). Ethical Issues in Neurology. 3rd edn. AAN Press, Lippincott Williams & Wilkins, Philadelphia. Bulleit TN, Krause JH (1999). Kickbacks, courtesies or cost effectiveness? Application of the Medicare Antikickback Law to the marketing and promotional practices of drug and medical device manufacturers. Food Drug Law J 54: 279. Charon R, Montello M (Eds.), (2002). Stories Matter: The Role of Narrative in Medical Ethics. Routledge, New York. Chatterjee A (2004). Cosmetic neurology. The controversy over enhancing movement, mentation, and mood. Neurology 63: 968–973. Chren M-M, Landefeld S (1994). Physicians’ behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary. JAMA 271: 684–689. Commonwealth of Massachusetts Trial Court Law Libraries (2012). Massaschusetts law about health care proxies and living wills. Updated November 1, 2012. Available at: www.lawlib.state.ma.us/subject/about/healthproxy.html (accessed November 2, 2012). Congressional Budget Office (2012). Medicare. Medicaid and CHIP. Available at: https://www.cbo.gov/topics/ health-care/medicare, and https://www.cbo.gov/topics/ health-care/medicaid. Council on Ethical and Judicial Affairs, American Medical Association (2010). Code of Medical Ethics with Annotations prepared by the Southern Illinois University Schools of Medicine and Law. American Medical Association. Chicago, IL. Council on Ethical and Judicial Affairs, American Medical Association (2010). Code of Medical Ethics with Annotations prepared by the Southern Illinois University Schools of Medicine and Law. Sect.5.04-5.1. American Medical Association, Chicago, Illinois. Delaware Medical Practice Act. 24 Del C Section 1731A. Available at: http://delcode.delaware.gov/title24/c017/ sc04/index.shtml#1731 (accessed November 1, 2012). Emanuel LL, Emanuel EJ (1989). The medical directive: a new comprehensive advance care document. JAMA 261: 3288–3292. Estate of Behringer v. Medical Ctr. 249 NJ. Super. 597, 592 A.2d 1251. (1991). Ethics and Humanities Subcommittee, American Academy of Neurology (1998). Assisted suicide, euthanasia and the neurologist. Neurology 50: 596–598. Ethics, Law and Humanities Committee, American Academy of Neurology (2000). Ethical dimensions of neurologic practice: a case-based curriculum for neurology residents. American Academy of Neurology, St. Paul, MN. Ethics, Law and Humanities Committee, American Academy of Neurology (2009). Responding to requests from adult patients for neuroenhancements. Neurology 73: 1406–1412. Fletcher JC, Lombardo PA, Spencer EM (2005). Fletcher’s Introduction to Clinical Ethics. 3rd edn. University Publishing Group, Hagerstown, MD. Gonzales v. Oregon, 546 U.S. 243 (2006).
Gostin LO (1997). Deciding life and death in the courtroom: from Quinlan to Cruzan, Glucksberg, and Vacco – a brief history and analysis of constitutional protection of the ‘right to die’. JAMA 278: 1523–1528. Halpern AL, Halpern JH, Doherty SB (2008). “Enhanced” interrogation of detainees: do psychologists and psychiatrists participate? Philos Ethics Humanit Med. http://dx. doi.org/10.1186/1747-5341-3-21. http://dx.doi.org/10.1186/ 1747-5341-3-21. http://www.peh-med.com/content/3/1/21. Accessed August 24, 2013. Hart HM (1958). The aims of the criminal law. Law Contemp. Probs. at 404. Health Insurance Portability and Accountability Act, PL 10491, 110 Stat, 1936 (1996). Held V (2006). The Ethics of Care: Personal, Political and Global. Oxford University Press, New York. Hippocrates (2002). Hippocratic Oath. North M (transl.), History of Medicine Division. National Library of Medicine Available at: http://www.nlm.nih.gov/hmd/ greek/greek_oath.html(accessed October 31, 2012). Illes J, Bird SJ (2006). Quoting E. Kandel in Neuroethics: a modern context for ethics in neuroscience. Trends Neurosci. 29 (9): 511–517. In Re E.G., A Minor 133 I11.2d 98, 549 N.E.2d 322 (1989). Jones NL, Sarata AK for the Congressional Research Service (2008). Genetic Information: Legal Issues Relating to Discrimination and Privacy. Order Code 3LR0006. Available at: http://www.ncsl.org/issues-research/ health/genetic-privacy-laws.aspx, via http://assets. opencrs.com/rpts/RL30006_20080310.pdf (accessed November 1, 2012). Jonsen AR, Siegler M, Winslade WJ (2010). Clinical Ethics. A Practical Approach to Ethical Decisions in Clinical Medicine. 7th edn. McGraw-Hill, New York. Jonson AR, Toulmin S (1989). The Abuse of Casuistry. University of California Press, Berkeley, CA. Katz D, Caplan AL, Merz JF (2003). All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth 3: 39–46. Leonard JA, Abel N, Cochrane T et al. (2010). Guidelines for ethical behavior relating to clinical practice issues in neuromuscular and electrodiagnostic medicine. Muscle Nerve 42: 480–486. Maimonides. The Oath of Maimonides. Sheridan Library Collection. Johns Hopkins University. Available at: http://guides.library.jhu.edu/content.php? pid¼23699&sid¼190571 (accessed October 21, 2012). Marks JH (2007). Doctors as pawns? Law and medical ethics at Guantanamo Bay. Seton Hall Law Rev 37: 711–731. Menikoff JA, Sachs GA, Siegler M et al. (1992). Beyond advance directives – health care surrogate laws. N Engl J Med 327: 1165–1169. Mitchell S (1992). Physician ownership of physical therapy services: effects on charges, utilization, profits, and service characteristics. JAMA 268: 2055–2059. Muramoto D (2008). Jehovah’s Witness bioethics. In: PA Singer, AM Viens (Eds.), The Cambridge Textbook of Bioethics. Cambridge University Press, New York, pp. 416–423.
National Conference of State Legislatures (2008). Genetic Privacy Laws. State and Statute descriptions. Available at: http://www.ncsl.org/issues-research/health/geneticprivacy-laws.aspx (accessed November 1, 2012). NIH Office on Research on Women’s Health. Background: Inclusion of women and minorities in clinical research. http://orwh.od.nih.gov/research/inclusion/background.asp Accessed August 22, 2013. NIH Revitalization Act of 1993. PL 103-43 107 Stat 122. North Carolina Department of Corrections v. North Carolina Medical Board, 363 N.C. 189, 675 S.E.2d 641, 644–645 (2009). Nuremberg Code. Available at: http://www.hhs.gov/ohrp/ archive/nurcode.html (accessed October 30, 2012). Office of Research on Women’s Health. Inclusion of women and minorities in clinical research. Available at orwh.od. nih.gov/research/inclusion/background.asp (accessed October 30, 2012). Oregon Death with Dignity Act (2011). Oregon Revised Statute 127.800–127.897. Available at: http://www.leg. state.or.us/ors/127.html (accessed October 28, 2012). Oregon Public Health Division (2012). Reports on the Oregon Death with Dignity Act. available at: http://public. health.oregon.gov/ProviderPartnerResources/EvaluationRee search/DeathwithDignityAct/Pages/ar-index.asp. O’Rourke KD, Boyle PJ (2011). Medical Ethics: Sources of Catholic Teaching. 4th edn. Georgetown University Press, Washington, DC. Parker M, Lucassen A (2005). Working toward ethical management of genetic testing. Lancet 360: 1685–1688. Patients’Rights Council(2011).Physician Assisted SuicideLaws. Montana Available at: http://www.patientsrightscouncil.org/ site/montana/ (accessed October 28, 2012). Pellegrino ED (1993). The metamorphosis of medical ethics. A 30-year retrospective. JAMA 269: 1158–1162. Pellegrino ED, Thomasma DA (1993). The Virtues in Medical Practice. Oxford University Press, New York. People v. Kevorkian, 248 Mich App. 373, 639 N.W.2d 291 (2001). Quill TE (1991). Death and dignity: a case of individualized decision making. N Engl J Med 324: 691–694. Reverby S (2000). Tuskegee’s Truths: Re-thinking the Tuskegee Syphilis (Studies in Social Medicine). University of North Carolina, Chapel Hill, NC. Rogers P (2007). Stark for Beginners: An Introduction to the Federal Physician Self-Referral Law. Published 78 OBJ 1957 (August 4, 2007). Roscoe LA, Malphurs JE, Dragovic LJ et al. (2000). Dr. Jack Kevorkian and cases of euthanasia in Oakland County, Michigan, 1990–1998. N Engl J Med 343: 1735–1736. Rothman DJ (1991). Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decisionmaking. Basic Books, New York.
Rowland D, Lyons B (1996). Medicare, Medicaid, and the Elderly Poor. Health Care Financ Rev 18: 61–69: Available at: www.socialsecurity.gov/history/pdf/RowlandandLyons. pdf (accessed October 30, 2012). Rubenstein LR, Pross C, Davidoff F et al. (2005). Coercive US interrogation policies: a challenge to medical ethics. JAMA 294: 1544. Snyder L, for the American College of Physicians Ethics, Professionalism, and Human Rights Committee (2012). American College of Physicians ethics manual, 6th edn. Ann Intern Med 156: 73–104. State of Ohio. Administrative Rule 4731-26-02. Available at: http://codes.ohio.gov/oac/4731-26 (accessed October 31, 2012). Steinberg A (2003). Encyclopedia of Jewish Medical Ethics. transl. by Rosner F Feldheim Publishers, Jerusalem. Sutton P (2011). The Stark law in retrospect. Ann Health Law 20: 15–48. Swedlow MHSA, Johnson G, Smithline N et al. (1992). Increased costs and rates of use in the California Workers’ Compensation System as a result of self-referral by physiicans. N Engl J Med 327: 1502–1506. Tarasoff v. Regents of the University of California. 17 Cal. 3d 425, 551 P.2d 334, 131 Cal. Rptr. 14 (1976). Ulrich LP (2001). The Patient Self Determination Act. Meeting the Challenges in Patient Care. Georgetown University Press, Washington, DC. Vacco v. Quill, 521 U.S. 793 (1997). Vassilades v. Garfinckel’s, Brooks Bros., 492 A.2d 580 (D.C. Ct. App. 1985). Washington v. Glucksberg 521 U.S. 702 (1997). Washington State Legislature (2008). Chapter 70.245. The Washington Death with Dignity Act. http://apps.leg.wa. gov/RCW/default.aspx?cite=70.245 Accessed August 25, 2013. Wazana A (2000). Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA 283: 373–380. Whitman JQ (2008). The Origins of Reasonable Doubt: Theological Roots of the Criminal Trial. Yale University Press, New Haven, CT. World Medical Association (1948, amended 2006). Declaration of Geneva. Available at: http://www.wma. net/en/30publications/10policies/g1/index.html (accessed November 1, 2012). Zeidman LA (2011a). Neurosciences in Nazi Europe Part I: eugenics, human experimentation, and mass murder. Can J Neurol Sci 38: 696–703. Zeidman LA (2011b). Neuroscience in Nazi Europe Part II: resistance against the Third Reich. Can J Neurol Sci 38: 826–838. Ziegler SJ (2005). Physician-assisted suicide and criminal prosecution: are physicians at risk? J Law Med Ethics 33: 349–358.