For almost a century, the Food and Drug Administration (FDA) has regulated nutrients and other dietary supplement ingredients and products under the food provisions initially of the Federal Food and Drugs Act of 1906 and now of the Federal Food, Drug and Cosmetic Act of 1938 (“FD&C Act”), as amended. Congress amended the FD&C Act through the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960 to strengthen FDA authority over food ingredient safety. In 1976, Congress enacted the Vitamin-Mineral Amendments which provides that FDA may limit the contents of dietary supplements only for safety reasons. In 1994, Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”) to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary supplements and dietary ingredients.

Live kidney donation involves a delicate balance between saving the most lives possible and maintaining a transplant system that is fair to the many thousands of patients on the transplant waiting list. Federal law and regulations require that kidney allocation be equitable, but the pressure to save patients subject to ever-lengthening waiting times for a transplant has been swinging the balance toward optimizing utility at the expense of justice.

This article traces the progression of innovations created to make optimum use of a patient's own live donors. It starts with the simplest – direct donation by family members – and ends with voucher donations, a very recent and unique innovation because the donor can donate 20 or more years before the intended recipient is expected to need a kidney. In return for the donation, the intended recipient receives a voucher that can be redeemed for a live kidney when it is needed. Other innovations that are discussed include kidney exchanges and list paired donation, which are used to facilitate donor swaps when donor/recipient pairs have incompatible blood types.

The discussion of each new innovation shows how the equity issues build on each other and how, with each new innovation, it becomes progressively harder to find an acceptable balance between utility and justice. The article culminates with an analysis of two recent allocation methods that have the potential to save many additional lives, but also affirmatively harm some patients on the deceased donor waiting list by increasing their waiting time for a life-saving kidney. The article concludes that saving additional lives does not justify harming patients on the waiting list unless that harm can be minimized. It also proposes solutions to minimize the harm so these new innovations can equitably perform their intended function of stimulating additional transplants and extending the lives of many transplant patients.

Proposals to reduce national expenditures for health care under Medicare and other programs raise questions about the limits on legislative power to distribute health care benefits. The constitutional guarantee of equal protection has been a weak source of protection for the sick, largely because they fail to qualify for special scrutiny under traditional equal protection analysis. Recent decisions of the United States Supreme Court suggest that the Justices seek a newer, more flexible approach to reviewing claims of unequal protection. This Article examines the application of the equal protection guarantee to health-related claims. It argues that traditional equal protection analysis is too rigid and newer rationality review too imprecise to provide just eligibility determinations. The Article concludes that courts should subject claims of unequal protection in the health care context to heightened scrutiny, as health care plays a special role in assuring equality of opportunity.

Stakeholders in law, medicine, and religion are unable to reach consensus about how best to address conflicts between healthcare providers' conscientious objections to treatment and patients' rights to access medical care. Conscience laws that protect objecting providers and institutions from liability are criticized as too broad by patient advocates and as too narrow by defenders of religious freedom. This Article posits that some of the tension between these stakeholders could be mitigated by statutory recognition of a duty on the part of healthcare institutions or providers to disclose conscientiously motivated limitations on practice. While this solution would not guarantee a patient's access to treatment, referral, or information from any given provider, it would prevent some of the more egregious cases of denial of treatment—those where patients are not made aware that a legal and clinically defensible treatment option is excluded from a provider's or institution's scope of practice and so have no opportunity to seek care elsewhere.

This Article presents the first comprehensive analysis of the contribution of behavioral science to the legal response to the COVID-19 pandemic. At the descriptive level, the Article shows how different psychological phenomena such as loss aversion and cultural cognition influenced the way policymakers and the public perceived the pandemic, and how such phenomena affected the design of laws and regulations responding to COVID-19. At the normative level, the Article compares nudges (i.e., choice-preserving, behaviorally informed tools that encourage people to behave as desired) and mandates (i.e., obligations backed by sanctions that dictate to people how they must behave). The Article argues that mandates rather than nudges should serve in most cases as the primary legal tool used to regulate behavior during a pandemic. Nonetheless, this Article highlights ways in which nudges can complement mandates.

Mental illness is a serious problem in the United States. Based on “current epidemiological estimates, at least one in five people has a diagnosable mental disorder during the course of a year.” Fortunately, many of these disorders respond positively to psychotropic medications. While psychiatrists write some of the prescriptions for psychotropic medications, primary care physicians write more of them. State legislatures, seeking to expand patient access to pharmacological treatment, granted physician assistants and nurse practitioners prescriptive authority for psychotropic medications. Over the past decade other groups have gained some form of prescriptive authority. Currently, psychologists comprise the primary group seeking prescriptive authority for psychotropic medications.

The American Society for the Advancement of Pharmacotherapy (“ASAP”), a division of the American Psychological Association (“APA”), spearheads the drive for psychologists to gain prescriptive authority. The American Psychological Association offers five main reasons why legislatures should grant psychologists this privilege: 1) psychologists’ education and clinical training better qualify them to diagnose and treat mental illness in comparison with primary care physicians; 2) the Department of Defense Psychopharmacology Demonstration Project (“PDP”) demonstrated non-physician psychologists can prescribe psychotropic medications safely; 3) the recommended post-doctoral training requirements adequately prepare psychologists to prescribe safely psychotropic medications; 4) this privilege will increase availability of mental healthcare services, especially in rural areas; and 5) this privilege will result in an overall reduction in medical expenses, because patients will visit only one healthcare provider instead of two–one for psychotherapy and one for medication.

The centrality of freedom as a philosophical construct is often neglected in contemporary academic circles and popular media outlets when it comes to discussions of crime, criminals, and the criminal law. This is surprising, especially since freedom—its absence or its presence—is an important ethical dimension underpinning all transgressive acts, including delinquency and crime. More specifically, the notion of freedom problematizes wayward conduct because transgression can (and does) emerge from freedom's limits rather than its excesses. What this suggests, then, is that criminality is not necessarily an artifact of one's autonomy gone awry or of making “bad” choices; rather, criminality may be a moment of self-discovery, transformation, and transcendence in which a “critical freedom” is borne. This is a period marked by living life on the edge; of contesting thresholds and boundaries in which “a plethora of original ideas, thoughts, inventions, new forms of resistance, and so forth” emerge.

Kidney chains are a recent and novel method of increasing the number of available kidneys for transplantation and have the potential to save thousands of lives. However, because they are novel, kidney chains do not fit neatly within existing legal and ethical frameworks, raising potential barriers to their full implementation.

Kidney chains are an extension of paired kidney donation, which began in the United States in 2000. Paired kidney donations allow kidney patients with willing, but incompatible, donors to swap donors to increase the number of donor/recipient pairs and consequently, the number of transplants. More recently, transplant centers have been using non-simultaneous, extended, altruistic donor (“NEAD”) kidney chains—which consist of a sequence of donations by incompatible donors—to further expand the number of donations. This Article fully explains paired kidney donation and kidney chains and focuses on whether NEAD chains are more coercive than traditional kidney donation to a family member or close friend and whether NEAD chains violate the National Organ Transplant Act's prohibition on the transfer of organs for valuable consideration.

Opposition to abortion is based in part on the assumption that personhood is achieved at or shortly after fertilization of the egg. This interpretation of personhood arises from a contemporary application of the ancient doctrine of preformationism, a doctrine which holds that there is a preformed individual, in an ontological sense, within the developing entity. The assumption that the fertilized egg is unique in its capacity to develop into a human being is at least in part responsible for the opinions of those opposed to abortion. Yet, the uniqueness of the zygote in its capacity to develop into an adult organism is qualified by the discovery that development may be possible in a number of other ways. Consideration of the phenomena of cloning, parthenogenesis and chimerism can relieve moral ambiguity about abortion and may reduce opposition to that practice.

Artificial intelligence (AI) is being tested and deployed in major hospitals to monitor patients, leading to improved health outcomes, lower costs, and time savings. This uptake is in its infancy, with new applications being considered. In this Article, the challenges of deploying AI in mental health wards are examined by reference to AI surveillance systems, suicide prediction and hospital administration. The examination highlights risks surrounding patient privacy, informed consent, and data considerations. Overall, these risks indicate that AI should only be used in a psychiatric ward after careful deliberation, caution, and ongoing reappraisal.

The increasing use of human tissues in medical research has spawned a host of ethical and legal debates. Legal analysis in this area has almost exclusively focused on the question of property rights in both the tissues used in research and in the resulting products. One illustrative case is Moore v. Regents of the Unversity of California, in which a patient sued his doctor for conversion of his spleen which had been removed for therapeutic purposes. The doctor later used the spleen to develop a patented and profitable cellline. This Comment examines and rejects the property law approach to this issue. Instead, this Comment proposes two legislative changes which would 1) eliminate any trade in human tissues and 2) require doctors to inform their patients of any research interest in proposed medical procedures. These proposals resolve the problem presented in Moore, and avoid the misleading, and inevitably unanswerable, question of property rights.

Doctors have two ethical duties: to cure disease or ease suffering and, also, to do no harm. The ethical duty to “Do No Harm” has been used to justify two sides of a pendulum swing in the philosophy of opioid prescribing for pain. In the 1990s, it was invoked to expand prescribing, and more recently to justify dramatic reductions in prescription opioid use. In this Article, we explore whether prescribing opioids for pain presents challenges that differ from the ordinary mandate physicians face as they balance the call for action with the imperative to do no harm [DNH].

We argue that the treatment of pain differs in three important ways. First, the fact that pain is present and occurrent reduces uncertainty about the need for action, and thus strengthens the reasons to act. Second, while DNH applies to both physicians and policymakers, each has distinct duties: physicians have a duty to the individual patient; policymakers have a duty to society. As a result, harm from drug diversion should weigh little when clinicians decide how to treat individual patients. Public health officials, by contrast, rightly consider societal effects. However, in doing so, they must adopt policies that mitigate the ethical burdens placed on physicians, respect the testimony of patients in pain, and pay particular attention to how policy guidance is likely to be implemented by others. Finally, we address what duties are owed to patients who are currently taking opioid medication, given evidence that they are experiencing significant barriers in receiving healthcare. We argue that once treatment has been initiated, there are special duties to these patients.

Regulation of the health care system to achieve appropriate containment of overall costs is characterized by Professor Havighurst as requiring public officials to engage, directly or indirectly, in the rationing of medical services. This rationing function is seen by the author as peculiarly difficult for political institutions to perform, given the public's expectations and the symbolic importance of health care. An effort on the part of regulators to shift the rationing burden to providers is detected, as is a trend toward increasingly arbitrary regulation, designed to minimize regulators’ confrontations with sensitive issues. Irrationality and ignorance are found to plague regulatory decision making on health-related issues, even though it is the consumer who is usually thought to suffer most from these disabilities. The author argues that consumer choice under some cost constraints is a preferable mechanism for allocating resources because it better reflects individuals’ subjective preferences, has a greater capacity for facing trade-offs realistically, and can better contend with professional dominance of the resource allocation process.

In view of the unlikelihood of regulation that is both sensitive and effective in containing costs, the author proposes that we rely primarily on consumer incentives to reform the system. A simple change in the tax treatment of health insurance or other health plan premiums, to strengthen consumers’ interest in cost containment while also subsidizing needy consumers, is advocated. Steps to improve opportunities for innovation in cost containment by health insurers, HMOs, and other actors are outlined briefly.

Justice Stewart’s 1966 dictum about the inevitability of government success in challenging mergers under Section 7 of the Clayton Act held true for another fifteen years or so. In the early 1980s, however, federal enforcement agencies, the Department of Justice (DOJ) and the Federal Trade Commission (FTC), began to find the federal courts less hospitable to antitrust merger cases as more sophisticated economic inquiries and changing proof burdens complicated the task of identifying anticompetitive mergers. Indeed, since the early 1980s, the government has lost more litigated merger cases than it has won and has come under criticism from some quarters for becoming gun shy and not adequately policing the wave of consolidations that have occurred over the past decade.

Hospital mergers, however, are a different story. Until two years ago, the government rode a streak of important victories in federal courts and FTC administrative proceedings, and had obtained consent decrees from scores of hospitals that had announced plans to merge.

Many individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.

The peer review privilege prevents patient-plaintiffs from obtaining the hospital records prepared in connection with quality review proceedings. The privilege, created by statute in most states, is rationalized by the need for confidentiality in promoting complete and candid peer review. In this Article, the Author argues that the privilege cannot effectively promote confidentiality since a common exception allows physicians to obtain the records when seeking judicial review of proceedings leading to their exclusion or dismissal from hospital medical staffs. More significantly, the Author notes that while the privilege began as a device to protect physicians from testifying against their will in malpractice suits—a condonation of the “conspiracy of silence”—it has evolved into a vehicle which enables hospitals to conceal the evidence of their own neglect.

As of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana1 to treat various illnesses or conditions, with legalization statutes currently pending in eight other states. Despite the growing number of states that allow for the prescription and use of medicinal marijuana, the federal government still classifies the drug as a Schedule I controlled substance, the strictest classification of controlled substances and the only type healthcare providers may not legally prescribe. As states continue to deliberate the merits of allowing access to marijuana for therapeutic use, it is useful to examine the structural and political forces that have prevented a similar movement at the federal level. This Note does so, and argues that proactive changes—either legislative or administrative—are necessary to remove the handicap that the current regulatory system places on attempts to change federal marijuana policy.