In 1990, Congress enacted the Americans with Disabilities Act (ADA). This Note examines the legislative history of the ADA and uncovers Congress's intent to impose a duty on health care providers to treat people with disabilities unless an individual poses a “direct threat” to the health or safety of others. This Note posits that, with the passage of the ADA, Congress imposed a statutory duty on health care providers to give care to people infected with HIV who qualify under the statute. This Note concludes that while the “direct threat” exception may lessen the impact of the ADA, those infected with HIV should enjoy greater access to health care than ever before.

The Affordable Care Act (ACA) may be the most important health law statute in American history, yet much of the most prominent legal scholarship examining it has focused on the merits of the court challenges it has faced rather than delving into the details of its priority-setting provisions. In addition to providing an overview of the ACA's provisions concerning priority setting and their developing interpretations, this Article attempts to defend three substantive propositions.

First, I argue that the ACA is neither uniformly hostile nor uniformly friendly to efforts to set priorities in ways that promote cost and quality.

Second, I argue that the ACA does not take a single, unified approach to priority setting; rather, its guidance varies depending on the aspect of the healthcare system at issue (Patient Centered Outcomes Research Institute, Medicare, essential health benefits) and the factors being excluded from priority setting (age, disability, life expectancy).

Third, I argue that cost-effectiveness can be achieved within the ACA's constraints, but that doing so will require adopting new approaches to cost-effectiveness and priority setting. By limiting the use of standard cost-effectiveness analysis, the ACA makes the need for workable rivals to cost-effectiveness analysis a pressing practical concern rather than a mere theoretical worry.

The use of placebos by physicians for therapeutic purposes is a common part of clinical medical practice. This Article examines the legal and ethical ramifications of placebo prescription. In particular, ethical concerns are related to substantive legal theories that may be advanced to attack or defend the practice of placebo therapy in particular cases. The author concludes that, under certain strictly denned circumstances, the use of placebos in patient care is ethically and legally justifiable. However, from any perspective, the rights and duties inherent in the physician-patient relationship must be respected by the physician when considering the clinical use of placebos.

Prompted by criticisms of long delays in its drug approval processes, the Food and Drug Administration (FDA or the Administration) took a number of measures in recent years to expedite access and increase availability of new drugs for terminally ill patients. These reforms began in the late 1980s, as acquired immune deficiency syndrome (AIDS) advocacy organizations openly criticized the FDA, noting that its policies were insufficient to address the prevalence of AIDS and the lag time for FDA approval of new AIDS treatments. The FDA's primary responsibility is to promote efficacy and ensure safety of new drugs. Consequently, the FDA must balance patients' desires to obtain new medications to treat serious and lifethreatening illnesses against government's desires to protect patients from abuses of the new drug approval process. The structure of the FDA's regulatory procedures is, therefore, essential to providing safe, effective medical treatments to patients. FDA regulations and guidelines set forth standards and practices that pharmaceutical companies must follow to gain approval of newly developed drugs.

As Canada approaches the end of its first decade of government-run health care with universal coverage and controlled costs, the majority in the United States Congress has proposed repealing the federal guarantee of health coverage to poor and disabled persons embodied in Medicaid. This somber turn in the history of American health care comes only a few years after an optimistic President Clinton resurrected the efforts of Presidents Truman and Nixon to establish universal coverage. Clinton’s own party quashed his Health Security Act prior to any formal debate. Characterizing the plan as Byzantine government that would limit choice, health insurance companies, the very industry President Clinton tried to accommodate by rejecting the Canadian model, opposed the plan. Ironically, the possibility of such legislation accelerated the movement by health care insurers and other large-scale payers to assume control of health care delivery through the establishment of “managed care” systems. While this movement has initially reduced costs, it has also restricted consumers’ choice and imposed new administrative procedures.

Patents and other statutory types of market protections are used in the United States to promote scientific research and innovation. This incentive is especially important in research intensive fields such as the pharmaceutical industry. Unfortunately, these same protections often result in higher monopoly pricing once a successful product is brought to market. Usually this consequence is viewed as the necessary evil of an incentive system that encourages costly research and development by promising large rewards to the successful inventor. However, in the case of the AIDS drug Zidovudine (AZT), the high prices charged by the pharmaceutical company owning the drug have led to public outcry and a re-examination of government incentive systems.

This Note traces the evolution of these incentive programs — the patent system, and, to a lesser extent, the orphan drug program — and details the conflicting interests involved in their development. It then demonstrates how the AZT problem brings the interest of providing inventors with incentives for risky innovative efforts into a sharp collision with the ultimate goal of such systems: ensuring that the public has access to the resulting products at a reasonable price. Finally, the Note describes how Congress and the courts have attempted to resolve these problems in the past, and how they might best try to solve the AZT problem in the near future.

Understanding the factors that impact a juvenile's adjudicative competence in delinquency and criminal proceedings today requires some familiarity with mental illness, mental retardation, and developmental immaturity. Current research and studies shed new light on these factors that juvenile advocates, prosecutors, judges, and policymakers must routinely confront. This article discusses some of the issues involved in competency determinations of juveniles awaiting trial; addressing both the more traditional factors, such as mental illness and mental retardation, and some of the more recent studies and literature identifying developmental immaturity as an emerging basis for challenging the competency of juveniles to stand trial.

Juvenile justice systems routinely presume that adolescents accused of delinquent or criminal misconduct are competent to stand trial. Adults charged with criminal misconduct are also presumed to be competent. Competency requires that citizens accused of criminal misconduct understand the charges against them, have rudimentary understanding of the court process, be able to understand and answer questions posed to them by their counsel, and be able to make decisions about their trial such as whether to testify, and whether to accept or reject plea bargains.

Congress granted qualified immunity from liability for peer review participation to physicians, osteopaths and dentists, created a national practitioner data bank to track inept, incompetent or unprofessional physicians, and enacted procedural rules for due process, privilege restrictions, and reporting and disbursement of information. The Health Care Quality Improvement Act of 1986 is now in full force, and peer review participants are anxious to cloak themselves with immunity from actions brought by health care professionals. Although its goals are worthy, HCQIA's effects remain to be seen. Serious loopholes appear to exist, warranting close monitoring and possibly early amendment of the Act. Cautious judicial assessment is needed, in order to prevent not only circumvention of the Act's requirements by artful litigants, but also use of the national data bank by health care entities as a pretext for denying privileges and escaping antitrust liability.

The advent of artificial intelligence (“AI”) holds great potential to improve clinical diagnostics. At the same time, there are important questions of liability for harms arising from the use of this technology. Due to their complexity, opacity, and lack of foreseeability, AI systems are not easily accommodated by traditional liability frameworks. This difficulty is compounded in the health care space where various actors, namely physicians and health care organizations, are subject to distinct but interrelated legal duties regarding the use of health technology. Without a principled way to apportion responsibility among these actors, patients may find it difficult to recover for injuries. In this Article, I propose that physicians, manufacturers of clinical AI systems, and hospitals be considered a common enterprise for the purposes of liability. This proposed framework helps facilitate the apportioning of responsibility among disparate actors under a single legal theory. Such an approach responds to concerns about the responsibility gap engendered by clinical AI technology as it shifts away from individualistic notions of responsibility, embodied by negligence and products liability, toward a more distributed conception. In addition to favoring plaintiff recovery, a common enterprise strict liability approach would create strong incentives for the relevant actors to take care.

In 1971, New York Times journalist James Reston watched as brain surgery was preformed in the former Red Cross Hospital in Shanghai with acupuncture as the only anesthesia. “[Patients] were anesthetized merely by the insertion of very thin three-inch stainless steel needles into the body … and they were not only perfectly conscious while their skulls were laid open before us but remarkably alert within half an hour after the operation.” One patient, a fifty-four-year-old man named Chuan Leao, had been suffering from epilepsy as a result of a large tumor in the frontal lobe of his brain. “He seemed sensibly puzzled by being introduced to a couple of American strangers during his ordeal but was courteous and patient, and we listened to his comments while the tumor was removed and even watched him eat oranges slices and ask for more while the operation was going on.”

Thanks to medical technology, thousands of elderly patients suffer the agony of debility, from which many of them would choose to be released if they knew how to effect a choice. Prolonging their metabolism is unfair to them and to their families, and strains the nation's overburdened health care resources. Medical directives offer elderly patients avenues of escape from unwanted treatment. Health care for the aged should include informed access to these means of choice.

The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled “Right to Know” statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death.

In this Article, I strive not only to show the remarkably similar critiques each side marshals but also to use these concerns to think in more nuanced ways about the goals of informed consent and whether the disclosure mandates achieve those goals. I first argue in favor of the aspirational goals of informed consent as a process that allows patients to participate in their medical decision making. While conceding the inherently political nature of abortion and end-of-life care, I also contend that the significance of decisions regarding those matters warrants, at least in theory, legislative efforts to ensure that patients have the opportunity to engage in deliberative and informed decision making.

In describing and responding to the similar critiques of both sets of laws—the political bias of the statutes; the efforts to persuade, especially with non-medical information; the potential vulnerability of the targeted audience; and the interference with physician discretion—I uncover and challenge some of the presumptions about informed consent inherent in those critiques. Although information that persuades or influences is not per se problematic, I argue that disclosure of information that is inaccurate, untrue, or emotionally inflammatory harms informed consent. Even well-crafted informed consent mandates, however, are insufficient to promote truly deliberative decision making because they oversimplify the complexity of these decisions and fail to respond to the fact that informed consent is a process that requires more than simply the delivery of information; it also requires dialogue and discussion. This Article ends with suggestions for ways to try to promote such a dialogue.

Throughout the history of the mental health profession, many psychotherapists have asserted that homosexuality is a mental condition or defect that may be corrected through treatment. Homosexuality was not officially declassified as a mental illness until 1973, and it was not until recently that mainstream mental health organizations renounced the claim that therapy can alter sexual orientation. Sexual orientation change efforts (SOCE) involve various types of psychotherapy, from the familiar and seemingly benign talk therapy to forms of behavioral therapy that include “masturbatory reconditioning, rest, visits to prostitutes[,] excessive bicycle riding,” and even physical abuse. SOCE are now widely regarded by mainstream mental health practitioners as unscientific, ineffective, and mentally and emotionally harmful. Nevertheless, due to persistent societal disapproval of homosexuality, some mental health providers continue to engage in SOCE, often causing their patients to experience shame and anxiety well into adulthood.

In recent years, complementary and alternative medicine (“CAM”) has grown in both popularity and economic import across all segments of society and is now an established presence in the lives of millions of Americans. It has generated its own field of adherents, practitioners, opponents, lobbyists and counter-lobbyists, case law, and regulations. On one side of the CAM equation stand the advocates of CAM: its practitioners and satisfied patients. On the other stand its detractors: its dissatisfied patients, groups within the established or mainstream medical community, and historically, the American Medical Association (“AMA”). In the aggregate, the two sides engage in large scale scientific and philosophical battles over how best to treat or address the health care needs of patients. On a smaller scale, individuals on each side are essentially lobbying to protect their professions and their jobs. The struggle between the two warring camps fills volumes of medical, legal and popular scholarship. However, it is not the point of this Note to address the validity of the debate between CAM and mainstream medicine.

Any discussion of health care reform in the United States inevitably draws comparisons from the Canadian model. This Article frames the debate over the merits of the Canadian system by introducing its basic features, exploring its advantages, and discussing its limitations. In evaluating the prospects for a Canadian-type system in the United States, the author focuses on the need to rethink — as Canada has — the viability of market-based approaches to health care.

In Roe v. Wade, the Supreme Court held that the constitutionally protected right to privacy includes a woman's right to terminate pregnancy. Following the decision, anti-abortion groups turned to Congress to limit or negate that right. As a result of their efforts, several "human life" statutes and constitutional amendments have been proposed. This Article focuses on the implications of proposed amendments that seek to ban or limit the availability of abortions indirectly by broadening the definition of "person" to include unborn individuals. The Article discusses the potentally serious effects such an amendment would have in areas unrelated to abortion. It finds that the resulting chaos and uncertainty would have great social costs, and concludes that if abortions are to be banned or restricted, a human life amendment that directly deals with abortion is preferable to one that defines "person" to include the unborn.

In Parham v. J.R., 442 U.S. 584 (1979), the U.S. Supreme Court held that a parent or a guardian can commit a minor to a mental institution if a staff physician certifies that the minor should be committed, even if the minor strenuously opposes their decision. The Court specifically rejected claims that commitment of a minor by a parent or guardian without an adversary hearing is a deprivation of the minor's liberty without due process of law. This Note reviews the Parham opinion, with special attention to its impact on “mature minors” and wards of the state and to its definition of a neutral factfinder. The Note argues first that the Court's failure to establish special safeguards for “mature minors” and wards of the state is inconsistent with constitutional standards of due process, and second, that the Court's acceptance of staff physicians as neutral factfinders may be unwarranted. The Note recommends the creation of moire stringent procedural safeguards for the commitment of minors by parents and guardians, including the use of independent mental health professionals as “neutral factfinders.”

Park v. Chessin, a recent New York case, marked the first step toward judicial acceptance of the theory of “wrongful life.” Wrongful life suits involve a cause of action brought by an infant, against a physician, alleging that the physician's failure to inform the child's parents of the possibility of their bearing a severely defective child was the proximate cause of the infant's birth, and thus resulted in harm to the infant. This Note explores recent legal developments that give precedential support to the development of the theory of wrongful life. Furthermore, it demonstrates that the awarding of monetary damages is an appropriate remedy for the wrongful life plaintiff, and it examines possible methods for measuring those damages. The Note concludes with an analysis of the capability of courts to adjudicate wrongful life suits, and of the possible ramifications of judicial acceptance of the theory of wrongful life.