For the past two decades, the medical profession and society have debated the definition of death. Some reasonable consensus has been reached on this issue, in theory and in practice. In the last few years, however, a far more important debate has been evolving — the definition of human personhood. Human personhood has been discussed extensively in the past with respect to the abortion question and other issues concerning the beginning of life. More recently, however, the definition of personhood has been raised with respect to termination of treatment decisions at the end of life and, in particular, on the appropriate care of patients in a persistent vegetative state.

Our major premise is that consciousness is the most critical moral, legal, and constitutional standard, not for human life itself, but for human personhood. There is nothing highly original in our approach to this particular issue; others have advanced similar arguments in recent years.

Neuroimaging has advanced our understanding of how the living brain operates, providing structural and functional images of both healthy and diseased brains. This technology pervades today's society, particularly affecting the legal arena. Some judges argue that scientific evidence, which offers insight into the offender's mental state, is crucial because it is the only means of determining whether an offender's punishment is proportional to his crime. Other judges argue that “objective” evidence does not “wholly determine the controversy,” and focus instead on their duty as gatekeepers to independently evaluate scientific evidence. If courts use brain images to make their culpability determinations more objective and sound, these images must meet pertinent legal standards and shed light on medical conditions. For neuroimaging to meet these legal and medical standards with scientific integrity, scientists must convincingly correlate the dynamic images in a person's brain with the way the person is thinking or acting at that moment.

A neurologist with abdominal pain goes to see a gastroenterologist for treatment. The gastroenterologist asks the neurologist where it hurts. The neurologist replies, “In my head, of course.” Indeed, while we can feel pain throughout much of our bodies, pain signals undergo most of their processing in the brain. Using neuroimaging techniques like functional magnetic resonance imaging (“fMRI”) and positron emission tomography (“PET”), researchers have more precisely identified brain regions that enable us to experience physical pain. Certain regions of the brain's cortex, for example, increase in activation when subjects are exposed to painful stimuli. Furthermore, the amount of activation increases with the intensity of the painful stimulus. These findings suggest that we may be able to gain insight into the amount of pain a particular person is experiencing by non-invasively imaging his brain.

Such insight could be particularly valuable in the courtroom where we often have no definitive medical evidence to prove or disprove claims about the existence and extent of pain symptoms.

In 1989 and 1991, the Oregon legislature enacted a series of initiatives to extend health coverage to uninsured state residents. Among these initiatives is an act that seeks to extend a modified set of Medicaid benefits to state residents with family incomes below the federal poverty level. This act also reduces benefits the state is now required to provide to Medicaid-enrolled women of childbearing age and children. This Article explores the legal context in which the Oregon Medicaid experiment must be evaluated. It argues that by reducing the level of coverage to which tens of thousands of exceedingly poor, Medicaid-eligible women and children are entitled, the experiment falls outside the scope of valid research that the United States Department of Health and Human Services may either sanction or fund. The Article also discusses the implications of the Oregon experiment, if approved, for the future direction of the Medicaid program in particular, and for health care reform for the poor, generally.

The spread of acquired immune deficiency syndrome (AIDS) demands a comprehensive and effective public health response. Because no treatment or vaccine is currently available, traditional infection control measures are being considered. Proposals include compulsory testing and screening of selected high risk populations. The fairness and accuracy of compulsory screening programs depend upon the reliability of medical technology and the balancing of public health and individual confidentiality interests. This Article proposes criteria for evaluating compulsory testing and screening programs. It concludes that voluntary identification, education, and counselling of infected persons is the most effective means of encouraging the behavioral changes that are necessary to halt the spread of AIDS.

The debate concerning the legal and ethical bases of guardian refusal of medical treatment on behalf of incompetent patients often ignores critical distinctions among types of patients and guardians. For example, patients who have expressed preferences regarding treatment while competent are distinguishable from patients who have always lacked the competency requisite to expressing a treatment preference. “Bonded guardians,” whose relationship with the patient preexisted guardianship, should have a different role in the decision-making process than “nonbonded guardians,” who were strangers to the patient prior to the guardian-ward relationship.

This Article proposes criteria for guardian treatment refusal on behalf of incompetent patients. Under the model for guardian decision making presented here, bonded guardians should be preferred over nonbonded guardians, and bonded guardians should be allowed discretion to make treatment choices, limited only by a standard of reasonableness policed by the courts. The Author presents legal and ethical justifications for the bonded guardian's heightened role. Finally, he considers the proper roles of health professionals, hospital ethics committees, and judges in the decision-making process.

Changes in technology sometimes raise important public policy choices and require that we clarify key values and reexamine legal concepts. Such is the case with the development of electronic medical records (EMRs), which facilitate obtaining patient data from provider and insurer records. EMRs expand our ability to tap patient data and thereby create great potential benefits as well as risks. This new technology requires that we clarify the ambiguous property interests in patient data. How the law defines ownership of patient data will shape whether its benefits can be developed and also affects patient confidentiality.

EMRs make it feasible to collect aggregate patient data that can be used to vastly improve medical knowledge, patient safety and public health. Researchers have long used patient data from clinical trials to evaluate the benefits and risks of drugs and medical therapy, compare their relative effectiveness, and analyze health care cost and quality.

In this Article, Dr. Arnold S. Relman, the Editor of The New England Journal of Medicine, takes issue with the 1977 Saikewicz decision of the Massachusetts Supreme Judicial Court, which addressed the question of whether chemotherapy should be provided to a severely retarded 67-year-old man who had developed acute leukemia. Dr. Relman interprets Saikewicz as requiring that medical treatment decisions involving the life or death of incompetent patients must receive judicial resolution instead of resolution by the patient's family and physicians. This rule, he asserts, violates medical tradition, and its application will result in serious problems, such as the unnecessary prolongation of the suffering of many seriously ill persons. Dr. Relman proposes, as an alternative to the Saikewicz approach, that in such cases judicial resolution should occur only when there is disagreement, concerning treatment, among next of kin, or between next of kin and attending physicians, or when there is a complaint of injury or of wrongdoing. In all other situations, resolution solely by next of kin and attending physicians should be sufficient. Adequate protection of the interests of the incompetent patient could be achieved by a requirement that the physician in charge document in the medical record that the treatment decision received the concurrence of the family and advance approval of a group of the physician's professional colleagues who have no vested interest in the outcome of the decision.

The pharmaceutical industry's dependence on intellectual property rights (IPRs), especially patents, to exclude competitors and thereby recoup past expenditures, incentivize future investments in research and development (R&D), and maximize profits is well known. Although initially content to solidify patent rights in the rich-country markets of North America, Europe, and Japan, in the last quarter of the 20th century the industry has increasingly turned its attention to emerging markets in Latin America, Asia, and even Africa as sites of future market expansion. Big middle-income countries like Brazil, India, China, and Indonesia have growing middle classes that increasingly favor allopathic medicine over the more traditional medicines of their elders. Obtaining monopoly rights in these growing markets could help the pharmaceutical industry weather the storm of increased consumer, business, and government blow-back against supra-competitive drug prices charged in rich country markets.

Psychiatric and psychological predictions of dangerousness are used in a number of American jurisdictions to convince a judge or jury that a convicted murderer should be sentenced to death. Empirical research has demonstrated, however, that psychiatric and psychological predictions of dangerousness generally are inaccurate. This Article describes the current use of such predictions in capital sentencing hearings and examines their status under existing professional codes of ethics. It argues that the rendering of these predictions by psychiatrists and psychologists is contrary to the scientific and healing traditions of their professions and urges psychiatrists and psychologists to adopt an ethical ban on predictions of dangerousness in the capital sentencing context.

National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants.

This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants—those in federal research and those abroad—are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances.

This Article examines alternative compensation mechanisms and offers a concrete no-fault compensation proposal built on systems already in place. The proposed system can be implemented in the United States and countries around the world to help harmonize various national compensation systems and to more equitably and effectively make those injured by research whole.

In December of 2003 the Medicare Modernization Act (MMA) added section 223 to the Internal Revenue Code, creating a federal tax subsidy for money contributed to (and earnings accumulated on) health savings accounts, or HSAs. Though public attention was largely focused at that time on the provisions of the MMA creating the new Medicare prescription drug benefit, the MMA was also a major victory for advocates of “consumer-driven health care” who believe that HSAs have the potential to control the cost and improve the quality of health care in the United States, and perhaps even to increase health care access.

Consumer-driven health care advocates believe that the key reason health care costs are out of control in the United States is that most Americans are too generously insured. They believe the solution is to increase consumer sensitivity to cost and effectiveness by making people spend their own money for health care.

Neither bioethics nor health law is old as an established discipline. Modern bioethics dates from the late 1960s or early 1970s. Health law as a domain characterized by its own casebooks, courses, and specialists arguably began somewhat earlier. While each has far older precursors, the two fields have seen a modern resurgence in the last thirty years or so. Yet each in these three decades has been dominated by a certain method or paradigm. In bioethics that has come to be known as “principlism, ” deductive reasoning from a limited set of middle-level ethical principles, albeit with some reciprocal attention to the implications of the case at hand for those principles. No comparable term has emerged in health law, and the field has arguably been less enamored of philosophical abstraction. But the pattern has often been similar: the creation of middle-level rules (on informed consent, surrogate decision-making, advance directives and so on) and then their downward application with insufficient attention to the clinical context, the specific characteristics of the disputants (such as insurance status, race or ethnicity, and gender), and whether the rules will actually work in medical settings.

In November 2011, Australia became the first country in the world to legislate for “plain packaging” of tobacco products. As of December 1, 2012, the packaging of tobacco products sold in Australia must be a standard, drab dark brown color; and the printing of tobacco company logos, brand imagery, colors, or promotional text on that packaging and on individual tobacco products is prohibited. While the Australian scheme is described as “plain packaging,” tobacco packaging is required to be far from “plain” in the ordinary sense of the word. The scheme requires large health warnings composed of graphics, warning statements and explanatory messages, and information messages.

Plain packaging of tobacco products—which has also been called “generic packaging” or “standardized packaging”—is not a new idea. It was proposed as far back as June 1986, when the Canadian Medical Association agreed to a motion in favor of its adoption.

Patients continue to find new ways of reaching their physicians. In the past, patients and their health care providers developed relationships through the course of everyday affairs and across a wide variety of social exchanges. Although other methods of communicating were introduced into the medical context, telephones, pagers and voicemail all retained some connection to individual voices. Moreover, medical practitioners and patients alike never anticipated that these technologies would substitute for genuine personal interactions. Nor did they anticipate that another new technology, electronic mail (e-mail), would shift communications back in time to the days when letter writing formed the basis for diagnosing and relating. E-mail in medical practice has already begun to reconfigure the patient-physician relationship in the electronic age.

The current political economic crisis in the United States places in sharp relief the tensions and contradictions of racial capitalism as it manifests materially in health care and in knowledge-producing practices. Despite nearly two decades of investment in research on racial inequality in disease, inequality persists. While the reasons for persistence of inequality are manifold, little attention has been directed to the role of medical education. Importantly, medical education has failed to foster critical theorizing on race and racism to illuminate the often-invisible ways in which race and racism shape biomedical knowledge and clinical practice. Medical students across the nation are advocating for more critical anti-racist education that centers the perspectives and knowledge of marginalized communities. This Article examines the contemporary resurgence in explicit forms of white supremacy in light of growing student activism and research that privileges notions of innate differences between races. It calls for a theoretical framework that draws on Critical Race Theory and the Black Radical Tradition to interrogate epistemological practices and advocacy initiatives in medical education.

Over the past five years, there have been over 140 reported incidents of counterfeit and mislabeled drugs being sold by legitimate pharmacies in the United States. Thousands of patients have consumed these medications, sometimes with dire consequences. The extent of counterfeits in the legitimate market, however, is unknown. It is certain that the detected incidents of fakes are a fraction of the total number of incidents.

How did these drugs wind up in the bloodstreams of unsuspecting patients? Despite elaborate safety precautions, strict regulations and battalions of enforcement personnel, the stream of phony pharmaceuticals continues unabated. This article will consider the practical and legal dimensions of trade in Trojan drugs.

This Article examines the extent to which the U.S. healthcare system is equitable for older Latinos, using the World Health Organization (WHO) and the related Organization for Economic Cooperation and Development (OECD) criteria on health outcomes, access/responsiveness and financing. We argue that improving health equity requires more than actions aimed at health behavior and culturally-based beliefs targeted at the individual. Improving equity also requires changes in broader social and political processes affecting entire populations and organizations of care, paying special attention to how these changes affect the Latino elderly.

Healthcare is particularly important for the older population. Persons age 65 and older have the highest overall rates of death, disease and disability, as well as the most frequent and intense use of medical services. U.S. public policy has acknowledged the high medical care needs of many elderly by establishing Medicare as a universal health insurance starting at age 65, and supplementing it with Medicaid, the public-assistance program for low-income older persons.

To overcome the unattractiveness of small markets, the United States government provides financial aid and incentives for drug manufacturers to create cures for rare diseases under the Orphan Drug Act (“the Act”). Recent research integrating genetic information and pharmacology holds promise for creating more effective drugs targeted at smaller populations than ever before. In the near future, it seems that a flood of new drugs targeted at small disease populations could take advantage of the government benefits under the Act. Drug applicants will include true orphan drugs along with “Trojan” applicants that seek to co-opt the benefits for drugs that should not qualify as orphans. Currently, the FDA appears ill prepared to discern between the two types of applicants and prevent abuse of the system.

In 1983, the federal government passed the Act. Congress designed the Act and subsequent modifications to provide incentives for companies to bring drugs for rare diseases to market.

The term medical futility has become a shorthand way to describe a situation in which a patient demands and a physician objects to the provision of certain medical treatment, on the ground that the treatment will provide no medical benefit to the patient. The dilemma of medically futile care has gained prominence as a subject for debate in medical and legal literature, has been discussed implicitly and explicitly in court opinions, and has weighed heavily in the debate surrounding health care reform and accompanying discussion of allocation of health care resources.

Recently, the issues surrounding the provision of nonbeneficial care became the subject of a federal court opinion. On February 10, 1994, the United States Court of Appeals for the Fourth Circuit handed down its decision in In re Baby K, a case that has since served as the central focus for debate over the provision of medical treatment deemed inappropriate or futile by a patient’s physician.