Healthcare is not immune to the deeply rooted inequalities in American society. To this day, racial and ethnic differences exist in the quality and outcomes of healthcare that cannot be attributed to socioeconomic or other healthcare access factors. Lawyers committed to social justice have long dedicated energy and attention to these continued disparities. As a lawyer litigating against segregation in healthcare facilities noted in 1966, “The treatment accorded Negroes by Southern medical facilities … reflects a striking contradiction between law and practice.” Past efforts to achieve equality in healthcare through civil rights litigation, education and local organizing have been effective to a degree, but have lost their influence in the current healthcare environment. In a renewed effort to achieve racial and ethnic equality in healthcare, some advocates are turning to quality as an indirect route to attaining this goal. The quality approach requires changing the traditional healthcare framework by incorporating new methods for achieving quality into every level of the system, including the patient level, the clinical level, the healthcare organization level and the governance level.

Color it green. In a health care era driven by consumer demand, consumers are increasingly seeking Internet-based health services. Every day approximately seventy-three million Americans access the Internet in search of health information, with an average of six-million people seeking health advice. At present, a supply of over one-hundred thousand health-related websites serve the public’s demand for information and advice, with an average of one-thousand five hundred new sites added monthly. Surprisingly, consumers and students make up more than 30% of all healthrelated website users.4 From this union of cyberspace and the medical field, cybermedicine has emerged.

What does cybermedicine encompass? Cybermedicine is “the science of applying Internet and global networking technologies to medicine and public health, of studying the impact and implications of the Internet, and of evaluating opportunities and the challenges for health care.” General use of the Internet under this definition encompasses exploration and exploitation of the Internet for consumer health education, patient self-support, and professional medical education and research.

In the words of its sponsor, Senator Jacob Javits, the Employee Retirement Income Security Act (ERISA) was enacted in 1974 “to maintain the voluntary growth of private [pension and employee benefit] plans while at the same time making needed structural reforms in such areas as vesting, funding, termination, etc. so as to safeguard workers against loss of their earned or anticipated benefits....” Ironically, one of ERISA’s provisions—its indeterminate provision for the preemption of state law—has probably created more uncertainty about the adequacy and security of health care benefits than any other piece of legislation. Neither ERISA nor any other federal statute comprehensively regulates the content of employer provided health care plans, including benefits provided through managed care organizations (MCOs).

Persons afflicted with acquired immune deficiency syndrome (AIDS) or its preceding medical conditions face a potential problem with assured access to basic threshold medical care. Subject to certain limitations, there is no guarantee that a physician will fulfill the health care needs of any population of patients. Individuals with AIDS, thus, have a considerable interest in the development of a duty on behalf of physicians to provide treatment. This Note first highlights the limits of the legal duty to treat. It then examines the theoretical impetus propelling an ethical duty to treat. The Note concludes that the grounds for imposing an ethical duty on physicians are too weak to support that result, but the creation of an AIDS-specific legal duty is a viable alternative.

Low-income countries experience significant morbidity and mortality from avoidable infectious diseases, but all too often life-saving innovative vaccines are only available in high-income markets. The Generic Open (GO) license proposal posits that an increase in generic entry will lower prices through greater competition and increase vaccine availability in low-income markets. However, the GO proposal, as currently structured, is unlikely to function as envisioned in the vaccine market. Innovator vaccine firms will be unlikely to participate in the program because the payments in the GO license do not adequately compensate firms for all lost profits. Additionally, the price reductions from competitive entry are unlikely because the vaccine market is already characterized by low, and in some cases unsustainable, prices. I propose a potential adaptation where developing world vaccine manufacturers serve as contract suppliers to innovator firms for a given period of time. Donors could also share in the initial costs of capacity with the developing world manufacturers. Sales of developing world manufactured vaccines would be sold solely to UN procurement agencies under a confidential pricing or rebate system. This would increase overall product availability, maintain market separation, and decrease costs to UN agencies.

Medical malpractice claims are filed nearly ten times more frequently in America than they are in Great Britain. British patients generally adopt a less adversarial stance toward medical malpractice than do American patients. This Article examines the British malpractice system, as compared with the American system, and explores the differences between the two, in terms of costs and fees, liability rules, statutory provisions, and judicial attitudes toward malpractice litigation. The Article also discusses British social and institutional factors, such as the “taint” of litigation and the National Health Service, and evaluates how these factors affect British malpractice litigation. The Article presents the alternative forums available to British patients in seeking satisfaction for their medical service complaints. The Article concludes with an evaluation of how these factors achieve the three societal objectives of malpractice litigation: reparation, emotional vindication and deterrence.

In order to protect the nation from harmful or worthless drugs and devices, the Food and Drug Administration (FDA or the Agency) is legislatively authorized to restrict the sale of prescription drugs or medical devices to those whose efficacy and safety have been reviewed and approved by the Agency. Drugs and devices are approved for a specific medical purpose. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such “off-label” treatments have proven to be essential to the successful treatment of some very serious illnesses.

In these off-label situations, the FDA is faced with a dilemma. On the one hand, off-label use of prescription drug and devices gives rise to a series of major problems for the FDA. While the drug and devices in question have been vetted and approved by the FDA for their designated purpose, at no point has the FDA reviewed the supporting scientific data to determine efficacy for the off-label purpose.

Reducing the incidence of HIV infection continues to be a crucial public health priority in the United States, especially among populations at elevated risk such as men who have sex with men, transgender women, people who inject drugs, and racial and ethnic minority communities. Although most HIV prevention efforts to date have focused on changing risky behaviors, the past decade yielded efficacious new biomedical technologies designed to prevent infection, such as the prophylactic use of antiretroviral drugs and the first indications of an efficacious vaccine. Access to prevention technologies will be a significant part of the next decade's response to HIV, and advocates are mobilizing to achieve more widespread use of these interventions. These breakthroughs, however, arrive at a time of escalating healthcare costs; health insurance coverage therefore raises pressing new questions about priority-setting and the allocation of responsibility for public health. The goals of this Article are to identify legal challenges and potential solutions for expanding access to biomedical HIV prevention through health insurance coverage. This Article discusses the public policy implications of HIV prevention coverage decisions, assesses possible legal grounds on which insurers may initially deny coverage for these technologies, and evaluates the extent to which these denials may survive external and judicial review. Because several of these legal grounds may be persuasive, particularly denials on the basis of medical necessity, this Article also explores alternative strategies for financing biomedical HIV prevention efforts.

When Louis Brandeis and Samuel Warren introduced the phrase “the right to privacy” as the title of an article in the Harvard Law Review in December 1890, they were primarily concerned about a right of privacy from the news media. “The press,” they wrote, “is overstepping in every direction the obvious bounds of propriety and of decency. Gossip is no longer the resource of the idle and of the vicious, but has become a trade, which is pursued with industry as well as effrontery. To satisfy a prurient taste the details of sexual relations are spread broadcast in the columns of the daily papers.”

There are a remarkable number of similarities between science and the law. Each discipline sets as a gold standard a search for precision. For example, scientists utilize the scientific method—a specific set of principles and procedures designed to aid them in a systematic pursuit of knowledge. Following the scientific method involves the recognition and formulation of a problem, the collection of data through observation and possibly experimentation, the formulation of a hypothesis and the testing and confirmation of the hypothesis formulated. The law, in turn, seeks its form of precision through the careful use of words, as in finely crafted statutes or regulations and contractual language that seek to eliminate the possibility of vagueness or confusion. Each discipline utilizes an approach or methodology that strives to minimize or eliminate the possibility of error and to arrive at a form of “truth” that it recognizes as being maximal within the confines of the rules it has established, be they rules of scientific method or legal rules of evidence.

The 2010 federal health insurance reform act includes an individual mandate that will require Americans to carry health insurance. This article argues that even if the mandate were to catalyze universal health insurance coverage, it will fall short on some of the policy objectives many hope to achieve through a mandate if implemented in a fragmented insurance market. To uncover this problem, this article sets forth a novel framework that disentangles three different policy objectives the individual mandate can serve. Namely, supporters of the mandate might hope for it to: (1) facilitate greater health and financial security for the uninsured (“paternalism”); (2) eliminate inefficiencies in health care delivery and financing (“efficiency”); and/or (3) require the healthy to buy insurance to help fund medical care for the sick (“health redistribution”). Health redistribution — the primary focus of this article — is a shifting of wealth from the healthy to the sick through the mechanism of risk pooling. Many see health redistribution as a means to enable all Americans to more equitably access medical care on the basis of need, rather than on the basis of ability or willingness to pay.

Drawing on evidence from the implementation of an individual mandate in Massachusetts's health reform in 2006, this article reveals that the fragmented American health insurance market will thwart the mandate's ability to achieve these objectives— in particular the goal of health redistribution. Fragmentation is an atomization of the insurance market into numerous risk pools that has been driven by market competition and regulation. It prevents Americans from sharing broadly in the risk of poor health and, in doing so, entrenches a system where access to medical care remains tied to ability to pay and individualized characteristics. The final section of this article examines how various policies, including some in the new law (e.g., insurance regulation and exchanges) and others not (e.g., expanded public insurance), can reduce fragmentation so that the mandate can successfully serve all desired objectives and in the process gain greater legitimacy over time.

In this Article, which draws primarily on continental West European views on death and dying, the author contends that the Harvard criteria for irreversible coma (1968) are not reliable for diagnosing death in comatose patients under resuscitation treatment. The Article suggests that use of the Harvard Criteria to diagnose death leaves such patients legally unprotected against surgical assaults such as organ removal and biomedical experiments while they still may be living and capable of perception, possibly including the perception of pain and the spoken word. An alternative to the Harvard Criteria—angiography—is offered, and several additional issues related to the definition and diagnosis of death are discussed. Finally, the author suggests that even prior to death, termination of resuscitation treatment of irreversibly comatose patients, though followed by death, should be lawful.

This Article discusses the Texas Supreme Court's holding in Jacobs v. Theimer that the parents of a defective child had a cause of action for damages against a physician for alleged negligent failure to inform the mother during pregnancy that she had contracted rubella and therefore might have a defective child, thereby causing her to lose the opportunity to have an abortion. The Article raises a number of questions that posi-Jacobs courts probably will confront concerning the duty of physicians and genetic counselors to keep their clients informed; describes some social and medical developments—including recent progress in medical genetics and prenatal diagnosis—which are likely to make Jacobs a significant precedent; evaluates the court's decision to allow a damage suit only for the costs of treating and caring for the child's defects; and briefly addresses the question of whether the Jacobs case comes within the sphere of suits for what has come to be known as “wrongful birth” and “wrongful life.”

Use of “natural” and “all natural” claims on food and beverage products has increased exponentially over the last decade. Studies have consistently found that the claims influence consumer behavior—consumers seek out and are willing to pay a premium for products that make Natural claims. Not surprisingly, the Natural market has grown significantly, surpassing $40 billion in annual revenues. Despite strong consumer demand for Natural products, a majority of consumers have mistaken beliefs about the meaning of Natural claims.

Despite the fact that physicians have dispensed prescription drugs for profit for several years, the practice is currently under intense challenge and controversy. This recent flare-up can be explained by several factors including the involvement of the Federal Trade Commission (FTQ, increased competition among physicians, alternative delivery systems and drug repackagers.

Federal laws including the Food Drug and Cosmetic Act and Controlled Substances Act regulate dispensing practices, but have been interpreted to regulate dispensing by pharmacists, not physicians. All states have laws applicable to the dispensing of prescription drugs by physicians, but the wording of these laws raises unclear legal issues. Both uncertainty about these legal issues and pharmacists' concern over the increase in physician dispensing has promoted state legislative efforts to restrict or regulate the practice. These legislative efforts and the corresponding regulatory actions by state boards have triggered FTC involvement.

From a social policy perspective physician dispensing raises significant concerns of ethics, conflicts of interest, patient welfare and economics. Based upon social policy, physician dispensing for profit is not a practice which should be condoned or allowed to flourish.

In a typical magnetic resonance imaging (“MRI”) study of the brain, subjects are screened for contraindications before being placed in the bore of a large machine, the MRI scanner, which contains a powerful magnet. The scanner produces cross-sectional images of brain tissue as the subjects undergo a series of brief electromagnetic pulses, perceptible only as noise and vibration. If the protocol involves functional MRI (“fMRI”), a popular research technique for obtaining indirect measurements of brain activity, equipment might be used to present stimuli (sounds or pictures) during the scan, but generally the study involves no invasive procedures, no physical discomfort, and no ionizing radiation. Upon completion of the scan, MRI data is transferred to an investigator's computer for further analysis, often in combination with behavioral test results and clinical information obtained from subjects or their medical records.

This procedure sounds benign, and usually is. But an MRI scanner is a powerful medical device, capable of causing serious injury or death if operated carelessly.

Health care is being capitated throughout the United States, and much of the spread of capitation is attributable to the efforts of insurers to contain costs. The present lack of comprehensive studies evaluating the impact of capitation on overall health care quality leaves vast room for speculation.

Capitation does, however, carry a very fundamental certainty with broad implications. Whether the arrangement calls for a fixed sum for treating a particular ailment, a set fee for meeting all of an individual patient’s health care needs, or a standard charge for supplying all the medication for a specific condition, capitation sets limits. Because the health care costs for any given patient or condition are in reality zero-sum rather than fixed, capitation is about pooling patients and rationing. It involves denying services to some patients despite a general contractual commitment to coverage, presumably so that more patients can be covered or receive better care. The implications of capitation are even more significant when set fully in the context of the overall health care reform now underway. Simultaneously and comprehensively, health care is being managed, made for-profit, and consolidated.

When the government decides to assume a major role in providing and paying for healthcare, the government also has to decide exactly what constitutes appropriate, reasonable, or essential healthcare under its program. Congress, of course, recognized this necessity when it passed the Patient Protection and Affordable Care Act (ACA), and the statute itself provides authority to the Secretary of Health and Human Services (HHS) to determine the “essential health benefits” that must be covered under the ACA beginning in 2014, both by insurers offering plans within governmentally sponsored exchanges and on the individual and smallemployer markets outside the exchanges. In a decision that was hailed as both “politically astute” and problematic for the goals that the ACA itself was supposed to accomplish, HHS shunted off the task of defining the term “essential health benefits” to the individual states.

Recent advances in molecular and behavioral genetics are providing theoretical models to explain complex behavior — learning disabilities and behavioral problems — in simple biological terms. There are intrinsic difficulties in interpreting genetic information. Yet genetic explanations are particularly appealing in school systems pressed by demands for efficiency and accountability. Thus, genetic explanations are affecting the way children are categorized in the schools. This Article reviews genetic advances bearing on educational issues and their implementation through biological tests. It suggests the social consequences and legal implications of the growing prevalence of genetic assumptions.

Orphan drugs, essential for die treatment of persons widi rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote die development of orphan drugs have met widi modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes die provisions of die Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that die goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, die Note acknowledges diat liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers’ liability concerns.