The authors present a case study to illustrate how a mentally impaired but socially intact nursing home resident, who had no one to act as an advocate for her, was denied appropriate treatment for an acute illness which ultimately resulted in her death. The case raises important questions about advocacy for the mentally-impaired, acutely-ill institutionalized patient. This Article explores the role of the advocate, how advocates are selected, what qualities and talents they should possess, and what responsibilities should be assigned to them. The authors suggest that nursing home residents should be encouraged to engage in self-advocacy to the greatest extent possible. The competent elderly should be urged to name their preferred advocates. Individuals who serve in advocacy roles should be advised to seek information regarding the patient's wishes from those who know the patient well. Furthermore, there is a need for quality education and training of those who serve in advocacy roles on behalf of nursing home residents, and state laws need to specify the responsibilities of persons who serve as advocates.

This Article examines the question of civil liability arising, both in tort and in contract, as a result of the “wrongful birth” of a child following an unsuccessful sterilization operation. After a general overview of the concept and background of wrongful birth, the Article deals with tort liability in a sterilization-wrongful-birth action, suggesting in particular that there are four stages in the sterilization process at which a physician's conduct may fall below the standard required by law, and discussing the effect of negligence at each of the four stages. The alternative claim for breach of warranty is then examined, with emphasis on the practical difficulties involved in establishing contractual liability in this type of case. Finally, the Article discusses public policy and assessment of damages issues involved in the wrongful birth action, and evaluates the merits of some of the arguments that have been advanced under these headings—particularly the “overriding benefit” theory—to defeat claims for wrongful birth.

The governance of reproductive science is fraught with controversy in nearly every jurisdiction across the globe. Worldwide, legislators and policy makers have struggled to craft meaningful and ethical parameters for the regulation of this new and evolving area of biotechnology. In most countries, it is agreed that some form of regulatory oversight over reproductive technologies is necessary. There is far less consensus, however, as to the type of regulatory structure that should be established. Recent debates over reproductive science have focused on two of the most controversial practices in this area: embryonic stem cell research and cloning technology. Specifically, interested parties have struggled over whether these practices are so egregious that they should be altogether prohibited, or whether they ought to be permitted, but subject to particular legislative limits and regulatory oversight.

The difficulties that most countries have experienced in devising legislation pertaining to embryonic stem cell and cloning research emanate from the moral ambiguity that characterizes this area of science.

In December 1998, Iceland's Parliament, the Althing, passed the Act on a Health Sector Database (the Database Act or Act), a highly controversial law authorizing the development of a Health Sector Database (the Database) to collect genetic and medical information already contained in various locations around Iceland as part of Iceland's national health system. As a result of the Database Act, Iceland is the only country in the world with laws authorizing collection and storage of the genetic heritage of an entire population by a private biotechnology corporation with rights to exploit the data as a commercial commodity. Many databases now exist in Iceland as individual and segregated entities that contain detailed medical information about every Icelandic person, both living and dead, dating back to 1915 when the recording commenced.

Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to individual patient needs. Compounding is as old as the practice of pharmacy and close to the heart of the modern profession. Indeed, the mortar and pestle – an iconic emblem of compounding – have long been the prevailing symbol of pharmacy. Prior to the emergence of commercially available drug products, the practice of compounding was the practice of pharmacy – to create medicines, early pharmacists inevitably needed to extract and compound natural vegetable, animal, and mineral substances. In one impressive example of successful early compounding, God commanded Moses to “compoundeth” a holy anointing oil of myrrh, cinnamon, cassia, olive oil, and sweet calamus. Not generally one to shrink from a challenge, Moses followed God’s recipe and used his compounded oil to anoint the vessels of the Tabernacle and High Priest.

Between 1.7 and 4% of the world population is born with intersex conditions, having primary and secondary sexual characteristics that are neither clearly male nor female. The current recommended treatment for an infant born with an intersex condition is genital reconstruction surgery to render the child as clearly sexed either male or female. Every day in the United States, five children are subjected to genital reconstruction surgery that may leave them with permanent physical and emotional scars. Despite efforts by intersexed people to educate the medical community about their rejection of infant genital reconstruction surgery, the American medical community has not yet accepted the fact that differences in genital size and shape do not necessarily require surgical correction.

Genital reconstruction surgery may involve removing part or all of the penis and scrotum or clitoris and labia of a child, remodeling a penis or creating a vaginal opening. While the initial surgery is typically performed in the first month of a child's life, genital reconstruction surgery is not only performed on infants.

Tax exemption is an ancient, honorable and expensive tradition. Tax exemption for hospitals is all of these three, but it also places in sharp focus a fundamental problem with tax exemption in general. Organizations can retain their tax exemption while changing circumstances or expectations undermine the rationale that led to the exemption in the first place. Hospitals are perhaps the best example of this problem. The dramatic changes in the health care environment have eliminated most of the characteristics of a hospital that originally persuaded the citizenry to grant it an exemption. Hospitals have entered into competition with tax-paying businesses, and have increasingly behaved like competitive actors. Such conduct may well be beneficial, but it does not follow that tax exemption is appropriate. Rather than an undifferentiated subsidy, a shift to focused goals will provide charitable hospitals with the opportunity and incentive to “do the right thing.”

Infanticide, like most other species of homicide, is probably coeval with the human race itself. In modern Western civilization, what were formerly the most powerful incentives to infanticide have virtually disappeared. As with other social problems that affluence has seemed to solve, however, infanticide has reappeared in a new form that seems to have been made possible by affluence itself. This "new infanticide" occurs in a place whose very existence is the result of a tremendously wealthy society's devotion to its most vulnerable and least “useful” members. The modern neonatal intensive care unit, which treats, and often saves, extremely ill newborn children, who during most of history would surely have died, has proven to be a setting where many of the age-old incentives for infanticide have begun to operate again. The “new infanticide” consists of withholding food or needed medical treatment from selected infants who suffer from one or more serious, though treatable, medical problems. The national government has now enacted legislation designed to curtail the practice of infanticide by the medical profession. This paper traces the genesis of that legislation, explores the problem to which it is addressed, and evaluates its prospects for success.

Current estimates approximate that the population over sixty-five years of age will increase from 40 million in 2010 to 72.1 million by 2030. As society ages, the number of elderly with cognitive deficits that impair decision-making abilities will also increase. This will place additional burdens on families and probate courts seeking to balance individual autonomy with necessary protections. A legal determination of incompetency is a prerequisite to a judicial order appointing a guardianship or other protective mechanism. The current legal-medical model for competency determinations fails to reflect the complexities of declining capacity in an aging population. A global structure for competency determinations leaves a critical gap between competent and incompetent. The gap between competence and incompetence not only raises concerns about how to classify those that fall between the two, but also highlights the lack of legal protections for those within the gap. A revised model is needed to provide protections to individuals who do not yet meet the threshold for incompetence but require additional protections for their personal or financial welfare. This Article provides an unprecedented examination of the legal model for determining competence through a comparison of the medical model for evaluating capacity. While a number of legal scholars have examined the appointment and oversight of guardians, fewer articles have critically examined the process by which individuals are declared incompetent. This Article presents a comprehensive overview of competency and clinical capacity determination procedures, legal mechanisms available to protect individuals with declining capacity, and policy recommendations for improving legal protections in light of inefficiencies related to legal competency determinations.

The development and application of technologies will arguably be the major driving force for the evolution of world society in the first part of our new century. In medicine, agriculture, material science, communications and a host of other areas, new technologies promise unimaginable changes in our lives. And yet, in the midst of the euphoria surrounding this rush of invention, there is concern. When asked, people often say they are scared of what they do not know and scared of today's pace and power of invention. Putting aside the voice of the modern Luddite, it appears that while few want to stop the rush toward more and better technology, there is apprehension about the potential risks of the new technologies—risks that have not been sufficiently considered.

To allow the state to first choose the criminal sanction, which requires a finding of a specific state of mind, and when that sanction is completed, to choose another sanction which requires a finding of the opposite state of mind, is a mockery of justice which places both the criminal and civil systems for dealing with sexual predators in disrepute.

By committing individuals based solely on perceived dangerousness, the Statute in effect sets up an Orwellian “dangerousness court,” a technique of social control fundamentally incompatible with our system of ordered liberty guaranteed by the constitution….

The healthcare system is sick. The players are incentivized to maximize their own benefit and externalize their costs onto the other parties. This paper examines the warped incentives that underlie the system. The tort system, lacking expertise and slow to adapt, is unable to overcome cognitive biases to adequately solve the problems. Clinical practice guidelines could pose a solution, but not as they are currently developed. Guidelines promulgated by healthcare associations are infected by a web of conflicts of interest with every player in the industry. Government agencies, and their revolving doors, are underfunded and also subject to the industry's web of conflicts. Even if adequate guidelines could consistently be produced, state legislatures and courts have been unwilling and unable to substantially incorporate guidelines into the legal landscape. Lastly, this article proposes a private regulation regime that could be a solution which would align all of the players' incentives to society's interests.

Managed health care has recently generated a great deal of distrust, even anger, in the public mind. To be sure, much of this public reaction is based on anecdotal evidence and one-dimensional thinking. But many unbiased experts observing managed care today are themselves unhappy with the health care industry's performance. While these observers find little justification for the current political backlash against managed care, they are also disappointed that today's health plans have not made a more positive difference. Indeed, informed observers commonly regret that the new arrangements for the financing and delivery of care have done so little to get physicians to adopt truly efficient practices, achieving not only cost reductions but also substantial improvements in health status and patient outcomes— that is, in the quality of care. Although managed care has not demonstrably harmed the overall quality of health care in the United States, it has done little to improve it.

Selective non-treatment decisions involving severely handicapped neonates have recently come under renewed judicial and legislative scrutiny. In this Article, the Author examines the legal, ethical and social considerations attendant to the non-treatment decision. In Part II of this Article the Author discusses the predominant ethical viewpoints relating to this issue and proposes a new moral standard based on personal interests. Part III presents a survey of the jurisprudence relating to selective non-treatment decisions. Parts IV and V of this Article provide a critical examination of the recently enacted Child Abuse Amendments of 1984, a federal legislative initiative designed to regulate treatment decisions relating to handicapped infants. The Author suggests that the ethical standards and treatment criteria proposed in this Article may prove useful to courts seeking to balance the handicapped neonate's constitutional right to privacy with the requirements of the new federal law.

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword.

This article evaluates consumerism and the regulatory mechanism of which it is essentially an example — legally mandated disclosure of information. We do so by assessing the crucial assumptions about human nature on which consumerism and mandated disclosure depend. Consumerism operates in a variety of contexts in a variety of ways with a variety of aims. To assess so protean a thing, we ask what a patient's life would really be like in a consumerist world The literature abounds in theories about how medical consumers should behave. We look for empirical evidence about how real people actually buy health plans, choose providers, and select treatments.

We conclude that consumerism, and thus mandated disclosure generally, are unlikely to accomplish the goals imagined for them. Consumerism's prerequisites are too many and too demanding. First, consumers must have choices that include the coverage, care-takers, and care they want. Second, reliable information about those choices must be available. Third, information must be put before consumers, especially by doctors. Fourth, consumers must receive the information. Fifth, the information must be complete and comprehensible enough for consumers to use it. Sixth, consumers must understand what they are told. Seventh, consumers must be willing to analyze the information. Eighth, consumers must actually analyze the information and do so well enough to make good choices.

Our review of the empirical evidence concludes that these prerequisites cannot be met reliably most of the time. At every stage people encounter daunting hurdles. Like so many other dreams of controlling costs and giving patients control, consumerism is doomed to disappoint. This does not mean that consumerist tools should never be used. It means they should not be used unadvisedly or lightly, but discreetly, advisedly, soberly, and in the fear of error.

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

Implicit in any discussion of quality in health care are ideas about responsibility: who is responsible to define quality, who is responsible to deliver it, and who is responsible when the quality of care is unsatisfactory. The thesis of this article is that due to economics, ethics, and law, we have placed these responsibilities almost exclusively on physicians, but that powerful economic changes now require a reallocation of the responsibilities of providers, patients, and payers in defining and delivering quality in health care.

In the past half-century an extraordinarily generous, uncritical reimbursement system has empowered physicians to define and deliver quality that is interventionist and highly technological. Longstanding ethical precepts hold that physicians are responsible for their patients, and modern economic arrangements have encouraged physicians to focus on their patients’ welfare, virtually to the exclusion of costs or other competing considerations.

What proportion of health care resources should go to programs likely to benefit older citizens, such as treatments for Alzheimer’s disease and hip replacements, and what share should be given to programs likely to benefit the young, such as prenatal and neonatal care? What portion should go to rare but severe diseases that plague the few, or to common, easily correctable illnesses that afflict the many? What percentage of funds should go to research, rehabilitation or to intensive care? Many nations have made such hard choices about how to use their limited funds for health care by explicitly setting priorities based on their social commitments. In the United States, however, allocation of health care resources has largely been left to personal choice and market forces. Although the United States spends around 14% of its gross national product (GNP) on health care, the United States and South Africa are the only two industrialized countries that fail to provide citizens with universal access.

“On the Internet, nobody knows you're a dog,” says one canine to another as they sit in front of a computer in the classic New Yorker cartoon. This can also apply to those who seek or provide medical care online. On the Internet, nobody knows if you're male or female, elderly or adolescent, fit or obese, hirsute or bald, virile or impotent. In addition, in many cases, nobody knows if the “physician” or “pharmacist” on the other end of the line is a properly licensed physician or pharmacist, where they are located, what the knowledge level or training of the consulting practitioner is, or whether the medications being shipped are of the appropriate level of quality, potency or dosage. And, if the ease with which one is able to procure pharmaceuticals online is any indication, there are plenty of unscrupulous entrepreneurs selling drugs on the Internet who do not appear to care.

The rapid growth of medical technology gives rise to difficult dilemmas concerning the appropriateness of, and access to, new equipment and devices capable of maintaining life or improving its quality. Such a dilemma already exists, for example, with regard to kidney dialysis machines. In 1972, Congress amended the Social Security Act to make such machines available under Medicare to all who needed them. But almost immediately the overwhelming cost of such equipment—in the billions of dollars—made the original appropriations totally inadequate, and prompted serious questions of whether access to kidney dialysis should be made available at public expense—and, if so, to whom.

This Comment takes the reader 25 years into the future through the medium of a hypothetical U.S. Supreme Court decision** regarding a federal health agency's regulations that establish a system for allocating artificial hearts to those whose lives can be lengthened by implantation. The author assumes that a national health insurance system has been enacted and implemented, that all physicians are employees of the federal government, and that the enabling legislation has placed broad powers in the hands of the federal government to regulate the development and allocation of scarce and expensive medical resources. The opinions of the various Supreme Court Justices reflect a broad range of legal and ethical viewpoints, and—in keeping with the difficult, indeed frightening, life-or-death issues involved—are often intensely personal in nature.