The birth of the world's first “test-tube baby,” a child conceived by in vitro fertilization (IVF), raises serious medical, ethical, and legal problems. This Note explores the present controversy over the use of IVF and advocates federal regulation of the technique. Furthermore, this Note argues that, in order to deter unduly hazardous use of IVF and to compensate its victims, an experimenter should be subject to civil liability for either negligent, or willful and nonconsensual, destruction of an IVF conceptus, and held strictly liable when an IVF child is born with severe defects that are attributable to the use of the technique.

Since 2001, stem cell science in the United States has been explicitly constrained by federal prohibitions. Under an executive order announced by President George W. Bush on August 9 of that year, U.S. researchers can only receive federal funding for work done on the limited number of embryonic stem cell lines (an estimated sixty to sevent-eight) created prior to the executive order. Continued research on embryonic stem cells (ESCs) is not expressly prohibited. But, under the Bush administration's executive order, no federal funds can be used to develop new embryonic stem cells lines, or even to work on new lines developed after August 2001.

The problems with these restrictions, according to their critics, are threefold. First, they sharply limit the funds available to a high-cost, early-stage endeavor, limiting the pace of scientific discovery in the process. Second, they force stem cell researchers to maintain an administratively absurd line between research conducted in federally-funded laboratories (which include most university facilities) and that conducted in spaces free of federal funds.

Women with opioid use disorder (“OUD”) are more likely than other women to experience sexual assault, unintentional pregnancy, transactional sex and coercion regarding reproductive health care choices than women without OUD. Laws described as family friendly may be punitive rather than helpful to women and rarely apply to men. Laws regarding reproductive health and OUD are unevenly enforced and therefore biased against poor, minority women. As part of a larger study oriented toward strengthening systems of care related to the intersection of HIV and OUD, we conducted an analysis of state laws related to pregnant and postpartum women with OUD. Data on disparities in child removals and pregnant women’s use of evidence-based treatment for OUD by income and race were captured for the five states with the most restrictive laws in both categories. Laws that were purportedly designed to improve reproductive health outcomes for women with OUD and/or their children often have the opposite of the expressed intended outcome. There is a relationship between restrictive reproductive choice and coercive OUD treatment policy for women. Restrictive state regulations for pregnant women with OUD persist despite negative outcomes for maternal and child health. Altering coercive and/or criminalizing regulation and redefining ‘family friendly’ may improve outcomes for individuals and families.

The structure and principal decision-making processes of the American health care system have, in recent years, evolved to closely resemble those of the legal-judicial system. This transformation reflects important common values that underlie both systems, including the values of life and liberty. This Article analyzes quasi-legal features of the health care system and draws conclusions about how those features might be used to address the problem of health care rationing. It concludes that coverage rules, if properly developed, can provide the sort of objective framework necessary to evaluate claims of health care needs. This Article also demonstrates that by defining legitimate health care needs, society can thereby potentially eliminate or forestall the need to ration necessary care. This can be achieved by using carefully developed coverage rules, rather than the informal rules currently in place, in conjunction with already existing due process methods for interpreting and implementing those rules.

The American public firmly believes both in the rule of law and in the progressive and beneficial effects of science. Public opinion polls show that legal and scientific institutions continue to command wide respect, even in a period of diminished trust. According to a recent survey conducted by the Office of Technology Assessment (OTA), the Supreme Court and the scientific community each received higher confidence ratings than political institutions, the media, education, and even organized religion. Yet the impacts of science and the law can at times be profoundly antithetical, for the former acts as a force for social transformation, while the latter seeks to maintain the stability and continuity of societal institutions and norms of conduct. Vannevar Bush's famous metaphor “the endless frontier“ captured the sense of limitless aspiration associated with science and technology through much of this century.

This article describes an assessment role performed by clinical psychologists in the employment context, and examines how it has been evaluated by the courts from the standpoint of discrimination against persons with disabilities. Guidelines are offered for making fitness-for-duty decisions which are legally defensible, and examples of the decision-making process are provided. Data-based limitations on professional expertise are articulated, and conclusions drawn are aimed at practicing psychologists and the courts dealing with these uncertainties. Issues are analyzed principally in relation to the Rehabilitation Act of 1973 and the Americans with Disabilities Act (ADA), which has been passed by both houses of Congress.

Over the past decade more than 1,000 "DES daughters" have filed lawsuits against the manufacturers of DES, alleging that their in utero exposure to the drug caused various reproductive tract abnormalities, including cancer. Plaintiffs now allege that their grandmothers' use of DES during pregnancy caused genetic damage leading to cancer in third generations. This Note addresses the validity of preconception tort liability in the context of third-generation DES cases. Plaintiffs in preconception tort liability cases have sought recovery under both negligence and strict liability causes of action. Courts should recognize the validity of preconception tort liability and allow a strict liability cause of action in third-generation cases.

States struggle to maintain a facade of sovereignty against the large-scale migration of immigrants and asylum seekers, who are trying to find their way into the receiving societies. Increased borders control, reinforced socio-legal boundaries and detention facilities are some of the constant efforts' states employ to quell the immigration of asylum seekers and control their presence. Disciplinary power often appears in a centralized form, such as borders and immigration systems, but also in decentralized, dispersed forms, ranging from medical practices, media and market influences, as well as many others, which were termed by Foucault as biopower. This force - which in its broad meaning describes deliberate attempts to interfere with the essential human existence and manage all spheres of life - is defined by Foucault as a ‘political power [that] had assigned itself the task of administering life’. Biopower is employed to manage, regulate and govern lives, produce obedience, and subordinate individuals and communities to disciplinary practices. The control over lives should be understood comprehensively, so that includes ‘a life of the city…political life, economic life…’ as well as ‘the management of … money … information, communication, water, sheep, grain …’. Accordingly, we argue that food is a form of biopower, an apparatus utilized to control and govern asylum-seekers. We posit that the state uses food to monitor the individuals' well-being, the community life, and affect the social existence. In this article, “food” refers to the role sustenance plays in providing nutrition and reinforcing socio-cultural values.

In the United Kingdom, how does the National Health Service (NHS or the Service) respond to the pressures imposed on it by patients, doctors and the government? What techniques for distributing resources have been adopted for managing these pressures? Part I of this Article explains the administrative evolution of the NHS. Part II discusses the legal framework surrounding the allocation of resources throughout the different tiers of the NHS: (1) from the Secretary of State for Health to health authorities, (2) from health authorities to hospitals and general practitioners (GPs), and (3) from doctors to patients. Part III comments on the case for a standing committee to advise the government on matters of resource allocation within the NHS. It also considers the legal, political, and managerial contributions to the debate and, in particular, comments on the future of the traditional notion of clinical freedom.

Section A describes the culture that developed within the NHS, Section B discusses the pressure for reform that developed during the 1980s, and Section C reviews the system of the “internal market” for health that was introduced in 1990.

As organ transplantation procedures become accepted as standard medical practice, it is anticipated that the frequency of liability claims against transplant care providers will increase. This article examines current statutory and common law analyses of malpractice issues in transplantation, with particular attention given to issues of informed consent as they arise both for the organ donor and donee.

Imagine a world in which parents can genetically enhance their child's height so that he becomes a professional basketball player. Or imagine a law school student preparing for the bar who takes out an extra loan to genetically enhance his intelligence. What if going to your physician for a routine physical included the option of genetically enhancing any trait you desired? And what if such a practice was expensive and, therefore, only available to the privileged members of society? Is this desirable or should the U.S. government ban genetic enhancement? What if the government bans it and citizens travel abroad to receive genetic enhancement treatments? Can the U.S. government do anything to prevent access to illegal genetic enhancement abroad?

The United States' health care system is mired in uncertainty. Public opinion on the Patient Protection and Affordable Care Act (“ACA”) is undeniably mixed and politicized. The individual mandate, tax subsidies, and Medicaid expansion dominate the discussion. This Article argues that the ACA and reform discourse have given short shrift to a more static problem: the law of emergency care. The Emergency Medical Treatment and Active Labor Act of 1986 (“EMTALA”) requires most hospitals to screen patients for emergency medical conditions and provide stabilizing treatment regardless of patients' insurance status or ability to pay. Remarkably, this law strengthened the health safety net in a country that has no universal health care. But it is an unfunded mandate that responded to the problem of emergency care in a flawed fashion and contributed to the supposed “free rider” problem that the ACA attempted to cure.

But the ACA has also not been effective at addressing the issue of emergency care. The ACA's architects reduced funding for hospitals that serve a disproportionate percentage of the medically indigent but did not anticipate the Supreme Court's ruling in NFIB v. Sebelius, which made Medicaid expansion optional. Public and non-profit hospitals now face a scenario of less funding and potentially higher emergency room utilization due to continued uninsurance or underinsurance. Alternatives to the ACA have been insufficiently attentive to the importance of emergency care in our health system. This Article contends that any proposal that does not seriously consider EMTALA is incomplete and bound to produce some of the same problems that have dogged the American health care system for the past few decades. Moreover, the Article shows how notions of race, citizenship, and deservingness have filtered into this health care trajectory, and in the context of reform, have the potential to exacerbate existing health inequality. The paper concludes with normative suggestions on how to the mitigate EMTALA's problems in ways that might improve population health.

I’m convinced that physical containment is overrated and, while reassuring to the psyche, is hardly the line of defense one would like to put the greatest reliance upon.

So what you have to keep asking yourself is: Suppose the worst happens, what are the consequences?

Consumer concerns about their health care have attracted intense attention as more Americans get care through prepaid managed care plans. A recent poll sponsored by the Kaiser Family Foundation reported that over half of Americans believe that managed care has decreased the quality of their health care. Journalistic reports and widely publicized court decisions involving coverage denials for gravely ill people have fueled consumer concerns as well. Consumer protection and access to high quality health care is an issue that resonates deeply with the American public, and reforms are in order.

How can an agency like the U.S. Food & Drug Administration (“FDA”) effectively regulate software that is constantly learning and adapting to real-world data? Continuously learning algorithms pose significant public health risks if a medical device can change overtime to fundamentally alter the nature of a device post-market. This Article evaluates the FDA’s proposed regulatory framework for artificially intelligent medical devices against the backdrop of the current technology, as well as industry professionals’ desired trajectory, to determine whether the proposed regulatory framework can ensure safe and reliable medical devices without stifling innovation. Ultimately, the FDA succeeds in placing effective limits on continuously learning algorithms while giving manufacturers freedom to allow their devices to adapt to real-world data. The framework, however, does not give adequate attention to protecting patient data, monitoring cybersecurity, and ensuring safety and efficacy. The FDA, medical device industry, and relevant policymakers should increase oversight of these areas to protect patients and providers relying on this new technology.

During the last year, the proposal of “enterprise” liability for medical malpractice became a major issue in debates about health care and malpractice reform. The idea, however, was not new. In scholarly work over an extended period, we have been developing the systematic case for the concept of enterprise — or, as we originally termed it, “organizational” — liability for medical malpractice. After several years of debating the critics of our proposal to shift the focus of liability for medical injury from individual physicians to the organizations that deliver health care, we were naturally gratified that the idea was now on the national agenda.

In particular, we recommended adoption of enterprise liability to President Clinton's Health Care Task Force. The Task Force did embrace a version of the idea as its own, but then encountered stiff resistance from a number of special interests.

Even as the Clinton administration considers an increased federal commitment to mental health care, delivery of such care remains fixed at the state level. In Massachusetts, state officials are privatizing mental health care on an unprecedented scale, an experiment that promises to provide better care at lower cost. This Note explores whether privatization can achieve that lofty goal, given a legal system that has made individual patient autonomy its preeminent value. The author concludes that wide-scale privatization and modern notions of self-determination can only coexist with a significant investment in the support services that are critical to the community tenure of former state hospital patients.

In this Comment, the Massachusetts Commissioner of Public Health views the federal government’s 1976-77 Swine Flu Immunization Program, which was sharply criticized by Dr. Cyril Wecht in a recent Article in this journal, as a classic example of a public policy decision made under conditions of stress and uncertainty. Once the responsible government officials had made a public commitment to immunize the entire populace of the United States, he contends, they found it very difficult to reformulate the program in response to changing information concerning its relative costs and benefits. Dr. Fielding offers suggestions for avoiding in the future some of the problems that surrounded the Swine Flu Program and for preventing further erosion of public confidence in essential preventive medicine programs.