American Journal of Law & Medicine最新文献

Firstly, I would like to thank George Annas, Wendy Mariner, and Fran Miller for nurturing the field of health law, and keeping the collaboration vibrant for more than half a century.

In 1974, the Center for Law and Health Sciences at the Boston University School of Law provided legal background papers on informed consent to research to the newly created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Sciences. These papers were written by George J. Annas, the Center's Director, as well as Barbara F. Katz and I, who were staff attorneys at the time. These papers can be found in the appendices to the Commission reports¹ and in our book Informed Consent to Human Experimentation: The Subject's Dilemma,² in which we present a refined version of those papers. This project introduced me to the world of human research ethics and the complexities of protecting the rights and welfare of research subjects.³ Over the past fifty years, I have sat on Institutional Review Boards (IRBs), been a member of the FDA's Pediatric Research Advisory Board, and engaged in varying activities related to human subject protection. During this time, I took for granted that consent forms were the best method for ensuring that subjects were thoroughly informed about all aspects of the proposed research. Like many IRB members, I spent considerable time reviewing, editing, and debating with other IRB members about the precise wording of these forms.

The celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the "Center") provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 1958¹ and that continues to make headlines more than sixty-six years later - organ transplantation. Transplantation is useful as an illustration of the joint fields of health law, bioethics, and human rights. It is a field that grew with us from infancy to maturity during the time of the Center's growth and that illustrates how several related disciplines - most notably law and medical sciences - are essential to the development of organ transplantation. Additionally, organ transplantation and experiments involving organ transplantation have produced some of the most spectacular cases of human experimentation. Because of both the novelty and human drama these experiments involve, I will use some of them as examples of the pivotal health law and bioethics work the Center engages in. These examples, and others that will be touched on, lead me to conclude that there is no field that matches the life and death drama of health law, especially in the human organ transplantation field. This selective history of health law at the Center, including the definition of death and the limits of surrogate consent, suggest that the legal and bioethical issues brought to us by innovative organ transplantation surgery are unlikely to be exhausted any time soon.

This Note explores an alarming, decades-old trend that has received renewed attention from enforcement agencies and the media: nursing homes suing family members and friends ("relatives") for residents' unpaid bills. As justification, nursing homes point to "responsible party" clauses within admission agreements signed by relatives during the admission process. Undeterred by the 1987 Federal Nursing Home Reform Act's (FNHRA) prohibition on requiring relatives to act as financial guarantors in exchange for residents' admission, nursing homes use carefully worded "responsible party" clauses to obtain virtually the same result: relatives' total liability for residents' unpaid balances. Relatives are frequently caught off-guard by these lawsuits; many who sign admission agreements do so without a proper understanding of the potential liability they are assuming and have limited (if any) access to residents' assets. This problem is aggravated by several aspects of the admission process that disadvantage relatives, such as the stressful and emotional nature of admission, the complicated language in admission agreements, and the inadequate-at times, misleading-guidance provided by nursing homes. This Note examines the tension between the FNHRA's financial protections for relatives and nursing homes' admission practices and use of "responsible party" clauses. Furthermore, this Note proposes solutions aimed at better informing relatives of the legal risks associated with "responsible party" clauses.

Debates over the effectiveness, constitutionality, and fairness of medical malpractice damage caps are as old as the laws themselves. Though some courts have struck down damage caps under state constitutional provisions, the vast majority hesitate to invalidate malpractice reform legislation. Instead, statutory interpretation offers a non-constitutional method of challenging the broad scope of damage caps without fully invalidating legislative efforts to curtail "excessive" malpractice liability. This Note examines the term "health care providers" in construing malpractice reform laws and identifies two predominant forms of statutory interpretation that state courts apply. In doing so, this Note offers recommendations for courts and legislatures to best balance the goals of the malpractice reform movement with patients' interests in recovery for medical injuries.

Medicaid plays a significant role in the health care space, providing insurance coverage to nearly one quarter of the U.S. population. In recent years, managed care organizations have taken on an increasingly prominent role in the Medicaid space, and in many instances have become the sole insurance option for Medicaid recipients. The scale and method of implementation for managed care programs has varied widely from state to state. This Note discusses the many methods by which a state can enact managed care within its Medicaid program, and summarizes the challenges with assessing the success of such programs. It proposes a uniform approach to managed care reporting requirements designed to increase transparency and accountability across state lines, and in turn ensure quality care for Medicaid managed care beneficiaries.

The United States Supreme Court's decision in Dobbs v. Jackson Women's Health Organization made it drastically harder for women to access abortions. The Dobbs decision has had a disproportionate impact on women who are incarcerated or on some form of community supervision such as probation or parole. This Note analyzes a potential right to an abortion for women involved in the criminal justice system, even those living in states that have banned or deeply restricted abortion access after the Dobbs decision. In doing so, this Note looks for different constitutional avenues to protect incarcerated women's right to an abortion, including under the Eighth Amendment to the U.S. Constitution.

Pre-pandemic, employer-sponsored health insurance (ESI) covered 175 million workers and their dependents, the equivalent of 49% of the country's total population. ESI, a valuable tax preference to employer and employee alike, spurred worker job dependence on employers resulting in access to healthcare dependent upon continued employment. With the advent of the pandemic and the dramatic increase in unemployment, the number of uninsured increased by more than 2.7 million people. Then, unemployment proliferated further by an unprecedented exit from the workforce dubbed the "Great Resignation." Over 47 million Americans voluntarily quit their jobs in a movement characterized as a general labor strike. The pandemic opened the floodgates to workers' concerns about COVID safety in the workplace, wage stagnation despite increases in the cost of living, enduring job dissatisfaction, and increased demand for a remote-working environment. Data shows that the unemployed shifted to the Affordable Care Act marketplace or to the public payer option, Medicaid, for coverage. This shift signals a change, post-pandemic, away from the destabilizing system of access to care based on employment and unwanted job dependence and provides a policy argument favoring the more stabilizing influence of public insurance options in the health insurance market.