Journal of Law Medicine & Ethics最新文献

After performing an abortion in 1973, Dr. Kenneth Edelin was indicted and convicted of manslaughter. Dr. Edelin's conviction was reversed 50 years ago. However, the conflict between the medical and legal systems, the use of abortion prosecution to control patients and providers, and the framing of a fetus as a person feel just as relevant to today's abortion landscape.

In recent years, we have seen an immense expansion in recombinant DNA, especially in its use in gene therapy applications. Throughout its history, the United States set up several mechanisms of national safety and ethical oversight for rDNA to ensure that we proceeded with its use appropriately. As our knowledge and experience with it grew, there has been increasing pressure to decrease the oversight and monitoring requirements for its use. In 2019, the National Institutes of Health amended the NIH Guidelines for Research Involving Recombinant DNA Molecules eliminated three national mechanisms for guidance, monitoring, and review of this biotechnology. Four years later, we revisit these changes and their implications for a current emerging biotechnology: xenotransplantation. By better understanding the motivations for these mechanisms and analyzing the test case, we argue that these changes have worrisome implications for our ethical oversight of emerging biotechnologies both in the realm of gene transfer technologies and beyond.

The second Trump administration has shaken the foundations of US leadership in global health, with this column assessing rapid shifts in global health governance. By analyzing how the administration's anti-science ethos, foreign assistance cuts, and multilateral disengagement have undermined global solidarity, the column considers the destabilizing impacts on global health and examines how other states, regional bodies, and international organizations are responding to this US decline. This examination reveals both strains for global health promotion and resilience within a changed governance landscape.

Post-Dobbs v. Jackson, abortion regulation is left entirely to the states. Laws that restrict access to abortion generally allow for exceptions when determined necessary for the life or safety of the pregnant patient. Some states, e.g., Ohio, use a "subjective" legal standard when determining whether an abortion is medically necessary. Other states, e.g., Texas, rely on an "objective" legal standard, whereby the necessity of an abortion is not determined by any particular physician's judgments, but rather by the judgment of a hypothetical "reasonable physician." Though objective legal standards are widespread in American jurisprudence, they are a poor fit for clinical judgments about the medical necessity of abortion. On the contemporary model of clinical decision-making, medical judgment is irremediably subjective. In addition to being responsive to patient values and medical evidence, medical judgment is, and should be, informed by physician values. Because Texas abortion regulations rely on an objective standard of judgment that fails to correspond to a medically meaningful category, they fail to provide adequate guidance to physicians regarding the circumstances under which abortion is legally protected.

Since the mid-20th century, medical devices have proliferated in clinical care, operating rooms, and in everyday life via home health and wearable technologies. Medical devices include a broad range of technologies such as imaging devices, genomic assays, surgical implants, assistive devices, and health monitors. Unlike pharmaceuticals, food, and cosmetics, the United States Food and Drug Administration (FDA) did not prioritize medical device regulation in the early 1900s; devices only became a site of concern post-World War II as more complex and invasive technologies were developed and used in health care. Drawing on analysis of FDA regulations, government documents, historical media coverage, and FDA oral histories, this article traces the evolution of medical device regulation, historicizing persistent debates that position technological innovation and regulation in tension with one another. We demonstrate how limited legal authority prior to 1976 positioned FDA as lagging behind the proliferation of medical devices, which continues to haunt device regulation today. We then analyze the values embedded in device risk classifications and regulatory pathways, considering the consequences for the public's safety and trust.

Just as court reporters are the "ears" of the courtroom, court artists are the "eyes" of the courtroom. The adage "a picture is worth a thousand words" shows the importance of the integrity of that image. Because the artist's sketch can convey information pertaining to the health of a defendant/plaintiff/witness, misrepresentation by the artist must be avoided so as to foster honest journalism. From a bioethics perspective, courtroom art should align to the live, physical (visible) presentation, even if one or more elements of the physical presentation has been fabricated. Similarly, invisible illnesses and symptoms should not be added to courtroom sketches. The court artist has a duty of objectivity and clinical honesty in their artwork. This fosters justice and journalistic integrity.

This article argues that weekly "tiny research assignments" in introductory health law courses promote active learning and deepen student engagement. These focused exercises also build foundational research and communication skills by replacing passive lecture with concise, student-driven investigation tied to each week's topic.

The knowledge of the Social Determinants of Health (SDH) approach implies Health in All Policies and thorough cultural and social transformations, as well as whole-of-government, whole-of-society policies and governance to address health inequities. Nonetheless, this article argues that in the currently dominant rational decision-making model in health policymaking, these policy implications from the knowledge of the SDH approach would lead to an intrinsic contradiction with the logic of modern bureaucracy based on the legal authority as suggested by Max Weber. Using two examples of social determinants of health - universal health coverage and housing issues - this article demonstrates the potential of the polis model proposed by Deborah Stone to take advantage of the knowledge of the SDH approach to pursue structural policy interventions.

This paper examines the prescription stimulant shortage in the United States, a crisis that has intensified since the FDA's 2022 announcement of an Adderall shortage. The regulatory, systemic, and societal factors driving the shortage are analyzed - including the surge in attention-deficit/hyperactivity disorder (ADHD) diagnoses, expanded use of telehealth services, and disproportionate impact of the shortage on marginalized communities. It's argued that existing health inequities are exacerbated by barriers to medication access as current regulatory frameworks are ill-equipped to address the growing demand for prescription stimulants, causing substantial harm to patients. A series of reforms are proposed - including modernizing the DEA's quota system, strengthening interagency collaboration between the DEA, FDA, and HHS, and diversifying pharmaceutical supply chains to enhance resilience. These reforms aim to balance the dual imperatives of preventing misuse and ensuring equitable access to medications for patients with legitimate medical needs. By offering a comprehensive analysis of the prescription stimulant shortage and actionable policy recommendations, this paper seeks to inform regulatory reform, foster a more adaptive, patient-centered approach to ADHD care, and provide a roadmap for addressing one of the most pressing healthcare challenges of our time.

Major shifts underway in US vaccine policies reflect widespread misinformation, notably including unproven claims of harms from vaccines. Vaccination misconceptions also include an array of falsities about the scope and extent of governmental powers and protections. Exposing these "legal myths" clarifies existing foundations of vaccine laws and policies, providing guidance on appropriate responses to quell vaccine hesitancy.