American Journal of Law & Medicine最新文献

This Note explores how correctional health care companies attempt to circumvent mass tort liability by filing for bankruptcy, further exacerbating the challenges incarcerated individuals face in accessing the legal system. In Section I, I provide background on the increasing trend of prisons outsourcing their required health care capabilities to correctional health care corporations, the high rates of medical malpractice and adverse medical outcomes in prisons that contract with correctional health care companies, and the barriers incarcerated individuals face in seeking relief for medical malpractice. Section II provides an overview of Chapter 11 bankruptcy and the Texas Two-Step maneuver, explaining how they serve as mechanisms for resolving mass tort claims. To demonstrate this, I present a case study of Corizon's attempted Texas Two-Step. In Section III, I analyze Corizon's Texas Two-Step in light of Harrington v. Purdue Pharma's prohibition of nonconsensual third-party releases and argue that the approved reorganization plan was nonconsensual, given institutional barriers to accessing the legal system in prisons. I also suggest and evaluate additional efforts that should be explored to decrease both medical malpractice and barriers to seeking relief in correctional settings.

The direct-to-prescription business model promises quick and easy access to prescription medication without the expense and burden associated with a traditional doctor's visit by instantly pairing consumers with prescribers via telemedicine. Though ostensibly built on telemedicine's remote professional setting, this business model strains the values traditionally underlying the relationship between prescriber and patient. This article offers a sustained focus on the legal and ethical problems in the relationship among platforms, prescribers, and consumers/patients and identifies potential regulatory access points.The entire direct-to-prescription business model hinges on the participation of licensed professionals who have legal and ethical duties to ensure patient safety. Adopting the best version of this model means respecting and enforcing the values underlying the professional-patient relationship. Entrenchment of the worst aspects of this model, by contrast, threatens to undermine the role of professionals, professional ethics, and ultimately, consumer/patient safety. Consequently, I suggest that the professional regulation and ethics of telemedicine ought to apply and be fully enforced.

Medicaid work requirements were found in 2018 to be contrary to the Medicaid statute because, according to the D.C. Circuit, "the objective of Medicaid was to furnish medical assistance." Even though the Secretary of Health and Human Services determined that the work requirements were "likely to assist in improving health outcomes," the court concluded that "better health outcomes as [an] objective of Medicaid … lacks textual support. Indeed, the statute makes no mention of that objective."With the second Trump administration making Medicaid work requirements a centerpiece of its budget, the "objectives of Medicaid" reemerge as both an important statutory constraint on the program and a foundational question for health policy. Though the upcoming debate will likely ride on the efficacy of work requirements, the broad implications of the litigation will inevitably shape broad implications for future Medicaid policy.This article delves into the Medicaid statute to reveal its core objectives, and it makes one legal and one policy claim. First, Medicaid's statutory language does support the promotion of better health outcomes as one of the program's objectives, and second, providing services that fall outside "medical assistance" is critical in improving health outcomes to beneficiaries. As an empirical matter, nonmedical services have become a staple of health care delivery in recent decades, including in some of Medicaid's signature initiatives, and a careless revisitation of the legality of work requirements undermine some of the program's most important advances.To address the legality of work requirements, courts should embrace Medicaid's broader objectives and instead apply one of the statute's mostly ignored requirements: states must evaluate the efficacy of their innovations. The Medicaid statute encourages states to experiment with new health care delivery strategies to find more affordable and cost-effective strategies to promote population health, including those that rely on nonmedical interventions, but the constraint is not whether those innovations are consistent with Medicaid's legal objectives but rather whether they are empirically shown to improve population health. And precisely because public health research has identified a wealth of social, behavioral, and nonmedical interventions that have proven to be effective in promoting population health, a proper understanding of the Medicaid statute and the program's objectives are critical in implementing effective health policy, in the second Trump administration and beyond.

This Article presents original empirical research examining how consumers interpret dietary supplement label claims. Through a controlled experiment with a nationally representative sample, we test the Dietary Supplement Health and Education Act's core assumption - that consumers derive different meanings from various claim types. Our findings reveal a fundamental disconnect: while consumers clearly distinguish disease claims and nutrient content claims, they interpret structure/function claims and health claims as equivalent, despite their vastly different regulatory treatment. These results challenge the regulatory logic of the current four-tiered system and raise significant consumer protection concerns. We propose reforms including consolidating structure/function and health claims into a single category with uniform substantiation requirements, implementing consumer-tested disclosures, and strengthening oversight mechanisms. Without such reforms, dietary supplement regulations will continue to provide only the illusion of consumer protection.

This article will focus on the use of AI tools in diagnosis and patient treatment in hospitals and health care systems. AI vendors promise efficiencies in workplaces: various forms of AI are already being developed to read x-rays and other medical scans, to diagnose a wide range of patient conditions, and to offer a partnership (or risk displacement) of physicians. AI is being pushed to transform medical diagnostics, care quality, patient safety, clinical experience, and efficiencies all over hospital operations. These AI technologies however are still novel and new, and studies proving efficacy or disclaiming it are often based on small scale studies or other limitations.I will take a quick look at the tools that comprise the use of AI in health care and the claims of effectiveness of AI alone or in partnership with physicians in making clinical decisions. I will then look at the ways in which AI can fail to meet its promises, causing serious harms. Finally, I will examine the prospects of a hybrid regulatory/liability model to regulate AI risks as hospitals and providers expand their uses of AI tools.

The use of AvertD, a genetic test to assess an individual's risk of developing opioid use disorder, will expose physicians to liability. Critics of the test argue that the test itself is unreliable, often resulting in false positives, which will lead to potential undertreatment of pain, and false negatives, which will lead to inappropriate opioid prescriptions. But if the test is available, physicians will use it. And often, due to a combination of genetic determinism and genetic illiteracy, physicians will rely on the test to make opioid prescription decisions without also looking to the environmental, socioeconomic, lifestyle, and other factors that contribute to an individual's opioid use disorder risk.Genetic test results that purport to predict opioid use disorder - or really, any behavioral or psychiatric trait or diagnosis - may have enormous consequences for individual lives. When patients are harmed by physicians' negligent clinical decision making, they can often turn to tort law for a remedy. This article covers various physician liability scenarios, from inappropriate prescribing based on genetic test results to failure to test and informed consent issues. Physicians could face liability for prescribing opioids after a positive test result, or for denying pain medication due to false positive test results, or for prescribing opioids to patients despite negative results that prove false, or for failing to administer the test at all. This article concludes that existing tort frameworks offer insufficient protection for patients and fail to ensure appropriate integration of these tests into clinical practice. And relying on tort law will not mitigate the individual and societal harms raised by the introduction of a polygenic risk score test for opioid use disorder.

Despite the routine assessment of decisional capacity in the clinical context, the concept of capacity is contested, and its measurement is flawed. For example, scholars and clinicians disagree about the criteria for demonstrating capacity. There is further lack of consensus about whether some types of medical decisions should require more evidence of capacity. Moreover, there is robust literature demonstrating that formal capacity assessment instruments are not always valid and reliable.This Article focuses on these and other issues, namely the fact that (in)capacity as currently understood is often not viewed relationally and contextually. (In)capacity is viewed as a cognitive property of an individual - an individual has capacity or does not. However, properly conceived, (in)capacity is constituted in interaction with others (e.g., health care providers, family, friends) and one's environment, and mediated through one's body and experience of health, illness, or disability. When this reality is not acknowledged, clinicians, caregivers, family members, and others miss opportunities to strengthen patients' decisional capacity by modifying how they communicate with patients and by changing patients' environment to improve decision-making. In fact, not acknowledging the relational and contextual nature of (in)capacity likely leads to weakening of patients' decision-making abilities and the unnecessary disqualification of patients from contemporaneous decision-making, which subsequently negatively affects patient interests in maintaining autonomy and bodily integrity and experiencing wellbeing.This Article will foreground the relational and contextual nature of (in)capacity and address problems with capacity assessments for adult patients in the medical decision-making context, propose reforms to the capacity assessment process, and conclude by discussing the implications of these arguments in other decision-making contexts.

Patients experiencing pregnancy complications have died after being denied emergency medical treatment in states with restrictive abortion laws even where the laws ostensibly allow pregnancy termination when necessary to save a patient's life. For patients experiencing miscarriage, premature rupture of membranes, placental abruption, severe hypertensive disorders, ectopic pregnancy, and other conditions, a treating physician's decision about whether their condition qualifies as an emergency under state law can mean the difference between life and death. Physicians who treat obstetric emergencies report being torn between delivering evidence-based care and protecting themselves from criminal prosecution. This article frames physician decision-making about emergency abortion within the larger institutional context in which those decisions arise, providing a taxonomy of the myriad hospital policies that impact physicians who treat obstetric emergencies. It evaluates these institutional procedures' efficacy with respect to the dual goals of protecting pregnant patients' health and limiting providers' exposure to legal risk. The article concludes that the optimal institutional approach grants full deference to physicians' clinical judgment while also providing robust institutional support in the form of comprehensive legal guidance and guaranteed legal representation for physicians who are prosecuted for making good faith medical judgments. It calls upon hospitals to re-commit to their primary mission of providing high quality patient care, and to dedicate resources to supporting physicians who deliver evidence-based care despite unrelenting legal and political pressures.