HealthLawProf Blog

Teaching Dobbs as a Contemporary Case Study of Federalism in Action and an Introduction to the Cross-Disciplinary Nature of the Law

Antonia Miceli (Arizona State University), Teaching Dobbs as a Contemporary Case Study of Federalism in Action and an Introduction to the Cross-Disciplinary Nature of the Law, 17 St. Louis U.L.J. Health L. & Pol’y (2024):

With its decision in Dobbs v. Jackson Women's Health Organization, the U.S. Supreme Court ended the constitutional right to an abortion, overturning Roe v. Wade and Planned Parenthood v. Casey, and returned the issue of legal access to an abortion to the states. Prior to Dobbs, reproductive rights and the right to an abortion were firmly situated within the substantive due process and fundamental rights coverage of law school constitutional law courses. But this coverage often falls late in, or completely outside the scope of, the required constitutional law curriculum at U.S. law schools. This Article offers the Dobbs decision as an opportunity for constitutional law professors to begin their coverage of the right to an abortion earlier in the required constitutional law curriculum in a manner that moves away from a strictly “Case-Method” study of law to a more accessible cross-disciplinary study of law.

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Gatekeeping Drugs

David A. Simon (Northeastern University), Gatekeeping Drugs (Northeastern U. Sch. of L. Rsch. Paper) (forthcoming):

How much evidence should pharmaceutical manufacturers be required to provide before they can market new drugs? With drug costs ballooning to over $500 million and marketing approval decisions increasingly contested, scholars have reached two conflicting views. Public-health scholars tend to think high evidentiary standards overseen by a strong governmental gatekeeper are important to medical progress and protecting consumers while pro-market scholars view them as impediments to innovation and a threat to public health. This Article shows these seemingly diametrically opposed views can be married using an existing system that reimburses certain unapproved uses of approved drugs-so-called off-label uses-based on evidence that they work. In these cases, reimbursement acts like an initial gatekeeper with respect to certain unapproved uses by "approving" them through payment. This system of off-label approval, therefore, resembles one that pro-market scholars desire: drug approval regulates drug entry to the market and reimbursement regulates (unapproved) drug use once on the market. Extending this system across all drug regulation reveals that changing drug approval standards has benefits and costs that both pro-market and public-health scholars have not fully considered. It demonstrates that the potential benefits of changing drug approval are difficult to predict given the costs imposed by significantly disrupting the existing drug ecosystem. This suggests reform to drug approval should be methodical, carefully controlled, and measured.

Biomanipulation

Laura K. Donohue (Georgetown University), Biomanipulation, 113 Geo. L.J. (forthcoming):

Scientific and technological advances in the latter part of the 20th century catapulted biometrics forward. Thus, Carleton Simon in 1935 may have postulated using retinal vasculature for biometric identification. But it took forty years for an Eyedentify patent to bring the idea to fruition. In 1937, John Henry Wigmore similarly anticipated using oscilloscopes to identify individuals by speech patterns. Decades later, digitization and speech processors made voiceprint identification possible. Biological discoveries led to the adoption of deoxyribonucleic acid (DNA) sequencing. And while Alphonse Bertillon in the late 19th century postulated iris distinctions, it was only in 1991 that John Daugman patented a means of extracting and encoding their unique patterns.

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Swimming Together Upstream: How to Align MLP Services with U.S. Healthcare Delivery

William M. Sage (Texas A&M University), Keegan Warren (Texas A&M University), Swimming Together Upstream: How to Align MLP Services with U.S. Healthcare Delivery, 51 J. of Law, Med. & Ethics (2023):

Medical-legal partnership (MLP) embeds attorneys and paralegals into care delivery to help clinicians address root causes of health inequities. Notwithstanding decades of favorable outcomes, MLP is not as well-known as might be expected. In this essay, the authors explore ways in which strategic alignment of legal services with healthcare services in terms of professionalism, information collection and sharing, and financing might help the MLP movement become a more widespread, sustainable model for holistic care delivery.

To Bury or to Cremate? Forced Fetal Disposition in a Mother's World

Kenneth J. Schwalbert Jr. (University of Louisville), To Bury or to Cremate? Forced Fetal Disposition in a Mother's World, 62 U. of Louisville L. Rev. (2023):

Seven states have implemented so-called "fetal death" statutes. These statutes require fetal remains—from miscarriage or abortion—to be disposed of by cremation or burial. These statutes are explicit in that fetal remains cannot be disposed of as medical waste. This Note argues the validity of fetal death statutes implemented by seven states. The statutes are vague and do not specify who pays for the funeral services as a result of fetal death. Is it the mother or the state? I propose that if the state is going to claim an interest in the fetus, the state should pay for the disposition because not doing so would cause an undue burden on the mother. I also propose more defined statutory language to define terms and procedures regarding fetal death.

Regulating Digital Health Care for the Cognitively Impaired

Kathryn Huber (University of Arizona), Tara Sklar (University of Arizona), Regulating Digital Health Care for the Cognitively Impaired, 19 J. of Health and Life Sciences L. (2024):

Americans are living longer, and delivering high-quality, effective, and cost-efficient health care remains critically important, especially as the number of older adults with cognitive impairment increases. Relatedly, a growing number of older adults are preferring to “age in place” and receive care in their homes. This preference aligns with advances being made in digital health technologies (e.g., remote patient monitoring devices, telehealth) and Medicare coverage for in-home virtual health care services. However, efforts to integrate digital health care into the lives of older adults living with cognitive impairments present unique barriers and challenges due to their confused mental state or fluctuating capacity, which can limit their ability to provide meaningful informed consent; their vulnerability to privacy violations regarding their health data; their lack of digital health equity; difficulties operating the technology, navigating online platforms and applications; and effectively communicating with their providers. These challenges usually result in this particular demographic being far less likely to participate in the digital health ecosystem compared to their younger counterparts. This Article will address those challenges and their related regulatory and legal hurdles and will propose reforms for emerging models of digital health care that address the current shortcomings in caring for older adults with cognitive impairment.

Book Review – Diabetes: A History of Race and Disease

Oliver Kim (University of Pittsburgh), Book Review – Diabetes: A History of Race and Disease, 109 J. of Medical Reg. (2023):

This review examines historian Arleen Marcia Tuchman's Diabetes: A History of Race and Disease. Her book attempts to provide a historical explanation as to how we perceive diabetes-- which affects one in ten Americans-- and the implications this has for public health and law. 

Brief for Amici Curiae Legal Scholars, Moyle v. U.S./Idaho v. U.S.

Nicole Huberfeld (Boston University), Brief for Amici Curiae Legal Scholars, Moyle v. U.S./Idaho v. U.S. (B.U. Sch. of L. Rsch. Paper) (forthcoming):

This is an amicus brief that several scholars filed in Moyle v. U.S. The brief argues Idaho fundamentally misunderstands the Emergency Medical Treatment and Labor Act (EMTALA), the law of which did not change after Dobbs overturned Roe v. Wade and Planned Parenthood v. Casey. At the urging of physicians, and in the face of substantial evidence that hospitals were dumping vulnerable patients, Congress chose in 1986 to define stabilizing treatment for medical emergencies by incorporating clinical guidelines. This included action not only to save a patient’s life, but also to prevent risks to their health, which was understood to include abortion where necessary to address a medical emergency. 

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Teaching Global Health Law: Preparing the Next Generation for Future Challenges

Lawrence O. Gostin (Georgetown University), Sarah L. Bosha (Georgetown University), Benjamin Mason Meier(University of North Carolina), Teaching Global Health Law: Preparing the Next Generation for Future Challenges, 52 J. of L., Med. & Ethics (2024):

Following from sweeping law reforms across the global health landscape, there is a need to prepare the next generation to advance global health law to ensure justice for a healthier world. Educational programs across disciplines have increasingly incorporated the field of global health law, with new courses examining the law and policy frameworks that apply to the new set of public health threats, non-state actors, and regulatory instruments that structure global health. Such interdisciplinary training must be expanded throughout the world to prepare future practitioners to strengthen global health law — ensuring a foundation for global health in legal studies and law and global health studies. Meeting this imperative for global health law teaching — establishing academic courses and textbooks on global legal responses to shared health threats — will be necessary to support students to address the global health challenges of the future.

Social Welfare Functions and Health Policy: A New Approach

Matthew D. Adler (Duke University), Social Welfare Functions and Health Policy: A New Approach (Duke L. Sch. Pub. L. & Legal Theory Series) (2024):

The social welfare function (SWF) framework converts the possible outcomes of governmental policy choice into vectors (lists) of interpersonally comparable well-being numbers, measuring the lifetime wellbeing of each individual in the population of interest. The SWF proper is a rule for ranking these vectors. The utilitarian SWF adds up well-being numbers. A prioritarian SWF adds up well-being numbers plugged into a strictly increasing and strictly concave transformation function. Governmental policies are conceptualized as probability distributions over well-being vectors. A recent literature applies the SWF framework to health policy. This article first provides a brief overview of the SWF framework and then reviews some of the key concepts and findings that have emerged from this literature. One such concept is the "social value of risk reduction" (SVRR): the marginal social value (as calculated by the SWF) per unit of reduction in fatality risk for a given individual. The SVRR is the analogue, within the SWF framework, to the value-of-statistical-life (VSL) concept within benefit-cost analysis. This article explicates the SVRR concept and reports on recent theoretical findings and simulations that illustrate the properties of utilitarian and prioritarian SVRRs and their differences from VSL.

The Health and Human Rights Impact Assessment: The Preeminent Value of Equity

Lawrence O. Gostin (Georgetown University), Eric Friedman (Georgetown University), The Health and Human Rights Impact Assessment: The Preeminent Value of Equity, 26 Health and Hum. Rts. J. (2024):

The Health and Human Rights Journal launched 30 years ago at the dawn of the era of health and human rights. Health and human rights were more often viewed as being in tension than in harmony, and there was little guidance on the right to health itself. With the unabashed discrimination against people living with HIV/AIDS in the name of public health at the forefront of our minds, Jonathan Mann and one of us (LOG) sought to provide practical guidance on when and how human rights could be limited in the name of public health, developing the first health and human rights impact assessment. A singular lesson from the AIDS pandemic, amplified by the COVID-19 pandemic, is that equity must be at the core of health and human rights assessments. 


Non-discrimination is at the core of human rights; without this principle, rights could practically be denied at will. Under human rights law, this is a far-reaching principle, encompassing not only intentional, facially discriminatory measures, but also substantive, indirect discrimination. Equity has also moved to the core of global health. Even with significant overall global health improvements during the Millennium Development Goals era, inequities within countries stubbornly persisted. And while the life expectancy gap between richer and poorer countries narrowed, the difference remains nearly a full generation. Meanwhile, the AIDS movement and an increasingly empowered health and human rights civil society forced the world's attention on marginalized and discriminated against populations. 


Health and human rights assessments now regularly include equity as a core component, along with participation of affected populations. Several UN human rights special rapporteurs have encouraged human rights impact assessments’ use. With these assessments’ growing potential and this deepening legal recognition, it is time to recognize that as indispensable tools of governments and businesses to protect against human rights violations, and with relatively low resource requirements, conducting equity-focused, participatory health and human rights assessments is an immediate, core obligation of the right to health. UN human rights bodies should endorse this understanding, and along with the World Health Organization, offer guidance. Civil society organizations need not wait until this happens, though, to press governments to incorporate these assessments in their legal frameworks – an advance in health and human rights that could be transformative.

 

Limitations of Medical Licensing: The Role of State Boards of Medicine in the Dissemination of Medical Misinformation

Oliver Kim (University of Pittsburgh), Limitations of Medical Licensing: The Role of State Boards of Medicine in the Dissemination of Medical Misinformation, 16 Northeastern U. L. Rev. (2024):

The COVID-19 pandemic put a spotlight on the longstanding issue of dissemination of medical misinformation. As our understanding of the virus rapidly evolved, public health officials and policymakers clashed with certain health professionals who expressed not only skepticism but hostility to efforts to address the public health emergency. States regulate the practice of medicine by various health professionals—physicians, nurses, pharmacists, and many others— by granting a license to operate within a scope of practice set by statute. Critics question how health professionals could circulate misinformation and even disinformation while retaining their licenses. Shouldn’t physicians face consequences for disseminating misinformation capable of harming their patients and the general public? Shouldn’t those whom society trusts to hold a license to practice medicine be held to high standards? Such laws are part of states’ traditional police powers to protect the public from harm. In addition to private enforcement through tort claims, states also entrust boards to credential, license, and discipline health professionals. As representatives of health professionals themselves, boards can distinguish between practice variations (for instance, off-label use) and negligent acts that threaten patient and public health. But as this Article demonstrates, state medical boards face legal and policy obstacles to take such actions. This Article consists of three parts. Part I provides an overview of the role and function of state medical boards. Part II will discuss the role of public policy in how physicians convey medical information. Finally, Part III will explain the limits of boards and licensing as a means of reducing the spread of misinformation.

A Constitutional False Claims Act

Benjamin J. McMichael (University of Alabama), Mackenzi Barrett (Vanderbilt University), W. Kip Viscusi (Vanderbilt University), A Constitutional False Claims Act, 102 Wash. U. L. Rev. (forthcoming):

The False Claims Act (FCA) represents one of the most important sources, if not the most important source, of liability in the healthcare system and other industries that routinely provide goods and services to the federal government. Originally designed to police fraud during the Civil War, the FCA has become a general statute to enforce many other complex legal schemes. Because failure to comply with complicated statutes and regulations can lead to a reimbursement claim being defined as false under the FCA, the FCA serves as a blunt instrument to cudgel those who fail to comply with the minutiae of federal regulatory schemes. And because the FCA provides for treble damages and a civil monetary penalty of nearly $30,000 per claim and because individual relators can file suit on behalf of the United States and collect a bounty up to 30% of the recovery, the FCA has become a vehicle for pervasive and extremely large damages. 

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Poked, Prodded, and Privacy: Parents, Children, and Pediatric Genetic Testing

Allison Whelan (Georgia State University), Poked, Prodded, and Privacy: Parents, Children, and Pediatric Genetic Testing, 109 Iowa L. Rev. (2024):

"Knowledge is power," so the saying goes. But does that always prove true? What if knowledge comes without the power or resources to act? What if knowledge is unwanted and uninvited?

Significant advancements in genetics and genomics have thrust these and other difficult questions into the professional and public discourse. These developments include "pediatric predisposition genetic testing" ("PPGT"), a term used in this Article to describe genetic testing performed on a minor with parental consent to either determine with certainty or predict the risk that the minor will develop an adult-onset disease. 

PPGT pits parental rights against children's rights in unique and unprecedented ways. American law and tradition have long recognized the rights of parents to consent to myriad types of healthcare services for their children, presuming that parents act in their children's best interests. But PPGT raises questions about that presumption. Problematically, PPGT may impose unwanted information on nonconsenting children--information those children must live with for the rest of their lives. Too often, children become pawns in larger sociopolitical battles fought primarily between parents and the state, with the children's rights and interests cast aside. With PPGT, where science has outpaced law and policy, children's rights face subordination yet again.

To mitigate harm and protect children's rights in this "age of genetics," this Article argues for the development of a novel theoretical framework: a "right to future privacy." In doing so, it eschews the existing jurisprudence's myopic focus on parental rights and parent-state conflicts and proposes a framework that accounts for children's privacy and autonomy amid fast-developing, and often under-regulated, technologies like PPGT. At a time when privacy rights are threatened by myriad sources, this Article reaffirms and reinvigorates the value of children's lifelong genetic and personal privacy.

The Intersection of Special Education and Family Law: Thoughts for Family Law Attorneys in Divorce and Custody Cases

Richard D. Marsico (New York Law School), The Intersection of Special Education and Family Law: Thoughts for Family Law Attorneys in Divorce and Custody Cases (2024):

The Individuals with Disabilities Education Act (IDEA) requires participating states to provide a free appropriate public education (FAPE) to children with disabilities.  The IDEA gives parents of children with disabilities significant rights and major responsibilities in developing and maintaining their child’s education. Getting the most out of the IDEA for their children requires parents to commit substantial time and financial resources that are difficult to provide in the best circumstances.  When parents are having marital difficulties, separated, undergoing a divorce, or negotiating child custody, these difficulties can be exacerbated as parents navigate the intersection of the federal IDEA and state family law rules regarding educational decision-making while at the same time acting as parents for their children.   Providing special education to a child with a disability is an ongoing process that requires and benefits from parental participation. Neither the provision of special education nor the need for parental involvement pause during divorce proceedings or after custody is determined. The purpose of this article is to provide information about the IDEA to family law attorneys that will help them protect the educational rights of children with disabilities and their parents during divorce and custody proceedings. This article provides a survey of the IDEA, focusing on the role, rights, and expectations of parents of children with disabilities under the IDEA. It examines the intersection between the IDEA and family law by describing the IDEA’s statutory language and federal court decisions that define a “parent” for purposes of exercising parental rights under the IDEA and the importance of a state’s family law in determining who is a parent for exercising IDEA’s rights.    The article then creates an “action plan” for family law attorneys representing a parent of a child with disabilities in a divorce or custody dispute to ensure that their client’s rights are protected.  The plan  identifies by category a list of parental rights under the IDEA, provides a set of questions to ask clients in divorce and custody cases who have children with disabilities to establish an informational baseline, identifies the documents attorneys should obtain, and includes a list of issue-spotting questions designed to assist attorneys in monitoring the provision of special education and designing custody agreements that clearly and comprehensively protect their client’s special education rights. 

 

How Neuroscience Can Improve the Sentencing of Defendants with Autism Spectrum Disorder

Colleen M. Berryessa (Rutgers University), Carolina R. Caliman (Rutgers University), How Neuroscience Can Improve the Sentencing of Defendants with Autism Spectrum Disorder (2024):

Defendants with Autism Spectrum Disorder (ASD) face a myriad of difficulties at every stage of the legal process-which not only can negatively affect their experiences in court but also the fairness, efficacy, and legitimacy of their outcomes at sentencing. This chapter explores how advances in neuroscience can help positively impact the sentencing and aftercare of defendants with ASD in the United States, specifically focusing on the role of neuroscience in shaping more appropriate and prosocial legal decision-making during the sentencing proceedings of diagnosed defendants. First, the chapter will discuss how neuroscience may aid legal decision-makers to better contextualize an ASD diagnosis and its neurodiversity during sentencing proceedings. Then, it will explore how neuroscience can be used to cultivate better models of care and service innovations when developing and implementing sentencing accommodations for defendants with ASD. Finally, the chapter will describe how neuroscience is being used to increase the education, awareness, and training of legal decision-makers, including judges, attorneys, and court personnel, on ASD and its forensic relevance to sentencing and other legal processes.

Crisis of Conscience in Post-Roe America

Elizabeth Sepper (University of Texas at Austin), Crisis of Conscience in Post-Roe America, 25 J. of Contemp. Legal Issues (2024):

This keynote lecture was presented in November 2022 at the UC San Diego Institute for Practical Ethics and University of San Diego School of Law’s Center for Health Law Policy and Bioethics Conference on The Role of Conscience in the Practice of Medicine and the Rule of Law.  It begins by summarizing my previous writing to show that since Roe, the law has systematically favored refusing individuals and institutions. As I concluded more than a decade ago, this asymmetry was unjustified, because “[c]onscience equally may compel a doctor or nurse to deliver a controversial treatment to a patient in need.” After Dobbs v. Jackson Women’s Health Organization, the asymmetry may deepen. In restrictive states, the crisis of conscience for willing providers will increase, even as rights to refusal expand. I identify several possible complications for the legal framework governing conscience in medicine. Notably, as refusal bills broaden, they may (unintentionally) shield providers committed to delivering at least some care. And as abortion bans grow more severe, hospitals once categorized as refusing may find themselves willing to perform life- and health-saving abortions. They may experience irreconcilable tension between abortion bans and their (religious and moral) healthcare mission. Finally, I turn to issues of conscience in those states seeking to safeguard abortion. The normalization of refusal and the reach of religious healthcare systems will erect major barriers to the expansion of reproductive healthcare in these states. State policies expanding abortion access will have to be carefully designed around shifting constitutional doctrine related to the religion and speech rights of healthcare institutions.

Countering Workplace Wellness Bias through Wellness-Legal Partnerships

Barbara Zabawa (University of Missouri), Countering Workplace Wellness Bias through Wellness-Legal Partnerships, Clev. St. U. J. of L and Health (forthcoming):

In the current United States economy, wellness is predominantly marketed to society’s privileged individuals, catering to a mostly white and high-income clientele. When marginalized communities encounter wellness services, such as in the workplace, they are faced with an Implicitly biased industry. These biases include an emphasis on individual behavior change without considering social determinants of health (SDOH), cultural appropriation of wellness activities for capitalistic gain, use of biased health measures like Body-Mass Index (BMI) and constant images of and expectations of achieving a stereotypical healthy body. The legal community must wake up to these biases and advocate for more equitable wellness services. Wellness-Legal Partnerships (WLPs) are one type of tool that lawyers can use to address inequities baked into current workplace wellness programming. Specifically, lawyers can create WLPs through existing Employee Assistance Programs (EAPs) at Certified B Corporations to address SDOH. Part I of this paper explores the current state of the wellness industry and how the biases of emphasizing individual behavior, cultural appropriation of wellness activities, use of BMI and broadcasting the stereotypical healthy body image adversely impact historically marginalized people. Part II examines workplace wellness programs and how those programs not only incorporate the biases prevalent in the wider wellness industry, but how workplace wellness laws under the Affordable Care Act (ACA) and the Americans with Disabilities Act (ADA) arguably encourage them to do so. Part III explores the history and legal framework of EAPs and their current use by employers and employees. Part III introduces the concept of WLPs by describing the WLP role model, Medical-Legal Partnerships (MLPs) and how WLPs can adopt many of the same MLP concepts and apply them to workplace wellness programs. Then, this Part offers a roadmap on how to start implementing WLPs in workplace wellness programs to demonstrate how these partnerships can not only address SDOH faced by employees, but also offer broader advocacy services by lawyers dedicated to addressing the multiple biases that currently exist in wellness services.

Embryos Are Not People, but Disability Is Difference: Toward an Antidiscrimination Theory for Reproductive Services

Kristen Popham (Columbia University), Embryos Are Not People, but Disability Is Difference: Toward an Antidiscrimination Theory for Reproductive Services (2024):

Developments in reproductive technology are introducing new possibilities for reproductive health, genetic testing, and disease eradication. Simultaneously, legislators and the judiciary have decreased autonomy in reproductive choices. This fatal combination presents challenges for many women seeking reproductive care and protection from federal antidiscrimination laws when healthcare providers make decisions based on unsubstantiated and even intolerant preconceptions about the quality of disabled life. Parallel to other civil rights statutes, the Americans with Disabilities Act (ADA) covers people, and primarily people with disabilities. Under Title III of the ADA, “[n]o individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation.” The 2008 Amendments clarified that disability definitions should be construed broadly, favoring coverage to the maximum extent possible under the terms of the ADA. Yet the ADA has not been interpreted to afford broad coverage to those with unexpressed genetic indicators for disability. The ADA and its Amendments provide little recourse, then, for women with genetic indicators for disease who are denied assisted reproductive technology (ART) services on that basis. This Note highlight the risks of letting unchecked fertility clinic discretion in assisted reproductive technology persist and proposes several possible solutions that bridge antidiscrimination principles and women’s autonomy.

Differences by Race and Ethnicity in Title IX's Effect on Women's Health

Delaney Beck (Vanderbilt University), Joni Hersch (Vanderbilt University), W. Kip Viscusi (Vanderbilt University), Differences by Race and Ethnicity in Title IX's Effect on Women's Health (Vand. L. Rev. Rsch. Paper No. 24-3) (2024):

Title IX greatly expanded adolescent females’ participation in athletic activities, which may have led to health benefits that extend into later life. Previous research has not explored whether health benefits arising from Title IX differ by race or ethnicity and has not examined women at older ages when health problems become more evident. This article examines the effect of Title IX on racial and ethnicity disparities in health outcomes by considering women ages 42–52. White women in these age groups exhibit declines in their self-assessed health status and increases in many health-related ailments, consistent with other evidence on temporal trends in health for women in this age range. Compared to white women, both Black and Hispanic women report the opposite pattern, as there is greater improvement in the post-Title IX period in overall health status. Black and Hispanic women also exhibit greater declines relative to white women in smoking rates post-Title IX, which should confer a broad range of risk reductions. The more favorable impact of Title IX for Black and Hispanic women indicate that investments in women’s sports may enhance both equity and efficiency.