Law Commons^™

Fda's New Approval Plan For Covid-19 Vaccines: An Inquiry Of "Benefit" Rather Than The Statutory Scope Of "Safety, Purity, And Potency"?, Henry Yat-Shing Kwan

Journal of Law and Health

This article analyzes the FDA's proposed policy plan issued in May 2025 regarding the approval of Covid-19 boosters for different groups of persons. It offers two constructive recommendations that will help prevent constitutionality challenge on impermissible intrusion of the freedom of health.

The first is to avoid using the confusing term "benefit" but instead focus on the statutory parameters of "safety, purity, and potency." The affected group can make a strong case that their free choice of vaccination should not be deprived, as long as the vaccine qualifies for the statutory thresholds of being safe, pure, and potent. They are …

Patent Pending: How The Current Patent Utility Requirement Hinders Biotechnological Innovation, Madison Drlik

Journal of Law and Health

The legal system is always playing catch up to adapt to new legal landscapes, doctrines, and technology; however, patent law needs help to compete with biotechnological research in the race towards innovation. Biotechnological research in the realm of human health and medicine often involves the use of therapeutic drugs. The field of healthcare biotechnology takes biological systems and processes and generates novel, creative solutions to a number of human health conditions. However, the translation process for a new drug, therapy, or process is long and expensive which requires investors to help the researchers and scientists move their creations from inception …

Stealth Consolidation: Healthcare’S Process Of Quietly Dodging Antitrust Enforcement, Nathan Rush

Washington and Lee Law Review Online

The healthcare industry has become highly concentrated due to increased rates of consolidation. Mergers and acquisitions among healthcare providers have become extremely common, making dominant hospital systems the norm. When healthcare provider markets are highly concentrated, competition deteriorates, leaving patients to suffer the consequences: higher prices for lower quality care.

The federal antitrust agencies tasked with preserving competition have failed to combat the consolidation trends that are plaguing the healthcare industry. Vertical consolidation between hospitals and physician groups has especially gone unchecked. The Hart-Scott-Rodino Act, a federal antitrust law, requires merging parties to give the agencies pre-merger notice. This law, …

Soft Law Governance Of Artificial Intelligence In Healthcare, Gary E. Marchant

Akron Law Review

No abstract provided.

Private Equity And Non-Profit Status In The Us Healthcare System, Sam Halabi, Sanvi Belani, George O'Hara

Akron Law Review

No abstract provided.

Dying Well: Hospice Care As A Diminished Promise, Barry R. Furrow

Akron Law Review

No abstract provided.

Reconnect Or Disconnect?: Using Technology To Address Loneliness And Social Isolation For Aging Adults And Its Regulation, Laura C. Hoffman

Akron Law Review

No abstract provided.

Poverty & Period Products: Achieving Menstrual And Abortion Justice Through Public Benefit Programs, Allyson Crays

American University Journal of Gender, Social Policy & the Law

Low-income people need and deserve access to quality menstrual products through public benefit programs as a public health and reproductive justice issue. Whether someone is managing their monthly period, a medical abortion, or post-pregnancy discharge, menstrual products are essential to ensure that person’s safety and bodily

autonomy. Low-income people on public benefit programs who menstruate face a variety of stigmas and barriers, and these programs are in a unique position to increase access to menstrual products to work toward menstrual and abortion justice. This Article outlines the history of public benefit programs and the stigmas accompanying them. It also details …

Health Truth To Power: Professional Collaboration To Bolster Trust Against Misinformation, William M. Sage, Keegan D. Warren

Faculty Scholarship

This Article is about health, leaving aside more general challenges to shared civic information today. The Article begins by surveying the principal challenges for health information in post-pandemic, arguably post-truth America, and then describes briefly the sources and limits of medical professional authority. Noting the double-edged sword of free speech guarantees under the U.S. Constitution, the Article continues by commenting on speaking truth to government, to industry, and to the crowd. Next, the Article considers the physicians’ role in speaking truth to power from the perspective of standard medical professional ethics and identity, comparing it to that of lawyers. Finally, …

Law’S Limits: Abortion And The Social Determinants Of Health, Maya Manian

Scholarly Articles in Law Reviews & Journals

After Dobbs: How the Supreme Court Ended Roe but Not Abortion (“After Dobbs”) is a prescient and timely response to the U.S. Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and upended nearly five decades of constitutional protection for abortion. In this meticulously structured oral history, law professor David S. Cohen and sociologist Carole Joffe center the voices of abortion providers, clinic administrators, funders, and advocates from across the country. After Dobbs, not only documents the extraordinary persistence of abortion supporters in the face of legal devastation but also bears witness to …

Unwanted Medical Treatment Harms Patients: Taxonomy Of Healthcare Consent Infractions, Thaddeus Pope

Faculty Scholarship

Patients in the United States are subject to an ever-growing “avalanche” of unwanted medical treatment (UMT).  This is ethically, economically, and legally wrong. First, UMT constitutes a serious violation of patient autonomy and self-determination.  Second, it is waste (and often fraud or abuse) of scarce healthcare resources.  Third, but for rare exceptions, administering UMT contravenes settled legal rules and principles around consent and battery.

This article describe four types of unwanted medical treatment and how the law addresses (or fails to address) them.  The four types of UMT are (1) treatment over patient objections, (2) treatment with zero consent, (3) …

The Fiduciary Game, Lauren R. Roth

Elisabeth Haub School of Law Faculty Publications

Fiduciary duties are supposed to bridge the gap between public and private law. Private actors who engage in “public or quasi-public” functions (e.g., corporate directors and pension administrators) are often subject to fiduciary constraints to protect vulnerable parties who lack power in relationships with these actors. Recently, scholars have argued that both courts and legislatures have inappropriately expanded the use of fiduciary duties to purely private relationships. But what if the problem is not the expansion of fiduciary duties to private relationships, but the increasing delegation of public powers to private actors whose behavior cannot be adequately constrained by fiduciary …

Gilded Crowns: How Wisconsin Can Address The Growing Phenomenon Of Private Equity In Dentistry, Connor D. Reed

Marquette Law Review

In recent years, for-profit businesses and private interests have gained a substantial foothold in dentistry, often in the form of private equity investment in dental service organizations. While there is an undeniable upside to this influx of investment, the dangers are too substantial to ignore. Wisconsin's Corporate Practice of Medicine laws are not as robust for dentistry as they are for medicine generally, making the practice of dentistry in Wisconsin ripe for private equity exploitation. This Comment explores solutions to that problem. By looking to the laws of other states, its own existing laws, and some previous legislative efforts, Wisconsin …

Situating Stillbirth Within A Reproductive Justice Methodology Amidst Perilous Politics, Jamie Abrams

Book Reviews

Stillbirth and the Law, published in 2025 by the University of California Press, offers both a deeply personal and rigorously insightful examination of how law, medicine, and policy intersect around stillbirth. Jill Lens brings her full self to this work in ways that reflect deep feminist roots cultivated over years of Lens’s impressive scholarly production. Lens channels her lived experience of stillbirth into a comprehensive analysis that combines data, theory, law, narrative, policy, and pragmatic solutions.

The reader leaves the book equally feeling Lens’s deep love and longing for her son, Caleb, and equipped with a lengthy list of tools, …

Bodily Autonomy After Dobbs: A Queer Black Perspective, Eliot T. Tracz

Journal of Race, Gender, and Ethnicity

This article considers the impact of the Dobbs ruling from a black, queer perspective. It argues that the ripple effect of the Dobbs decision threatens the safety of queer black people in ways which, due to poor data collection, may not be widely understood or analyzed. It then suggests several ways in which the state and federal government can avoid these outcomes. Section II discusses the concept of bodily autonomy and the impact of the Dobbs decision. It begins by defining bodily autonomy as a concept with emphasis on the cases upon which it is founded. It then moves on …

First Amendment Protection For Unlicensed Wellness Coaches, Barbara Zabawa

Faculty Works

This article examines the constitutional implications of state efforts to license unregulated wellness practitioners, particularly wellness coaches. As occupational licensing expands, wellness services—ranging from nutrition counseling and life coaching to mindfulness and holistic practices—face increasing scrutiny. The paper argues that most wellness coaching involves speech rather than conduct and therefore qualifies for First Amendment protection. Drawing on Supreme Court and lower court precedent, it distinguishes between professional judgment that may justify state regulation and speech-based coaching practices that pose minimal risk of harm. The analysis situates wellness coaching within broader debates over professional regulation, consumer empowerment, and the marketplace of …

The Case Against State Emotional Support Animal Documentation Laws, Krista Wirth

Animal Law Review

Under the Fair Housing Act (FHA), a tenant with a service animal or emotional support animal (ESA) may request a reasonable accommodation from their housing provider to have their assistance animal live with them in housing that might not otherwise permit animals. In recent years, several states have implemented laws that aim to address “fraudulent” emotional support animals (“state ESA laws”). These laws limit the types of acceptable verifying documentation or place requirements on a healthcare provider’s ability to produce documentation to verify an individual’s disability and disability related need for a support animal—documentation an individual often needs to support …

Access To Primary Care And Health Care Fragmentation, Sharona Hoffman, Ishani Ganguli

Faculty Publications

This Article examines the growing crisis of long primary care wait times and the health care fragmentation that is associated with them. Patients who feel ill or are worried about new symptoms must often wait weeks or longer for appointments. In the wake of excessive wait times for primary care physician (PCP) appointments, patients increasingly turn to convenience care models such as urgent care centers, retail clinics, direct-to-consumer telemedicine, and at-home testing. While these alternatives offer prompt attention, they sacrifice other core functions of primary care and may exacerbate poor health outcomes and inequities. The Article argues that long wait …

Enforcing International Humanitarian Law Through The Business Responsibility To Respect Human Rights, Tara Van Ho

Faculty Articles

Insulation produced by the Danish company Rockwool—or its Russian subsidiary—lines thirty-one Russian Navy warships. Though not a weapon, this material is essential to the vessels’ operation. Did Rockwool have a responsibility under international law to stop the transfer of the insulation to the Russian Navy before Russia’s 2022 invasion of Ukraine? This article examines the business responsibilities under the 2011 United Nations Guiding Principles on Business and Human Rights (“UNGPs”). In doing so, the article finds that the business responsibility to respect human rights in the UNGPs provides a strong mechanism for enforcing international humanitarian law (“IHL”). However, it requires …

Could Have Seen That Coming: New York State Department Of Health Taken To Task For Failing To Provide Proper Oversight Of Medicaid Managed Care Provider Networks, Lance Plunkett Jd, Llm

The New York State Dental Journal

A recent audit conducted by the Office of the New York State Comptroller (OSC) found that the New York State Department of Health (NYSDOH) oversight of Medicaid managed care healthcare provider networks was largely illusory and a paperwork sham. This raises the much larger question of whether Medicaid managed care is really serving the population of Medicaid patients. It is already almost a given that it is not serving healthcare providers well.

Fda After Loper Bright, Erika Lietzan

Faculty Publications

Loper Bright, which overruled the Chevron decision from 1984, tells us that a court should determine the meaning of all statutory provisions for itself, rather than deferring to the views of the federal agencies that implement those provisions. But the overruling of Chevron may have less of an impact on the U.S. Food and Drug Administration than conventional wisdom supposes. Most challenges to FDA action do not concern its statutory interpretations. And the agency prevailed in most cases involving statutory interpretation, before the Chevron doctrine took hold. After 1984, when the doctrine did apply, the agency often lost cases at …

Advancing Neurotech Justice In Youth Digital Mental Health: Insights From An Interdisciplinary And Cross-Generational Workshop, Francis X. Shen, Craig W. Mcfarland, Donnella S. Comeau, Leo Anthony Celi, Benjamin C. Silverman, Sepideh Abdi, Mahsa Alborzi Avanaki

Articles

Researchers and clinicians are increasingly looking to leverage artificial intelligence (AI) and digital tools to improve psychiatric care. Of particular promise is addressing the youth mental health crisis. Yet, the introduction of AI-enabled digital technologies for psychiatric treatment of young adults raises a host of ethical, legal, and societal issues (ELSI). To provide guidance in addressing these issues, we convened a two-day meeting at the Radcliffe Institute for Advanced Study at Harvard University: Advancing Neurotech Justice in Mental Health: Insights from an Interdisciplinary and Cross-Generational Workshop. The meeting brought together a diverse cohort of 17 experts and 5 students …

A New Framework For Drug Pricing Law And Policy, Rachel E. Sachs

Indiana Law Journal

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

When Death Is Not Binary, Teneille R. Brown

Indiana Law Journal

There are few dichotomies more recognized than the one between life and death. Given the many legal rights that pivot on this distinction, one would think that the law has exceptionally clear standards for diagnosing death. It may surprise you then to learn that the line between legal life and death is no longer so obvious. That is, in a growing number of cases, there is now disagreement about whether someone is legally dead or alive. This is due to two things: the development of medical devices that can breathe for patients with severe brain injuries, and neuroimaging technology that …

Reconceiving Safety Regulation For Ai And Ml Medical Software, Barbara J. Evans, Eric S. Rosenthal, Azra Bihorac

UF Law Faculty Publications

This article explores the challenges of regulating AI and ML clinical decision support tools intended to assist trained health care professionals in delivering clinical care. Two old, twentieth-century regulatory models have dominated discussions of medical AI policy since 2013. Thinking inside these old regulatory boxes has not produced effective regulatory solutions to address the novel risks AI poses in clinical care. The first regulatory box treats software as a medical device, which tasks medical device regulators with making software safe but neglects the crucial roles physicians, nurses, administrators, medical practice regulators, and other health oversight bodies must also play to …

True Man, Captive Mother: Abortion As A Fundamental Self-Defense Right, Nicholle Vandy

Indiana Journal of Law and Social Equality

Abortion healthcare has faced significant challenges since the Supreme Court held in Dobbs v. Jackson Women’s Health Organization that there exists no constitutional right to abortion. Contrastingly, the right to bear arms, grounded in the right to self-defense, has strong constitutional protections, as highlighted in New York State Rifle & Pistol Association v. Bruen. The extension of the right to self-defense is exemplified by the proliferation of Stand Your Ground laws in numerous states.

This Comment examines the growing tension between self-defense doctrine, particularly through Stand Your Ground laws, and the increasing criminalization of abortion in various states. It …

Immortal Justice: Why The Henrietta Lacks Family Merits Restitution Today, Suzette Malveaux

Scholarly Articles

Almost three quarters of a century have passed since Henrietta Lacks had her cells biopsied from her cervix without her knowledge or consent. Upon discovering that Henrietta’s cells were immortal, scientists have been able to solve the most vexing medical problems of modern times and save countless lives worldwide. Aware of the cells’ scandalous origins, big pharma has nonetheless commercialized and wildly profited from the HeLa cell line without sharing the benefit with Henrietta’s family, who has been left traumatized and destitute by the initial theft.

Despite the passage of time, Henrietta’s family is seeking restitution today from pharmaceutical companies …

The Law’S Failure To Protect Our Drinking Water From Pfas, Emily Levine

Indiana Law Journal

How did per- and polyfluoroalkyl substances (PFAS), the forever chemicals known to harm human health and appear in most Americans’ blood, spread so widely in drinking water? Why didn’t someone with the power and knowledge to stop this crisis step in sooner? Simply imposing limits on PFAS levels in public water systems is the bare minimum to protect American drinking water—a necessary step but only the starting point of a long path toward creating a regulatory framework that can withstand the whims of changing presidential administrations and political influences.

     It is too easy for the EPA Administrator, either out of …

Religious Riders And The Sherman Act, Bailey Sanders

Faculty Scholarship

Can corporations engage in anticompetitive behavior on the basis of religious belief? While the answer may seem like an obvious no, in fact this question has largely been overlooked. It has hovered at the margins of the debate over religious exemptions: Proponents of religious exemptions have essentially argued that there is no harm in providing such exemptions to businesses because a competitive market will ensure consumers who might be denied services or goods by a religious firm can still obtain those goods and services elsewhere. But what if religiously minded businesses act in ways that are specifically designed to limit …

The Effect Of Provider Diversity On Racial Health Disparities: Evidence From The Military, Michael Frakes, Jonathan Gruber

Faculty Scholarship

We assess the relationship between the racial diversity of medical providers and racial health disparities in the use of preventive care and in patient outcomes. We use unique data from the Military Health System, where we observe providers as patients so that we can identify their race, and where moves across bases change exposure to provider race in a plausibly exogenous fashion. We consider patients with four chronic, deadly, but manageable illnesses, where the relationship with the provider may have the most direct impact on health. We find striking evidence that provider racial diversity leads to reduced disparities in maintenance …