Health Law and Policy Commons^™

"Market Shift Liability" For Generic Drugs: Market Share Theory's Eccentric New Cousin, Lars Noah

Texas A&M Law Review

Market share liability, which permits allocating proportional responsibility to each tortious member of an industry when victims cannot identify the exact source of their injurious exposure, enjoyed its judicial heyday in the 1980s. It originated in the peculiar setting of litigation over a distinctive cancer that developed decades after in utero exposure to the drug diethylstilbestrol (“DES”), which a few hundred companies had produced and sold for the prevention of miscarriages before federal regulators withdrew it from the marketplace. Although judges have occasionally attempted novel extensions of this theory to other products, and academic commentators remain fascinated by its use, …

The Deregulation Of Cancer, Daniel G. Aaron

Texas A&M Law Review

Fifty years ago, the U.S. embarked on a radical new path. Under pressure from the environmental movement, Congress passed an array of statutes aimed at regulating carcinogens out of our world. This regulatory experiment sprawled from air and water to food and consumer products.

Legal scholars have paid scant attention to this wave of cancer regulation despite its size and importance and the public’s apparent interest in avoiding carcinogens. But there is a growing literature finding flaws with individual regimes within the framework, such as the Clean Air Act, the Toxic Substances Control Act, and the Tobacco Control Act. In …

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Medical-Legal Partnership As Value-Based Primary Care: Interprofessional Teamwork For Health-Related Social Needs, Jin K. Park, Andrew F. Beck, Keegan D. Warren, William M. Sage

Faculty Scholarship

Today’s primary care physicians are being asked to address patients’ health-related social needs (HRSN) as part of their routine care practices. An aging population, with a growing complement of intersecting medical and social needs, increases this burden on primary care. Medical-legal partnerships (MLP) are interprofessional collaborations that combine clinical and legal expertise to address HRSN involving housing, public benefits, employment, and other domains remediable by civil legal assistance. A value-based approach to integrating MLP into the health system may help primary care practices more effectively address HRSN and, in turn, better balance revenue and expenses. At the practice and healthcare …

Transforming Blood Management Systems In Developing Countries Through Technological And Artificial Intelligence-Driven Innovations, Sandeep Bhargava, Shaun Aaron Abram, Srividhya Ragavan

Faculty Scholarship

It is critical to ensure the safe and quality supply of blood among various stakeholders; however, this remains a significant challenge in today’s world, especially in developing countries. These countries face severe problems, including blood shortages, fragmented regulatory frameworks, and inconsistent quality control measures. To tackle these challenges, countries like India are trying to implement the use of artificial intelligence (AI) and its derivative platforms to transform blood collection, testing, storage, and distribution by enabling interoperability, real-time compliance monitoring, automated donor screening, optimized inventory management, and advanced component separation. The article argues that developing countries must adopt both regulatory reform …

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, …

Dialing In Or Dialing Out? The Relationship Between State Telemedicine Law And Access To Buprenorphine, Stacey A. Tovino

Texas A&M Law Review

This Article begins by reporting the results of a comprehensive 50-state survey assessing state laws and other state sources governing the telemedicine induction (“tele-induction”) and subsequent telemedicine prescription (“tele-prescription”) of buprenorphine for the treatment of opioid use disorder (“OUD”) following the expiration of the COVID-19 public health emergency (“PHE”). Original, concrete findings include: (1) the glaring patchwork of state law governing the tele-induction and subsequent tele-prescription of buprenorphine for the treatment of OUD in the United States; (2) the variety of primary authorities and secondary sources that house relevant permissions, prohibitions, and affiliated requirements; (3) the number of primary authorities …

Public Funds, Public Functions, Private Actors: The Cognitive Dissonance Of Us Health Law, William M. Sage

Faculty Scholarship

This chapter begins with the evolution of American medicine from a “sovereign” self-regulating profession focused on direct patient service to a large industry that serves the social sector but that, because of its professional heritage, receives extensive public subsidies without equivalent public accountability. Next, the chapter identifies regulatory dynamics in American health care governance that structurally discourage movement from the prevailing, if dissonant, private law framework to one explicitly grounded in public law. The chapter concludes by highlighting the challenges and opportunities inherent in a private law approach to what is intuitively a public law domain.

Moral Politics Theory Applied To Abortion: Utopias, Dystopias, And Dobbs, Susan Ayres

Faculty Scholarship

This article examines Moral Politics Theory (MPT) as a way to understand current tensions in the US concerning reproductive justice. MPT, as developed and researched for over thirty years by cognitive scientist, George Lakoff, provides a way to explain differences in political worldviews. According to Lakoff’s research in Moral Politics and Don’t Think of an Elephant!, conservatives tend to hold a strict-father model, and progressives hold a nurturant-parent model. People in the political middle tend to endorse both models; Lakoff labels those in the middle as “biconceptuals,” and discusses how this group is most susceptible to persuasion because metaphors frame …

The United States Healthcare System: From Medicare To Post-Pandemic Health Policy, William M. Sage

Faculty Scholarship

My purpose in this essay is to comment on national health policy in the United States over the past sixty years.  My conclusions are less optimistic than what I had hoped when I began my teaching and research career in the 1990s to be able to say in 2025.  In particular, the successful expansion of publicly supported health coverage via the passage of the Affordable Care Act (“ACA” or “Obamacare”) in 2010 seems to have triggered -- though I hesitate to say that it caused – a backsliding from broader commitments to clinical performance, population health, and social solidarity that …

Make America Healthy: Reducing High Pharmaceutical Prices Without Reducing Innovation, Srividhya Ragavan

Faculty Scholarship

Cost of medication in the United States has historically remained one of the highest in the world. The conundrum that the United States has faced in balancing innovation with affordability of life-saving medications is palpable, especially when faced with the reality of patent monopolies conflicting with healthcare obligations. The result is an overflow of issues, which emphasize the need to delineate limits on innovation to balance pharmaceutical novelty with robust public health within the United States. This has increasingly shifted the focus of patent law into the realm of healthcare issues. Naturally, it leads to an inquiry about how best …

China, The Trips Waiver, And The Global Pandemic Response, Peter K. Yu

Faculty Scholarship

This chapter identifies three distinct reasons why China took a middle-of-the-road position in the debate on the COVID-19 TRIPS waiver at the WTO. It also recounts the country’s more assertive position in the run-up to the adoption of the Ministerial Decision on the waiver. Drawing eight lessons from the international debate on the waiver and the subsequent Ministerial Decision, the chapter offers insights into the future role China can or will play in future international policy debates at the intersection of intellectual property and public health, including during the next pandemic.

Intellectual Property, Genetic Resources, And Associated Traditional Knowledge, N.S. Gopalakrishnan, Srividhya Ragavan, Narendran Thiruthy

Faculty Scholarship

The recently concluded WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge mandates disclosure requirements in patent applications, thereby creating an obligation to attribute the use of genetic resources and traditional knowledge. The WIPO member countries thus have an opportunity to modify their national patent laws, so that they can effectively control genetic resources and traditional knowledge. This article examines the choices that the biodiversity-rich countries have when designing their national legal systems to implement the treaty.

Why Mlp Legal Care Should Be Financed As Health Care, William M. Sage, Keegan D. Warren

Faculty Scholarship

Medical-legal partnership (MLP) integrates the unique expertise of lawyers into collaborative clinical environments. MLP teams meet the needs of individual patients while also detecting structural problems at the root of health inequities and advancing solutions at the institutional, community, and system levels. Yet MLPs today operate in limited settings and survive on scant budgets. Expanding their impact requires secure funding. Financing MLPs as health care can do the following: (1) help address inequity at the point of care; (2) enable expert diagnosis and treatment of nonmedical drivers of health; (3) enhance team-based practice in health care organizations; (4) offer another …

The Limits Of Immigrant Resilience, Huyen Pham, Natalie C. Cook, Ernesto Amaral, Raymond Robertson, Suojin Wang

Faculty Scholarship

Economists have identified important adaptations that immigrant workers have made to weather economic crises. During times of economic contraction, immigrant workers have moved across industries or geographical locations, downshifted to part-time work, and accepted lower wages to stay employed. Evidence from the Great Recession (2007–2009) shows the benefits of that economic resilience: immigrant workers were more likely than native-born workers to remain continuously employed, to have shorter periods of unemployment when they lost their jobs, and to regain jobs more quickly in the recovery period. Of course, these adaptations had significant personal costs for immigrant workers and their families, but …

Charging Abortion, Milan Markovic

Faculty Scholarship

As long as Roe v. Wade remained good law, prosecutors could largely avoid the question of abortion. The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization has now placed prosecutors at the forefront of the abortion wars. Some chief prosecutors in antiabortion states have pledged to not enforce antiabortion laws, whereas others are targeting even out-of-state providers. This post-Dobbs reality, wherein the ability to obtain an abortion depends not only on the politics of one’s state but also the policies of one’s local district attorney, has received minimal scrutiny from legal scholars.

Prosecutors have broad charging discretion, …

The Wages Of Crying Roe: Some Realism About Dobbs V. Jackson Women’S Health Organization, Neil S. Siegel

Faculty Scholarship

The U.S. Supreme Court’s reasoning in Dobbs v. Jackson Women’s Health Organizationcannot be taken seriously. The Court’s stated rationale for rejecting continued protection of the abortion right—that abortion is not deeply rooted in nineteenth century history and tradition—applies with equal force to other substantive due process rights that the DobbsCourt repeatedly insisted were not under threat even without considering stare decisis, including contraception, sexual intimacy between consenting adults, and same-sex marriage. One should add inter-racial marriage and protection from involuntary sterilization to that list. Rather than applying its draconian version of the “history and tradition” test in a …

Wipo Negotiations On Intellectual Property, Genetic Resources And Associated Traditional Knowledge, Peter K. Yu

Faculty Scholarship

At the 2000 General Assembly, the World Intellectual Property Organization (WIPO) established the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) to address intellectual property issues relating to genetic resources, traditional knowledge (TK) and traditional cultural expressions (TCEs). Although the IGC initially focused its work on studying these issues, it obtained a new mandate to accelerate its work in October 2009 and began text-based negotiations on an international instrument, or international instruments, a few months later. These negotiations paved the way for WIPO to convene a diplomatic conference to conclude an International Legal Instrument Relating …

Swimming Together Upstream: How To Align Mlp Services With U.S. Healthcare Delivery, William M. Sage, Keegan D. Warren

Faculty Scholarship

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.

Maternal Exposure To Ssris Or Snris And The Risk Of Congenital Abnormalities In Offspring: A Systematic Review And Meta-Analysis, Weiyi Huang, Robin Page, Theresa Morris, Susan Ayres, Alva Ferdinand, Samiran Sinha

Faculty Scholarship

Background

The association of maternal exposure to selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) with the risk of system-specific congenital malformations in offspring remains unclear. We conducted a meta-analysis to examine this association and the risk difference between these two types of inhibitors.

Methods

A literature search was performed from January 2000 to May 2023 using PubMed and Web of Science databases. Cohort and case-control studies that assess the association of maternal exposure to SSRIs or SNRIs with the risk of congenital abnormalities were eligible for the study.

Results

Twenty-one cohort studies and seven case-control …

Historic Tensions Involving International Intellectual Property Protection Of Medical Technology With Disastrous Public Health Consequences, Srividhya Ragavan, Swaraj Paul Barooah

Faculty Scholarship

Historic tensions have pervaded the alliance of intellectual property's ill-fated accord with trade. The intersections of the alliance have impacted access to medical technologies resulting in plaguing public health with disastrous consequences in select parts of the globe, the first of which was perhaps most notably seen during the HIV-AIDS crisis at the turn of the century. At this time, WTO’s sacrosanct norms from the accord between trade and intellectual property rights essentially force African countries to choose between international trade sanctions, and saving thousands of lives by allowing exceptions to patent rights. While much has been written about global …

Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu

Faculty Scholarship

This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …

The Health Care Industry Is Ready For A Revolution: Its Privacy Laws Are Not, Erin Rutherford

Student Scholarship

This paper highlights the costs and benefits associated with the gathering, storing, analyzing, and digitizing of health information; examines current privacy laws and their inadequacies in the new and constantly changing digital health world; and then provides a proposal framework to balance encouraging innovation while protecting individual autonomy. The article specifically proceeds as follows. This paper first discusses of the evolution of the health industry, from paper records to the wide array of sources generating health information today. Next, it considers the benefits to the ever-increasing amount of health information, which, while considerable can often be in tension with privacy …

Pro-Choice Plans, Brendan S. Maher

Faculty Scholarship

After Dobbs v. Jackson Women’s Health Organization, the United States Constitution may no longer protect abortion, but a surprising federal statute does. That statute is called the Employee Retirement Income Security Act of 1974 (“ERISA”), and it has long been one of the most powerful preemptive statutes in the entire United States Code. ERISA regulates “employee benefit plans,” which are the vehicle by which approximately 155 million people receive their health insurance. Plans are thus a major private payer for health benefits—and therefore abortions. While many post-Dobbs anti-abortion laws directly bar abortion by making either the receipt or provision of …

A Response To Rules Of Medical Necessity, Brendan S. Maher

Faculty Scholarship

Professors Monahan and Schwarcz’s recent Article in the Iowa Law Review, Rules of Medical Necessity, is a must-read for multiple audiences. In this short Response, I informally describe health insurance, and—using that perspective—describe and comment on why Rules of Medical Necessity is a piece of work that not only deserves attention from experts in the field, but is also one that casual readers should choose first when attempting to understand how health insurance works in theory and practice.

Deferring Intellectual Property Rights In Pandemic Times, Peter K. Yu

Faculty Scholarship

This Article examines an unprecedented proposal that India and South Africa submitted to the World Trade Organization (WTO) in October 2020, which called for a waiver of more than 30 provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights to help combat COVID-19. It begins by recounting the proposal's strengths and weaknesses. The Article then identifies the challenges surrounding the negotiation and implementation of the proposed waiver. It shows why these two sets of challenges were neither separate nor sequential, but deeply entangled at the time of the international negotiations.

To respond to these challenges and the negotiation …

Designing For Justice: Pandemic Lessons For Criminal Courts, Cynthia Alkon

Faculty Scholarship

March 2020 brought an unprecedented crisis to the United States: COVID-19. In a two-week period, criminal courts across the country closed. But, that is where the uniformity ended. Criminal courts did not have a clear process to decide how to conduct necessary business. As a result, criminal courts across the country took different approaches to deciding how to continue necessary operations and in doing so many did not consider the impact on justice of the operational changes that were made to manage the COVID-19 crisis. One key problem was that many courts did not use inclusive processes and include all …

Optimizing Disaster Preparedness Planning For Minority Older Adults: One Size Does Not Fit All, Omolola E. Adepoju, Luz E. Herrera, Minji Chae, Daikwon Han

Faculty Scholarship

By 2050, one in five Americans will be 65 years and older. The growing proportion of older adults in the U.S. population has implications for many aspects of health including disaster preparedness. This study assessed correlates of disaster preparedness among community-dwelling minority older adults and explored unique differences for African American and Hispanic older adults. An electronic survey was disseminated to older minority adults 55+, between November 2020 and January 2021 (n = 522). An empirical framework was used to contextualize 12 disaster-related activities into survival and planning actions. Multivariate logistic regression models were stratified by race/ethnicity to examine the …

Data Privacy In The Time Of Plague, Cason Schmit, Brian N. Larson, Hye-Chung Kum

Faculty Scholarship

Data privacy is a life-or-death matter for public health. Beginning in late fall 2019, two series of events unfolded, one everyone talked about and one hardly anyone noticed: The greatest world-health crisis in at least 100 years, the COVID-19 pandemic; and the development of the Personal Data Protection Act Committee by the Uniform Law Commissioners (ULC) in the United States. By July 2021, each of these stories had reached a turning point. In the developed, Western world, most people who wanted to receive the vaccine against COVID- 19 could do so. Meanwhile, the ULC adopted the Uniform Personal Data Protection …

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Student Scholarship

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to(1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory licensing …