Health Law and Policy Commons^™

Prescribing A Balance: Sustaining Environmental Health With Pharmaceutical Interest In Puerto Rico, Derek Warzel

Indiana Law Journal

Puerto Rico, often referred to as the “Medical Cabinet of the U.S.A.,” is a hub for pharmaceutical manufacturing, contributing significantly to the American medical supply chain and Puerto Rico’s economy. However, decades of industrial activity, compounded by climate events like Hurricane Maria, have led to severe environmental damage, particularly through groundwater contamination and damaged Superfund sites. This Note examines the historical intersection of economic incentives and environmental neglect in Puerto Rico, focusing on the pharmaceutical industry’s impact. By critically analyzing the Superfund program and proposing reforms, this Note advocates for a balanced approach: introducing proactive environmental protections and financial incentives …

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 …

Birth On Mother Earth: Mitigating The Maternal Health Crisis, Jill C. Engle

Faculty Scholarship

Maternal health outcomes in the U.S. are remarkably poor, especially when compared to those in other industrialized countries. For example, our maternal death rate is more than twice that of Canada’s. Women of color in the U.S. suffer maternal morbidity and mortality at rates considerably higher than white women. Indigenous women experience the worst maternal health outcomes of all. Yet, most maternal deaths and injuries are preventable. Furthermore, rates of maternal harm, including death, are lower when midwives and similar birthing attendants are involved. This Article is the first to fully explore the unique skillset of traditional birth attendants (TBAs). …

Environment Scan Of Generative Ai Infrastructure For Clinical And Translational Science, Hua Xu, Jiang Bian, Chunhua Weng, Yifan Peng, Betina Idnay, Zihan Xu, William G. Adams, Mohammad Adibuzzaman, Nicholas R. Anderson, Neil Bahroos, Douglas S. Bell, Cody Bumgardner, Thomas Campion, Mario Castro, James J. Cimino, I. Glenn Cohen, David Dorr, Peter L. Elkin, Jungwei W. Fan, Todd Ferris, David J. Foran, David Hanauer, Mike Hogarth, Kun Huang, Jayashree Kalpathy-Cramer, Manoj Kandpal, Niranjan S. Karnik, Avnish Katoch, Albert M. Lai, Christophe G. Lambert, Lang Li, Christopher Lindsell, Jinze Liu, Zhiyong Lu, Yuan Luo, Peter Mcgarvey, Eneida A. Mendonca, Parsa Mirhaji, Shawn Murphy, John D. Osborne, Ioannis C. Paschalidis, Paul A. Harris, Fred Prior, Nicholas J. Shaheen, Nawar Shara, Ida Sim, Umberto Tachinardi, Lemuel R. Waitman, Rosalind J. Wright, Adrian H. Zai, Kai Zheng, Sandra Soo-Jin Lee, Bradley A. Malin, Karthik Natarajan, Nicholson Price, Rui Zhang, Yiye Zhang

Articles

This study reports a comprehensive environmental scan of the generative AI (GenAI) infrastructure in the national network for clinical and translational science across 36 institutions supported by the CTSA Program led by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) at the United States. Key findings indicate a diverse range of institutional strategies, with most organizations in the experimental phase of GenAI deployment. The results underscore the need for a more coordinated approach to GenAI governance, emphasizing collaboration among senior leaders, clinicians, information technology staff, and researchers. Our analysis reveals that 53% of …

Federalism, State Action, And Workers’ Medical Privacy, Ani B. Satz

Faculty Articles

Injured workers entering state workers’ compensation systems effectively forego their medical privacy. This is due to widespread judicial misinterpretation of the HIPAA Privacy Rule (HPR) as excluding injured workers from federal medical privacy protections. As a result, medical privacy for workers’ compensation claims is effectively governed by state law. This Article argues that states have failed to protect the medical privacy of injured workers adequately and that there is a pressing need for legislative reform. The Article presents the first comprehensive survey in the legal literature of state action protecting the medical privacy of injured workers. Part I describes the …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Faculty Articles

In her important book, Unwired: Gaining Control Over Addictive Technologies, Gaia Bernstein illustrates the value of a comparative approach, drawing lessons from fights around the regulation of tobacco and ultra-processed food for the regulation of social media. Building on Bernstein’s work, this symposium contribution aims to draw additional insight from experience with drug and gambling regulation for the regulation of social media, video games, AI, and other potentially-addictive technologies.

Specifically, after introducing Bernstein’s book and the foundation it lays, we draw six lessons from the study of psychoactive drugs and gambling. As we elaborate below: Lesson one is that …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

The Alchemy Of Sin: Turning Tobacco Sin Tax Revenue Into Public Health Gold, Audre L. Sylvester

Lewis & Clark Law Review

This Note proposes a reallocation of tobacco excise tax revenue towards health and education programs related to tobacco cessation. Revenue collected from federal excise taxes on tobacco products is currently used to support the daily and long-term operations of the United States while tobacco cessation and education programs remain underfunded and underutilized. This Note examines the history of these “sin taxes,” their modern-day function, and the issues that arise from the current allocation of sin tax revenue to support the argument that revenue from federal sin taxes on tobacco products should be exclusively allocated to a dedicated federal trust fund …

Cause Of Death? -- It's Probably Not What's Reported On The Death Certificate, Lauren R. Roth

Lewis & Clark Law Review

In the age of big data, this country has a data problem—inaccurate and incomplete information in death certificates. The problem has long been hidden by the numbers reported—as have the people whose deaths go uncounted, but the COVID-19 pandemic unveiled the scope of the issue. Since the beginning of the pandemic, “excess deaths” (i.e., any deaths above the number predicted by existing mortality models) have increased significantly. Most of these excess deaths are likely attributable to COVID-19 because the decedent was never tested for COVID-19 or it was one of multiple factors contributing to their death. Other deaths are uncounted …

The Legal Ramifications Of Israel’S Destruction Of Gaza’S Healthcare System, Serene Mistkawi

Lewis & Clark Law Review

This Comment argues that Israel’s attacks on the medical infrastructure of Gaza are a violation of international law because hospitals are protected zones and medical personnel are civilians. To Israel’s response that Hamas is attack-ing from hospitals, thereby rendering them legitimate targets, this Comment presents a number of responses: (1) there is little to no evidence that Hamas is doing this; (2) even if Hamas is doing this, the military gains from attacking hospitals are outweighed by the civilian deaths; (3) even if Hamas is doing this and there is significant military gain from attacking hospitals, the interna-tional rules have …

Middlemen At A Price: The Role Of State-Level Laws In Restricting Pharmacy Benefit Managers, Patrick W. Schrader

Lewis & Clark Law Review

Pharmacy Benefit Managers (PBMs) have evolved from simple third-party payors into powerful intermediaries controlling prescription drug access for over 289 million Americans. Operating with minimal federal oversight, just six PBMs dominate 96% of the market, employing practices that systematically increase drug costs while claiming to reduce them. This Comment examines four primary mechanisms through which PBMs exploit the pharmaceutical supply chain: rebate manipulation, spread pricing, step therapy requirements, and formulary control. Federal regulatory efforts remain nascent and ineffective. The Centers for Medicare and Medicaid Services requires only basic reporting without substantive restrictions. Proposed federal legislation has repeatedly stalled, leaving states …

Dentistry And The Law: The Difference Between ‘Non-Covered’ Vs. ‘Disallowed’ Services, Daniel Schulte Jd

The Journal of the Michigan Dental Association

The article clarifies the distinction between "non-covered" and "disallowed" services in dental plan audits. Non-covered services are not included in the patient’s dental plan, often due to plan limitations, while disallowed services are covered but deemed non-payable due to issues like claim deficiencies or lack of documentation. Dentists must review their contracts to understand obligations regarding non-covered services and ensure compliance with HIPAA for patient-paid services. For disallowed services, contesting decisions may be possible depending on the agreement with the dental plan.

J Mich Dent Assoc January 2025

The Journal of the Michigan Dental Association

Each month, the Journal of the Michigan Dental Association provides news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. It is the primary publication reaching Michigan dentists. The January issue sets the tone for February, the observance of Children’s Dental Health Month.

Michigan Academy of Pediatric Dentistry President Jessica Bentoski welcomes readers to this special issue, which features a cover feature on “Approaches to Care for Children with Special Needs in Dental Settings: Desensitization and Teledentistry” and a supporting article on “General Dentists’ Education, Knowledge, Attitudes, and Behavior Concerning the Effects …

Recent Changes In Discretionary Denials Of Drug Patent Challenges, S. Sean Tu, Arti K. Rai, Aaron S. Kesselheim

Faculty Scholarship

Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of “discretionary denials,” invoking a new “settled expectations” rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Fighting Fgm In Minnesota: Minnesota Legislation Vs. Model Legislation, Molly Rosenfield

Mitchell Hamline Law Review

No abstract provided.

Dobbs V. Brown, Benjamin H. Barton

Dickinson Law Review (2017-Present)

Dobbs v. Jackson Women’s Health Organization1is the most important and impactful Supreme Court decision since at least Roe v. Wade, and potentially since Brown v. Board of Education. Past survey data show that most Americans can only name two Supreme Court opinions: Roe and Brown. Dobbs will surely join that list. This Article compares the history, drafting, and opinions of Dobbs and Brown to show what a missed opportunity Dobbs represents. Regardless of whether you agree or disagree with the opinion, it should be clear that Dobbs was one of those unique times (like that of Brown) where the Court …

Advancing Virtual Care Practices Across The Cognitive Impairment Continuum, Tara Sklar, Kathryn Huber

Health Matrix: The Journal of Law-Medicine

As the population of older adults grows, providing high-quality, costeffective healthcare for those with cognitive impairments is an increasing priority. The COVID-19 pandemic accelerated the shift towards receiving virtual care at home through temporary Medicare flexibilities. However, the uncertainty surrounding the continuing extension of these flexibilities at the federal level and variations in reimbursement policies across the states present challenges for virtual care practices to meet the rising demand for care amid unprecedented workforce shortages. Sustainable, long-term reimbursement at the federal and state levels, a trained and integrated healthcare workforce, and adherence to recognized accreditation standards and guidelines are essential …

A Small Price To Pay For Better Mental Health Crisis Care: Why States Should Be Funding The New 988 Hotline Through Phone Fees, Katherine Menello

Law Student Publications

Mental health care in the United States is uncoordinated, underresourced, and overall insufficient. Mental health crisis care is much the same, but with much higher stakes. The lack of a comprehensive mental health crisis care system across the country has led to law enforcement involvement becoming the default system in most communities. Yet, an overwhelming majority of Americans want a better way; in a survey conducted in summer 2023, “85% of people sa[id] they want a mental health response to someone experiencing a mental health, drug or suicide crisis, not a police response.”...