Health Law and Policy Commons^™

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 …

The New Over-The-Counter Oral Contraceptive Pill—Assessing Financial Barriers To Access, Christopher Robertson, Anna Braman

Faculty Scholarship

In July 2023, the Food and Drug Administration (FDA) approved Opill (norgestrel), the first over-the-counter (OTC) daily oral contraceptive pill in the United States, a move that could dramatically improve practical access to family planning. Opill’s price, however, hasn’t been made public and may not be revealed until the drug enters the market in early 2024. Although contraceptive pills generally cost between $10 and $50 per month without insurance, there’s no indication that Opill’s price will fall within this range. In addition, although the manufacturer (Perrigo) has expressed interest in a consumer-assistance program, it hasn’t released details regarding eligibility for …

Education, Employment, And Healthcare: Personal And Societal Strategies For Transitioning Servicemembers' Fiscal Sustainability, Kan Samuel

Faculty Scholarship

No abstract provided.

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, …

(Re)Criminalizing Abortion: Returning To The Political With Stories, George J. Annas

Faculty Scholarship

Abortion stories have always played a powerful role in advancing women’s rights. In the abortion sphere particularly, the personal is political. Following the Court’s reversal of Roe v. Wade, abortion politics, and abortion storytelling, take on an even deeper political role in challenging the bloodless judicial language of Dobbs with the lived experience of women.

Continuous Reproductive Surveillance, Michael Ulrich, Leah R. Fowler

Faculty Scholarship

The Dobbs opinion emphasizes that the state’s interest in the fetus extends to “all stages of development.” This essay briefly explores whether state legislators, agencies, and courts could use the “all stages of development” language to expand reproductive surveillance by using novel developments in consumer health technologies to augment those efforts.

Introduction: Securing Reproductive Justice After Dobbs, Aziza Ahmed, Nicole Huberfeld, Linda C. Mcclain

Faculty Scholarship

When we conceptualized this symposium, Roe v. Wade was still the law of the land, albeit precariously. We aimed to commemorate its fiftieth anniversary by exploring historical, legal, medical, and related dimensions of access to abortion as well as the challenges ahead to secure reproductive justice. With the leak of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization on May 2, 2022, we shifted to mark the dawn of a new era. In the nearly identical official opinion announced on June 24, 2022, Justice Samuel Alito, writing for the majority (6-3), overturned Roe and Planned Parenthood …

Dobbs V. Jackson Women’S Health: Undermining Public Health, Facilitating Reproductive Coercion, Aziza Ahmed, Dabney P. Evans, Jason Jackson, Benjamin Mason Meier, Cecília Tomori

Faculty Scholarship

Dobbs v. Jackson Women’s Health continues a trajectory of U.S. Supreme Court jurisprudence that undermines the normative foundation of public health — the idea that the state is obligated to provide a robust set of supports for healthcare services and the underlying social determinants of health. Dobbs furthers a longstanding ideology of individual responsibility in public health, neglecting collective responsibility for better health outcomes. Such an ideology on individual responsibility not only enables a shrinking of public health infrastructure for reproductive health, it facilitates the rise of reproductive coercion and a criminal legal response to pregnancy and abortion. This commentary …

Federalism, Leadership, And Covid-19: Evolving Lessons For The Public’S Health, Nicole Huberfeld

Faculty Scholarship

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law and much more. This collection provides a critical reflection on what changes the pandemic has already introduced, and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global 'stress test,' and explore how the US and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies …

Dying In Isolation: Public Health Implications Of Transportation And Burial Of Human Remains During A Pandemic A Fifty State Survey, Christopher Ogolla

Faculty Scholarship

No abstract provided.

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

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 …

Diverse Patients’ Attitudes Towards Artificial Intelligence (Ai) In Diagnosis, Christopher Robertson, Andrew Woods, Kelly Bergstrand, Jessica Findley, Cayley Balser, Marvin J. Slepian

Faculty Scholarship

Artificial intelligence (AI) has the potential to improve diagnostic accuracy. Yet people are often reluctant to trust automated systems, and some patient populations may be particularly distrusting. We sought to determine how diverse patient populations feel about the use of AI diagnostic tools, and whether framing and informing the choice affects uptake. To construct and pretest our materials, we conducted structured interviews with a diverse set of actual patients. We then conducted a pre-registered (osf.io/9y26x), randomized, blinded survey experiment in factorial design. A survey firm provided n = 2675 responses, oversampling minoritized populations. Clinical vignettes were randomly manipulated in eight …

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 …

Global Pull Incentives For Better Antibacterials: The Uk Leads The Way, Kevin Outterson, John Rex

Faculty Scholarship

The article from Leonard and the team from the National Institute for Health and Care Excellence, NHS England, and NHS Improvement [1] asks the question whether the UK subscription program can restore the antibacterial pipeline, with an insiders’ description of the process and strategy that led to implementation (briefly, a ‘pull incentive’ of reimbursement for new antibacterials that is delinked from volume of sales with payments based on the added value to the whole health and social care system).

Governments [2,3,4,5,6,7,8,9], academics …

Masking Vulnerability: Including Ppe As A Covered Service In Health Insurance, Mary Leto Pareja

Faculty Scholarship

The COVID-19 pandemic laid bare the shared vulnerability inherent in the human condition, prompting a collective recognition of our physical susceptibility to infectious diseases. While great strides have been made in combating COVID-19 through vaccinations and treatments, a portion of the population remains profoundly vulnerable due to health conditions that make the disease more dangerous, that limit vaccine efficacy, or that prevent vaccination altogether. This article explores a path forward by proposing a solution within health benefit plans—encompassing both private health insurance and public health benefits. Specifically, the article advocates for a coverage mandate for over-the-counter personal protective equipment (PPE) …

Feminist Legal Theory And Praxis After Dobbs: Science, Politics, And Expertise, Aziza Ahmed

Faculty Scholarship

Fifty years ago, in Roe v. Wade, Justice Blackmun set into motion the idea that abortion should be a decision between a woman and her doctor.' That idea traveled from the Supreme Court decision to popular discourse; with it, came the notion that when it comes to reproduction, medical experts are a key part of women's liberation. In Dobbs v. Jackson Women's Health Organization, the court ignored the role of experts and threw the question of who should decide when and how a person has an abortion to the people. In my essay for this symposium issue dedicated to feminist …

“Made To Feel Broken”: Ending Conversion Practices And Saving Transgender Lives, Jennifer Levi, Kevin M. Barry

Faculty Scholarship

There has been a recent unprecedented, coordinated campaign by state governments to deny gender-transition care to transgender youth. It is within this context that Florence Ashley argues in Banning Transgender Conversion Practices: A Legal and Policy Analysis that legislation banning conversion practices is both lifesaving to transgender people directly affected and an important step in securing health and the recognition of dignity for all transgender people. The Authors highly recommend the book as a thoughtful and well-researched look at the issue. They also expand on several topics discussed in the book, including the harm caused by these practices, the constitutionality …

Increasing Compliance With International Pandemic Law: International Relations And New Global Health Agreements, Matthew M. Kavanagh, Clare Wenham, Elize Massard Da Fonseca, Laurence R. Helfer, Elvin Nyukuri, Allan Maleche, Sam F. Halabi, Adi Radhakrishnan, Attiya Waris

Faculty Scholarship

No abstract provided.

The Rise And Fall Of A Reproductive Right: Dobbs V. Jackson Women’S Health Organization, Carol Sanger

Faculty Scholarship

Although the phrase “Post-Roe Era” is still used by those who want to underscore the loss wrought last June by Dobbs v. Jackson Women’s Health Organization, it is only a matter of time before the present state of reproductive constitutionalism solidifies into the more authoritarian “Dobbs Era.” In these early days of transition, states are still figuring out what they want the legal status of abortion to be, ever since Dobbs overruled both Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, thus tossing the issue of abortion’s legality back to the states for …

Hospitals Suing Patients: How Hospitals Use N.C. Courts To Collect Medical Debt, Barak Richman, Sara Sternberg Greene, Sean Chen, Julie Havlak

Faculty Scholarship

From January 2017 through June 2022, North Carolina hospitals brought 5,922 lawsuits to collect medical debt against 7,517 patients and family members. These actions were brought in small claims court, state district, and state superior courts, and generated 3,449 judgments for hospitals totaling $57.3 million, or an average of $16,623 per judgment.

Hospitals took advantage of North Carolina’s allowance of 8% annual interest on judgments, including by refiling actions to sustain judgments issued ten years earlier. These interest charges and other additional fees totaled an estimated $20.3 million, or 35.4% of the judgments awarded. Some patients faced more than a …

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel E. Sachs, W. Nicholson Price Ii

Faculty Scholarship

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Un-Erasing Race In A Medical-Legal Partnership: Antiracist Health Justice Advocacy By Design, Danielle Pelfrey Duryea, Peggy Maisel, Kelley Saia

Faculty Scholarship

This Article covers a potential response to a Massachusetts state law which has been interpreted to require health care providers and birthing hospitals to report to state authorities any infant born to a person taking medication of opioid use disorder. While the statute mandates reports where a professional has "reasonable cause to believe that a child is suffering physical or emotional injury" as a result of substance dependence at birth, the Article highlights that many institutions report all infants born to persons with substance abuse disorders, regardless of risk of harm, for fear of penalty for failure to report. As …

Ordered Liberty After Dobbs, Linda C. Mcclain, James E. Fleming

Faculty Scholarship

This Essay explores the implications of Dobbs v. Jackson Women’s Health Organization for the future of substantive due process (SDP) liberties protecting personal autonomy, bodily integrity, familial relationships (including marriage), sexuality, and reproduction. We situate Dobbs in the context of prior battles on the Supreme Court over the proper interpretive approach to deciding what basic liberties the Due Process Clause (DPC) protects. As a framing device, we refer to two competing approaches as “the party of [Justice] Harlan or Casey” versus “the party of Glucksberg.” In Dobbs, the dissent co-authored by Justices Breyer, Sotomayor, and Kagan represents the party of …

Family Needs, Family Leave In 2023, Katharine B. Silbaugh

Faculty Scholarship

Instituting support for women and children is a difficult task to imagine in a world that is removing reproductive freedom and healthcare. In this hypothetical, do we treat the removal of abortion care as a force majeure, natural disaster, or an earthquake? If so, after the earthquake, the community bands together and works tirelessly to compensate for what has happened. But the removal of abortion care was not a natural disaster-it was planned, and it is embedded in background conditions that are pushing further away from support for women and children.

The primary task of this Article is to respond …

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 …