Health Law and Policy Commons^™

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 …

Sports Participation By Athletes With Cardiovascular Disease, Matthew W. Martinez, Michael J. Ackerman, George J. Annas, Aaron L. Baggish, Sharlene M. Day, Kimberly G. Harmon, Jonathan H. Kim, Benjamin D. Levine, Margot Putukian, Rachel Lampert

Faculty Scholarship

Millions of young people participate in competitive sports, with well-documented physical and psychological benefits.1 Athletes may be diagnosed with cardiovascular disease (CVD) during evaluation of symptoms, routine preparticipation screening, or clinically indicated family screening. When this occurs, decisions about return-to-play (RTP) are difficult, especially in circumstances when risk may exist or be unknown. Historically, expert consensus documents such as the Bethesda Conference Proceedings,2 provided a “yes/no” approach to RTP after a diagnosis of a CVD such as hypertrophic cardiomyopathy (HCM) or long QT syndrome (LQTS). These recommendations were made with a paucity of data, and were predicated on a zero-risk …

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

Municipal Abortion Bans: When Local Control Clashes With State Power, Laura D. Hermer

Faculty Scholarship

Anti-abortion activists are using different strategies in different states. Some focus on restricting zoning for abortion clinics. Others address the licensure of abortion providers. Some purport to create a cause of action for private individuals to sue neighbors and others in their municipality who get an abortion. Still, others seek to enforce the federal Comstock Act, alleging that it prohibits the mailing of abortifacients and preempts state abortion law to the contrary.

This Article evaluates the likely success of each of these strategies in two states in which they are currently being tried: Nebraska and New Mexico. Part I will …

Access To Care And Outcomes With The Affordable Care Act For Persons With Criminal Legal Involvement: A Scoping Review, James René Jolin, Benjamin A. Barsky, Carrie G. Wade, Meredith B. Rosenthal

Faculty Scholarship

IMPORTANCE By expanding health insurance to millions of people in the US, the Patient Protection and Affordable Care Act (ACA) may have important health, economic, and social welfare implications for people with criminal legal involvement—a population with disproportionately high morbidity and mortality rates.

OBJECTIVE To scope the literature for studies assessing the association of any provision of the ACA with 5 types of outcomes, including insurance coverage rates, access to care, health outcomes, costs of care, and social welfare outcomes among people with criminal legal involvement.

EVIDENCE REVIEW The literature search included results from PubMed, CINAHL Complete, APA Psycinfo, Embase, …

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 …

Human Rights In Hospitals: An End To Routine Shackling, Neil Singh Bedi, Nisha Mathur, Judy D. Wang, Avital Rech, Nancy Gaden, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Medical students (NSB, NM, JDW) spearheaded revision of the policy and clinical practice for shackling incarcerated patients at Boston Medical Center (BMC), the largest safety net hospital in New England. In American hospitals, routine shackling of incarcerated patients with metal restraints is widespread—except for perinatal patients—regardless of consciousness, mobility, illness severity, or age. The modified policy includes individualized assessments and allows incarcerated patients to be unshackled if they meet defined criteria. The students also formed the Stop Shackling Patients Coalition (SSP Coalition) of clinicians, public health practitioners, human rights advocates, and community members determined to humanize the inpatient treatment of …

Structural Sex Discrimination: Why Gynecology Patients Suffer Avoidable Injuries And What The Law Can Do About It, Christopher Robertson, Annabel Kupke, Louise P. King

Faculty Scholarship

The nearly four million Americans who undergo gynecological surgeries each year suffer avoidable lifelong, painful, and disabling injuries. This Article diagnoses the root cause in our legal framework for healthcare finance and identifies legal solutions.

America’s public-private system for reimbursing healthcare pays for procedures rather than outcomes, and it pays substantially more for work on male rather than female anatomies. This disparity is due to the federal government’s reliance on a secretive industry committee to set those rates, and the committee’s reliance on junk science surveys, allowing self-interested and gender-biased responses, contrary to objective measures.

As payors disvalue the bodies …

Rethinking Foundations And Analyzing New Conflicts: Teaching Law After Dobbs, Nicole Huberfeld, Linda C. Mcclain, Aziza Ahmed

Faculty Scholarship

This Article draws on our diverse and complementary areas of scholarly expertise and teaching experiences across law school and public health curricula to offer a multidisciplinary model for teaching in a variety of courses after Dobbs. Teaching reproductive rights and justice poses extensive challenges in the wake of Dobbs' overruling Roe v. Wade and Planned Parenthood v. Casey, upending a half century of precedents protecting a constitutional right to abortion, and returning the issue to "the people" and the states. This Article offers theoretical and pedagogical perspectives on teaching courses in Reproductive Rights and Justice, as well …

Confusion, Chaos, And Conflict In U.S. Law And Health Care After Dobbs, Nicole Huberfeld

Faculty Scholarship

The U.S. Supreme Court’s Dobbs decision caused a proliferation of contradictory state laws and judicial decisions that are producing confusion for health care providers, which in turn limits access to care for all patients of reproductive age. This paper documents the rapidly changing legal landscape to investigate and contextualize the significance of these inter‑state conflicts and illustrate how inequities deepen when health care is left in the hands of state governments without national law to provide guardrails. Drawing on interdisciplinary scholarship, including legal, medical, and public health research, this essay considers how traditional federalism theory, which encourages sub‑government variation, does …

Sharing Pathogen Sequence Data For Global Scientific Research Under The Nagoya Protocol To The Convention On Biological Diversity, Jerome H. Reichman, Carolina Dos S. Ribeiro, George B. Haringhuizen, Paul F. Uhlir

Faculty Scholarship

The Nagoya Protocol to the Convention on Biological Diversity (CBD) has threatened to impede access to genetic resources and related data for cross-border scientific research. In principle, every use of genetic resources would require a set of contracts under the CBD, in a “bilateral” regime. The related transaction costs could overwhelm many transnational research undertakings, affecting even public health responses to outbreaks and epidemics. However, the Nagoya Protocol also offers a unique opportunity to resolve this dilemma, despite struggles to define the meaning and coverage of “digital sequence information.” The coverage of genetic sequence data under the CBD remains controversial …

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.

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 …

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 …

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.

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 …

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 …

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 …