Health Law and Policy Commons^™

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

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 …

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, …

Reproductive Rights & Absolutist Abortion Bans: Beatriz V. El Salvador & Human Rights Standards In The Inter-American Court Of Human Rights, Jordan Schucker

Human Rights Brief

On December 20, 2024, the Inter-Amer­ican Court of Human Rights (IACtHR) issued its judgment in Beatriz v. El Salvador. The case concerned an impoverished Salvadoran woman, known as Beatriz, who had severe pre-existing conditions impacting her pregnancy, including systemic lupus erythematosus, lupus nephritis, and rheumatoid arthritis. After a first pregnancy,  in 2012 that triggered severe preeclampsia, she became pregnant again in 2013. Ultrasounds showed the fetus was anencephalic, making it incompatible with life outside the uterus.

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 …

State Mifepristone Regulation Following Genbiopro V Raynes, Greer Donley, Lewis Grossman, Patricia J. Zettler

Scholarly Articles in Law Reviews & Journals

After the US Supreme Court eliminated the federal constitutional right to abortion in 2022, several high-profile legal fights have centered on US Food and Drug Administration (FDA) oversight of mifepristone. Mifepristone (200 mg) is approved, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days' gestation. Legal battles over Mifepristone have included a lawsuit challenging the FDA’s initial approval of the drug and the sufficiency of FDA-required restrictions on the drug, as well as lawsuits arguing, to the contrary, that FDA-required restrictions are unnecessary and must be eliminated.

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Brief Of 12 Narcolepsy Patients, Public Interest Organizations, Medical Professionals, And Professors Of Law And Medicine As Amici Curiae In Support Of Defendants-Appellees (Amended To Add Further Signatories), Charles Duan

Amicus Briefs & Court Filings

A prior copy of this brief was filed, inadvertently omitting one signatory. This brief has accordingly been amended to correct the error, reflected in the Certificate as to parties and the Appendix.

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

The State Of The Medical Cannabis Industry And Enforcement Against Illegal Cannabis Shops, Chaz Brooks

Legislative Testimony & Comments

My name is Professor Chaz Brooks, and I am joined by several of my students who have assisted on this project, Khumar Gasimzada, Christian Nunez, and Olivia Woodmansee. Professor Priya Baskaran and I co-lead the Entrepreneurship Law Clinic at American University Washington College of Law, where we provide legal support to small businesses and entrepreneurs in Washington, D.C. (the “District” or “D.C.”). Over the past year, we have worked closely with Sean and Lashonia Thompson-El of DC Native Botanicals who received a Conditional Social Equity License for a cultivation center in October 2023. Today, we testify not only on their …

Pumpable Hours: Legal Protections For Lactating Individuals Through The Lens Of The Legal Profession, Elise Gonzalez

American University Journal of Gender, Social Policy & the Law

The Supreme Court denied women the right to be admitted to the legal profession in 1872. Since this ruling, women have entered the legal profession with force in growing numbers. Today, women comprise nearly 55% of law students across the country and 40% of practicing attorneys in the United States. Despite the growing number of women in the legal profession, women are often reminded of the profession’s sexist history, particularly during a period that is uniquely connected to women—motherhood.

Dobbs And Sterilization Decision-Making: Understanding The Coercive Spillover Effects In Reproductive Choice, Thomas Williams

Scholarly Articles in Law Reviews & Journals

The Supreme Court majority in Dobbs v. Jackson Women’s Health Organization argued their decision would have limited impact beyond abortion rights. This Article examines how Dobbs and subsequent state abortion restrictions are likely to increase women’s reliance on permanent sterilization procedures, particularly among already marginalized populations. Drawing on emerging data and historical context, I argue that some post-Dobbs sterilizations should be understood as effectively coerced by state policies, implicating reproductive justice concerns and potentially undermining fundamental rights established in Skinner v. Oklahoma. Then, I demonstrate how interdisciplinary bioethics frameworks and methodologies can help courts better understand the full implications of …

U'Wa Indigenous People Vs. Columbia: Potential Applications Of The Escazu Agreement, Ariana Lippi

Sustainable Development Law & Policy

Though the case is ongoing, and results are still to be seen, it in many ways sets a precedent for indigenous communities in Latin America seeking redress for environmental and cultural injustices. With Colombia’s recent ratification of The Escazú Regional Agreement (the Agreement herein) in 2022, this case presents a unique opportunity for implementation of the Agreement and greater accountability within existing domestic legislation.

Natural Resources In The Arctic: The Equal Distribution Of Uneven Resrouces, Ganeswar Matcha, Sudarsanan Sivakumar

Sustainable Development Law & Policy

This paper analyses the governance machine in place at the Arctic and examines the application of the principles of “common heritage of mankind” at the Arctic. This paper also offers some tentative propositions aimed at protecting Out Bound investment rights and how the World Trade Organization or other countries, like the U.S., can intercede in the Arctic investment sphere and attempt to regulate along with the United Nations Convention for the Law of the Sea.

Incentivizing Sustainability In American Enterprise: Lessons From Finnish Model, Vasa T. Dunham

Sustainable Development Law & Policy

The disparate climate performances of Finland and the United States, two of the wealthiest countries in the world, bring to light the question of how corporate responsibility has been inspired in each jurisdiction. Having established the urgency of the climate crisis and the importance of corporate behavior in optimizing a given country’s approach to protection of the global environment, an examination of each nation’s legal frameworks may shed light on features of the corporate regime that are effective in advancing sustainability goals and those that are not.22 Part I of this paper establishes a comparative framework by providing background on …

Editor's Note, Shade Streeter, Reagan Ferris

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

The Inter-American Court Of Human Rights Address "Obstetric Violence" In Rodriguez Pacheco Et Al. V. Venezuela, Lily Cantor

Human Rights Brief

The Inter-American Court of Human Rights (“the Court”) decision on reparations and costs in the case of Rodriguez Pacheco et al. v. Venezuela is one of several that the Court analyzed in recent years relating to women’s obstetric health, indicating a rising interest in the area of reproductive rights.

Out-Of-State Abortion On Company Dime: An Analysis Of State Legislation And Erisa, Erin Elizabeth Hanlon

American University Business Law Review

This Note analyzes the various types of state abortion bans, focusing on those with aiding and abetting clauses. These bans impose civil liability for anyone, including companies providing abortion access benefits, who help a pregnant person gain access to abortion. Additionally, this Note analyzes federal legislation to determine if any retaliatory actions taken against companies violate federal law. This legislation includes the Employee Retirement Income Security Act (“ERISA”) which creates uniformity in insurance and benefits coverage by superseding any state law that references or relates to an ERISA plan. Many advocates believe that ERISA is a company’s greatest defense to …

A Health Justice Approach To Abortion, Maya Manian

Scholarly Articles in Law Reviews & Journals

The Supreme Court’s watershed decision in Dobbs v. Jackson Women’s Health Organization, overturning fifty years of precedent protecting abortion rights, has led to chaos in both the legal and public health landscapes. With Roe v. Wade eliminated, reproductive rights and justice advocates urgently need new frameworks to help regain access to comprehensive reproductive health care in the long term. Recently, a number of legal scholars have argued in favor of medicalizing civil rights—adopting the framework of health justice to talk about civil rights issues. Scholars argue that the health justice framework could be used to advance civil rights in the …

Owning Health Equity Entrepreneurship, Capital, And Community-Owned Health, Thomas Williams

Scholarly Articles in Law Reviews & Journals

There is a long history of recognized health disparities affecting marginalized communities in the United States. These disparities have complicated and deep roots, but multiple factors can be controlled in the short term, such as access to high-quality medical care. Public and private institutions often use incentives to focus the efforts of private actors towards specified goals; incentives can also be calibrated to mitigate health disparities through a health equity entrepreneurial model.

To understand the possibilities and complications of this model of health equity-focused entrepreneurship, this Article uses the Black and American Indian maternal mortality and morbidity crises as a …

Patient Access To At-Home Health Care Device Data Toward A Legal Framework, Charles Duan, Christopher J. Morten

Contributions to Books

No abstract provided.

Prioritizing Regional Wildlife Conservation By Rejuvenating The Western Hemisphere Convention On Nature Protection, Shade Streeter, David Hunter, William Snape Iii

Sustainable Development Law & Policy

Last year, parties to the Convention on Biological Diversity (“CBD”), representing nearly every nation, signed a milestone agreement committing, among other things, to conserve thirty percent of Earth’s lands and oceans to stave off the rapid diminution of the planet’s biodiversity. Implementing these global commitments will require not only strong domestic measures, but also enhanced regional cooperation targeting the conservation of the region’s migratory wildlife and shared resources. Although the United States is the sole major holdout from the CBD, it can still reassert its leadership in regional wildlife conservation by rejuvenating the Convention on Nature Protection and Wildlife Preservation …

Unclos, Undrip & Tartupaluk: The Grim Tale Of Hans Isle And Graense, Christopher Mark Macneill

Sustainable Development Law & Policy

“Inuit have lived in the Arctic from time immemorial.” The Arctic, in the face of climate change, has become a hot spot for exploration, resource extraction, and increased shipping and scientific activity. “[The] Inuit . . . have had a common and shared use of the sea area and the adjacent coasts” among their own communities, and contemporaneously with the world. This vast circumpolar Inuit Arctic region includes land, sea, and ice stretching from eastern Russia (Chukotka region) across the Berring Strait, to Alaska, the Canadian Arctic, and Greenland, representing an Inuit homeland known as Nunaat. Hans Isle, a small …

The Great Climate Migration: A Critique Of Global Legal Standards Of Climate-Change Caused Harm, Mariah Stephens

Sustainable Development Law & Policy

Approximately 2.4 billion people, or about forty percent of the global population, live within sixty miles (one hundred kilometers) of a coastline. The United Nations (“U.N.”) determined that “a sea level rise of half a meter could displace 1.2 million people from low-lying islands in the Caribbean Sea and the Indian and Pacific Oceans, with that number almost doubling if the sea level rises by two metres.” The U.N. also reports that “sudden weather-related hazards” have internally displaced an annual average of 21.5 million people since 2008. Within the next few decades, this number is likely to continue to increase. …

The Future Of Crypto-Asset Mining: The Inflation Reduction Act And The Need For Uniform Federal Regulation, Liz Guinan

Sustainable Development Law & Policy

Crypto-asset mining is energy-intensive and environmentally harmful, presenting challenges and opportunities for federal, state and local governments, regulators, and society as a whole. As of December 2021, the United States has thirty-eight percent of the global crypto network hash rate, which is the total amount of computational power used to mine and process crypto transactions, making the United States the world’s largest crypto-asset mining industry. The total electricity consumption of crypto-asset mining in the United States is estimated to be around 121.36 terawatt-hours (“TWh”) per year, which is equivalent to the electricity consumption of approximately 10.9 million households in the …

Editors' Note, Rachel Keylon, Meghen Sullivan

Sustainable Development Law & Policy

For more than two decades, the Sustainable Development Law and Policy Brief (“SDLP”) has published works analyzing emerging legal and policy issues within the fields of environmental, energy, sustainable development, and natural resources law. SDLP has also prioritized making space for law students in the conversation. We are honored to continue this tradition in Volume XXIII.

Endnotes

Sustainable Development Law & Policy

No abstract provided.

Using Federal Public Lands To Model A New Energy Future: Why The Biden Administration Should Prioritize Renewable Energy Development On Public Lands, Meghen Sullivan

Sustainable Development Law & Policy

Oil and gas extraction on public lands and waters is responsible for twenty percent of U.S. greenhouse gas emissions. If American public lands were their own country, they would be the fifth-largest greenhouse gas emitter in the world. As of 2020, only twenty percent of total U.S. electricity generation came from renewable energy sources. While renewable energy development on public lands has increased, most renewable energy comes from private lands. However, public lands contain immense renewable energy potential; for example, it is estimated that half of this country’s geothermal resources are found on public lands. Despite underutilized renewable energy potential …

Crumbling Crown Jewels: Addressing The Impact Of Recreational Overuse In America's National Parks, Ellen Spicer

Sustainable Development Law & Policy

National Parks are the “crown jewels” of America. However, in recent years they have become subjected to rampant overcrowding and overuse, so much so that they are being loved to death. The 1916 National Park Service (“NPS”) Organic Act calls for the conservation of “the scenery and the natural and historic objects and the wild life . . . and to provide for the enjoyment of the same in such manner and by such means as will leave [park sites] unimpaired for the enjoyment of future generations.” Due to increased visitation, one of the mandates of the NPS is being …