Law Commons^™

The Fall Of Fda Review, Daniel G. Aaron

Utah Law Faculty Scholarship

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency’s work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA’s core function is to oversee a special legal regime called “premarket review.” Congress has prohibited all marketing of certain types of products (like drugs) …

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 …

“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 …

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 …

Reserve System Design For Allocation Of Scarce Medical Resources In A Pandemic: Some Perspectives From The Field, Parag A. Pathak, Govind C. Persad, Tayfun Sönmez, M. Utku Unver

Sturm College of Law: Faculty Scholarship

No abstract provided.

Commentary On Reynolds V. Mcnichols, Aziza Ahmed

Faculty Scholarship

The 1973 case Reynolds v McNichols concerns a woman who was repeatedly arrested on suspicion of and for “prostitution.” During these arrests, Roxanne Reynolds, the defendant, was subject to forced examination and treatment. The arrests and examinations were authorized by Section 735 of the Revised Municipal Code of the City and County of Denver, which directed the Department of Health and Hospitals “to use every available means to ascertain the existence of and investigate all suspected cases of communicable venereal disease, and to determine the sources of such infections.” Reynolds argued that the ordinance was unconstitutional because it was irrational, …

Why Money Is Well Spent On Time, Michael Ulrich

Faculty Scholarship

There are a few reasons why incentivizing clinicians to spend more time with patients can improve health outcomes. Doing so affords clinicians time to assess social determinants’ influences on their patients’ health experiences; offers opportunities to identify and respond to patients’ loneliness; and helps motivate patients’ trust in health care, strengthen patient-clinician relationships, and bolster patients’ adherence to clinicians’ recommendations.

Worker Participation In A Time Of Covid: A Case Study Of Occupational Health And Safety Regulation In Ontario, Alan Hall, Eric Tucker

Articles & Book Chapters

This study examines worker voice in the development and implementation of safety plans or protocols for covid-19 prevention among hospital workers, long-term care workers, and education workers in the Canadian province of Ontario. Although Ontario occupational health and safety law and official public health policy appear to recognize the need for active consultation with workers and labour unions, there were limited – and in some cases no – efforts by employers to meaningfully involve workers, worker representatives (reps), or union officials in assessing covid-19 risks and planning protection and prevention measures. The political and legal efforts of workers and unions …

Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs

Articles

Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and …

Brief Of Amici Curiae In Support Of Applicant' Application To Vacate The Injunction In Biden V. Nebraska, Jeffrey Lubbers

Amicus Briefs

Amici curiae are law professors at law schools around the nation. They respectfully move for leave to file the enclosed brief in support of Applicants' application to vacate the injunction entered by the United States Court of Appeals for the Eighth Circuit pending appeal of the preliminary injunction issued by the United States District Court for the Eastern District of Missouri, including leave to file without ten days' notice to the parties, as ordinarily required by this Court's Rule 37.2(a), and leave to file in 8½-by-11-inch format, as provided in Rule 33.2.

Sunshine Laws Behind The Clouds: Limited Transparency In A Time Of National Emergency, Ira P. Robbins

Articles in Law Reviews & Other Academic Journals

The COVID-19 pandemic dramatically changed the way citizens lived their lives, businesses operated, and governments functioned. With most people forced to stay home, the pandemic also disrupted how people received their news and other essential information. Public records and public meetings had to adapt to face the growing challenges in a locked-down world. While some governmental bodies were able to keep up with the threat that COVID-19 posed against transparency, others either failed to acclimate to the new normal or actively took advantage of the circumstances to limit how much the public knew not only about the crisis, but about …

Advocates’ Perspectives On The Canadian Prison Mother Child Program, Martha Paynter, Clare Heggie, Ruth Martin-Misener, Adelina Iftene, Gail Tomblin Murphy

Articles, Book Chapters, & Popular Press

Over twenty years ago, Correctional Services Canada launched the Mother Child Program (MCP) to mitigate harms of separating incarcerated mothers from their babies. It has never been subjected to internal evaluation or independent study. The aim of the qualitative study was to explore the experiences of advocates employed by Elizabeth Fry Societies (EFS), community organizations dedicated to the support of incarcerated women, with respect to supporting people who were pregnant or had young children while federally incarcerated and did or did not participate in the MCP.

Newsletter, Fall 2022

Newsletter

No abstract provided.

Segmented Innovation In The Legalization Of Mitochondrial Transfer: Lessons From Australia And The United Kingdom, Myrisha S. Lewis

Faculty Publications

The U.S. is often characterized as a leader in innovation—a home of Nobel Prize‐winning scientists, innovators, and abundant research funding. Yet, in the area of assisted reproduction combined with genetic modification or substitution, what I call “reproductive genetic innovation,” that characterization begins to wane. This Article focuses on the regulation of mitochondrial transfer, a subset of reproductive genetic innovation. While human clinical trials related to mitochondrial transfer go forward in the U.K., the clinical use of the technique remains illegal in the U.S. due to a system of subterranean regulation by the U.S. Food and Drug Administration and a now-recurring …

A Copernican View Of Health Care Antitrust, William M. Sage, Peter J. Hammer

Faculty Scholarship

Sage and Hammer use the analogy of Copernican astronomy to suggest that understanding the dramatic change wrought by managed care requires a conceptual reorientation regarding the meaning of competition in health care and its appropriate legal and regulatory oversight. Both share the belief that misperceiving the world limits potential for technical and social progress.

Transgender Rural Communities And Legal Rights To Gender-Affirming Health Care, Valarie K. Blake, Nathan R. Hamons

Scholarly Works

No abstract provided.

The Academic Medical-Legal Partnership: Training The Next Generation Of Health & Legal Professionals To Work Together To Advance Health Justice, Vicki W. Girard, Deborah F. Perry, Lisa P. Kessler, Yael Cannon, Prashasti Bhatnagar, Jessica Roth

Georgetown Law Faculty Publications and Other Works

As the national medical-legal partnership (MLP) movement grows, the need for doctors, nurses, social workers, other health professionals, and lawyers who have the knowledge, skills, and experience to collaborate effectively in this holistic healthcare approach is increasing. Given the unique role that institutions of higher education play in training students as they develop their professional identities, members of the Georgetown University Health Justice Alliance sought to build on prior efforts to define the MLP model by focusing on MLPs that exist in academic settings as a specific type of MLP. This report is based on the results of an environmental …

Medicaid Expansion Expectations, Deborah Farringer

Law Faculty Scholarship

Although financial stability in rural hospitals has been a relatively long-standing national problem, in the last decade, hospital closures and the incidence of highly distressed hospitals in rural areas have disproportionately impacted certain states. States that have not expanded their Medicaid programs under the Affordable Care Act, which implemented a program to extend additional federal support to cover adults living below 138% of the federal poverty line (referred to herein as “Medicaid Expansion”), are bearing the brunt of this crisis. Although the reason for hospital closures is multi-faceted and complex, health policy experts have consistently identified the lack of Medicaid …

Race And Regulation Podcast Episode 8 - Vaccination Equity By Design, Olatunde C. Johnson

Penn Program on Regulation Podcasts

Racial disparities have occurred in COVID-19’s health effects and fatalities. They have persisted through the rollout of COVID-19 vaccines too, which saw a greater uptake in socioeconomically privileged segments of the population. These outcomes did not have to occur. Olatunde Johnson of Columbia Law School discusses how regulators could have made different policy design choices to promote greater equity in the vaccine rollout—and she draws key lessons not only for the next public health emergency but also for improving racial equity more generally.

A Multicenter Weighted Lottery To Equitably Allocate Scarce Covid-19 Therapeutics, Douglas B. White, Erin K. Mccreary, Chung-Chou H. Chang, Mark Schmidhoffer, J. Ryan Bariola, Naudia N. Jonassaint, Govind C. Persad, Robert D. Truog, Parag A. Pathak, Tayfun Sönmez, M. Utku Unver

Sturm College of Law: Faculty Scholarship

Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need. Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oralantiviral Paxlovid.

Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend …

Antiabortion Civil Remedies And Unwed Fatherhood As Genetic Entitlement, Yvonne F. Lindgren

Faculty Works

Antiabortion civil remedy laws in effect in five states grant putative fathers the right to sue abortion providers for wrongful death regardless of their relationship to the gestating parent. While these laws represent an important new development in the movement to restrict the abortion right, they also expand parental recognition of unwed fathers. Constitutional law requires that unwed fathers who seek to assert parental rights must establish that they possess both biological connection and a relationship with their child or the gestating parent—what has come to be known as “biology-plus.” However, antiabortion civil remedy laws vest parental recognition and rights …

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 …

Can Moral Framing Drive Insurance Enrollment In The Us?, Christopher Robertson, Wendy Netter Epstein, David Yokum, Hansoo Ko, Kevin Wilson, Monica Ramos, Katherine Kettering, Margaret Houtz

Faculty Scholarship

To encourage health insurance uptake, marketers and policymakers have focused on consumers’ economic self-interest, attempting to show that insurance is a good deal or to sweeten the deal, with subsidies or penalties. Still, some consumers see insurance as a bad deal, either because they rationally exploit private risk information (“adverse selection”), or irrationally misperceive the value due to cognitive biases (e.g., optimism). As a result, about 30 million Americans remain uninsured, including many who could afford it.

At the same time, polling suggests that Americans view health insurance through a moral lens, seeking to protect those with pre-existing conditions especially. …

What Nations Owe Each Other Before The Next Pandemic, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach, Kashish Aneja

Georgetown Law Faculty Publications and Other Works

On December 1, 2021, the World Health Assembly adopted a resolution establishing an Intergovernmental Negotiating Body (INB) to determine the content and form of a new pandemic agreement. A portion of the public has advocated for a non-binding agreement while others stress that nationalism should be prevented, with steps taken to monitor and enforce national compliance. The INB has needed to grapple with how the principle of national sovereignty, and the accompanying principle of non-interference, will be addressed with respect to the agreement’s content and form, including obligations to share data, resources, and personnel, and to relinquish control over certain …

The End Of Roe V Wade And New Legal Frontiers On The Constitutional Right To Abortion, I. Glenn Cohen, Melissa Murray, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On June 24, 2002, the US Supreme Court ended the constitutional right to abortion in Dobbs v Jackson Women’s Health Organization. The Court’s majority decision authored by Justice Samuel Alito was substantially the same as a draft opinion leaked a month earlier. The regulation of abortion will now be decided by the states, with about half currently or will soon ban or severely restrict abortion access. In this Viewpoint, we explain the Dobbs ruling and what it means for physicians, public health, and society.

We focus on new legal frontiers in the constitutional right to abortion, including medication abortion …

Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher

Penn Program on Regulation Podcasts

As mandated by the U.S. Food and Drug Administration, clinical trials for new pharmaceuticals enroll healthy people as paid research participants to test for drug safety and tolerability. But the social injustices from these trials are too often overlooked. Drawing on her award-winning book, Adverse Events, Jill Fisher of UNC-Chapel Hill’s Center for Bioethics explains how clinical drug trials attract disproportionate participation by racial and ethnic minorities who then disproportionately assume risks of participating in these trials, often just to stay financially afloat.

No-One Receives Psychiatric Treatment In A Squad Car, Judy A. Clausen, Joanmarie Davoli

Faculty Scholarship

No abstract provided.

Sidelined Again: How The Government Abandoned Working Women Amidst A Global Pandemic, Jessica K. Fink

Faculty Scholarship

Among the weaknesses within American society exposed by the COVID pandemic, almost none has emerged more starkly than the government’s failure to provide meaningful and affordable childcare to working families—and, in particular, to working women. As the pandemic unfolded in the spring of 2020, state and local governments shuttered schools and daycare facilities and directed nannies and other babysitters to “stay at home.” Women quickly found themselves filling this domestic void, providing the overwhelming majority of childcare, educational support for their children, and management of household duties, often to the detriment of their careers. As of March 2021, more than …

Reforming Age Cutoffs, Govind C. Persad

Sturm College of Law: Faculty Scholarship

This Article examines the use of minimum age cutoffs to define eligibility for social insurance, public benefits, and other governmental programs. These cutoffs are frequently used but rarely examined in detail. In Part I, I examine and catalogue policies that employ minimum age cutoffs. These include not only Medicare and Social Security but also other policies such as access to pensions and retirement benefits, eligibility for favorable tax treatment, and eligibility for discounts on governmentally provided goods and services. In Part II, I examine different rationales underlying eligibility and discuss the imperfect fit between these rationales and the use of …