Law Commons^™

Brief For Amici Curiae Legal Scholars Supporting Respondent, Nicole Huberfeld, Timothy S. Jost, Linda C. Mcclain, Wendy E. Parmet, Erwin Chemerinsky, Elizabeth Mccuskey, Danielle Pelfrey Duryea, Gabriel Scheffler, George J. Annas

Faculty Scholarship

QUESTION PRESENTED: Whether the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, preempts Idaho law in the narrow but important circumstance where terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health but the State prohibits an emergency-room physician from providing that care.

Against Bankruptcy: Public Litigation Values Versus The Endless Quest For Global Peace In Mass Litigation, Abbe Gluck, Elizabeth Chamblee Burch, Adam Zimmerman

Scholarly Works

Can bankruptcy court solve a public health crisis? Should the goal of “global peace” in complex lawsuits trump traditional litigation values in a system grounded in public participation and jurisdictional redundancy? How much leeway do courts have to innovate civil procedure?

These questions have finally reached the Supreme Court in Harrington v. Purdue Pharma L.P., the $6 billion bankruptcy that purports to achieve global resolution of all current and future opioids suits against the company and its former family owners, the Sacklers. The case provides a critical opportunity to reflect on what is lost when parties in mass torts find …

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 …

Patients Versus Profits, Isaac ("Zack") D. Buck

Scholarly Works

Private equity (PE) has come to health care. With it: layoffs, cuts, and new pressures for providers, higher prices for payers, and questions from patients about quality and excessive care. PE firms, driven solely by a profit motive, take over health care entities, “lean” them down, load them with debt, and hope to extract a profit for their investors when they sell the hospital, physician group, or nursing home. Their entry into health care has been stealthy but dramatic: upwards of a third of all for-profit hospitals in the United States, and 40 percent of America’s emergency rooms, are now …

Defining Health Affordability, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Affordable health care, insurance, and prescription drugs are priorities for the public and for policymakers. Yet the lack of a consensus definition of health affordability is increasingly recognized as a roadblock to health reform efforts. This Article explains how and why American health law invokes health affordability and attempts, or fails, to define the concept. It then evaluates potential affordability definitions and proposes strategies for defining affordability more clearly and consistently in health law.

Part I examines the role health affordability plays in American health policy, in part by contrasting the United States’s health system with systems elsewhere. Part II …

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 …

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 …

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 …

Sanitation: Reducing The Administrative State’S Control Over Public Health, Lauren R. Roth

Scholarly Works

On April 18, 2022, in Health Freedom Defense Fund, Inc. v. Biden, United States District Judge Kathryn Kimball Mizelle vacated the mask mandate issued by the Centers for Disease Control and Prevention. Following a framework laid out in other decisions restricting CDC actions in response to COVID-19, the court found that the agency lacked statutory authority to protect the public from the virus by requiring mask wearing during travel and at transit hubs because Congress did not intend such a broad grant of power. Countering decades of public health jurisprudence, the federal district court failed to defer to experts and …

The Who’S 75th Anniversary: Who At A Pivotal Moment In History, Lawrence O. Gostin, Danwood Mzikenge Chirwa, Helen Clark, Roojin Habibi, Björn Kümmel, Jemilah Mahmood, Benjamin Mason Meier, Winnie Mpanju-Shumbusho, K. Srinath Reddy, Attiya Waris, Miriam Were

Georgetown Law Faculty Publications and Other Works

The World Health Organisation (WHO) was inaugurated in 1948 to bring the world together to ensure the highest attainable standard of health for all. Establishing health governance under the United Nations (UN), WHO was seen as the preeminent leader in public health, promoting a healthier world following the destruction of World War II and ensuring global solidarity to prevent disease and promote health. Its constitutional function would be ‘to act as the directing and coordinating authority on international health work’. Yet today, as the world commemorates WHO’s 75th anniversary, it faces a historic global health crisis, with governments presenting challenges …

Reevaluating Regional Law Reform Strategies After Dobbs, Jamie Abrams

Articles in Law Reviews & Other Academic Journals

This article studies the triad of 2016 social media campaigns known as “#AskDr.Kasich,” “#askbevinaboutmyvag,” and “#PeriodsforPence.” While these campaigns, each located in the regional mid-South, were motivated by restrictive state abortion bills, they uniquely positioned menstruation and women’s bodies at the center of their activism—not abortion alone. They leveraged, as a political fault line, the contradiction of these states’ governors’ perceived disgust relating to basic women’s reproductive health, relative to their patriarchal assuredness in regulating and controlling women’s bodies.

In so doing, they tapped into meaningful disruptions in the geographies, religiosities, and masculinities of abortion politics. These campaigns achieved regional …

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.

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. …

Addressing Stigma And False Beliefs About Mental Health: A New Direction For Mental Health Parity Advocacy, Claire Sontheimer, Michael Ulrich

Faculty Scholarship

Despite laws designed to protect mental health and substance use parity in the United States, real parity remains an aspiration. Under the current system, insurance companies use multiple tactics to deny coverage for or delay the provision of mental health and substance use disorder (MH/SUD) treatment. The difficulty of enforcing parity creates a barrier to achieving the goal of accessible behavioral health services. Rather than a continued effort to legislate our way out of this conundrum, it may be useful to look further upstream. Critical impediments to achieving such parity include the basic attitudes and beliefs about mental and behavioral …

What The Harm Principle Says About Vaccination And Healthcare Rationing, Christopher Robertson

Faculty Scholarship

Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated …

Interjurisdictional Abortion Wars In The Post-Roe Era, Maya Manian

Articles in Law Reviews & Other Academic Journals

The Supreme Court appears poised to overrule fifty years of precedent holding that pre-viability prohibitions on abortion are unconstitutional. In a leaked draft opinion of Dobbs v. Jackson Women Health Organization, Justice Alito proclaims that Roe v. Wade and Planned Parenthood v. Casey must be overruled and abortion left to the states to regulate. During oral argument in Dobbs, Justice Kavanaugh suggested that overturning Roe would return the Court to a postion of "neutrality" on abortion. Justice Kavanaugh's assertion falls in line with claims by anti-abortion jurists that reversing Roe would simplify abortion law by returning the issue to the …

Sociotechnical Safeguards For Genomic Data Privacy, Ellen W. Clayton, Zhiyu Wan, Et Al.

Vanderbilt Law School Faculty Publications

Recent developments in a variety of sectors, including health care, research and the direct-to-consumer industry, have led to a dramatic increase in the amount of genomic data that are collected, used and shared. This state of affairs raises new and challenging concerns for personal privacy, both legally and technically. This Review appraises existing and emerging threats to genomic data privacy and discusses how well current legal frameworks and technical safeguards mitigate these concerns. It concludes with a discussion of remaining and emerging challenges and illustrates possible solutions that can balance protecting privacy and realizing the benefits that result from the …

E-Racing Tobacco & Nicotine-Related Health Disparities, Michael Ulrich

Faculty Scholarship

In the past, tobacco companies used targeted advertising to integrate menthol cigarettes and addict the Black community, generating tobacco-related health disparities. As Juul has come under attack, they have utilized the tobacco playbook to protect itself and deflect criticism by donating to a historically Black medical school and recruiting leaders in the Black community. This helped to create a "Black shield" for menthol cigarettes, which are only now at risk of being regulated, and has the potential to do the same in the vape industry. If proactive steps are not undertaken, health tobacco-related health disparities will continue.

Quarantine, Isolation, And Metaphorical Takings: Balancing Individual Rights And Public Health Responses To Disease Outbreaks, Thomas Williams

Articles in Law Reviews & Other Academic Journals

Quarantine and isolation are methods employed by public health officials to control the spread of dangerous disease pathogens through physical isolation of those exposed or symptomatic. While use of these methods has declined in the last century through advances in medical knowledge and treatment, emerging disease threats will likely require increased reliance on them. Despite this, quarantine statutes and related regulations fail to provide compensation to those subject to them, and little recourse exists to make those individuals whole for losses incurred, though the pandemic has highlighted a need for work in this area. One means of shifting the burden …

Adding Principle To Pragmatism: The Transformative Potential Of "Medicare-For-All" In Post-Pandemic Health Reform, William M. Sage

Faculty Scholarship

“Medicare-for-All” should be more than a badge of political identity or opposition. This Article examines the concept’s potential to catalyze policy innovation in the U.S. health care system. After suggesting that the half century of existing Medicare has been as much “Gilded Age” as “Golden Age,” the Article arrays the operational possibilities for a Medicare-for-All initiative. It revisits America’s recent history of pragmatic rather than principled health policy, and identifies professional and political barriers to more sweeping reform. It focuses on four aspects of health policy that have become apparent: simultaneous inefficiency and injustice in medical care, neglect of the …

Social Justice, Civil Rights, And Bioethics, Kathy Cerminara

Faculty Scholarship

A stunning confluence of events in the United States in the first few months of 2020 have illustrated pervasive systemic prejudice against vulnerable people resulting in increased risk of death. Combined and situated among other, similar incidents too numerous to mention here, they present an opportunity for bioethicists to help change the impact of implicit bias, white privilege, and prejudice in shaping the very ability to live a healthy life in America. The current lack of care and even outright cruelty rendering a variety of vulnerable populations susceptible to early death illustrate why there must be more attention paid to …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

All Faculty Scholarship

Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Post-Pandemic Privacy Law, Tiffany C. Li

Law Faculty Scholarship

COVD-19, the global pandemic that began in 2019, altered how we live our lives in just about every way imaginable. Some of those changes were obvious-for example, those who were fortunate enough to be able to work from home began working online-while other changes were more subtle. The latter category included unprecedented levels of data collection by governments and organizations purporting to collect information that would help stop the pandemic's spread. Given the deadly nature of COVID-19, few would question any public health efforts, no matter their impact on privacy. However, the lack of attention to privacy issues during the …

One Child Town: The Health Care Exceptionalism Case Against Agglomeration Economies, Elizabeth Weeks

Scholarly Works

This Article offers an extended rebuttal to the suggestion to move residents away from dying communities to places with greater economic promise. Rural America, arguably, is one of those dying places. A host of strategies aim to shore up those communities and make them more economically viable. But one might ask, “Why bother?” In similar vein, David Schleicher’s provocative 2017 Yale Law Journal article, Stuck! The Law and Economics of Residential Stagnation urged dismantling a host of state and local government laws operating as barriers to migration by Americans from failing economies to robust agglomeration economies. But Schleicher said little …

A Code Of Ethics For Gene Drive Research, George J. Annas, Chase L. Beisel, Kendell Clement, Andrea Crisanti, Stacy Francis, Marco Galardini, Roberto Galizi, Julian Grunewald, Greta Immobile, Ahmad S. Khalil, Ruth Muller, Vikram Pattanayak, Karl Petri, Ligi Paul, Luca Pinello, Alekos Simoni, Chrysanthi Taxiarchi, J. Keith Joung

Faculty Scholarship

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species. At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery. A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest …

Identifying Meaningful Dietary Intake And Physical Activity Questions For Individual And Population Health, Jennifer Bennett Shinall, David G. Schlundt, Et Al.

Vanderbilt Law School Faculty Publications

We aimed to identify valid screening questions for adults regarding physical activity and dietary behaviours that (a) were correlated with BMI, (b) were deemed by patients and providers to be relevant to clinical care, and (c) have utility for longitudinal understanding of health behaviours in populations. The goal was to identify screening questions that could be implemented at annual health care visits. First, we identified dietary behaviour questions and solicited patient input. Next, we tested both physical activity and dietary behaviour questions in a large sample to test their potential utility. Finally, we used cognitive interviews with patients and physicians …

Video; Health Law & Ethics 2020, Kathy Cerminara, Jonathan Kroner Law Office, Mcdermott Will & Emery Llp, Lubell & Rosen, Gerald M. Morris

NSU Law Seminar Series

This program will focus on the current climate of health law and the necessary steps used through federal practice to adjust to the ever-changing atmosphere of new legislation. Attendees will learn about the various paths within the practice, about emerging new laws, outreach and training, and how to become involved in the federal practice of health law. The presenters will explain what you need to get started, what different types of experiences and exposure might be helpful in entering the field and instruct you on maintaining ethics by knowing and following the Federal Rules of Civil Procedure and Model Rules …

Tuberculosis, Human Rights, And Law Reform: Addressing The Lack Of Progress In The Global Tuberculosis Response, Matthew M. Kavanagh, Lawrence O. Gostin, John Stephens

Georgetown Law Faculty Publications and Other Works

In 2018, the United Nations General Assembly convened the first-ever high-level meeting (HLM) on tuberculosis (TB). Since that time news on the world’s most lethal infectious disease is not good—the 2019 WHO TB report shows 1.2 million people died from TB, a number that has fallen just 11% since 2015, less than one-third of the way towards the End TB Strategy milestone of a 35% reduction (to about 850 million deaths) by 2020. The same number of people, 10.0 million, are estimated to have fallen ill with TB in 2018 as in 2017. The stubborn persistence of TB is attributable …

Paying For Unapproved Medical Products, Kelly Mcbride Folkers, Alison Bateman-House, Christopher Robertson

Faculty Scholarship

This symposium article examines the use of investigational (un-approved) medical products in the United States, with particular focus on who pays for this use. In the United States, the question of who pays for the use of approved medical products for their intended indications is complicated enough, with some expenses borne by private payers, some by public payers, some covered as charity care, and some paid out of pocket by patients. A separate question is off-label use, in which an approved medical product is used for an unapproved indication. In this article, we focus on a narrower issue: what entities …

Setting The Standard: Multidisciplinary Hallmarks For Structural, Equitable And Tracked Antibiotic Policy, Kevin Outterson, Claas Kirchhelle, Paul Atkinson, Alex Broom, Komatra Chuengsatiansup, Jorge Pinto Ferreira, Nicolas Fortané, Isabel Frost, Christoph Gradmann, Stephen Hinchliffe, Steven J. Hoffman, Javier Lezaun, Susan Nayiga, Scott H. Podolsky, Stephanie Raymond, Adam P. Roberts, Andrew C. Singer, Anthony D. So, Luechai Sringernyuang, Elizabeth Tayler, Susan Rogers Van Katwyk, Clare I. R. Chandler

Faculty Scholarship

There is increasing concern globally about the enormity of the threats posed by antimicrobial resistance (AMR) to human, animal, plant and environmental health. A proliferation of international, national and institutional reports on the problems posed by AMR and the need for antibiotic stewardship have galvanised attention on the global stage. However, the AMR community increasingly laments a lack of action, often identified as an ‘implementation gap’. At a policy level, the design of internationally salient solutions that are able to address AMR’s interconnected biological and social (historical, political, economic and cultural) dimensions is not straightforward. This multidisciplinary paper responds by …