Law Commons^™

The Nih-Moderna Vaccine: Public Science, Private Profit, And Lessons For The Future, Christopher J. Morten

Faculty Scholarship

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

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, …

When Desperate Patients Go To Court For Unproven Treatments - The Battle For Hospital Independence, Christopher Robertson, Margaret Houtz

Faculty Scholarship

As the Covid-19 pandemic wears on, patients have asked courts to compel hospitals to administer unproven therapies, with mixed legal results. Although talk radio hosts, politicians, and social media users have promoted various treatment approaches, they have given particular attention to ivermectin. The Food and Drug Administration (FDA) has approved ivermectin for use in humans for treating onchocerciasis (river blindness), intestinal strongyloidiasis, certain other parasitic worms, head lice, and skin conditions such as rosacea. Although this approval facilitates legal offlabel use for prophylaxis against or treatment of other conditions, both the FDA and the Centers for Disease Control and Prevention …

Menstrual Dignity And The Bar Exam, Marcy L. Karin, Margaret E. Johnson, Elizabeth B. Cooper

Faculty Scholarship

This Article examines the issue of menstruation and the administration of the bar exam. Although such problems are not new, over the summer and fall of 2020, test takers and commentators took to social media to critique state board of law examiners’ (“BOLE”) policies regarding menstruation. These problems persist. Menstruators worry that if they unexpectedly bleed during the exam, they may not have access to appropriately sized and constructed menstrual products or may be prohibited from accessing the bathroom. Personal products that are permitted often must be carried in a clear, plastic bag. Some express privacy concerns that the see-through …

Race, Risk, And Personal Responsibility In The Response To Covid-19, Aziza Ahmed, Jason Jackson

Faculty Scholarship

The COVID-19 crisis has tragically revealed the depth of racial inequities in the United States. This Piece argues that the disproportion­ate impact of the pandemic on racial minorities is a symptom of a failing approach to public health, one that privileges individual behaviors over the structural conditions that generate vulnerability and inequitable health outcomes. Despite clear racial disparities in illness and deaths, the neoliberal ideology of personal responsibility shifts the onus for mitigation of risk away from the social and legal determinants of health and onto the individual. To understand how and why these disparate racial outcomes arise, this Piece …

Making America A Better Place For All: Sustainable Development Recommendations For The Biden Administration, John C. Dernbach, Scott E. Schang, Robert W. Adler, Karol Boudreaux, John Bouman, Claire Babineaux-Fontenot, Kimberly Brown, Mikhail Chester, Michael B. Gerrard, Stephen Herzenberg, Samuel Markolf, Corey Malone-Smolla, Jane Nelson, Uma Outka, Tony Pipa, Alexandra Phelan, Leroy Paddock, Jonathan D. Rosenbloom, William Snape, Anastasia Telesetsky, Gerald Torres, Elizabeth Ann Kronk Warner, Audra Wilson

Faculty Scholarship

In 2015, the United Nations Member States, including the United States, unanimously approved 17 Sustainable Development Goals (SDGs) to be achieved by 2030. The SDGs are nonbinding; each nation is to implement them based on its own priorities and circumstances. This Article argues that the SDGs are a critical normative framework the United States should use to improve human quality of life, freedom, and opportunity by integrating economic and social development with environmental protection. It collects the recommendations of 22 experts on steps that the Biden-Harris Administration should take now to advance each of the SDGs. It is part of …

Antibiotic Development & Economic, Regulatory And Societal Challenges, Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, John Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Capitalizing On Healthy Lawyers: The Business Case For Law Firms To Promote And Prioritize Lawyer Well-Being, Jarrod F. Reich

Faculty Scholarship

This Article is the first to make the business case for firms to promote and prioritize lawyer well-being. For more than three decades, quantitative research has demonstrated that lawyers suffer from depression, anxiety, and addiction far in excess of the general population. Since that time, there have been many calls within and outside the profession for changes to be made to promote, prioritize, and improve lawyer well-being, particularly because many aspects of the current law school and law firm models exacerbate mental health and addiction issues, as well as overall law student and lawyer distress. These calls for change, made …

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Learned Hand And The Objective Theory Of Contract Interpretation, Daniel P. O'Gorman

Faculty Scholarship

No abstract provided.

A Perspective On Incentives For Novel Inpatient Antibiotics: No One-Size-Fits-All, Kevin Outterson

Faculty Scholarship

The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.

Women Of Color And Health: Issues And Solutions, June Cross, Nia Weeks, Kristen Underhill, Chloe Bootstaylor

Faculty Scholarship

Chloe Bootstaylor: Welcome to our second panel. This panel focuses on women of color in health, issues, and solutions. The session is inspired by Professor June Cross of the Columbia School of Journalism and her recent film, Wilhemina’s War, which follows the story of Wilhemina Dixon and depicts the obstacles that Americans with HIV/AIDS face in accessing not only adequate healthcare but also financial, infrastructural, and social support in their communities.

This panel will consist of Professor Underhill and Nia Weeks. June Cross will join us a little later on. We will start with a clip from her film, …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

An International Legal Framework To Address Antimicrobial Resistance, Kevin Outterson, Steven J. Hoffman, John-Arne Rottingen, Otto Cars, Charles Clift, Fiona Rotberg, Göran Tomson, Anna Zorzet, Zain Rizvi

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Challenges For People With Disabilities Within The Health Care Safety Net, Michael Ulrich

Faculty Scholarship

Medicare and Medicaid were passed to serve as safety nets for the country's most vulnerable populations, yet, the disabled community continues to be one whose health care needs are not being met. This group is all too frequently left to suffer health disparities due to cultural incompetency, stigma and misunderstanding, and an inability to create policy changes that covers the population as a whole and their acute and long-term needs.

Trafficked? Aids, Criminal Law And The Politics Of Measurement, Aziza Ahmed

Faculty Scholarship

Since early in the HIV epidemic, epidemiologists identified individuals who transact sex as a high-risk group for contracting HIV. Where the issue of transacting sex has been framed as sex work, harm-reduction advocates and scholars call for decriminalization as a primary legal solution to address HIV. Where the issue is defined as trafficking, advocates known as abolitionists argue instead for the criminalization of the purchase of sex.

Global health governance institutions are porous to these competing ideas and ideologies. This article first historicizes the contestation between harm-reduction and abolition in global governance on health. The paper then turns to a …

Children's Health In A Legal Framework, Elizabeth S. Scott, Clare Huntington

Faculty Scholarship

The interdisciplinary periodical Future of Children has dedicated an issue to children’s health policy. This contribution to the issue maps the legal landscape influencing policy choices. The authors demonstrate that in the U.S. legal system, parents have robust rights, grounded in the Constitution, to make decisions concerning their children’s health and medical treatment. Following from its commitment to parental rights, the system typically assumes the interests of parents and children are aligned, even when that assumption seems questionable. Thus, for example, parents who would limit their children’s access to health care on the basis of the parents’ religious belief have …

With Liberty And Access For Some: The Aca's Disconnectfor Women's Health, Nicole Huberfeld

Faculty Scholarship

The ACA denies to women the "basic security" of providing insurance for a procedure that statistics show one in three women will need during their reproductive lifetime. On one hand, the access-enhancing elements of the ACA are likely to help women, who earn lower wages, need more medical care, and live longer than men, to gain access to preventive and regular healthcare and to keep the insurance that they have. On the other hand, poor women and women of color will lose ground in access to abortion, because the ACA prevents insurance payment for abortions through both public and private …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale, Elizabeth A. Reilly, Jeffery Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

“Rugged Vaginas” And “Vulnerable Rectums”: The Sexual Identity, Epidemiology, And Law Of The Global Hiv Epidemic, Aziza Ahmed

Faculty Scholarship

AIDS remains amongst the leading causes of death globally. Identity is the primary mode of understanding HIV and organizing in response to the HIV epidemic. In this Article, I examine how epidemiology and human rights activism co-produce ideas of identity and risk. I call this the "identity/risk narrative ": the commonsense understanding about an identity group's HIV risk. For example, epidemiology offers the biological narrative of risk: anal sex and the weak rectal lining make men who have sex with men more vulnerable to HIV; while the fragility of a woman's vaginal wall provides a biological foundation for women's vulnerability. …

Comment: Emerging Epa Regulation Of Pharmaceuticals In The Environment, Gabriel Eckstein

Faculty Scholarship

The May 25, 2012, report — entitled EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal — disapproved of EPA’s lack of progress in determining whether certain pharmaceuticals found in surface, ground, and drinking water qualify as hazardous waste, as well as in establishing an evaluation and regulatory process for pharmaceutical wastes. As a result of the report, EPA is now considering mechanisms for assessing and regulating the presence of certain pharmaceutical products in the environment as hazardous wastes under the Resource Conservation and Recovery Act.

“We Have The Right Not To Be Rescued...”: When Anti-Trafficking Programmes Undermine The Health And Well-Being Of Sex Workers, Aziza Ahmed, Meena Seshu

Faculty Scholarship

This paper highlights the impact of raid, rescue, and rehabilitation schemes on HIV programmes. It uses a case study of Veshya Anyay Mukti Parishad (VAMP), a sex workers collective in Sangli, India, to explore the impact of anti-trafficking efforts on HIV prevention programmes. The paper begins with an overview of the anti-trafficking movement emerging out of the United States. This U.S. based antitrafficking movement works in partnership with domestic Indian antitrafficking organisations to raid brothels to “rescue and rehabilitate” sex workers. Contrary to the purported goal of assisting women, the anti-trafficking projects that employ a raid, rescue, and rehabilitate model …

The Truth About Regulation In America, Rena I. Steinzor

Faculty Scholarship

The special interests leading the accelerating crusade against regulation have re-ignited a potent coalition of industry lobbyists, traditional conservatives, and grassroots Tea Party activists. The politicians speak in generic terms for public consumption: “the nation is broke,” “big government is bad,” “regulation costs trillions.” Behind the scenes, industry lobbyists target for repeal dozens of regulations that are designed to control pollution, ensure drug, product, and food safety, and eliminate workplace hazards. In an effort to bring light and air to an often misleading and always opportunistic national debate, this essay presents five truths about the state of health, safety, and …

Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson

Faculty Scholarship

In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.

Feminism, Power, And Sex Work In The Context Of Hiv/Aids: Consequences For Women's Health, Aziza Ahmed

Faculty Scholarship

This paper examines the involvement of feminists in approaches to sex work in the context of HIV/AIDS. The paper focuses on two moments where feminist disagreement produced results in favor of an "anti-trafficking" approach to addressing the vulnerability of sex workers in the context of HIV. The first is the UNAIDS Guidance Note on Sex Work and the second is the "anti-prostitution pledge" found in the Presidents Emergency Plan for AIDS Relief. This article also examines the anti-sex work position articulated by abolitionist feminists and demonstrates the unintended consequences of the abolitionist position on women's health. By examining the actual …

Smoking And The First Amendment, Kevin Outterson

Faculty Scholarship

On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law. For the first time, Congress had given the Food and Drug Administration (FDA) authority to directly regulate tobacco products, with the aim of improving public health. And indeed, effective tobacco control would be a remarkable public health achievement — and might be possible if the law is allowed to stand. But on November 7, 2011, a federal judge in Washington, D.C., issued a preliminary injunction blocking some of its key provisions as unconstitutional restrictions on commercial speech, and the battle seems likely …

Human Rights And Intellectual Property: Mapping The Global Interface, Laurence R. Helfer, Graeme W. Austin

Faculty Scholarship

Human Rights and Intellectual Property: Mapping the Global Interface explores the intersections between intellectual property and human rights law and policy. The relationship between these two fields has captured the attention of governments, policymakers, and activist communities in a diverse array of international and domestic political and judicial venues. These actors often raise human rights arguments as counterweights to the expansion of intellectual property in areas including freedom of expression, public health, education, privacy, agriculture, and the rights of indigenous peoples. At the same time, the creators and owners of intellectual property are asserting a human rights justification for the …