Law Commons^™

Returning Integrated Genomic Risk And Clinical Recommendations: The Emerge Study, Ellen W. Clayton, Jodell E. Linder, Aimee Allworth, Sara T. Bland, 100 Others...

Vanderbilt Law School Faculty Publications

The potential of artificial intelligence (AI) to reduce health care disparities and inequities is recognized, but it can also exacerbate these issues if not implemented in an equitable manner. This perspective identifies potential biases in each stage of the AI life cycle, including data collection, annotation, machine learning model development, evaluation, deployment, operationalization, monitoring, and feedback integration. To mitigate these biases, we suggest involving a diverse group of stakeholders, using human-centered AI principles. Human-centered AI can help ensure that AI systems are designed and used in a way that benefits patients and society, which can reduce health disparities and inequities. …

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 …

“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 …

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 …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

The Ripple Effects Of Dobbs On Health Care Beyond Wanted Abortion, Maya Manian

Articles in Law Reviews & Other Academic Journals

The Supreme Court’s momentous decision in Dobbs v. Jackson Women’s Health Organization to overturn fifty years of precedent on the constitutional right to abortion represents a sea of change, not only in constitutional law, but also in the public health landscape. Although state laws on abortion are still evolving after Dobbs, the decision almost immediately wreaked havoc on the delivery of medical care for both patients seeking abortion care and those not actively seeking to terminate a pregnancy.

This Article also argues that focusing the public’s attention on the deleterious consequences of abortion bans for health care beyond wanted abortion …

The Promise Of Telehealth For Abortion, Greer Donley, Rachel Rebouché

Book Chapters

The COVID-19 pandemic catalyzed a transformation of abortion care. For most of the last half century, abortion was provided in clinics outside of the traditional healthcare setting. Though a medication regimen was approved in 2000 that would terminate a pregnancy without a surgical procedure, the Food & Drug Administration required, among other things, that the drug be dispensed in person. This requirement dramatically limited the medication’s promise to revolutionize abortion because it subjected medication abortion to the same physical barriers of procedural care.

Over the course of the COVID-19 pandemic, however, that changed. The pandemic’s early days exposed how the …

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 …

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

Law Student Publications

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …

Pandemic As Transboundary Harm: Lessons From The Trail Smelter Arbitration, Russell A. Miller

Scholarly Articles

The COVID-19 pandemic has caused incalculable harm around the world. The fact that this immense harm can be traced back to a localized outbreak in or near Wuhan, China, raises questions about the responsibility China might bear for the pandemic under public international law. Famously applied in the seminal Trail Smelter Arbitration (1938/1941), the Transboundary Harm Principle provides that no state can use or allow the use of its territory in a manner that causes significant harm in the territory of other states. This article does not intend to tap into the unseemly, xenophobic spirit that animates much of the …

Addiction And Liberty, Matthew B. Lawrence

Faculty Articles

This Article explores the interaction between addiction and liberty and identifies a firm legal basis for recognition of a fundamental constitutional right to freedom from addiction. Government interferes with freedom from addiction when it causes addiction or restricts addiction treatment, and government may protect freedom from addiction through legislation empowering individuals against private actors’ efforts to addict them without their consent. This Article motivates and tests the boundaries of this right through case studies of emergent threats to liberty made possible or exacerbated by new technologies and scientific understandings. These include certain state lottery programs, addiction treatment restrictions, and smartphone …

Climate Security Insights From The Covid-19 Response, Mark P. Nevitt

Faculty Articles

The climate change crisis and COVID-19 crisis are both complex collective action problems. Neither the coronavirus nor greenhouse gas (GHG) emissions respect political borders. Both impose an opportunity cost that penalizes inaction. They are also increasingly understood as nontraditional, novel security threats. Indeed, COVID-19’s human cost is staggering, with American lives lost vastly exceeding those lost in recent armed conflicts. And climate change is both a threat accelerant and a catalyst for conflict—a characterization reinforced in several climate-security reports. To counter COVID-19, the President embraced martial language, stating that he will employ a “wartime footing” to “defeat the virus.” Perhaps …

Shared Responsibility Payment May Be A Tax Entitled To Priority Under The Bankruptcy Code, Ashton Bryan

Bankruptcy Research Library

(Excerpt)

The Patient Protection and Affordability Care Act ("ACA") provides that certain individuals must maintain minimum essential health insurance coverage throughout the year. If a person under the mandate fails to maintain the required insurance for one month or more, a shared responsibility payment ("SRP") is imposed on the taxpayer. The SRP is collected by the Internal Revenue Service ("IRS").

The Tax Cuts and Jobs Act ("TCJA") eliminated the individual mandate and reduced the SRP to zero for 2019 and thereafter. The SRPs for 2018 and prior years must be reported to the IRS on the applicable tax return. Otherwise, …

Parens Patriae After The Pandemic, Meredith Johnson Harbach

Law Faculty Publications

The COVID-19 pandemic prompted extraordinary state action to protect American children. Acting in its longstanding role as parens patriae, the state stepped in to protect children and their families from the ravages of the pandemic as well as from the dramatic upheaval it precipitated. This Article will evaluate the state’s pandemic response vis-à-vis children and their families, mining the experience for lessons learned and possible ways forward. Specifically, this project will argue that the state’s pandemic response represented a departure from the state’s conventional approach to parens patriae. Conventional practice prior to the pandemic was characterized by a state model …

Increasing Compliance With International Pandemic Law: International Relations And New Global Health Agreements, Matthew M. Kavanagh, Clare Wenham, Elize Massard Da Fonseca, Laurence R. Helfer, Elvin Nyukuri, Allan Maleche, Sam F. Halabi, Adi Radhakrishnan, Attiya Waris

Faculty Scholarship

No abstract provided.

Dobbs In A Technologized World: Implications For Us Data Privacy, Jheel Gosain, Jason D. Keune, Michael S. Sinha

All Faculty Scholarship

In June of 2022, the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, overturning 50 years of precedent by eliminating the federal constitutional right to abortion care established by the Court’s 1973 decision in Roe v. Wade. The Dobbs decision leaves the decision about abortion services in the hands of the states, which created an immediately variegated checkerboard of access to women’s healthcare across the country. This in turn laid bare a profusion of privacy issues that emanate from our technologized world. We review these privacy issues, including healthcare data, financial data, website tracking and …

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

All Faculty Scholarship

As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

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 …

Masking Vulnerability: Including Ppe As A Covered Service In Health Insurance, Mary Leto Pareja

Faculty Scholarship

The COVID-19 pandemic laid bare the shared vulnerability inherent in the human condition, prompting a collective recognition of our physical susceptibility to infectious diseases. While great strides have been made in combating COVID-19 through vaccinations and treatments, a portion of the population remains profoundly vulnerable due to health conditions that make the disease more dangerous, that limit vaccine efficacy, or that prevent vaccination altogether. This article explores a path forward by proposing a solution within health benefit plans—encompassing both private health insurance and public health benefits. Specifically, the article advocates for a coverage mandate for over-the-counter personal protective equipment (PPE) …

Conditions Of Participation: Incorporating The History Of Hospital Desegregation, Sallie Sanford

Articles

Our students ought to know about the history of formal hospital segregation and desegregation. To that end, this article urges those who teach foundational health law and policy courses to do three things. First, to teach the Simkins case. Second, to swap out the usual Medicare signing ceremony picture for one that includes W. Montague Cobb, M.D., Ph.D. Third, to highlight how the implementation of that program for the elderly led, in a matter of months, to the desegregation of hospitals throughout the country.

Conditions Of Confinement In Nova Scotia Jails Designated For Men: East Coast Prison Justice Society Visiting Committee Annual Report 2021-2022, Sheila Wildeman, Harry Critchley, Hanna Garson, Laura Beach, Margaret-Anne Mchugh

Reports & Public Policy Documents

This is the second Annual Report of the East Coast Prison Justice Society (“ECPJS”) Visiting Committee (“VC”).

The purpose of the ECPJS VC is to bring increased accountability and transparency to the Nova Scotia correctional system in light of human rights standards, domestic and international. While the Elizabeth Fry Society of Mainland Nova Scotia provides human rights monitoring of conditions of incarceration experienced by women and non-binary people in federal prisons and provincial jails in the Atlantic region, and the federal Office of Correctional Investigator provides further oversight of conditions in federal prisons, there is no comparable independent oversight of …

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and …

'More Of The Same, But Worse Than Before': A Qualitative Study Of The Challenges Encountered By People Who Use Drugs In Nova Scotia, Canada During Covid-19, Emilie Comeau, Matthew Bonn, Sheila Wildeman, Matthew Herder

Articles, Book Chapters, & Popular Press

Background

To learn about the experiences of people who use drugs, specifically opioids, in the Halifax Regional Municipality (HRM), in Nova Scotia, Canada during the COVID-19 pandemic through qualitative interviews with people who use drugs and healthcare providers (HCP). This study took place within the HRM, a municipality of 448,500 people. During the pandemic many critical services were interrupted while overdose events increased. We wanted to understand the experiences of people who use drugs as well as their HCPs during the first year of the pandemic.

Methodology

We conducted a qualitative study using semi-structured interviews with 13 people who use …

National Federation Of Independent Business V. Sebelius, 567 U.S. 519 (2012), Elizabeth Weeks, Mary Ann Chirba, Alice A. Noble

Scholarly Works

In National Federation of Independent Business v. Sebelius, decided in 2012, twenty-six states as well as private individuals and an organization of independent businesses challenged the constitutionality of two key components of the Affordable Care Act. The Court upheld the individual mandate but converted the Medicaid eligibility expansion from mandatory to optional for states. Elizabeth Weeks’ feminist rewrite breaks down the public law-private law distinction to get beyond the traditional view of health insurance as a commercial product providing individual financial protection against risk and instead to view it as effecting a risk pool premised on cross-subsidization of the health-care …

Federalism And The Right To Travel: Medical Aid In Dying And Abortion, Leslie P. Francis, John Francis

Utah Law Faculty Scholarship

This article explores how rights to movement may limit state efforts to restrict abortions, either directly or indirectly. We use the language of “movement” to encompass short-term visits, longer-term residency changes, and the movement of goods or services across state lines. We prefer “movement” to “travel” or “tourism,” as this language risks trivializing the seriousness of what might be at stake. However, since “travel” is the term used in many U.S. court decisions and other discussions concerning the right,7 we use that term as relevant to these. The centerpiece of our defense is the relationship between freedom of movement and …

Considering Vaccination Status, Govind C. Persad

Sturm College of Law: Faculty Scholarship

"This Article examines whether policies—sometimes termed “vaccine mandates” or “vaccine requirements”— that consider vaccination status as a condition of employment, receipt of goods and services, or educational or other activity for participation are legally permitted, and whether such policies may even sometimes be legally required. It does so with particular reference to COVID-19 vaccines.

Part I explains the legality of private actors, such as employers or private universities, considering vaccination status, and concludes that such consideration is almost always legally permissible unless foreclosed by specific state legislation. Part II examines the consideration of vaccination status by state or federal policy. …

Fair Domestic Allocation Of Monkeypox Virus Countermeasures, Govind C. Persad, R. J. Leland, Trygve Ottersen, Henry S. Richardson, Carla Saenz, G. Owen Schaefer, Ezekiel J. Emanuel

Sturm College of Law: Faculty Scholarship

Countermeasures for mpox (formerly known as monkeypox), primarily vaccines, have been in limited supply in many countries during outbreaks. Equitable allocation of scarce resources during public health emergencies is a complex challenge. Identifying the objectives and core values for the allocation of mpox countermeasures, using those values to provide guidance for priority groups and prioritisation tiers, and optimising allocation implementation are important. The fundamental values for the allocation of mpox countermeasures are: preventing death and illness; reducing the association between death or illness and unjust disparities; prioritising those who prevent harm or mitigate disparities; recognising contributions to combating an outbreak; …

Public Health Product Hops, Michael S. Sinha

All Faculty Scholarship

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

How Ai Can Learn From The Law: Putting Humans In The Loop Only On Appeal, I. Glenn Cohen, Boris Babic, Sara Gerke, Qiong Xia,, Theodoros Evgeniou, Klaus Wertenbroch

Faculty Scholarly Works

While the literature on putting a “human in the loop” in artificial intelligence (AI) and machine learning (ML) has grown significantly, limited attention has been paid to how human expertise ought to be combined with AI/ML judgments. This design question arises because of the ubiquity and quantity of algorithmic decisions being made today in the face of widespread public reluctance to forgo human expert judgment. To resolve this conflict, we propose that human expert judges be included via appeals processes for review of algorithmic decisions. Thus, the human intervenes only in a limited number of cases and only after an …

Interagency Dynamics In Matters Of Health And Immigration, Medha D. Makhlouf

Faculty Scholarly Works

When Congress delegates authority to an executive agency, it tells us something important about the expertise that Congress wishes to harness in policymaking on an issue. In the legal literature on interagency dynamics and cooperation, issues at the nexus of health and immigration are largely understudied. This Article extends this literature by examining how delegations of authority on issues at the intersection of health and immigration influence policymaking. In an analysis of how administrative law models apply to three topics in the shared regulatory space of the Department of Health and Human Services (“HHS”) and the Department of Homeland Security …