Law Commons^™

The Reemergence Of Vaccine Nationalism, Ana Santos Rutschman

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This short essay explores the reemergence of vaccine nationalism during the COVID-19 pandemic. The essay traces the pre-COVID origins of vaccine nationalism and explains how it can have detrimental effects on equitable access to newly developed vaccines.

Substance Use Disorder, Discrimination, And The Cares Act: Using Disability Law To Strengthen New Protections, Kelly K. Dineen, Elizabeth Pendo

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The COVID-19 pandemic is having devastating consequences for people with substance use disorders (SUD). SUD is a chronic health condition—like people with other chronic health conditions, people with SUD experience periods of remission and periods of exacerbation and relapse. Unlike people with most other chronic conditions, people with SUD who experience a relapse may face criminal charges and incarceration. They are chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. People with SUD are also at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions have led to …

Comments On The Preliminary Framework For Equitable Allocation Of Covid-19 Vaccine, Ana Santos Rutschman, Julia Barnes-Weise, Robert Gatter, Timothy L. Wiemken

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On September 1, 2020 the National Academies released a draft framework for Equitable Allocation of a COVID-19 Vaccine. In this response, we analyze the proposed framework and highlight several areas.

Among the proposed changes, we highlight the need for the following interventions. The final framework for distribution of COVID-19 vaccines should give a higher priority to populations made most vulnerable by the social determinants of health. It should incorporate more geography-based approaches in at least some of the four proposed phases of vaccine distribution. It should address the possibility of a vaccine being made available through an emergency use authorization …

The Case For Face Shields: Improving The Covid-19 Public Health Policy Toolkit, Timothy L. Wiemken, Ana Santos Rutschman, Robert Gatter

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As the United States battles the later stages of the first wave of COVID-19 and faces the prospect of future waves, it is time to consider the practical utility of face shields as an alternative or complement to face masks in the policy guidance. Without face shields specifically noted in national guidance, many areas may be reluctant to allow their use as an alternative to cloth face masks, even with sufficient modification.

In this piece, we discuss the benefits of face shields as a substitute to face masks in the context of public health policy. We further discuss the implications …

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

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As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

Legalizing Midwifery In Missouri, Michael A. Wolff

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Two decades after the Missouri Supreme Court upheld an injunction against the practice of midwifery, two midwives became lobbyists for the cause and, with the remarkable cooperation of friendly legislators and lobbyists, got a provision inserted in a health bill legalizing the practice of tocology, a synonym for midwifery that went unnoticed by legislators who voted for the lengthy bill in which it was inserted. Medical associations sued to invalidate this "stealth" provision but their efforts failed when the Missouri Supreme Court declined to grant standing to the doctors to "protect" the interests of the public. Thirteen years later, the …

Protecting The Rights Of People With Disabilities, Elizabeth Pendo

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One in four Americans — a diverse group of 61 million people — experience some form of disability (Okoro, 2018). On average, people with disabilities experience significant disparities in education, employment, poverty, access to health care, food security, housing, transportation, and exposure to crime and domestic violence (Pendo & Iezzoni, 2019). Intersections with demographic characteristics such as race, ethnicity, gender, and LGBT status, may intensify certain inequities. For example, women with disability experience greater disparities in income, education, and employment (Nosek, 2016), and members of under-served racial and ethnic groups with disabilities experience greater disparities in health status and access …

Vaccine Hesitancy: Experimentalism As Regulatory Opportunity, Ana Santos Rutschman, Timothy L. Wiemken

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This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost …

Post-Traumatic Stress Disorder (Ptsd) Coverage And Other Expanding Benefit Changes In The Workers’ Compensation Insurance Marketplace: Academic Legal Perspective, Michael C. Duff

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This paper discusses the increased use of causation presumptions in workers' compensation cases involving firefighters and other first responders. It also considers increasing workers' compensation coverage of post traumatic stress disorder with respect to those same categories of workers. The paper discusses how workers' compensation coverage of certain conditions tends to parallel the growth of potential tort liability, observes that disease presumptions were a feature of early 20th century workers' compensation statutes (and so are not new), and argues that recognition of workers' compensation "mental-mental" claims has been consistent with "zone of danger" expansion of the negligent infliction of emotional …

The Americans With Disabilities Act And Healthcare Employer-Mandated Vaccinations, Y. Tony Yang, Elizabeth Pendo, Dorit Rubinstein Reiss

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Battles around workplace vaccination policies often focus on the annual influenza vaccine, but many healthcare employers impose requirements for additional vaccines because of the increased likelihood that employees in this sector will interact with populations at increased risk of acquiring or experiencing harmful sequelae of vaccine-preventable diseases. The federal Centers for Disease Control and Prevention and many states recommend healthcare employees receive numerous vaccines, including measles, mumps, and rubella (“MMR”); tetanus, diphtheria, and pertussis (“Tdap”). However, recent outbreaks of once-eliminated diseases that are now resurgent and the rising antivaccination movement raise questions about how far employers can go to mandate …

Law, Structural Racism, And The Covid-19 Pandemic, Ruqaiijah Yearby, Seema Mohapatra

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Racial and ethnic minorities have always been the most impacted by pandemics because of: disparities in exposure to the virus; disparities in susceptibility to contracting the virus; and disparities in treatment. This article explains how structural racism, the ways in which laws are used to advantage the majority and disadvantage racial and ethnic minorities, has caused these disparities. Specifically, this article focuses on how employment, housing, health care, and COVID-19 relief laws have been manipulated to disadvantage racial and ethnic minorities, making minorities more susceptible to COVID-19 infection and death. This article uses Blumenshine’s 2008 framework to outline how structural …

The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman

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The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, …

PortugalʼS Response To Covid-19, Ana Santos Rutschman

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This essay for the Regulatory Review's special series on Comparing Nations’ Responses to COVID-19 examines the early response to the pandemic in Portugal. The essay focuses on measures adopted in connection with the declarations of state of emergency and state of calamity, as well as the treatment of migrant populations throughout the pandemic.

Reviving Focused Scrutiny In The Constitutional Review Of Public Health Measures, Robert Gatter

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This article re-examines the "focused scrutiny" standard proposed by Prof. Scott Burris in 1989 and argues for its application particularly during an infectious disease emergency such as the COVID-19 pandemic. Focused scrutiny seeks to tie judicial review of the constitutionality of public health measures closely to the facts of the particular disease and to evidence of the efficacy of each governmental action to prevent the spread of that disease, even when courts adopt rational basis testing.

Sex-Based Discrimination In Healthcare Under Section 1557: The New Final Rule And Supreme Court Developments, Brietta R. Clark, Elizabeth Pendo, Gabriella Garbero

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One of the primary goals of the Patient Protection and Affordable Care Act (PPACA) has been the reduction and elimination of health disparities, generally defined as population-level health differences that adversely affect disadvantaged groups, including disparities associated with sex and gender. Many of PPACA’s general provisions — expanded access to public and private insurance coverage, guarantee issue and pricing reforms, and coverage mandates — were expected to reduce barriers and eliminate discriminatory practices targeting or disproportionately impacting women and transgender individuals. Provisions like the Women’s Health Amendment, which mandated women’s preventive healthcare to be covered without cost sharing, and the …

Medicaid's Vital Role In Addressing Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

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Medicaid plays an essential role in helping states respond to crises. Medicaid guarantees federal matching funds to states, which helps with unanticipated costs associated with public health emergencies, like COVID-19, and increases in enrollment that inevitably occur during times of economic downturn. Medicaid’s joint federal/state structure, called cooperative federalism, gives states significant flexibility within federal rules that allows states to streamline eligibility and expand benefits, which is especially important during emergencies. Federal emergency declarations give the secretary of Health and Human Services temporary authority to exercise regulatory flexibility to ensure that sufficient health care is available to meet the needs …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

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This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

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Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

Center For Progressive Reform Report: Protecting Workers In A Pandemic--What The Federal Government Should Be Doing, Thomas Mcgarity, Michael C. Duff, Sidney A. Shapiro

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The "re-opening" of the American economy while the coronavirus that causes COVID-19 is still circulating puts workers at heightened risk of contracting the deadly virus. In some blue-collar industries, the risk is particularly acute because of the inherent nature of the work itself and of the workplaces in which it is conducted. And the risk, for a variety of reasons, falls disproportionately on people of color and low-income workers. With governors stay-at-home orders and other pandemic safety restrictions, Center for Progressive Reform Member Scholars Thomas McGarity, Michael Duff, and Sidney Shapiro examine the federal government's many missed opportunities to stem …

Ensuring The Reproductive Rights Of Women With Intellectual Disability, Nicole Agaronnik, Elizabeth Pendo, Tara Lagu, Christene Dejong, Aixa Perez-Caraballo, Lisa Iezzoni

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Background: Women with intellectual disability experience disparities in sexual and reproductive health care services.

Methods: To explore perceptions of caring for persons with disability, including individuals with intellectual disability, we conducted open-ended individual interviews with 20 practising physicians and three video-based focus group interviews with an additional 22 practising physicians, which reached data saturation. Interviews were transcribed verbatim. We used conventional content analysis methods to analyse transcripts.

Result: Physicians indicated that intellectual disability can pose challenges to providing sexual and reproductive health care. Observations coalesced around four themes: (1) communication; (2) routine preventive care; (3) contraception and sterilisation; and (4) …

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

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Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

Smoke Screens: An Initial Analysis Of The Coronavirus Lawsuits In The United States Against China And The World Health Organization, Ana Santos Rutschman, Robert Gatter

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In this short essay we provide a preliminary analysis of the lawsuits filed by Missouri against China, and New York against the World Health Organization over the COVID-19 pandemic. We also situate the lawsuits against the expanding coronavirus-related misinformation “epidemic.”

Covid-19 And The Conundrum Of Mask Requirements, Robert Gatter, Seema Mohapatra

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As states begin to loosen their COVID-19 restrictions, public debate is underway about what public health measures are appropriate. Many states have some form of mask-wearing orders to prevent the spread of COVID-19 infection. Public health guidance from the Centers for Disease Control and Prevention and the World Health Organization has conflicted. From a public health point of view, it is not clear what the right answer is. In the absence of directives, individuals are also making their own choices about mask use. At a time when public health measures, like shelter-in-place orders and social distancing, are being used to …

The Vaccine Race In The 21st Century, Ana Santos Rutschman

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In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting …

Knowledge Of Practicing Physicians About Their Legal Obligations When Caring For Patients With Disability, Nicole Agaronnik, Elizabeth Pendo, Julie Ressalam, Eric G. Campbell, Lisa Iezzoni

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doi: 10.1377/hlthaff.2018.05060 HEALTH AFFAIRS 38, NO. 4 (2019): 545–553

Permitted Incentives For Workplace Wellness Plans Under The Ada And Gina: The Regulatory Gap, Elizabeth Pendo, Brandon Hall

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Although workplace wellness plans have been around for decades, they have flourished under the Patient Protection and Affordable Care Act (“PPACA”) into a $6 billion-dollar industry. Under PPACA, a “wellness plan” is a program of health promotion or disease prevention offered by an employer that is designed to promote health or prevent disease and which meets the other applicable requirements of that subsection. Employers look to these programs to promote healthy lifestyles, improve the overall health of employees and beneficiaries, and reduce rising healthcare costs. PPACA’s amendments to the Health Insurance Portability and Accountability Act (“HIPAA”) permit employers to offer …

On The Judicialization Of Health, Ana Santos Rutschman

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The provision of health care has long been at the forefront of domestic and international debates, philosophical inquiries, and political agendas. A growing body of legal scholarship has added to the debate by examining the role of judicial review in the context of health-related litigation. What role, if any, should courts play in compelling the provision of health care or in furthering access to potentially life-saving medicines?

This question intersects with multiple strands of the law. For instance, it has an institutional component that interrogates the function(s) of courts within systems of checks and balances. It ties into constitutional design …

Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby

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Tort reform--legislation that aims to reduce medical malpractice suits --will not cut medical costs and improve health care unless the government addresses the proliferation of unnecessary medical errors that victimize hundreds of thousands of patients every year.

Yearby's research considers how laws enacted to grant equal access to quality health care actually can pose barriers to the disenfranchised, and she is critical of health care reform efforts that do not address the far-reaching problem of medical errors. Finding ways to curb what she calls the "alarming rate of these medical errors," not only will reduce medical malpractice suits, but save …

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

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Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding …

Segregation In St. Louis: Dismantling The Divide, For The Sake Of All [In Collaboration With], Thomas Harvey, John Mcannar, Michael-John Voss, Ascend Stl Inc., Community Builders Network Of Metro St. Louis, Metropolitan St. Louis Equal Housing And Opportunity Council (Ehoc), Team Tif

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Place matters. Where people live in St. Louis has been shaped by an extensive history of segregation that was driven by policies at multiple levels of government and practices across multiple sectors of society. The effect of segregation has been to systematically exclude African American families from areas opportunity that support economic, educational, and health outcomes.