Health Law and Policy Commons^™

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.

Jail Health And Early Release Practices, Brandon L. Garrett, Deniz Ariturk, Jessica Carda-Auten, David L. Rosen

Faculty Scholarship

Local jails in the United States incarcerate millions of people each year. The COVID-19 pandemic made jail health a pressing public health concern nationally, where releasing individuals from jails occurred across the country in order to prevent pandemic spread. But releases also faced substantial resistance and exposed long-standing challenges in delivering adequate healthcare in jail settings. People in jail have substantially higher levels of medical need than individuals in the general population, with large numbers having serious mental illnesses and substance use disorders. Further, overcrowded conditions and poor healthcare standards and delivery make jails harmful to those already-vulnerable people. What …

A Critique Of Expertise For Health Law, Aziza Ahmed

Faculty Scholarship

A health justice approach requires a progressive critique of expertise. This article considers two recent high-profile cases – the mask mandate and medication abortion -- to understand how we should think the mobilization of expertise in the context of public health law. Following from this, the article offers news ways to better understand how to think of the relationship between health law, expertise, and politics.

A Pandemic Instrument Can Start Turning Collective Problems Into Collective Solutions By Governing The Common-Pool Resource Of Antimicrobial Effectiveness, Isaac Weldon, Kathy Liddell, Susan Rogers Van Katwyk, Steven J. Hoffman, Timo Minssen, Kevin Outterson, Stephanie Palmer, A. M. Viens, Jorge Viñuales

Faculty Scholarship

To address the complex challenge of global antimicrobial resistance (AMR), a pandemic treaty should include mechanisms that 1) equitably address the access gap for antimicrobials, diagnostic technologies, and alternative therapies; 2) equitably conserve antimicrobials to sustain effectiveness and access across time and space; 3) equitably finance the investment, discovery, development, and distribution of new technologies; and 4) equitably finance and establish greater upstream and midstream infection prevention measures globally. Biodiversity, climate, and nuclear governance offer lessons for addressing these challenges.

Abortion Experts, Aziza Ahmed

Faculty Scholarship

The COVID-19 pandemic, and the overturning of Roe v. Wade,¹ has intensified the fight for access to medication abortion. ² As state governors put emergency orders into place limiting health care provisions to essential services, some also limited access to abortion, designating it a nonessential service. ³ In the face of these challenges, women's health advocates, in keeping with prior advocacy, have called for greater access to medication abortion.⁴ The increased reliance on telemedicine during the COVID-19 pandemic provides new possibilities for the provision of abortion medication that do not rely on a patient engaging in-person at a …

Trust, Brutality, And Human Dignity: How “Partial Birth Abortion” Helps Shape American Biopolitics, George J. Annas

Faculty Scholarship

In this Article, I explore how nearly continuous public rhetorical challenges to abortion in the political realm first led the public and the courts to turn away from a particular abortion procedure (intact dilation and extraction, also known as partial-birth abortion) which political agitators labeled as “barbaric” and then to view physicians who performed abortions not as legitimate professionals, but simply as “abortionists,” and sometimes as evil “Frankensteins.” “Abortionists” use no “medical judgment” and are unworthy of deference by state legislatures, Congress, or the courts when deciding how or when to perform an abortion. The concentration on the welfare of …

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 …

Viral Injustice, Brandon L. Garrett, Lee Kovarsky

Faculty Scholarship

The COVID-19 pandemic blighted all aspects of American life, but people in jails, prisons, and other detention sites experienced singular harm and neglect. Housing vulnerable detainee populations with elevated medical needs, these facilities were ticking time bombs. They were overcrowded, underfunded, unsanitary, insufficiently ventilated, and failed to meet even minimum health-and-safety standards. Every unit of national and sub-national government failed to prevent detainee communities from becoming pandemic epicenters, and judges were no exception.

This Article takes a comprehensive look at the decisional law growing out of COVID-19 detainee litigation and situates the judicial response as part of a comprehensive institutional …

Are Vaccine Lotteries Worth The Money?, Christopher Robertson, K. Aleks Schaefer, Daniel Scheitrum

Faculty Scholarship

This research evaluates the effects of the twelve statewide vaccine lottery schemes that were announced as of June 7, 2021 on state vaccination rates. We construct a dataset that matches information on the timing and location of these lotteries with daily, county-level data from the U.S. Centers for Disease Control (CDC) on the cumulative number of people who have received at least one dose of an emergency-authorized Covid-19 vaccine. We find that 10 of the 12 statewide lotteries studied (i.e., all but Arkansas and California) generated a positive, statistically significant, and economically meaningful impact on vaccine uptake after thirty days. …

What The Pandemic Taught Us: The Health Care System We Have Is Not The System We Hoped We Had, William M. Sage

Faculty Scholarship

The United States spends nearly twice as much per capita on medical care as any other country. The United States has the world’s most advanced biomedical technologies, sophisticated hospitals, and skilled health professionals. The United States has a national public health body, the Centers for Disease Control and Prevention (CDC), that is generally considered the world’s leader in infectious disease detection and response. Nonetheless, the United States suffered among the world’s worst COVID-19 disease burdens and outcomes, inflicting largely avoidable harm on patients, health professionals, and the broader community.

Why this happened is clearly important. But that it happened is …

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs

Faculty Scholarship

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …

Health Reform Reconstruction, Lindsay F. Wiley, Elizabeth Mccuskey, Matthew B. Lawrence, Erin C. Fuse Brown

Faculty Scholarship

This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades and calls for reconstruction. For more than a half-century, a cramped "iron triangle" ethos has constrained health reform conceptually. Reforms aimed to balance individual interests in cost, quality, and access to health care, while marginalizing equity, solidarity, and public health. In the iron triangle era, reforms unquestioningly accommodated four legally and logistically entrenched fixtures - individualism, fiscal fragmentation, privatization, and federalism - that distort and diffuse any reach toward social justice. The profound racial disparities and …

Title 42, Asylum, And Politicising Public Health, Michael Ulrich, Sondra S. Crosby

Faculty Scholarship

President Biden has continued the controversial immigration policy of the Trump era known as Title 42, which has caused harm and suffering to scores of asylum seekers under the guise of public health.1 The Centers for Disease Control and Prevention (CDC) ordered the policy in March 2020 with the stated purpose of limiting the spread of the coronavirus into the U.S.; though, CDC and public health officials have admitted this policy has no scientific basis and there is no evidence it has protected the public.2,3 Instead, the impetus behind the policy appears to be a desire to keep out or …

Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines, Kevin Outterson

Faculty Scholarship

Antibacterial medicines should be foundational for modern medicine—a key part of the infrastructure of contemporary practice. Recently, however, antibacterials have struggled commercially. Even with “push” incentives (grants paid before regulatory approval), antibacterials have failed on the market because revenues are tied to volume sold. There are policy initiatives under way in the United States and United Kingdom that explore paying for exceptional antibacterials with “pull” incentives (paid after regulatory approval) by delinking the payments from volume via other payment formats such as market entry rewards and subscriptions. This article discusses these initiatives but also proposes an expected net present value …

Waive Ip Rights & Save Lives, Srividhya Ragavan

Faculty Scholarship

In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries. The waiver was proposed as a tool to kick-start prevention, containment and treatment of COVID-19. While there is an imminent need to meet a growing supply-demand gap for all medical products, COVID-19 related products are urgently required in poorer nations to contain the pandemic. The waiver has an additional role to play in the larger trade schema. In enabling vaccination of populations across the globe, the waiver would be critical …

Medicaid Waivers, Administrative Authority, And The Shadow Of Malingering, Nicole Huberfeld

Faculty Scholarship

From 2018 through 2020, HHS approved state Medicaid demonstration waivers to impose new eligibility conditions such as work requirements, connecting current “personal responsibility” rhetoric and historical suspicion of malingering. The Biden administration reversed course but advocated to the Supreme Court for expansive administrative discretion. This approach supports health equity now but could enable reemergence of restrictive health policies down the road.

Gendered Complications Of Covid-19: Towards A Feminist Recovery Plan, Naomi Cahn, Linda C. Mcclain

Faculty Scholarship

COVID-19 exposed the limitations in the current economic system on public and private support for gender equity and the intersecting impact of gender, race, and class in that lack of support. Women of color, particularly those who are Black, Latina, or Native American, were at the intersection of the inequities in the pandemic economy. The catalogue of COVID-19’s impact covers all aspects of women’s lives: work, family, education, health, reproduction, mental and physical well-being, and leisure. This Article argues that COVID-19 has complex implications for gender equality and gender equity as state and local governments, the federal government, and private …

Trademarks And The Covid-19 Pandemic: An Empirical Analysis Of Trademark Applications Including The Terms "Covid," "Coronavirus," "Quarantine," "Social Distancing," "Six Feet Apart," And "Shelter In Place", Irene Calboli

Faculty Scholarship

True to its nature as a (hopefully) once in a lifetime event, the COVID-19 pandemic has led to a tsunami of trademark applications. These include the terms “COVID,” “Coronavirus,” and other medical and pandemic-management related terms. This unprecedented number of applications has been highlighted by several commentators in general terms in the past months. This Article examines these applications in detail. Notably, the Article presents the first and most complete survey of the applications filed between the onset of the pandemic and the end of 2020, which include the following terms: “COVID,” “Coronavirus,” “Quarantine,” “Social Distancing,” “Six Feet Apart,” and …

Antibiotic Resistance In The Patient With Cancer: Escalating Challenges And Paths Forward, Amila K. Nanayakkara, Helen W. Boucher, Vance G. Fowler Jr., Amanda Jezek, Kevin Outterson, David E. Greenberg

Faculty Scholarship

Infection is the second leading cause of death in patients with cancer. Loss of efficacy in antibiotics due to antibiotic resistance in bacteria is an urgent threat against the continuing success of cancer therapy. In this review, the authors focus on recent updates on the impact of antibiotic resistance in the cancer setting, particularly on the ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.). This review highlights the health and financial impact of antibiotic resistance in patients with cancer. Furthermore, the authors recommend measures to control …

Effects Of Political Versus Expert Messaging On Vaccination Intentions Of Trump Voters, Christopher Robertson, Keith Bentele, Beth Meyerson, Alexander Wood, Jacqueline Salwa

Faculty Scholarship

To increase COVID-19 vaccine uptake in resistant populations, such as Republicans, focus groups suggest that it is best to de-politicize the issue by sharing five facts from a public health expert. Yet polls suggest that Trump voters trust former President Donald Trump for medical advice more than they trust experts. We conducted an online, randomized, national experiment among 387 non-vaccinated Trump voters, using two brief audiovisual artifacts from Spring 2021, either facts delivered by an expert versus political claims delivered by President Trump. Relative to the control group, Trump voters who viewed the video of Trump endorsing the vaccine were …

Antimicrobial Resistance: Is Health Technology Assessment Part Of The Solution Or Part Of The Problem?, Abigail Colson, Alec Morton, Christine Årdal, Kalipso Chalkidou, Sally Davies, Louis Garrison, Mark Jit, Ramanan Laxminarayan, Itamar Megiddo, Chantal Morel, Justice Nonvignon, Kevin Outterson, John Rex, Abdur Razzaque Sarker, Mark Sculpher, Beth Woods, Yue Xiao

Faculty Scholarship

Antimicrobial resistance is a serious challenge to the success and sustainability of our healthcare systems. There has been increasing policy attention given to antimicrobial resistance in the last few years, and increased amounts of funding have been channeled into funding for research and development of antimicrobial agents. Nevertheless, manufacturers doubt whether there will be a market for new antimicrobial technologies sufficient to enable them to recoup their investment. Health technology assessment (HTA) has a critical role in creating confidence that if valuable technologies can be developed they will be reimbursed at a level that captures their true value. We identify …

Shifting Standards Of Judicial Review During The Coronavirus Pandemic In The United States, Wendy K. Mariner

Faculty Scholarship

Emergencies are exceptions to the rule. Laws that respond to emergencies can create exceptions to rules that protect human rights. In long lasting emergencies, these exceptions can become the rule, diluting human rights and eroding the rule of law. In the United States, the COVID-19 pandemic prompted states to change rules governing commercial and personal activities to prevent the spread of the coronavirus. Many governors’ executive orders were challenged as violations of the constitutionally protected rights of those affected. Judges are deciding whether emergencies can justify more restrictions than would be permitted in normal circumstances and whether some rights deserve …

Your Health Is In Your Hands? Us Cdc Covid-19 Mask Guidance Reveals The Moral Foundations Of Public Health, Cecília Tomori, Aziza Ahmed, Dabney P. Evans, Benjamin Mason Meier, Aparna Nair

Faculty Scholarship

In the second year of the COVID-19 pandemic, US public health policy remains at a crossroads. The US Centers for Disease Control and Prevention’s (CDC’s) May 28, 2021 guidance, which lifted masking recommendations for vaccinated people in most situations, exemplifies a troubling shift — away from public health objectives that center equity and toward a model of individual personal responsibility for health. CDC Director Rochelle Walensky emphasized that "your health is in your hands," undermining the idea that fighting COVID is a "public" health responsibility that requires the support of institutions and communities. The social impacts of this scientific guidance, …

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

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 …

American Punishment And Pandemic, Danielle C. Jefferis

Faculty Scholarship

Many of the sites of the worst outbreaks of the disease caused by the novel coronavirus (COVID-19) are America’s prisons and jails. As of March 2021, the virus has infected hundreds of thousands of incarcerated people and well over two thousand have died as a result contracting the disease caused by the virus. Prisons and jails have been on perpetual lockdowns since the onset of the pandemic, with family visits suspended and some facilities resorting to solitary confinement to mitigate the virus’s spread, thereby exacerbating the punitiveness and harmfulness of incarceration. With the majority of the 2.3 million people incarcerated …

Standard Racism: Trying To Use “Crisis Standards Of Care” In The Covid-19 Pandemic, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Lowering the standard of care in a pandemic is a recipefor inferior care and discrimination. Wealthy whitepatients will continue to get “standard of care” medi-cine, while the poor and racial minorities (especiallyblack and brown people) will get what is openlydescribed as substandard care rationalized by the asser-tion that substandard care is all that we can deliver tothem in a crisis. (IOM 2009) Paul Farmer’s experiencein responding to the Ebola outbreak in West Africa is ashocking, if extreme, example of how dangerous topatients this practice is. White patients were treatedwith the US standard of care, including transfer to theUS for treatment, …

Trade Marking ‘Covid’ And ‘Coronavirus’ In The Usa: An Empirical Review, Irene Calboli

Faculty Scholarship

Famous and sensational events often lead to several entities filing trade mark applications that include terms related to these events. The most recent example of this phenomenon is the COVID-19 pandemic, which has led to large numbers of (largely controversial) filings worldwide.

In this article, I review the applications including the terms ‘COVID’ and ‘Coronavirus’ filed with the United States Patent and Trademark Office (USPTO) in 2020 based on the data available and recorded by the end of January 2021. These data offer significant information related to the type of products for which the applications were filed, the type of …

The Effect Of Generic Market Entry On Antibiotic Prescriptions In The United States, Cecilia Kållberg, Jemma Hudson, Hege Salvesen Blix, Christine Årdal, Eili Klein, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan

Faculty Scholarship

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 …

Designing An Independent Public Health Agency, Jacqueline Salwa, Christopher Robertson

Faculty Scholarship

We believe that Congress should act on a bipartisan basis to fix U.S. public health institutions. Legislators could decide to merely buttress current institutions, as former commissioners have suggested be done for the FDA.1 Alternatively, legislators could consider a broad reorganization of public health functions and create a superagency, whose purview would include everything from the approval of drugs and devices to the maintenance of national stockpiles of protective equipment.

Marijuana Legalization And The Role Of The Massachusetts Legislature, Sean J. Kealy

Faculty Scholarship

The public is often frustrated when Congress or their state legislature is not responsive to their policy priorities. This was especially true during the effort to legalize marijuana in Massachusetts. The legislature consistently refused to take up the issue despite public support. Legalization advocates ultimately bypassed the legislature by turning to the ballot-initiative process on three occasions: first to decriminalize possession of small amounts of marijuana, then to legalize medical marijuana, and most recently to legalize recreational marijuana. After the electorate legalized recreational marijuana, the legislature further frustrated advocates, first by delaying implementation of key parts of the law and …