Law Commons^™

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 …

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 …

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 …

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 …

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

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 …

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.

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 Nanayakkara, Helen Boucher, Vance Fowler, Amanda Jezek, Kevin Outterson, David 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 …

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 …

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 …

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, …

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S F Orubu, Muhammad H. Zaman, John Rex, Christine Ardal

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020 [1]. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs [2]. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to …

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 recipe for inferior care and discrimination. Wealthy white patients will continue to get “standard of care” medicine, while the poor and racial minorities (especially black and brown people) will get what is openly described as substandard care rationalized by the assertion that substandard care is all that we can deliver to them in a crisis. (IOM Citation2009) Paul Farmer’s experience in responding to the Ebola outbreak in West Africa is a shocking, if extreme, example of how dangerous to patients this practice is. White patients were treated with the …

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, John-Arne Røttingen, Ramanan Laxminarayan, Kevin Outterson

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 …

Medical Cannabis And The Age Of Majority, Katharine B. Silbaugh

Faculty Scholarship

This Essay considers whether commercial cannabis retailers are adequately constrained in the sale of cannabis to 18- to 21-year-olds. It examines the intersection of the medical cannabis market, recreational cannabis market, and underlying status law regulating late adolescents aged 18 to 21. Because the age of majority licenses full medical decision-making, an 18-year-old can access medical cannabis but not recreational cannabis or alcohol. This Essay proceeds on the assumption that medical cannabis is a construct that has eased the process of achieving a legalized commercial cannabis market. The ambiguity around medical claims is comfortable in the libertarian soil of cannabis …

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 …

Book Review Of Law In The Time Of Covid-19, Jessie Wallace Burchfield

Faculty Scholarship

No abstract provided.

The Boston Medical Center Immigrant Task Force: An Alternative To Teaching Immigration Law To Health Care Providers, Sondra S. Crosby, Lily Sonis, George J. Annas

Faculty Scholarship

As healthcare providers engage in the politics of reforming and humanizing our immigration and asylum “system” it is critical that they are able to refer their patients whose health is directly impacted by our immigration laws and policies to experts who can help them navigate the system and obtain the healthcare they need.

The Private Option, Brendan S. Maher

Faculty Scholarship

Health care reform is once again in the air. Virtually all Democrats favor some meaningful expansion of public insurance, whether through single payer or the creation of a “public option” that would allow consumers dissatisfied with the private market to buy into a public program. Republicans, not surprisingly, have pushed back, not only against single payer, but also against the public option, saying it will drive private payors to extinction. All the political jousting implicates a larger and serious policy question; namely, what should be the role of private payors in the nation’s health care system?

Arguments to date on …

The Impact Of Covid-19 On Immigration Detention, Fatma Marouf

Faculty Scholarship

COVID-19 has spread quickly through immigration detention facilities in the United States. As of December 2, 2020, there have been over 7,500 confirmed COVID-19 cases among detained noncitizens. This Article examines why COVID-19 spread rapidly in immigration detention facilities, how it has transformed detention and deportation proceedings, and what can be done to improve the situation for detained noncitizens. Part I identifies key factors that contributed to the rapid spread of COVID-19 in immigration detention. While these factors are not an exhaustive list, they highlight important weaknesses in the immigration detention system. Part II then examines how the pandemic changed …

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

Faculty Scholarship

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

California V. Texas: The Role Of Congressional Procedure In Severability Doctrine, Mary Leto Pareja

Faculty Scholarship

The United States Supreme Court is once again considering a case that challenges the constitutionality of the Affordable Care Act (“ACA”). In this round of litigation, plaintiffs argue that because Congress lowered the individual mandate tax penalty to zero in the 2017 Tax Act that makes the individual mandate itself unconstitutional and that, furthermore, the individual mandate cannot be severed from the rest of the ACA. The District Court agreed with the plaintiffs and struck down the entire ACA, and the Supreme Court granted cert to hear this momentous question. A decision is expected by summer of 2021.

The ACA …

A Unified Theory Of Data, William Magnuson

Faculty Scholarship

How does the proliferation of data in our modern economy affect our legal system? Scholars that have addressed the question have nearly universally agreed that the dramatic increases in the amount of data available to companies, as well as the new uses to which that data is being put, raise fundamental problems for our regulatory structures. But just what those problems might be remains an area of deep disagreement. Some argue that the problem with data is that current uses lead to discriminatory results that harm minority groups. Some argue that the problem with data is that it impinges on …

The Ethics Of Research That May Disadvantage Others, Christopher Robertson

Faculty Scholarship

In prospective interventional research, a treatment may provide an advantage for the recipient over other humans not receiving it. If the intervention proves successful, the treated are better able to compete for a scarce ventilator, a class grade, or a litigation outcome, potentially risking the deaths, jobs, or incomes of non-treated persons. The concerns for “bystanders” have typically focused on direct harms (e.g., infecting them with a virus), unlike the mere competition for rivalrous goods at issue here.

After broadly scoping this problem, analysis reveals several reasons that such research is typically permissible, notwithstanding the potential setbacks to the interests …

Addressing Public Health’S Failings During Year One Of Covid-19, George J. Annas, Sandro Galea

Faculty Scholarship

By almost any measure, public health fell short during 2020. In retrospect, the list of what public health professionals, including federal and state public health officials, public health practitioners, and academics, could have done better is easy to articulate, and has already been the subject of angry books about the disasterous responses to the pandemic in Europe and the US [1,2]. It falls to all of us to pause, reflect, and ask: how do we move forward? We have five suggestions.