Law Commons^™

No Future But A Shared Future, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to …

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

Pediatric Covid-19 Vaccines: What Parents, Practitioners, And Policy Makers Need To Know, William J. Moss, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The US Food and Drug Administration (FDA) granted Emergency Use Authorization for Pfizer-BioNTech’s mRNA COVID-19 vaccine (BNT162b2) for children 5 to 11 years of age on October 29, 2021. The Centers for Disease Control and Prevention recommended use of the vaccine among children in this age group on November 2, 2021. Approximately 28 million children are now eligible for vaccination, with only those younger than 5 years remaining excluded from vaccine eligibility. The benefits of pediatric COVID-19 vaccines are clear. Vaccinations protect children, decrease spread to families and communities, and ensure educational continuity. What do parents, practitioners, and policy makers …

Twenty Years After The Anthrax Terrorist Attacks Of 2001: Lessons Learned And Unlearned For The Covid-19 Response, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The 20th anniversary of the terrorist attacks on September 11, 2001, resulted in deep national reflection. Less remembered are the events that began to unfold 7 days later as anonymous letters laced with deadly anthrax (Bacillus anthracis) spores began arriving at postal facilities, media companies, and congressional offices. The first death from inhaled anthrax exposure occurred on October 5, with an additional 4 deaths and 17 infections over the ensuing months.

The anthrax attacks exposed a health system ill-equipped to respond to acute emergencies. This article explores the lessons learned, and unlearned, from the anthrax attacks, through to …

Covid-19 Vaccine Mandates—A Wider Freedom, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

President Biden has required COVID-19 vaccinations across much of the US workforce, reaching nearly 100 million workers. Opponents call it unconstitutional, a violation of personal freedom, and even “un-American.” The truth is that vaccine mandates are lawful and deeply entrenched in US history and values. They constitute a “wider freedom” so that everyone in society can feel safer where they work, learn, worship, and live.

An International Agreement On Pandemic Prevention And Preparedness, Lawrence O. Gostin, Sam F. Halabi, Kevin A. Klock

Georgetown Law Faculty Publications and Other Works

During late 2021, national delegations are, or have, met at the United Nations General Assembly, the G20, and, most importantly, the Special Session of the World Health Assembly in November to determine whether the world needs a new international agreement to address pandemic prevention, preparedness, and response. The current international agreement, the International Health Regulations (2005), failed to work effectively – SARS-CoV-2 was not detected sufficiently early, relevant information was not shared efficiently, and the global response has not been coordinated. Even the most basic investigations were inadequate such as to discover the origins of SARS-CoV-2. Current proposals focus on …

It's Alright, Ma, It's Life And Life Only: Have Universities Been Meeting Their Legal Obligations To High-Risk Faculty During The Pandemic?, Gary J. Simson, Mark L. Jones, Cathren K. Page, Suzianne D. Painter-Thorne

Pepperdine Law Review

Even those universities most firmly committed to returning to in-person instruction in fall semester 2020 recognized that for health reasons some exceptions would need to be made. The CDC had identified two groups—people age sixty-five and over and people with certain medical conditions—as persons "at increased risk of severe illness from COVID-19," and it had spelled out various special precautions they should take to avoid contracting the virus. Given the CDC's unique stature, universities very reasonably could have been expected to grant exceptions to faculty falling into either group, but that's not what many universities did. We argue that, properly …

Working While Mothering During The Pandemic And Beyond, Nicole Buonocore Porter

Washington and Lee Law Review Online

Although combining work and family has never been easy for women, working while mothering during the pandemic was close to impossible. When COVID-19 caused most workplaces to shut down, many women were laid off. But many women were forced to work from home alongside their children, who could not attend daycare or school. Mothers tried valiantly to combine a full day’s work on top of caring for young children and helping school-aged children with remote school. But many found this balance difficult, leading to women’s lowest workforce participation rate in over forty years. And even women who did not quit …

Trade War, Ppe, And Race, Ernesto A. Hernandez-Lopez

Northwestern Journal of Law & Social Policy

Tariffs on Personal Protective Equipment (PPE), such as face masks and gloves, weaken the American response to COVID. The United States has exacerbated PPE shortages with Section 301 tariffs on these goods, part of a trade war with China. This has a disparate impact felt by minority communities because of a series of health inequity harms. COVID’s racial disparity appears in virus exposure, virus susceptibility, and COVID treatments. This Article makes legal, policy, and race-and-health arguments. Congress has delegated to the United States Trade Representative expansive authority to increase tariffs. This has made PPE supplies casualties of the trade war. …

Weathering The Pandemic: Dying Old At A Young Age From Pre-Existing Racist Conditions, Arline T. Geronimus

Washington and Lee Journal of Civil Rights and Social Justice

Mainstream social epidemiology now acknowledges the contributions of interpersonal racism, racialized stress, and implicit bias to population health inequity. It also increasingly recognizes that current and historical racist policies place barriers in the way of healthy lifestyles by institutionalizing food deserts, housing decay, and austerity urbanism. Essential as these developments are, they only skim the surface of how insidiously structural racism establishes and reproduces population health inequity. I coined the term “weathering” to describe the effects of sustained cultural oppression upon the body. Weathering expands on the more conventional “social determinants of health” approach to understand the contextually fluctuating and …

Empathy’S Promise And Limits For Those Disproportionately Harmed By The Covid-19 Pandemic, Theresa Glennon

Washington and Lee Journal of Civil Rights and Social Justice

Structural race, ethnicity, and class disparities in the United States concentrated and intensified the health, economic, and psychological impact of COVID-19 for certain populations. Those same structural disparities and the belief system that maintains them may also account for the weak policy response that left the United States with high rates of infection and death, economic devastation of individuals, families, and small businesses, and psychological distress. A more equal society with a stronger pre-pandemic safety net may have prevented or eased the disproportionate hardship and avoided the drama and cliffhanging. Or the shock of a pandemic and likelihood of extreme …

The Case For The Rodeo: An Analysis Of The Houston Livestock Show And Rodeo’S Inverse Condemnation Case Against The City Of Houston, Emilio R. Longoria

St. Mary's Law Journal

On March 11, 2020, Mayor of Houston, Sylvester Turner, (the Mayor) forced the Houston Livestock Show and Rodeo to close in order to slow the transmission rate of COVID-19 (coronavirus disease 2019). This use of the Mayor’s police powers caused a severe economic disruption, which the Rodeo is still recovering from today. This Article makes the case that the City’s forced closure of the Rodeo was a compensable taking under the Fifth Amendment to the U.S. Constitution and Article 1, Section 17 of the Texas Constitution—regardless of the fact the City acted pursuant to its police powers. Such a finding …

Rationing In The Time Of Covid And The Perils Of Anti-Subordination Rhetoric, Mark Kelman

Washington and Lee Law Review Online

With surges in COVID-19 cases threatening to overload some hospital facilities, we must face the possibility that therapeutic treatments will need to be rationed, at least in some places. I do not propose any particular ideal rationing scheme but caution strongly against adopting a position that Professor Bagenstos advocated this past spring, rejecting rationing on the basis of patient life expectancy simply because life expectancy based rationing might threaten the factual interests of those with disabilities and might conceivably be implemented by those making judgments that were not simply inaccurate but grounded in biased, unacceptably discriminatory intuitions that some decision …

Biological Threats Are National Security Risks: Why Covid-19 Should Be A Wake Up Call For Policy Makers, Rep. Eric M. Swalwell, R. Kyle Alagood

Washington and Lee Law Review Online

A national security strategy is the “nation’s plan for the coordinated use of all the instruments of state power—nonmilitary as well as military—to pursue objectives that defend and advance its national interest.” Perhaps the most straightforward national security objective is to protect the country from foreign invasion, but national security involves other objectives that aim to protect people in the United States as well as their values. For example, protecting U.S. elections from foreign interference is a security objective that advances the nation’s interest in democratic governance. The outbreak of a highly contagious disease like COVID‑19 strikes at the core …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Systemic Racism, The Government’S Pandemic Response, And Racial Inequities In Covid-19, Ruqaiijah Yearby, Seema Mohapatra

All Faculty Scholarship

During the COVID-19 pandemic, the federal and state governments have ignored racial and ethnic minorities’ unequal access to employment and health care that results in racial inequities in COVID-19 infections and deaths. In addition, they have enacted laws that further exacerbate these inequities. Consequently, many racial and ethnic minorities are employed in low-wage essential jobs that lack paid sick leave and health insurance. This lack of benefits causes them to go to work even when they are sick and prevents them from receiving appropriate medical treatment. As a result, racial and ethnic minorities have disproportionately been infected and died from …

Post-Pandemic Privacy Law, Tiffany C. Li

Law Faculty Scholarship

COVD-19, the global pandemic that began in 2019, altered how we live our lives in just about every way imaginable. Some of those changes were obvious-for example, those who were fortunate enough to be able to work from home began working online-while other changes were more subtle. The latter category included unprecedented levels of data collection by governments and organizations purporting to collect information that would help stop the pandemic's spread. Given the deadly nature of COVID-19, few would question any public health efforts, no matter their impact on privacy. However, the lack of attention to privacy issues during the …

(Un)Masking The Truth - The Cruel And Unusual Punishment Of Prisoners Amidst The Covid-19 Pandemic, Ariel Berkowitz

Touro Law Review

No abstract provided.

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Second Thoughts On Fda's Covid-Era Mental Health App Policy, Michael Mattioli

Articles by Maurer Faculty

As the coronavirus pandemic swept across the globe in April 2020, the US Food and Drug Administration (FDA) made an unusual decision. The agency announced that it would relax its enforcement of compliance rules for “digital therapeutics”—smartphone apps designed to address mental health disorders. The measure was a response to widely reported upticks in symptoms of anxiety, depression, and substance abuse brought on by the pandemic. As an added benefit, the agency explained, digital therapeutics could promote social distancing by removing patients’ need to visit health care providers.

This essay explores the possible lasting effects of the FDA’s temporary suspension …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …