Law Commons^™

Law School News: Rwu Law Remembers Sarah Weddington 12/30/2021, Michael M. Bowden

Life of the Law School (1993- )

No abstract provided.

A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day

Duke Journal of Constitutional Law & Public Policy Sidebar

The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …

Handbook For Sdg-Aligned Food Companies: Four Pillar Framework Standards, Nora Mardirossian, GaëLle Espinosa, Rico RincóN, Diana Marcela, Erin O’Dwyer, Abrania Marrero, Regan Plekenpol, Claudia P. Baethgen, Urvi Agarwal, Lisa E. Sachs, Jeffrey D. Sachs

Columbia Center on Sustainable Investment Staff Publications

The world food system is in crisis. Outright hunger, unhealthy diets and malnutrition occur parallel to food losses and waste. Farming families in poor countries suffer from extreme poverty. And food production is environmentally unsustainable and increasingly vulnerable to extreme weather events caused by climate change. A historic change of direction is needed to bring about a new era of food system sustainability. Our work aims to help companies, investors and other stakeholders move towards a more sustainable food system that is aligned with the Sustainable Development Goals.

Transforming the world food system to achieve sustainability in all its dimensions …

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. …

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 …

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 …

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 …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Direct-To-Consumer Genetic Testing, Ellen W. Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals’ responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such …

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 …

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

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 …

Texas Heartbeat Act Poses Threat To The Future Of Abortion Access, Kodie Mcginley

GGU Law Review Blog

As the abortion debate in the United States has grown increasingly tense over the recent years, a newly enacted Texas law could lay the groundwork for a national trend of restrictive abortion laws. SB 8, also known as the Texas Heartbeat Act, was first signed by Texas Governor Greg Abbott in May 2021, and came into effect on September 1st. The Texas Heartbeat Act is not the only recent bill that attempts to challenge Roe v. Wade. In 2018, Mississippi passed the Gestational Age Act, which bans abortions after 15 weeks of pregnancy. The Texas Heartbeat Act is even …

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

Articles

Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …

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 …

Coronavirus, Compulsory Licensing, And Collaboration: Analyzing The 2020 Global Vaccine Response With 20/20 Hindsight, Arjun Padmanabhan

Student Scholarship

In December 2019, COVID-19, a novel strain of the SARS-2 Virus, appeared in Wuhan, China. Within a year, over ninety million people had been infected, and two million had died. Amid all the death and desolation, humanity's ingenuity and willpower emerged in history's greatest vaccine race. The global community sought to find novel ways to protect innovation and intellectual property while still collaborating to roll out a vaccine in record time. Despite the presence of compulsory licensing provisions like 28 U.S.C. § 1498 and the Bayh-Dole Act in the U.S., and the TRIPS Agreement at the international level, the journey …

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

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 …

Supported Decisions As The Patient’S Own?, Leslie Francis

Utah Law Faculty Scholarship

This brief commentary addresses what I regard as the thorniest challenge to supported decision making: how to determine if a supported decision really is the decision of the supported person, rather than an insidious form of concealed paternalism or conflicts of interest. The risk that apparent supported decision-making really becomes the decision of the supporter looms as capacities wane. Peterson, Karlawash and Largent (PK&L), who offer a defense of supported decision making in health care for people with dynamic and diminishing capacity, are alert to these problems but skirt their implications. The authors’ model for supported decisionmaking is incomplete; at …

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 …

Biden’S Vaccination Mandate Plan: A Scatter-Shot Of Legal Solutions, Spencer Sellers

GGU Law Review Blog

The current COVID-19 pandemic is dominated by one trait. Data shows that nearly all COVID-19 related deaths in the United States are suffered by people who are not vaccinated. Hospitalizations are similarly unbalanced, with unvaccinated patients making up between 95% to 99.9% of the population of COVID-19 patients in hospitals.

In response, on September 9, 2021, President Joe Biden announced an action plan addressing the COVID-19 pandemic. The first part of the plan focused on increasing the population of domestically-vaccinated individuals. This first part of the plan can be divided into five policy goals. Four of those plan’s policy goals …

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.

Jordan's Public Policy Response To Covid-19 Pandemic: Insight And Policy Analysis, Wa’Ed Alshoubaki, Michael Harris

Public Administration Faculty Research

The aim of this study was to gain an understanding of how the Jordanian government has responded and continues to respond to the COVID-19 pandemic. It utilizes the interpretive policy analysis approach through document analysis. The analysis showed that Jordan created social protection policies to assist people who lost their jobs or whose work was suspended due to the coronavirus. The economic policies build solidarity and facilitate the private sector’s recovery. The health care measures firmly applied included lockdown, wearing masks, and restrictions on gatherings and public events. Jordan uses hard power and imposes sanctions on any violation that threatens …

Mid-Atlantic Ethics Committee Newsletter, Fall 2021

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Non-Elderly Adults On Disability In The Cf Population, Lea Nolan, Semret Seyoum, Julanne Wilson, Marsha Regenstein

Health Policy and Management Issue Briefs

No abstract provided.

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

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 …

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 …

Lessons Learned From The Hiv/Aids Pandemic And Access To Medicines For Covid-19 Treatment, Thalia Le

Independent Study Project (ISP) Collection

There is an imminent need to address the healthcare disparities in accessing all COVID-19 medicinal products in developing countries. While logistical issues like inadequate production facilities such as the lack of vaccines administration capacity, storage issues, gap between supply and demand as well as vaccine hesitancy can certainly play a part in impeding COVID19 medicines distribution, patent monopolies and intellectual property protection laws further exacerbated the problem, especially when vaccines were at its early stages of authorization. Historical and contemporary case studies of efforts to challenge patents on HIV AVRs treatment provide a useful lens through which we may glean …