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Structured To Fail: Lessons From The Trump Administration's Faulty Pandemic Planning And Response, Alejandro E. Camacho, Robert L. Glicksman

GW Law Faculty Publications & Other Works

The Trump Administration’s response to the COVID-19 pandemic is a stark reminder that poorly designed government can be a matter of life and death. This article explains how the Administration’s careless and delayed response to the crisis was made immeasurably worse by its confused and confusing reallocation of authority to perform or supervise tasks essential to reducing the virus’s ravages.

After exploring the rationale for and impact of prior federal reorganizations responding to public health crises, the article shows how a combination of unnecessary and unhelpful overlapping authority and a thoughtless mix of centralized and decentralized authority contributed to the …

Public Health In The Opioid Litigation, Daniel G. Aaron

Utah Law Faculty Scholarship

Today, the opioid crisis is playing out in the nation’s courts. Litigants have taken a microscope to defendant opioid companies whose misconduct ignited and exacerbated the opioid crisis. As the litigation continues, one could imagine numerous ways its resolution could contribute to the end of a multi-decade overdose crisis and prevent future ones. Options include holding defendant companies accountable, releasing previously secret information for research on root causes of the epidemic, and prohibiting future misconduct through injunctive relief. Unfortunately, to date, the litigation has not been so capacious. Rather, the participants—judge included—have been preoccupied with rapid monetary settlement. Though understandable, …

Antibiotic Development Incentives That Reflect Societal Value Of Antibiotics, Helen Boucher, Thomas M. File, Vance Fowler, Amanda Jezek, John Rex, Kevin Outterson

Faculty Scholarship

TO THE EDITOR—Rome and Kesselheim [1] claimed that rewarding developers of novel antibiotics with transferable exclusivity vouchers is an expensive approach to promoting antibiotic development. This analysis is incomplete as it focuses only on the cost of bringing new antibiotics to market without acknowledging their societal value. The authors also did not suggest an alternative approach. With patients running out of treatment options for resistant infections, failing to strengthen the antibiotic pipeline is not a reasonable option.

Antibacterial R & D At A Crossroads: We’Ve Pushed As Hard As We Can...Now We Need To Start Pulling!, John H. Rex, Kevin Outterson

Faculty Scholarship

In this issue of Clinical Infectious Diseases, Dheman et al [1] present an analysis by experts at the US Food and Drug Administration (FDA) of trends in antibacterial clinical development over the past 4 decades. By turns instructive and disturbing, this 40-year perspective provides insight into the impact of efforts to restore the antibacterial pipeline.

As a preview, the key messages from Dheman et al are all bad news for public health: (1) the number of new antibacterials in clinical development is (again) falling, (2) the risk of failure is rising, (3) the speed of clinical development …

Othering Across Borders, Steven Arrigg Koh

Faculty Scholarship

Our contemporary moment of reckoning presents an opportunity to evaluate racial subordination and structural inequality throughout our three-tiered domestic, transnational, and international criminal law system. In particular, this Essay exposes a pernicious racial dynamic in contemporary U.S. global criminal justice policy, which I call othering across borders. First, this othering may occur when race emboldens political and prosecutorial actors to prosecute foreign defendants. Second, racial animus may undermine U.S. engagement with international criminal legal institutions, specifically the International Criminal Court. This Essay concludes with measures to mitigate such othering.

Collaborative Governance Under The Endangered Species Act: An Empirical Analysis Of Protective Regulations, Robert L. Fischman, Vicky J. Meretsky, Matthew P. Castelli

Articles by Maurer Faculty

Recent conservation and administrative law scholarship emphasizes the need for potential legal adversaries to work together. Stakeholders and regulators can pool their political capital, money, property, expertise, and legal leverage to achieve more than could be accomplished through mere mechanical implementation of statutory commands. Most commentators associate collaboration with programs promoting fuzzy objectives to engage the public and advisory groups.

The Endangered Species Act (ESA) is a polarizing statute that imposes seemingly uncompromising mandates. But this Article demonstrates that the ESA actually provides rich opportunities for collaborative governance. In exploring this underappreciated success story, we document how conservation collaboration adapts …

Incarcerated Activism During Covid-19, M. Eve Hanan

Scholarly Works

Incarcerated people have a notoriously difficult time advocating for themselves. Like other authoritarian institutions, prisons severely curtail and often punish speech, organizing, and self-advocacy. Also, like other authoritarian institutions, prison administrators are inclined to suppress protest rather than respond to the grounds for protest. Yet, despite impediments to their participation, incarcerated people have organized during the pandemic, advocating for themselves through media channels, public forums, and the courts. Indeed, a dramatic increase in incarcerated activism correlates with the onset of the COVID-19 pandemic.

Just as the COVID-19 pandemic highlights injustice in other areas of criminal legal practices, it reveals both …

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 …

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

The Healthcare System And Pandemics: Where Is The Market Failure?, Sophia S. Helland, Edward R. Morrison

Faculty Scholarship

Barak D. Richman and Steven L. Schwarcz argue that healthcare providers played a central – and failing – role in stemming the fallout from the COVID-19 pandemic. Analogizing to the financial crisis of 2008, they view our healthcare system as a collection of providers, each maximizing returns to its own stakeholders in a laissez-faire regulatory environment that ignored the essential interconnectedness of providers. Because neither hospitals nor regulators were attuned to this interconnectedness, our healthcare system was unprepared for the pandemic, resulting in a reduced standard of care. Just as Dodd-Frank and related legislation view financial institutions as part of …

Covid-19 And Comparative Corporate Governance, Martin Gelter, Julia M. Puaschunder

Faculty Scholarship

With the pandemic caused by the novel coronavirus SARS-CoV-2 raging around the world, many countries’ economies are at a crucial juncture. The COVID-19 external shock to the economy has the potential to affect corporate governance profoundly. This Article explores its possible impact on comparative corporate governance. For an economy to operate successfully, a society must first find a politically sustainable social equilibrium. In many countries, historical crises—such as the Great Depression and World War II—have resulted in a reconfiguration of corporate governance institutions that set the course for generations. While it is not yet clear whether COVID-19 will have a …

My Body, My Choice: Biblical, Rabbinic, And Contemporary Halakhic Responses To Abortion, Adena Berkowitz

Touro Law Review

Since the Supreme Court grounded the right to an abortion in a constitutional right to privacy, legal and societal debate has continued around the status of a fetus in utero, a woman’s countervailing claims, and the interests of states and society as a whole. As American courts have faced an issue that intertwines legal, moral, and philosophical questions, so too the halakhic process confronts analogous complexities. The main line of Jewish tradition makes a much-needed contribution to the discussion of abortion. Without sharing the view that the fetus is from conception fully a person, it stops short of a complete …

Experimental? It Doesn't Mean What You Think It Means, Dorit Rubenstein Reiss, Arthur J. Caplan

Faculty Scholarship

No abstract provided.

Note: Foundational But Not Fundamental: No Right To The Environment, Robert Torres

Duke Environmental Law & Policy Forum

The world is on fire, and despite a general consensus among scientists that climate change is an imminent threat, recent decades have been devoid of legislatures capable of enacting meaningful legislation. The flames rage on as our President, an outspoken denier of climate change, adds fuel to the fire by stripping whatever attempts had been previously made to mitigate the effects of climate change. Forced to live in what seems a forsaken world, nineteen youths, a nonprofit organization, and a scientist on behalf of all future generations brought suit against the United States government, seeking more robust environmental protections. In …

Red Scare Or Red Herring: How The “China Initiative” Strategy For Non-Traditional Collectors Is Stifling Innovation In The United States, Bianca Tillman

Seattle Journal of Technology, Environmental, & Innovation Law

In 2018, the U.S. Department of Justice launched the “China Initiative” in response to the growing economic and national security threat posed by China. The China Initiative is a sweeping federal plan designed, in part, to protect the United States’ status as a leader in global innovation and scientific discourse. The U.S. is justified in its concern over China’s unfair practices to achieve military, technological, and economic prominence. While U.S. and Chinese intelligence agencies have spied on each other for decades, China has increased both the scope and the sophistication of its efforts to steal secrets from the U.S. in …

Alternative Data And Insider Trading: Are Investment Managers Assleep At The Wheel On Big Data Use?, William Montemarano

Brooklyn Journal of Corporate, Financial & Commercial Law

The rapid rise of “big data” has transformed the way that professional investors make investment decisions. In addition, the intersection of the United States federal securities laws and the use of “big data” to inform securities trading lies in uncharted waters. The nuanced and factually-dependent securities laws are far behind industry practices, and the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ) have remained largely silent on the issue to date. This Note argues that this combination of murky laws and rapidly evolving business practices gives rise to legal and regulatory risk, and that investment managers leveraging …

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

The "People's Total War On Covid-19": Urban Pandemic Management Through (Non-)Law In Wuhan, China, Philipp Renninger

Washington International Law Journal

Although COVID-19 was first detected in the People’s Republic of China, the pandemic now appears contained there. Western and Chinese media attribute this apparent success to the central level of the Chinese state and the Communist Party. However, this article reveals that local entities provided critical contributions to China’s COVID-19 management, particularly in the pandemic’s first epicenter: Wuhan city in Hubei province. Chinese cities like Wuhan can fight public health emergencies through legal and nonlegal instruments. Although Wuhan had prepared for possible pandemics, its existing plans, institutions, and warning systems initially failed against COVID-19. The city did not contain the …

Re-Conceptualizing The International Human Right To Health: An Analysis Of The Trends In Developing And Developed Countries’ Responses To Substance Use Disorders, Leonard Mukosi

San Diego International Law Journal

This Article juxtaposes addiction paradigms seen in the United States of America and Zimbabwe, two countries with diametrically dissimilar political, economic, and social systems. Thus, an insight is provided by this Article into how developing and developed countries are transitioning from punitive to curative approaches in addressing the problem of drug addiction. Positing that addiction is a health condition, this Article recognizes the optimum realization of the addict’s right to health is best met if the required international standards of health are implemented nationally to insure, treat, and evaluate addiction like other chronic illnesses.

Drug addiction is a brain disease …

An Australian Conundrum: Genomic Technology, Data, And The Covidsafe App, David Morrison, Patrick T. Quirk

Pace International Law Review

This paper examines the difficulties that have arisen in Australia in the use of its contact-tracing app. We examine the privacy implications around the use of the app, the wider economic imperative, and the balancing of those concerns against the health threat of the COVID-19 pandemic. We posit that default options are superior in times of emergency and rather than begging for the adoption of lifesaving technology, we suggest that the evidence gathered by behavioral economists provides an apposite and powerful alternative worthy of consideration.

Aamodt Litigation Settlement Completion, United States 116th Congress

Native American Water Rights Settlement Project

Amends the Aamodt Litigation Settlement Act (Pub. L. 11-291) to increase funding for Pueblo Water Facilities from $106.4 million to $243.4 million and making available $137 million for Regional Water System funding.

Navajo-Utah Water Rights Settlement Act, United States 116th Congress

Native American Water Rights Settlement Project

The purposes of this section are: (1) to achieve a fair, equitable, and final settlement of all claims to water rights in the State of Utah for (A) the Navajo Nation and (B) the United States, for the benefit of the Nation; (2) to authorize, ratify, and confirm the agreement entered into by the Nation and the State, to the extent that the agreement is consistent with this section; (3) to authorize and direct the Secretary (A) to execute the agreement and (B) to take any actions necessary to carry out the agreement in accordance with this section; and (4) …

Montana Water Rights Protection Act, United States 116th Congress

Native American Water Rights Settlement Project

The purposes of this Act are: (1) to achieve a fair, equitable, and final settlement of claims to water rights in the State of Montana, and in recognition of article I, and section 3 of article IX, of the Montana State Constitution for (A) the Confederated Salish and Kootenai Tribes of the Flathead Indian Reservation; and (B) the United States, for the benefit of the Tribes and allottees; (2) to authorize, ratify, and confirm the water rights compact entered into by the Tribes and the State, to the extent that the Compact is consistent with this Act; (3) to authorize …

Speaking Truth To Power And Power Speaking Truth: Accurate And Reliable Information In A Pandemic, Leslie E. Gerwin

San Diego Law Review

In this Article, I offer some preliminary ideas for how we might engage in a collective project to enable our government to improve its capacity to help us understand and respond to a future existential health threat. I first deconstruct the government informing process to analyze the points of information contestation based upon the realities we are experiencing. I then outline a project to create a space in which respected experts mediate knowledge claims and moderate contested opinions regarding the human risk of, and government response to, a public health threat. This idea embraces the ambitious goal of educating and …

More Than A Mask: Stay-At-Home Orders And Religious Freedom, Dorit Rubinstein Reiss, Madeline Thomas

San Diego Law Review

COVID-19 has changed our legal universe. Many states are responding by issuing stay-at-home orders, and as cases rise, may have to prohibit gatherings again. One issue states and courts have to grapple with is the relationship between stay-at-home orders and religion. Stay-at-home orders that require closing down churches may be challenged as violating the First Amendment’s guarantee of religious freedom. Under our current jurisprudence, these cases may be handled under a highly deferential standard or under strict scrutiny—depending on the specific order in question, as well as on whether the state has a Religious Freedom Restoration Act (RFRA). We recommend, …

The Covid Cases: A Preliminary Assessment Of Judicial Review Of Public Health Powers During A Partisan And Polarized Pandemic, Wendy E. Parmet

San Diego Law Review

In response to the very real possibility that there will be insufficient resources to properly respond to the COVID-19 pandemic, states have been developing crisis standard of care plans, which may authorize the prioritization of patients for scarce resources based on changing circumstances and increased demands. Due to the dearth of necessary resources and trained professionals during a public health emergency, the standard of care that clinicians may be able to provide during the COVID-19 pandemic may, by necessity, depart significantly from standard nonemergency medical practice. Adhering to crisis standards of care may expose health care providers and entities to …

Prisons And Pandemics, Camila Strassle, Benjamin E. Berkman

San Diego Law Review

This Article focuses on how to balance public health, public safety, and incarcerated people’s legal rights when implementing a program for early release from confinement. Ethical, epidemiological, and legal arguments all point to a need for an immediate reduction in the incarcerated population. However, this leaves open several points of reasonable disagreement about how to manage early release. These include how to set priorities for processing and releasing individuals across the country. For example, officials could prioritize screening individuals who are housed in facilities that have been hit hard by infection; or by screening individuals who have a safe place …

Health Insurance And The Undocumented Immigrant, Anja Diercks

Honors Theses

The purpose of this thesis is to perform a comparative analysis on how seven different countries (USA, South Africa, Germany, England, Canada, France and Singapore) organize their healthcare system to cope with the issue of undocumented immigrants and whether or not these systems in place were “fair.” The thesis will also explore the possible ways the United States could change to be more inclusive and fairer in the world of healthcare and health insurance for the undocumented immigrant. A study on what fairness means both in ethical and economical terms is done to suggest a new basis of a fair …

Climate Change Disclosures After Nifla, Daniel Abrams

University of Chicago Legal Forum

No abstract provided.

The Stellenbosch Consensus On Legal National Responses To Public Health Risks: Clarifying Article 43 Of The International Health Regulations, Roojin Habibi, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Margherita Cinà, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to global health emergencies such as the ongoing COVID-19 pandemic. Countries are permitted to exercise their sovereignty in taking additional health measures to respond to such emergencies if these measures adhere to Article 43 of this legally binding instrument. Overbroad measures taken during recent public health emergencies of international concern, however, reveal that the provision remains inadequately understood. A shared understanding of the measures legally permitted by Article 43 is a necessary step in …