Digital Commons Network^™

Of Mosquitoes And "Moral Convictions" In The Age Of Zika: How The Trump Administration's Gutting Of The Affordable Care Act's Contraceptive Mandate Jeopardizes Women's And Children's Health, Linda C. Fentiman

Health Matrix: The Journal of Law-Medicine

The Trump Administration’s efforts to undo the contraceptive mandate, a key component of the Affordable Care Act (ACA), threaten a major public health emergency, as well as the rule of law and separation of powers. The Trump Administration’s Rules greatly expand the grounds for exemption from the contraceptive mandate: they allow even publicly traded corporations to assert religious beliefs as a ground for exemption and exempt all employers except publicly traded corporations from compliance with the contraceptive mandate if they hold “moral convictions” in opposition to contraception. By denying women access to effective, affordable contraception, these Rules increase the odds …

Covid-19 And Public Accommodations Under The Americans With Disabilities Act: Getting Americans Safely Back To Restaurants, Theaters, Gyms, And “Normal”, Frank Griffin M.D., J.D.

SLU Law Journal Online

THIS IS A PRELIMINARY EXPEDITED VERSION OF THE OFFICIAL ARTICLE TO BE ORIGINALLY PUBLISHED IN SAINT LOUIS UNIVERSITY LAW JOURNAL VOLUME 65 NUMBER 2

COVID-19 permanently changed the way places of public accommodation like restaurants, theaters, medical facilities, arenas, gyms, and many other proprietors of mainstream American activities must operate in order to accommodate people with newly-defined, COVID-19-related disabilities under Title III of the Americans with Disabilities Act (ADA). The required modifications will affect all patrons and employees of these establishments. Under the ADA, places of public accommodation are barred from discriminating against people with disabilities in the full and …

Tell Me How It Ends: The Path To Nationalizing The U.S. Pharmaceutical Industry, Fran Quigley

University of Michigan Journal of Law Reform

The U.S. medicines system is broken. Millions of Americans suffer and some even die because they cannot afford medicines discovered by government-funded research. At the same time, corporations holding monopoly patent rights to those medicines collect some of the largest profits in modern capitalist history.

It does not have to be this way. The global legacy of treating essential medicines as a public good and the robust U.S. history of government seizure of private property for the public interest reveals a better path: the United States should nationalize its pharmaceutical industry.

U.S. statutory law already provides broad powers for the …

The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos

Articles

Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …

Ebola And Emerging Infectious Diseases In Armed Conflict: Contemporary Challenges In Global Health Security Laws And Policies, Caroline Sell

Minnesota Journal of International Law, Vols. 28:2 onward (2019-present)

No abstract provided.

Legislating A Negative Right To Health: Health Impact Assessments, Christina S. Ho

Seton Hall Law Review

No abstract provided.

Covid-19, Telehealth, And Substance Use Disorders, Stacey A. Tovino

Faculty Articles

No abstract provided.

Meat Processing Workers And The Covid-19 Pandemic: The Subrogation Of People, Public Health, And Ethics To Profits And A Path Forward, Kelly K. Dineen

Saint Louis University Journal of Health Law & Policy

The COVID-19 pandemic has highlighted and exacerbated existing health injustices. People who are Latino/Latinx, Black, Indigenous or members of other minority groups have disproportionately paid with their very lives. The pandemic has also exposed the complex interdependence of worker health and well-being, community health, and economic security. Industries like meat processing facilities—with congregate and high-density workplaces staffed by workers who are already disadvantaged by structural discrimination—must reckon with decades of subrogation and exploitation of workers. During this pandemic, the industry has pushed that exploitation to a point of no return. Policies to protect workers need a reset to an orientation …

The Nagoya Protocol And The Legal Structure Of Global Biogenomic Research, Sam F. Halabi, Michelle Rourke, Gian Luca Burci, Rebecca Katz

Faculty Publications

As life sciences technologies have advanced, so too has the potential for these international collaborations to lead to breakthrough medicines, enhance food security, and protect ecological systems. The linchpin of this progress is the development of high throughput genetic sequencing technologies. Researchers are now able to generate and compare large stretches of DNA - 1 million bases or more - from different sources quickly and inexpensively. Such comparisons can yield massive amounts of information about the role of inheritance in susceptibility to infection and illness as well as responses to environmental influences. In addition, the ability to sequence genomes more …

Early Access To Unapproved Medicines In The United States And France, Erika Lietzan

Faculty Publications

In 2018, President Trump signed a federal "right to try" law, claiming that it would give desperately ill patients earlier access to unapproved medicines, by allowing the patient, doctor, and drug company to arrange for access without federal oversight. Critics of the law argued that it would not meaningfully increase access to experimental medicines, because federal oversight was not the obstacle in the first place. And they were correct. U.S. law already permitted companies to provide terminally ill patients with early access to unapproved medicines. The problem was instead that companies did not take advantage of this option. This Article …

Buck V. Bell, American Eugenics, And The Bad Man Test: Putting Limits On Newgenics In The 21st Century, Alessandra Suuberg

Minnesota Journal of Law & Inequality

No abstract provided.

China’S Innovative Turn And The Changing Pharmaceutical Landscape, Peter K. Yu

University of the Pacific Law Review

No abstract provided.

Locked Up They Won’T Let Me Out: Giving Prisoners The Right To Die With Dignity In Oregon, Daniel Gill

Student Works

No abstract provided.

Vaccine Administration And Constitutional Protections: Substantive Due Process And Hpv Prevention, Valerie Mayzelshteyn

Student Works

No abstract provided.

Deadly Delay: The Fda's Role In America's Covid-Testing Debacle, Barbara J. Evans, Ellen Wright Clayton

UF Law Faculty Publications

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations (EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as having a practical binding effect even though the FDA lacked clear …

Is Solitary Confinement A Punishment?, John F. Stinneford

UF Law Faculty Publications

The United States Constitution imposes a variety of constraints on the imposition of punishment, including the requirements that the punishment be authorized by a preexisting penal statute and ordered by a lawful judicial sentence. Today, prison administrators impose solitary confinement on thousands of prisoners despite the fact that neither of these requirements has been met. Is this imposition a “punishment without law,” or is it a mere exercise of administrative discretion? In an 1890 case called In re Medley, the Supreme Court held that solitary confinement is a separate punishment subject to constitutional restraints, but it has ignored this holding …

Integrative Environmental Law: A Prescription For Law In The Time Of Climate Change, Alyson C. Flournoy

UF Law Faculty Publications

As the magnitude of the threat posed by climate change has become increasingly apparent, scholars and practitioners have begun a dialogue about how to reform environmental law to meet the challenge. Concepts like adaptive management, sustainability, and resilience have emerged in succession, as policy makers and scholars search for new moorings for our ethical and legal framework. While useful, these concepts have failed to provide a vision, goal, or solid ethical grounding for environmental law in the era of climate change. This project takes a new approach by exploring what we can learn from the field of Integrative Medicine. The …

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself …

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Covid-19 Vaccines As Global Public Goods, Jason W. Nickerson, Matthew Herder

Articles, Book Chapters, & Popular Press

Vulnerable: The Law, Policy and Ethics of COVID-19 confronts the vulnerabilities that have been revealed by the pandemic and its consequences. It examines vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance, and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices affect us all. COVID-19 has forced us to not only reflect on how we govern and how we set policy priorities, but also to ensure that pandemic preparedness, precautions, …

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

On Environmental Law, Climate Change, And National Security Law, Mark P. Nevitt

Faculty Articles

This Article offers a new way to think about climate change. Two new climate change assessments—the 2018 Fourth National Climate Assessment (“NCA”) and the United Nations Intergovernmental Panel on Climate Change’s Special Report on Climate Change— prominently highlight climate change’s multifaceted national security risks. Indeed, not only is climate change an environmental problem, it also accelerates existing national security threats, acting as both a “threat accelerant” and “catalyst for conflict.” Further, climate change increases the intensity and frequency of extreme weather events while threatening nations’ territorial integrity and sovereignty through rising sea levels. It causes both internal displacement within nations …

Covid-19 And First Nations’ Responses, Aimée Craft, Deborah Mcgregor, Jeffery G. Hewitt

Articles & Book Chapters

This chapter considers the federal government’s fettering of jurisdiction through inaction in the areas of clean water and housing. We consider a small sample of First Nations’ responses, taken on the basis of their assertions of jurisdiction and responses to the particular needs and circumstances of their communities. We conclude that First Nations are best positioned to make policy and law in response to COVID-19, and that the federal government can and must work with First Nations communities on resourcing their plans for wellness and emergency preparedness in relation to the pandemic, in accordance with a sui generis application of …

Federal Detention And “Wild Facts” During The Covid-19 Pandemic, Gabriel A. Fuentes

Journal of Criminal Law and Criminology

No abstract provided.

Lessons From Disaster: Assessing The Covid19 Response In Youth Jails & Prisons, Madalyn K. Wasilczuk

Faculty Publications

No abstract provided.

The Bad, The Ugly, And The Horrible: What I Learned About Humanity By Doing Prison Research, Adelina Iftene

Dalhousie Law Journal

Every Canadian academic conducting research with humans must submit an ethics application with their university’s Research Ethics Board. One of the key questions in that application inquired into the level of vulnerability of the interviewees. Filling in that question, I had to check nearly every box: the interviewees were incarcerated, old, under-educated, poor, Indigenous or other racial minorities, and likely had mental and physical disabilities. However, it was not until I met John that I understood what all those boxes actually meant. They were signalling that I was entering a universe of extreme marginalization—the universe of the forgotten. I learned …

The Free Exercise Clause And The Religious Exemption To Vaccinations: Why States Are Allowed To Implement Mandatory Vaccinations, Caroline Braga

Student Works

No abstract provided.

A Public Health Framework For Covid-19 Business Liability, Daniel Hemel, Daniel B. Rodriguez

Public Law and Legal Theory Working Papers

Businesses that reopen amid the COVID-19 pandemic face potential legal liability to customers and workers who contract the coronavirus through those enterprises’ operations. Federal and state lawmakers are actively considering proposals to narrow or expand such liability. These proposals have important economic and public-health implications. This article presents an analytical framework for evaluating liability regimes in the context of a communicable disease. The framework highlights the contrasting public-health consequences of liability before and after a customer or worker is exposed to the virus. Ex ante (before exposure), potential liability generates incentives for businesses to take precautions that reduce the risk …