Digital Commons Network^™

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Faculty Scholarship

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Animal Rights Activism And The Constitution: Are Ag-Gag Laws Justifiable Limits?, Jodi Lazare

Articles, Book Chapters, & Popular Press

Forthcoming in the Osgoode Hall Law Journal (2022).

It is a troubling time to be an animal rights activist in Canada. Recently, Alberta adopted legislation to create harsh penalties for trespassing onto private property, for obtaining permission to enter private property based on false pretences, and for interfering with vehicles on public highways. These laws relate to agricultural lands, to private property generally, and, where roads are concerned, to public property. Ontario, for its part, has adopted similar legislation aimed specifically at agricultural property. The legislation in both provinces purports to protect the security of farmers, their families, and rural …

A Solution For The Third-Party Doctrine In A Time Of Data Sharing, Contact Tracing, And Mass Surveillance, Tonja Jacobi, Dustin Stonecipher

Faculty Articles

Today, information is shared almost constantly. People share their DNA to track their ancestry or for individualized health information; they instruct Alexa to purchase products or provide directions; and, now more than ever, they use videoconferencing technology in their homes. According to the third-party doctrine, the government can access all such information without a warrant or without infringing on Fourth Amendment privacy protections. This exposure of vast amounts of highly personal data to government intrusion is permissible because the Supreme Court has interpreted the third-party doctrine as a per se rule. However, that interpretation rests on an improper understanding of …

Public Nuisance As Risk Regulation, Thomas W. Merrill

Faculty Scholarship

Public nuisance has always been defined in terms of the object of protection – the community, the public, or perhaps even the state as a whole. Public nuisance in this regard has been juxtaposed to private nuisance, which protects individual persons and their use and enjoyment of land. Commentary on public nuisance has thus long been concerned with defining (without notable success) what it means to advance a public as opposed to a private right.

In this paper, I offer a different take on the function of public nuisance. The common law is designed to provide redress for actual harm, …

The Need For Social Support From Law Schools During The Era Of Social Distancing, Michele Okoh, Inès Ndonko Nnoko

Faculty Scholarship

Law students have been faced with unparalleled stress during the syndemic. They must cope with being students during the COVID-19 pandemic but also must deal with stress related to social and political unrest. This essay recommends that law schools apply social support theory in developing interventions to effectively address the needs of law students now and in the future.

Social support theory focuses on the value and benefits one receives from positive interpersonal relationships. These positive relationships impact both mental and physical health and promote beneficial short and long-term overall health. However, not all supports are the same, and social …

Stemming The Shadow Pandemic: Integrating Sociolegal Services In Contact Tracing And Beyond, Medha D. Makhlouf

Faculty Scholarly Works

The COVID-19 pandemic has shed light on the challenges of complying with public health guidance to isolate or quarantine without access to adequate income, housing, food, and other resources. When people cannot safely isolate or quarantine during an outbreak of infectious disease, a critical public health strategy fails. This article proposes integrating sociolegal needs screening and services into contact tracing as a way to mitigate public health harms and pandemic-related health inequities.

No-Fault Vaccine Injury Compensation Systems Adopted Pursuant To The Covid-19 Public Health Emergency Response, Sam Halabi, Katherine Ginsbach, Katie Gottschalk, John Monahan, Judith Murungi

Emory International Law Review

No-fault vaccine injury compensation systems have developed over the course of the twentieth century, mostly in the richest countries in the world. Acknowledging that severe reactions to vaccines are rare, but can result in serious and sometimes complex injury, these systems provide financial and social support for those suffering these rare side effects. During the COVID-19 pandemic, and the rapid development and deployment of vaccines using novel technologies, these systems have proliferated not only among wealthy countries, where in their modern form they originated and spread, but also low- and middle-income ones. Adopting varying approaches to funding, eligibility, administration, process, …

Stifling Innovation: How Global Data Protection Regulation Trends Inhibit The Growth Of Healthcare Research And Start-Ups, Ryan Preston

Emory International Law Review

No abstract provided.

Barring Methadone Behind Bars: How Prisons Err When Denying Methadone Treatment To Inmates With Opioid Use Disorder, Julia Durst

Mitchell Hamline Law Review

No abstract provided.

Achieving Parity Of Coverage Between Mental And Physical Health Care, Erica A. Fishel

Student Works

No abstract provided.

No Shot, No School: The Case For Eliminating The Religious Exemption To Mandatory Vaccinations, Marc L. Rein

Student Works

No abstract provided.

Tsunami: Recommitting To Adress Aapi Mental Health In A Post-Covid Era, Oliver J. Kim

Nova Law Review

No abstract provided.

Market Myopia’S Climate Bubble, Madison Condon

Utah Law Review

A growing number of financial institutions, ranging from BlackRock to the Bank of England, have warned that markets may not be accurately incorporating climate change-related risks into asset prices. This Article seeks to explain how this mispricing occurs, drawing from scholarship on corporate governance and the mechanisms of market (in)efficiency. Market actors: (1) Lack the fine-grained asset-level data they need in order to assess risk exposure; (2) Continue to rely on outdated means of assessing risk; (3) Have misaligned incentives resulting in climate-specific agency costs; (4) Have myopic biases exacerbated by climate change misinformation; and (5) Are impeded by captured …

Viral Sovereignty, Vaccine Diplomacy, And Vaccine Nationalism: The Institutions Of Global Vaccine Access, Sam F. Halabi, Ana Santos Rutschman

Emory International Law Review

The COVID-19 pandemic has triggered a global vaccine race. Distributive questions about which countries will receive scarce doses and under which conditions pervade international law and diplomacy. This Article is the first to describe the phenomena that have driven the development of international vaccine-sharing mechanisms, identify the international organizational forces that explain the phenomena, and explain how international organizations may facilitate international cooperation before, during, and after global crises.

This Article explores the longstanding dissociation between global public health imperatives and nationalist responses to pandemics within the frameworks of “vaccine nationalism,” “viral sovereignty,” and “vaccine diplomacy.” The Article then considers …

Modelling Pretrial Detention, Melissa Hamilton

American University Law Review

Pretrial detention has become normative in contemporary criminal justice, rather than the exception to a rule of release for individuals not convicted of any crime. Even the opportunity for release with a bond amount often eludes the many individuals who are unable to afford, to pay. Defendants detained, pending trial suffer numerous negative consequences to their own legal cases, such as being more likely to feel pressured to plead guilty and to receive a prison sentence. The high numbers of those detained appear to disproportionately impact minorities and. have contributed to mass incarceration. As a. result, of these issues, the …

What’S The Beef? The Fda, Usda, And Cell-Cultured Meat, Tammi S. Etheridge

Washington and Lee Law Review

Over the past ten years, administrative law scholarship has increasingly focused on interactions between multiple agencies. As part of this trend, most scholars have called for policymakers to combine multiple agencies, rather than rely on a single agency, to solve policy problems. The literature in this area espouses the benefits of shared regulatory space. But very little of this scholarship addresses when shared jurisdiction is problematic. This is particularly concerning when an agency opts into or cedes oversight authority to another agency at will, with little regard for whether the second agency is an appropriate regulator. The case of cell-cultured …

Diversity's Pandemic Distractions, Jonathan Kahn

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Anti-Vax Fear* Speech: A Public-Health-Driven Policy Initiative When Counter-Speech Won't Work (*Fake, Flawed, Fraudulent, False, Endangering, And Reckless), Barbara Pfeffer Billauer

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Treating For Two: Reforming Maternal Substance Abuse Policy, Katherine Drabiak

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Why Not Both Nature And Nurture: Using Behavioral Genetic Markers As Sentencing Factors, Seely Kaufmann

Law Student Publications

"On the evening of July 1, 2013, Amos Wells was upset that his pregnant girlfriend, Chanice Reed, would not answer his calls. He then drove to where she, her mother Annette, and ten-year-old brother Eddie, lived. After arguing with Chanice and yelling at the top of his voice in a “bone-chilling scream,” Wells retrieved a handgun from his Chevrolet Tahoe parked in front of the house, and shot Chanice in the front yard as she screamed, “No, no, no.” Her mother then tried to bat the gun away before he shot her too. Further shots were heard before Wells finally …

Taxonomy And Restorative Justice: Can We Even See The Problem?, Dominique Day

Journal of Race, Gender, and Ethnicity

No abstract provided.

A Proportionality-Based Framework For Government Regulation Of Digital Tracing Apps In Times Of Emergency, Sharon Bassan

Dickinson Law Review (2017-Present)

Times of emergency present an inherent conflict between the public interest and the preservation of individual rights. Such times require granting emergency powers to the government on behalf of the public interest and relaxing safeguards against government actions that infringe rights. The lack of theoretical framework to assess governmental decisions in times of emergency leads to a polarized and politicized discourse about potential policies, and often, to public distrust and lack of compliance.

Such a discourse was evident regarding Digital Tracing Apps (“DTAs”), which are apps installed on cellular phones to alert users that they were exposed to people who …

Policies And Regulations Surrounding Opioid Use Disorder During Covid-19, Hannah Eaves

Student Works

No abstract provided.

Secrecy Nurtures Disease: Balancing Privacy Concerns With Covid-19 Contact-Tracing Measures, Julianna Dzwierzynski

Student Works

No abstract provided.

Battleground Of The Opioid Crisis: The Eighth Amendment Right To Medication-Assisted Treatment In Prisons And Jails, And Upon Release, Claire E. Scavone

Emory Law Journal

About eighty percent of all inmates in the United States need but will not receive treatment for their Opioid Use Disorder (OUD). Instead, they will leave prison with a 140 times greater chance of a fatal overdose than before their prison sentence. Although incarceration is conceivably an opportune time for the state to connect individuals with treatment, only about one percent of prisons and jails allow the use of Medication-Assisted Treatment (MAT). This failure has a myriad of causes. Notably, beliefs that OUD is a moral failure and that MAT either does not work or is dangerous are both among …

Elderly, Detained, And Justice-Involved: The Most Incarcerated Generation, Rachael Bedard, Joshua Vaughn, Angela Silletti Murolo

City University of New York Law Review

The “graying” of the United States prison system is a well-documented phenomenon that describes the aging of the population currently held in U.S. state and federal prisons. This is generally attributed to the large number of individuals who are aging in place in prisons around the country due to long sentences and restrictive parole practices. Less well-known or well-characterized is the fact that the U.S.’s justice-involved population outside of prisons is also “graying”—that the demographics of people who are being arrested, jail detained, transferred to prisons on new criminal convictions, and monitored under community surveillance programs are also changing to …

What Should Ethical And Strategic Employers Do About Covid-19 Vaccines?, Dale B. Thompson, Susan A. Suspina, Katherina G. Pattit, Dawn R. Swink

University of San Francisco Law Review

No abstract provided.

Out Of The Street And Into The State’S Arms: An Answer For The Drug Crisis?, Robert Corcoran

Student Works

No abstract provided.

The Law, Economics, And Governance Of Generation Covid-19 Long-Haul, Julia Puaschunder, Martin Gelter

Faculty Scholarship

The SARS-CoV-2 novel coronavirus is an external shock to all societies with lasting impacts that have changed individual, political, and corporate decisions profoundly. Increasing evidence reveals that an estimated 10-50% of those previously infected with COVID-19 face a longer-term or long-term health impact and/or chronic debilitation that in many cases comes and goes in waves. This phenomenon has already been referred to as a pandemic within the pandemic. The broad-based and long-term impact of COVID Long Haulers have also holds the potential to change our world and modern society, lasting through the following three outlined speculative trends: (1) The coronavirus …

Jail Health And Early Release Practices, Brandon L. Garrett, Deniz Ariturk, Jessica Carda-Auten, David L. Rosen

Faculty Scholarship

Local jails in the United States incarcerate millions of people each year. The COVID-19 pandemic made jail health a pressing public health concern nationally, where releasing individuals from jails occurred across the country in order to prevent pandemic spread. But releases also faced substantial resistance and exposed long-standing challenges in delivering adequate healthcare in jail settings. People in jail have substantially higher levels of medical need than individuals in the general population, with large numbers having serious mental illnesses and substance use disorders. Further, overcrowded conditions and poor healthcare standards and delivery make jails harmful to those already-vulnerable people. What …