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Common Measures Of Vaccination Intention Generate Substantially Different Estimates That Can Reduce Predictive Validity, Jessica Fishman, K. Aleks Schaefer, Daniel Scheitrum, Christopher Robertson, Dolores Albarracin

Faculty Scholarship

Surveys often estimate vaccination intentions using dichotomous ("Yes"/"No") or trichotomous ("Yes," "Unsure," "No") response options presented in different orders. Do survey results depend on these variations? This controlled experiment randomized participants to dichotomous or trichotomous measures of vaccine intentions (with “Yes” and “No” options presented in different orders). Intentions were measured separately for COVID-19, its booster, and influenza vaccines. Among a sample of U.S. adults (N = 4,764), estimates of vaccine intention varied as much as 37.5 ± 17.4 percentage points as a function of the dichotomous or trichotomous response set. Among participants who had not received the COVID-19 vaccine, …

Prescribed Child Abuse? Using The Americans With Disabilities Act To Deconstruct Discrimination Against Medication For Opioid Use Disorder In Child Abuse & Neglect Proceedings, Makenzie Stuard

The Scholar: St. Mary's Law Review on Race and Social Justice

The opioid crisis has disrupted parent-child relationships across the United States. While states actively seek to remove children from households with current drug use in order to protect the children, state entities often fail to protect the parent-child relationship itself by imposing counterproductive policies and stereotypes on parents who are in treatment for their drug use, which makes maintaining "recovery" and parental rights an uphill battle. This note argues that the Americans with Disabilities Act (ADA) provides a novel path to root out discrimination in child abuse and neglect proceedings against parents who either take prescribed buprenorphine or are interested …

Changes In Revenues Associated With Antimicrobial Reimbursement Reforms In Germany, Matt Mcenany, Kevin Outterson

Faculty Scholarship

Policy declarations from the G7 and other high-level meetings call for increased incentives for antimicrobial research and development (R&D). Governments fund push incentives like CARB-X and GARDP, and G7 countries are now designing pull incentives—financial rewards given to manufacturers post-market authorization that are intended to encourage the creation and introduction of novel antimicrobials. Germany has declared previously at the G7 that it has developed a pull incentive that will increase revenues from sales of important new antimicrobials, principally by exempting them from some aspects of health technology benefit assessments and reference pricing, which should result in higher prices. This policy …

Internet Drug Prohibition And The Opioid Overdose Crisis, Benjamin A. Barsky

Washington Law Review

The Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act) prohibits controlled substance tele-prescribing when it occurs without a preliminary in-person medical evaluation. This Article details the Ryan Haight Act’s consequences for the practice of telemedicine in general and opioid addiction treatment in particular. In doing so, it builds on literature exploring the tension between the federal criminal regulation of controlled substance prescribing and the management of large-scale public health crises, particularly the opioid overdose crisis.

By restricting the tele-prescription of certain controlled substances used for opioid addiction treatment, the Ryan Haight Act limits access to care for a …

Flattening The Curve: Why Amending The International Health Regulations Is The Common-Sense Solution To Future Pandemics, Brittney Graff

BYU Law Review

The COVID-19 pandemic presented an unprecedented challenge for the World Health Organization (WHO) and international community. The outbreak and ongoing pandemic prompted States to reassess the efficacy of the International Health Regulations (IHR). In November 2021, the World Health Assembly (WHA) decided to develop a new agreement to increase international pandemic preparedness. This paper analyzes the current gaps in the IHR to present a pragmatic approach wherein the WHA would amend rather than replace the IHR. It starts by examining the purpose and history of the IHR, including past revisions. It then addresses the constitutional framework of the IHR, and …

Covid-19 Tort Reform, Clayton J. Masterman

Journal Articles

In 2020 and 2021, 44 states and Washington, D.C. passed laws that limited tort liability related to COVID-19. The most common reforms immunized health care providers from malpractice or similar liability. A second category is limited liability to individuals or businesses for exposing others to the novel coronavirus. And a third category protected manufacturers of supplies used to detect and prevent COVID- 19 from products liability suits. The goals of these reforms included protecting health care providers from uncertainty in providing care for a novel disease, limiting the macroeconomic consequences of the pandemic, and encouraging the distribution of critical supplies …

Safeguarding The Pandemic Agreement From Disinformation, Alexandra Finch, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Complicating the negotiation of a global pandemic treaty has been a sustained disinformation campaign worldwide to undermine the agreement by making and amplifying spurious assertions about what it intends to accomplish and how it will do so. Central to the disinformation campaign are erroneous claims about national sovereignty and forcible takings of pandemic countermeasures. Further, legitimate and unfounded unease concern weakened intellectual property (IP) and speech rights. Having followed the negotiations and provided technical assistance to the World Health Organization's (WHO's) leadership, we set the record straight in several key areas.

Unplanned Pregnancy As An Independent Risk Factor For Antepartum Si In A Post Roe Vs. Wade World, Rianna Mcnamee

Rowan-Virtua Research Day

Abstract: The objective of this literature review is to determine whether unplanned pregnancy is an independent risk factor for developing antepartum SI. Background: The Supreme Court of the United States of America recently ruled that the constitution of the United States does not confer a right to abortion to its citizens. As of October 2023, twenty-one states had developed full or partial bans on abortion, resulting in millions of Americans residing in areas where terminating unplanned pregnancy is not a viable option. There is evidence that indicates antepartum suicidal ideation (SI) is higher than that of the general population, however …

Seventy-Five Years Of Global Health Lawmaking Under The World Health Organization: Evolving Foundations Of Global Health Law Through Global Health Governance, Benjamin Mason Meier, Alexandra Finch

O'Neill Institute Papers

The World Health Organization (WHO) has been shaped by global health law throughout its history. Drawing from the post-war establishment of global governance under the United Nations (UN), the modern foundations of global health law were laid by the WHO Constitution, which provided WHO with a range of normative authorities to realize its mandate as the UN’s directing and coordinating authority in global health. Yet WHO has faced political challenges in exercising these normative authorities to advance global health law, revealing the limitations of law as a foundation of global health governance. This article chronicles the 75-year evolution of global …

Shots Fired, Shots Refused: Scientific, Ethical & Legal Challenges Surrounding The U.S. Military's Covid-19 Vaccine Mandate, Shawn Mckelvy, L. William Uhl, Armand Balboni

St. Mary's Law Journal

The COVID-19 pandemic provided uncertain and challenging circumstances under which to lead a nation and the military that protects it. Those in charge and in command faced unique challenges—scientific, ethical, and legal—at our various levels of government to both keep people safe while keeping government and society functioning. While there were many successes to celebrate, there are also many criticisms for how this “whole-of-government approach” may have degraded some of our most cherished liberties along the way. The authors focus on the U.S. military’s vaccine mandate and propose military leaders may have failed to fully consider the evolving science, weigh …

The World Health Organization Was Born As A Normative Agency: Seventy-Five Years Of Global Health Law Under Who Governance, Lawrence O. Gostin, Benjamin Mason Meier, Safura Abdool Karim, Judith Bueno De Mesquita, Gian Luca Burci, Danwood Chirwa, Alexandra Finch, Eric A. Friedman, Roojin Habibi, Sam F. Halabi, Tsung-Ling Lee, Brigit Toebes, Pedro Villarreal

Georgetown Law Faculty Publications and Other Works

The World Health Organization (WHO) was born as a normative agency and has looked to global health law to structure collective action to realize global health with justice. Framed by its constitutional authority to act as the directing and coordinating authority on international health, WHO has long been seen as the central actor in the development and implementation of global health law. However, WHO has faced challenges in advancing law to prevent disease and promote health over the past 75 years, with global health law constrained by new health actors, shifting normative frameworks, and soft law diplomacy. These challenges were …

Teaching Global Health Law: Preparing The Next Generation For Future Challenges, Lawrence O. Gostin, Sarah L. Bosha, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

Following from sweeping law reforms across the global health landscape, there is a need to prepare the next generation to advance global health law to ensure justice for a healthier world. Educational programs across disciplines have increasingly incorporated the field of global health law, with new courses examining the law and policy frameworks that apply to the new set of public health threats, non-state actors, and regulatory instruments that structure global health. Such interdisciplinary training must be expanded throughout the world to prepare future practitioners to strengthen global health law — ensuring a foundation for global health in legal studies …

When Governors Prioritize Individual Freedom Over Public Health: Tort Liability For Government Failures, Barbara Pfeffer Billauer Jd, Ma, Phd

Journal of Law and Health

Over half the states have enacted laws diminishing or curtailing the rights of the executive branch (legislatures or governors) to enact laws to preserve, protect, or safeguard public health in the wake of the COVID-19 emergency. Governor DeSantis, of Florida, for example, effectively banned mask mandates in schools during the high point of the epidemic – based on flawed science and erroneous data – and now wants to make that response permanent. The rules effectuating this Executive Order were enacted under an emergency order finding a threat to public health. Nevertheless, the response promulgated by the Florida Department of Health …

How Bodily Autonomy Can Fail Against Vaccination Mandates; The Few Vs. The Many, Jason Yadhram

Journal of Law and Health

Humans have been a communal species since inception and continue to be so to this day. Because of this, if even a small scale of a measured population becomes severely ill, the entire remaining population and surrounding area is thrown into absolute chaos. In fact, we have seen these circumstances throughout history and in the recent COVID-19 pandemic yet, some of us have forgotten that the only way this chaos can be curbed, is by enacting a mandatory vaccination policy. Since COVID-19 however, vaccination mandates have become an uneasy topic of conversation in the United States for essentially one main …

Personal Data And Vaccination Hesitancy: Covid-19’S Lessons For Public Health Federalism, Charles D. Curran

Catholic University Law Review

During the COVID-19 vaccination campaign, the federal government adopted a more centralized approach to the collection of public health data. Although the states previously had controlled the storage of vaccination information, the federal government’s Operation Warp Speed plan required the reporting of recipients’ personal information on the grounds that it was needed to monitor the safety of novel vaccines and ensure correct administration of their multi-dose regimens.

Over the course of the pandemic response, this more centralized federal approach to data collection added a new dimension to pre-existing vaccination hesitancy. Requirements that recipients furnish individual information deterred vaccination among undocumented …

The Persistent Public Health Emergency, Yael Zakai Cannon

Georgetown Law Faculty Publications and Other Works

May 11, 2023 was ostensibly a day of celebration. With infections and deaths from COVID-19 down, the federal government announced the end of the official Public Health Emergency three years after its initial declaration. But the conclusion of the Public Health Emergency also signaled the termination of unprecedented health protection measures—outside the realm of healthcare—such as eviction and utility shutoff moratoria and emergency rental and utility assistance. These COVID-era measures successfully cut eviction filings nationally by more than half and provided people in many jurisdictions with the protections and assistance needed to maintain their electricity, heat, water, and gas. Now …

Disability, Race, And Health Beyond The Carceral State, Benjamin A. Barsky, Craig Konnoth, Michael Ashley Stein

Michigan Law Review

A review of Embodied Injustice: Race, Disability, and Health. By Mary Crossley.

Financing Reforms To Meet A Pivotal Moment In Global Health, Kevin A. Klock, Alexandra Finch, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

2024 will be the most important moment for global health since the World Health Organization’s founding in 1948, but only if states give major reforms their full political and financial backing. Bold new commitments in disease surveillance, capacity building, and more equitable access to health products cannot be achieved without ample and sustainable funding. In this essay, we discuss major reforms found in the emerging pandemic agreement and reformed International Health Regulations and then explore the significant challenges and opportunities for financing them.

Revisiting Compassionate Release: The Sentencing Commission’S Compassionate Changes To The 2023 Compassionate Release Policy Statement, Rachel Wilson

Cleveland State Law Review

Compassionate release is a well-established exception to the Sentencing Reform Act’s requirement that a defendant’s sentence not be reduced after its final imposition. The Act requires the Sentencing Commission, through policy statement, to describe “extraordinary and compelling reasons” warranting compassionate release. However, the Sentencing Commission’s failure to convene as a quorum for nearly four years precluded any policy statement updates. In that time, the COVID-19 pandemic and the Bureau of Prisons’ internal issues further complicated the compassionate release process. This Note analyzes the 2023 amendment to the compassionate release policy statement, its potential implications, and suggests additional steps to be …

Reducing Harm: The Legal Viability Of Supervised Consumption Sites In Georgia, Kathleen Kassa

Georgia State University Law Review

Every five minutes in the United States, someone dies from a drug overdose. This public health crisis, referred to as the opioid epidemic, caused the federal government and many states and localities to issue public health emergency declarations. Despite billions of dollars in funding and response at every level of government, overdoses continue to increase.

The complexity of addiction prevention and treatment, socioeconomic inequalities, and the stigmatization of drug use make the opioid crisis difficult to solve. The severity of the epidemic led many jurisdictions to adopt once-controversial harm reduction approaches aimed at reducing the stigma and negative impacts of …

Innovative Virtual Wellness Interventions At An Academic Medical Center: A Pilot Feasibility Study, Ritika Baweja, Michael Hayes, Aditya Joshi, Raman Baweja

Journal of Wellness

Introduction: There is generally a concerning likelihood of burnout in healthcare workers. Given the impact of COVID-19 on healthcare workers, our institution identified the need for wellness interventions to foster adaptive functioning and mitigate burnout. The purpose of this pilot project was to assess the feasibility of virtual holistic interventions like meditation, art, laughter therapy and dance and their impact on overall well-being of physicians and advanced practice providers (APPs).

Methods: A series of 12 virtual sessions (art therapy, dance therapy, mindfulness-based practices/meditation and laughter therapy) were offered to providers over a 6-month period. Participants completed an online survey reporting …

Be Careful What You Wish For: An Overreliance On Telemedicine Could Harm Health Equity, Chinelo Diké-Minor

Annals of Health Law and Life Sciences

No abstract provided.

From Deference To Indifference: Judicial Review Of The Scope Of Public Health Authority During The Covid-19 Pandemic, Wendy E. Parmet

Saint Louis University Journal of Health Law & Policy

For most of American history, courts have granted public health officials significant deference in construing the scope of their own authority. This changed during the COVID-19 pandemic, especially in the federal courts, where deference was replaced with skepticism as courts used the major questions doctrine to narrow the scope of public health powers. This Article examines this development and considers its implications for public health. Part II begins by recounting the long history of judicial deference to officials’ determination of the scope of their public health powers. Part III notes some of the problems with such deference and the pre-pandemic …

Authority To Improve Or Harm Health: The Public Health Front In A Decades-Long Battle Over Governmental Powers, Sabrina Adler, Sara Bartel, Heather Wong

Saint Louis University Journal of Health Law & Policy

Backlash to local, state, and federal responses to combat COVID-19 has resulted in a small but vocal cohort of legislatures and courts trying to change long-settled and foundational principles of public health decision-making. They have shifted authority away from experts and local decision-makers, limiting emergency response in ways that also impact day-to-day public health efforts. Considering some examples of other recent preemption efforts, it is clear that COVID-era backlash is part of a longer-term deregulatory agenda, often framed as an effort to keep “big government” out of people’s lives and to preserve individual freedoms. However, the impact of such deregulation …

The Model Public-Health Emergency Authority Act, Robert Gatter

Saint Louis University Journal of Health Law & Policy

The Uniform Law Commission recently approved the Model Public-Health Emergency Authority Act (MPHEAA or the Act or the Model Act). The MPHEAA grants governors specific and plenary powers to issue public health emergency orders while also ensuring executive branch transparency and accountability. The Act improves public health emergency preparedness by resecuring the legal foundation for states to respond effectively to future emergencies. However, more work is needed to enhance data collection and support vulnerable populations in emergencies.

This Article discusses the origins of the MPHEAA, key policy and drafting choices the Drafting Committee made in creating the MPHEAA, and the …

Doing More With Less: State Public Health Emergency Powers Post-Pandemic, Kelly J. Deere

Saint Louis University Journal of Health Law & Policy

Three years after COVID-19 arrived in the United States, many governors and public health officials are equipped with fewer—not more—public health emergency powers than at the start of the pandemic. This may seem counterintuitive, considering that this virus has killed more than 1.1 million Americans and counting. While public health emergency powers were stripped on the federal, state, and local level, this loss is most acutely felt at the state executive level. Some state legislatures passed laws banning state and local governments from implementing a mask or vaccine mandate, while others amended their state emergency disaster statutes to limit the …

What Is A Public Health Lawyer Today? Acting For, Against, And Beyond Public Health, Scott Burris

Saint Louis University Journal of Health Law & Policy

Health in America is not looking good. Unique among countries in the Organization for Economic Co-operation and Development, the basic measure of national health—life expectancy—was declining even before COVID-19. Public health, both as a system of institutions and as a profession working to promote longer and healthier lives, is also struggling. The normal insularity of the field’s professional culture—including a lack of legal competency—helped undermine the response to COVID-19, which was dismal by any measure. At this difficult time, this Article considers three different ways public health lawyers can make a contribution to public health as a goal and as …

The Future Of Jacobson V. Massachusetts And Modern Substantive Due Process For Public Health Preparedness, Helen S. Webster

Saint Louis University Journal of Health Law & Policy

Both the threat of public exposure to Ebola in the United States in 2014 and the COVID-19 pandemic beginning in 2020 prompted states to impose quarantine and mask mandates, among other responses, to protect the public’s health. When these state actions were eventually challenged on substantive due process grounds in courts across the nation, judges struggled to determine which legal test applied when reviewing the constitutionality of the state actions. On one hand, courts considered the precedent set forth in Jacobson v. Massachusetts, a 1905 Supreme Court case that upheld a Massachusetts vaccine mandate as a valid exercise of …

Covid-19 And Access To Healthcare At The Crossing Of Race, Poverty, And Rurality, Shavonnie R. Carthens

Law Faculty Scholarly Articles

Black Americans make up 7.7 percent of the rural population in the United States. During the COVID-19 pandemic many in this population found themselves at a unique intersection of inequity - being Black, poor, and residing in a rural area. Poverty is a known contributor to negative health outcomes and is a risk factor for death from coronavirus infection. The association between race and poverty, when examining infectivity and mortality rates of COVID-19, have disproportionately devastated Black Americans and other minorities. Further, research indicates the presence of a general “rural mortality penalty” wherein rural Black communities have higher death rates …

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …