Health Law and Policy Commons^™

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then examines the federal agency initiatives undertaken in …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

Quarantine And The Federal Role In Epidemics, Michael R. Ulrich, Wendy K. Mariner

Faculty Scholarship

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

Adoption Process For The Model Aquatic Health Code: An Example, William D. Ramos, Allison L. Fletcher, Mike Mettler, Marcus A. Yoder

International Journal of Aquatic Research and Education

In 2014 the U.S. Centers for Disease Control and Prevention (CDC) published the first edition of the Model Aquatic Health Code (MAHC). This document represented the inaugural introduction of a federal policy guideline with a direct focus in the area of aquatic venue operation and maintenance with the sole purpose of improving the nature of public health in the field. The Indiana State Department of Health (ISDH) began the review and adoption process soon after the policy’s release. The ISDH process is proposed as one method for others to consider. The background and history of the MAHC are presented in …

Legal Capacities Required For Prevention And Control Of Noncommunicable Diseases, Roger S. Magnusson, Benn Mcgrady, Lawrence O. Gostin, David Patterson, Hala Abou Taleb

Georgetown Law Faculty Publications and Other Works

Law lies at the centre of successful national strategies for prevention and control of noncommunicable diseases. By law we mean international agreements, national and subnational legislation, regulations and other executive instruments, and decisions of courts and tribunals. However, the vital role of law in global health development is often poorly understood, and eclipsed by other disciplines such as medicine, public health and economics. This paper identifies key areas of intersection between law and noncommunicable diseases, beginning with the role of law as a tool for implementing policies for prevention and control of leading risk factors. We identify actions that the …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Quarantine And The Federal Role In Epidemics, Michael R. Ulrich, Wendy K. Mariner

SMU Law Review

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

The Morality Of Compulsory Licensing As An Access To Medicines Tool, Margo A. Bagley

Faculty Articles

This Article contemplates the validity of theft rhetoric in relation to the right of countries to grant compulsory licenses from an unconventional perspective; that of biblical teachings on what it means to steal.

Part I describes the use of theft rhetoric in relation to IP infringement broadly and drug-patent compulsory licenses in particular.

Part II challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins.

Part III considers the cogency of the accusation that the issuance of compulsory licenses …

Witch Doctors, Zombies, And Oracles: Rethinking Health In America, Ali S. Khan

Health Matrix: The Journal of Law-Medicine

To the extent we can even refer to an American healthcare "system," it functions brilliantly ... to make money. The system is designed to reward executives or major shareholders of pharmaceutical & health insurance companies, healthcare facilities, and related entities. With a rapidly aging population, healthcare will soon surpass a fifth of our economy. Of course, the American healthcare system does not function brilliantly when one considers the perspective of patients and over-extended primary care providers. Prices are growing faster than inflation or wages, healthcare is twice as costly as other comparable nations, and one third is a result of …

When Trade Secrecy Goes Too Far: Public Health And Safety Should Trump Corporate Profits, Julie E. Zink

Vanderbilt Journal of Entertainment & Technology Law

This Article addresses the historical and ongoing use of trade secrets to withhold critical information from the public. Through its text and footnotes, the Article discusses the positives and negatives of trade secret protection; addresses historical and current examples of trade secret abuse; analyzes the inadequate solutions that have been tried and proposed; and, ultimately, recommends changing trade secret law by incorporating the precautionary principle into the definition of a trade secret to ensure that protection will no longer be available for information that endangers public health.

This Article is both timely and necessary, as the public is continually bombarded …

Fashioning Worker Protections To Combat The Thin Ideal's Cost On Fashion Models And Public Health, Erin E. Meyers

Vanderbilt Journal of Entertainment & Technology Law

Studies linking thin-obsessed media consumption to poor health outcomes for women have permeated the medical literature for years. The pressures female fashion models face to sacrifice their health for their jobs are perhaps even more disturbing. These harrowing issues are symptoms of the "thin ideal," the social norm glorifying a female body type so thin it is unattainable for most women. Despite the clear harm imposed by the thin ideal, the United States has done little to combat its effect on the working conditions of fashion models and on public health more generally. This Note suggests that the US fashion …

Medicaid For All?: State-Level Single-Payer Health Care, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

If single-payer health care is ever to become a reality in the United States, it will very likely be pioneered by a state government, much like Canada’s single-payer system was first adopted in the provinces. Canada’s system operates more like U.S. Medicaid — financed nationally but administered largely by the provinces — than U.S. Medicare. This article describes three basic strategies progressive U.S. state governments are exploring for achieving universal access to high-quality health care and better health outcomes for their residents. First, maximizing eligibility for the existing Medicaid program using matching federal funds. Second, taking up the mantle of …

Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik

Vanderbilt Journal of Entertainment & Technology Law

How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …

(Public) Health And Human Rights: Of Bridges And Matrixes, George J. Annas

Faculty Scholarship

Responding to President Trump's anti-Muslim executive order restricting immigration, the American Public Health Association (APHA) issued a press release recommitting the organization to human rights, noting that "health and human rights are inextricably linked." The organization underlined the basic human rights norm of nondiscrimination, noting that "all people should be valued equally, no matter their race, gender, sexual orientation, religion, immigration status, income or geographic region" and that whenever any groups of people are prevented from "experiencing basic human rights, all of our communities suffer" (APHA 2017). Human rights, especially the right to health, have also been at the core …

Supporting Mothers With Mental Illness: Postpartum Mental Health Service Linkage As A Matter Of Public Health And Child Welfare Policy, Jesse Krohn, Msed, Jd, Meredith Matone, Drph, Mhs

Journal of Law and Health

Through our work in youth advocacy as, respectively, legal and public health professionals, we are all too aware of the high levels of health care fragmentation experienced during pregnancy and postpartum by poor, young mothers of color. Meredith Matone’s research highlights the heightened risk of fragmentation for girls with histories of child welfare involvement. For example, she found that 66.7% of young mothers who had resided in out-of-home placements and who had taken antipsychotic medication prior to becoming pregnant failed to fill prescriptions for antipsychotics in their first postpartum year. Put another way, two-thirds of these vulnerable young mothers—a far …

The Prescription Drug Pricing Moment: Using Public Health Analysis To Clarify The Fair Competition Debate On Prescription Drug Pricing And Consumer Welfare, Ann Marie Marciarille

Faculty Works

Fair competition law and public health law talk past each other when discussing pharmaceutical pricing and distribution. The former cannot agree on the relevant definition of consumer welfare. The latter does not fully comprehend the highly complex but inherently collective nature of pharmaceutical drug acquisition in the United States. This essay proposes to inject public health discourse into this debate to enrich it, focus it, and render it more accessible to those who must live by its outcome.

Intersectional Complications Of Healthism, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

For Americans in the labor market with health conditions that fall outside the scope of the ADA, the rehabilitation Act, and GINA, antihealthism legislation, like the kind proposed by Roberts and Leonard, 9would unquestionably serve as a critical first step in increasing their legal protections in the workplace. Moreover, to the extent that such legislation would also operate outside the workplace, it could expand legal protections even for individuals who presently enjoy coverage by disability and genetic discrimination laws solely inside the workplace. Yet, as this article has argued, simple healthism-discriminatory animus based solely on health-may be surprisingly rare. Existing …

Can Right To Health Help Policy Makers To Address Maternal Mortality?: A Short Communication, Sumera Aziz Ali, Nadir Suhail, Savera Aziz Ali

Community Health Sciences

No abstract provided.

The Right For Autonomy, The Duty Of Disclosure And Public Health Considerations – The 2013 Polio Crisis In Israel As A Case Study, Dr. Nili Karako Eyal

Pace Law Review

Despite sharing the same theoretical framework of discussion with other papers, this paper addresses an ethical and legal issue that has received little attention in academic and public discourse: the duty of disclosure in the context of vaccinations. In particular, the paper addresses the question whether public health considerations provide a justification for restricting the duty of disclosure in the case of vaccination.

Delimitating the research question to the issue of disclosure has several implications. First, the decision to vaccinate the population with bOPV as describe above and the decision to adopt a voluntary vaccination policy are not the focus …

Ebola And Human Rights: Post-9/11 Public Health And Safety In Epidemics, George J. Annas

Faculty Scholarship

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism …

Vaccines And Airline Travel: A Federal Role To Protect The Public Health, Christopher Robertson

Faculty Scholarship

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority — especially under the Commerce Clause — to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could …

Paternalism, Self-Governance, And Public Health: The Case Of E-Cigarettes, Wendy E. Parmet

University of Miami Law Review

This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty, whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws …

Is The United States Prepared For A Major Zika Virus Outbreak?, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Zika virus has emerged as a global public health crisis with active transmission in the Americas and Caribbean. The World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC), and recently WHO reported there is a scientific consensus that Zika is a cause of microcephaly and Guillain-Barré syndrome (GBS). In the U.S. the Centers for Disease Control and Prevention (CDC) activated its emergency operations center at its highest capacity. President Obama requested $1.86 billion in emergency funding. Shamefully, Congress has yet to appropriate the funding needed for Zika preparedness, and the President has had to reallocate Ebola …

Disrupting The Path From Childhood Trauma To Juvenile Justice: An Upstream Health And Justice Approach, Yael Cannon, Andrew Hsi

Georgetown Law Faculty Publications and Other Works

A groundbreaking public health study funded by the U.S. Centers for Disease Control and Prevention (CDC) and the Kaiser Foundation found astoundingly high rates of childhood trauma, including experiences like abuse, neglect, parental substance abuse, mental illness, and incarceration. Hundreds of follow-up studies have revealed that multiple traumatic adverse childhood experiences (or “ACEs”) make it far more likely that a person will have poor mental health outcomes in adulthood, such as higher rates of depression, anxiety, suicide attempts, and substance abuse. Interestingly, the original ACE Study examined a largely middle-class adult population living in San Diego, but subsequent follow-up studies …

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Akron Intellectual Property Journal

On October 26, 2012, The University of Akron School of Law's Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants, and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

The Affordable Care Act, Experience Rating, And The Problem Of Non-Vaccination, Eric Esshaki

University of Michigan Journal of Law Reform Caveat

Polio, the whooping cough, and the mumps, among many other communicable diseases, were once prevalent in communities within the developed world and killed millions of people.1 The advent of vaccinations contained or eradicated several of these diseases.2 However, these diseases still exist in the environment3 and are making a comeback in the United States.4 Their persistence is directly attributable to the rising trend among parents refusing to vaccinate their children.5 One proposed solution to this problem is to hold parents liable in tort when others are harmed by their failure to vaccinate. Another proposed solution argues that parents should pay …

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Health Care And The Myth Of Self-Reliance, Nicole Huberfeld, Jessica L. Roberts

Faculty Scholarship

Both pillars of the Affordable Care Act that are designed to facilitate universal coverage — the low-income tax subsidy and Medicaid expansion — have been subject to high-profile Supreme Court cases. While in King v. Burwell the Court saved the ACA’s low-income subsidy, in NFIB v. Sebelius the Court frustrated Medicaid expansion, at least temporarily. We argue that there is a deeper story about health care access for the poor. Drawing from the history of the American health care system, vulnerability theory, and demographic data, we demonstrate that all Americans lead subsidized lives and could find themselves quickly moving from …

The Emerging Zika Pandemic: Enhancing Preparedness, Lawrence O. Gostin, Daniel Lucey

Georgetown Law Faculty Publications and Other Works

The Zika virus (ZIKV), a flavivirus related to yellow fever, dengue, West Nile, and Japanese encephalitis, originated in the Zika forest in Uganda and was discovered in a rhesus monkey in 1947. The disease now has “explosive” pandemic potential, with outbreaks in Africa, Southeast Asia, the Pacific Islands, and the Americas. Since Brazil reported Zika virus in May 2015, infections have occurred in at least 20 countries in the Americas. Puerto Rico reported the first locally transmitted infection in December 2015, but Zika is likely to spread to the United States. The Aedes species mosquito (an aggressive daytime biter) that …

Health Theater, Govind Persad

Sturm College of Law: Faculty Scholarship

"Security theater" has been defined as an effort to "provide the feeling of security instead of the reality. " The concept of security theater has been discussed in both the popular press and academic literature, but has not yet entered health law. This project suggests that a parallel category of "health theater" picks out a set ofpractices in medical screening and health care delivery that provide a mere simulacrum ofprotection against medical risk, rather than providing genuine medical benefit. Part I summarizes some of the distinctive advantages and disadvantages of health and security theater. Like security theater, health theater frequently …