Digital Commons Network^™

Liability Rules For Health Information, Jorge L. Contreras, Francisca Nordfalk

Utah Law Faculty Scholarship

The recent trend toward propertization of health data could pose significant challenges to biomedical research and public health. Property rule systems can result in sizable up-front costs in the acquisition of consent from individual data subjects, as well as the ongoing risk that data subjects will retract consent or object to unanticipated data uses, thus compromising existing data resources and analyses. We argue that property-based approaches to health data should be rejected in favor of liability rule frameworks for the protection of individual privacy interests. We demonstrate that liability rule frameworks for data governance are not only desirable from a …

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 …

Devalued, Turned Away, And Refused Health Care: What Happens To Women Of Color When Religion Dictates Patient Care, Elizabeth Boylan

Center for Gender & Sexuality Law

Columbia Law School's Law, Rights, and Religion Project, and the National Women’s Law Center hosted a Capitol Hill Briefing at 10:15 am on Thursday, May 24th to discuss the impact of religious health care refusals on women of color. The event, entitled Devalued, Turned Away, and Refused Health Care: What Happens to Women of Color When Religion Dictates Patient Care, was presented in cooperation with Senator Kamala Harris and Representative Bonnie Watson Coleman.

Plaintiff Cities, Sarah L. Swan

Vanderbilt Law Review

When cities are involved in litigation, it is most often as defendants. However, in the last few decades, cities have emerged as aggressive plaintiffs, bringing forward hundreds of mass-tort style claims. From suing gun manufacturers for the scourge of gun violence, to bringing actions against banks for the consequences of the subprime mortgage crisis, to initiating claims against pharmaceutical companies for opioid-related deaths and injuries, plaintiff cities are using litigation to pursue the perpetrators of the social harms that have devastated their constituents and their communities. Many courts and commentators have criticized these plaintiff city claims on numerous grounds. They …

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, Wendy K. Mariner, Michael Ulrich

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 …

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

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 …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

Intellectual Property And Public Health: A White Paper, Katharine A. Van Tassel

Katharine Van Tassel

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 State Giveth And Taketh Away: Race, Class, And Urban Hospital Closings, Shaun Ossei-Owusu

All Faculty Scholarship

This essay uses concepts from Bernadette Atuahene’s book We Want What’s Ours: Learning from South Africa’s Land Restitution Program to examine the trend of urban hospital closings. It does so by focusing specifically on the history of Martin Luther King, Jr. Community Hospital, a charitable hospital in South Los Angeles, California that emerged after the Watts riots in 1965. The essay illustrates how Professor Atuahene’s framework can generate unique questions about the closing of urban hospitals, and public bureaucracies more generally. The essay also demonstrates how Martin Luther King, Jr. Community Hospital’s trajectory hones some of Atuahene’s concepts in ways …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

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 …

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

Katharine Van Tassel

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 …

Cholera And Climate Change: Pursuing Public Health Adaptation Strategies In The Face Of Scientific Debate, Robin Kundis Craig

Utah Law Faculty Scholarship

Climate change will affect the prevalence, distribution, and lethality of many diseases, from mosquito-borne diseases like malaria and dengue fever to directly infectious diseases like influenza to water-borne diseases like cholera and cryptosporidia. This Article focuses on one of the current scientific debates surrounding cholera and the implications of that debate for public health-related climate change adaptation strategies.

Since the 1970s, Rita Colwell and her co-researchers have been arguing a local reservoir hypothesis for cholera, emphasizing that river, estuarine, and coastal waters often contain more dormant forms of cholera attached to copepods, a form of zooplankton. Under this hypothesis, climatically …

Moral Mode Switching: From Punishment To Public Health, Stephen Koppel

Dissertations, Theses, and Capstone Projects

A public health response to drug offenses has potential to improve both public safety and public health. However, the public’s desire for retribution represents a possible hindrance to reform. Relying on dual-process theory of moral decision-making, this dissertation examines agreement among laypeople about the relative blame deserved for various crime types, and probes several possible predictors of support—the need for cognition (“NFC”), intergroup bias, and free-will doubt—for retributive as well as consequentialist responses to crime. Findings from several web-based experiments show: (a) in comparison to core crimes (eg., murder) substantially less agreement about the relative blame deserved for noncore crimes …

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 …

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 …

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

Articles in Law Reviews & Other Academic 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 …

Pharming Out Data: A Proposal For Promoting Innovation And Public Health Through A Hybrid Clinical Data Protection Scheme, Lea M. Gulotta

Vanderbilt Journal of Transnational Law

The pharmaceutical industry, one of the largest industries in the world, is rapidly becoming globalized. Clinical trials, which are required for drugs to be approved for human use, are increasingly performed outside of the pharmaceutical company's home country in an attempt to save money. This is mainly due to drug development's steep costs, and the high risks involved in an industry where only 12 percent of products that begin development ever make it to market. In order to help offset these risks and encourage innovation, many countries offer clinical trial data certain protections through patents, market exclusivity, or trade secret …

Gun Violence: Chicago, Illinois, Kayla Dillon

Global Issues in Public Health

Gun violence has been, and continues to be, a significant problem in Chicago, Illinois. There have been several programs in place that have worked towards improving the level of gun violence. One of the most noticeable being Project Safe Neighborhood, which began in 2001. Part of what makes these programs, and programs similar to it, necessary is that it targets the populations most at-risk of gun violence. By targeting these specific regions of the city, these programs can provide the resources necessary to improve the condition of the city in the long-term, as well as prevent the condition from spreading …

Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi

Faculty Publications

The passage of the Comprehensive Addiction and Recovery Act of 2016 evidences a shift in federal legislative support from criminal justice oriented legislative alternatives to more health oriented legislative alternatives to addressing the ongoing Opioid Epidemic. Such a shift was preceded by a redefinition of problem drug use in the policy discourse from an issue of deviancy to a health issue. However, the redefinition of problem drug use as a health issue, has been dominated by policy narratives and causal stories that do not define problem drug use in a manner that aligns with a multi-modal public health oriented legislative …

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 …

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 …

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 …

The Built Environment, Justin Gundlach, Jennier Klein

Sabin Center for Climate Change Law

The built environment, which includes not only buildings but infrastructure, mediates several important climate impacts on public health and is also subject to diverse legal requirements. It is a subject of particular focus for policy efforts aimed at promoting adaptive responses to climate change on the part of institutions and individuals. This chapter presents key examples of public health impacts that arise from climate change but are mediated – possibly mitigated, possibly exacerbated - by elements of the built environment. It also describes the process and substance of adaptive responses to those impacts. Having presented these physical and policy contexts …

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 …

“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton

Articles

As a tide of marijuana legalization sweeps across the United States, there is a surprising lack of scrutiny as to whether the benefits of recreational marijuana outweigh the risks. Notably, marijuana edibles present special risks to the population that are not present in smoked marijuana. States that have legalized recreational marijuana are seeing an increase in edible-related calls to poison control centers and visits to emergency rooms. These negative reactions are especially prevalent in vulnerable populations such as children, persons with underlying preexisting conditions, and out-of-state marijuana novices. Unfortunately, research on edible marijuana is scant and state regulatory regimes are …

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 …