Digital Commons Network^™

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Is Affording Undocumented Immigrants Health Coverage A Radical Proposal?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

During the Democratic presidential debate on July 31, all 10 candidates raised their hands when asked if they would provide health insurance to undocumented immigrants. Among all Democratic ideas for health reform, this is least popular. A recent poll found that only 38% of respondents approve. The idea drew extensive criticism, which is understandable: Why should the United States provide health coverage for people who don’t have a legal right to be here? Extending coverage could be seen as rewarding individuals who have violated the law.

There are, however, strong reasons to afford health coverage for this population: modest economic …

Measles And Misrepresentation In Minnesota: Can There Be Liability For Anti-Vaccine Misinformation That Causes Bodily Harm?, Dorit Rubinstein Reiss, John Diamond

San Diego Law Review

Balancing protecting and compensating victims of harmful fake news and protecting freedom of speech and the information flow is both important and challenging. Vaccines are one area where misinformation can directly cause harm. When misrepresentation leads people to refuse vaccines, disease outbreaks can happen, causing harm, even deaths, and imposing costs on the community. The tort of negligent misrepresentation that causes physical harm appears a custom-made remedy for those affected. However, courts—appropriately— narrowed the tort to protect freedom of speech and the flow of information. This Article uses an especially egregious example of anti-vaccine misrepresentation to examine the boundaries of …

Ending Pandemics: Us Foreign Policy To Mitigate Today’S Major Killers, Tomorrow’S Outbreaks, And The Health Impacts Of Climate Change, Matthew M. Kavanagh, Harsha Thirumurthy, Rebecca Katz, Kristie L. Ebi, Chris Beyrer, Jamila Headley, Charles B. Holmes, Chris Collins, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Every U.S. President in recent decades has had to respond to at least one pandemic disease. Political leadership has proven decisive. In the coming years, U.S. foreign policy will face at least three inter-related issues: today’s major pandemics of AIDS, TB, and Malaria; future outbreaks with the potential to become pandemics; and rising risk from infectious diseases associated with climate change. A review of epidemiologic data shows global progress on each issue is threatened. A coordinated U.S. effort, across agencies and engaged with national and multilateral partners, could save lives and address significant foreign policy interests. Such an effort could …

Law & Health Care Newsletter, Fall 2019

Law & Health Care Newsletter

No abstract provided.

America’S Favorite Antidote: Drug-Induced Homicide In The Age Of The Overdose Crisis, Leo Beletsky

Utah Law Review

Nearing the end of its second decade, the overdose crisis in the United States continues to claim tens of thousands of lives. Despite the rhetorical emphasis on a “public health” approach, criminal law and its enforcement continue to play a central role among policy responses to this crisis. A legacy of the 1980s War on Drugs, statutory provisions that implicate drug distributors in overdose fatalities are on the books in many U.S. jurisdictions and federally. This Article articulates an interdisciplinary critique of these “drug-induced homicide” laws at a time of their increased popularity, expanding scope, and aggressive prosecution. That these …

A Framework For Tribal Public Health Law, Aila Hoss

Nevada Law Journal

No abstract provided.

Using And Misusing Legal Decisions: Why Anti-Vaccine Claims About Nvicp Cases Are Wrong, Dorit Rubinstein Reiss, Rachel Heap

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Dynamism Of Treaties, Yanbai Andrea Wang

Maryland Law Review

How do treaties change over time? This Article joins a growing body of scholarship focusing not on formal change mechanisms but instead on informal change arising from a treaty’s implementation in practice. Informal implementation is often murky, poorly documented, and may be indistinguishable from noncompliance. Yet it is significant both doctrinally under the Vienna Convention on the Law of Treaties—a set of rules for the formation and operation of treaties—and in its own right, when it does not meet the requirements to be doctrinally relevant. Based on a deep dive into the history of one of the oldest areas of …

Designing Development Programs For Non-Traditional Antibacterial Agents, John H. Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan J. Darrow, Kevin Outterson

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits …

Newsletter, Summer 2019

Newsletter

No abstract provided.

Responding To Biological Attacks, Barry Kellman

DePaul Journal of Health Care Law

No abstract provided.

Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise

DePaul Journal of Health Care Law

No abstract provided.

The Lancet Commission On Global Health Law: The Transformative Power Of Law To Advance The Right To Health, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A new report by The Lancet-O’Neill-Georgetown University Commission on Global Health and the Law shows how law can fulfill the global pledge of the human right to health, while “leaving no one behind.” I call this “global health with justice.” We need both health and justice. By global health, I mean ever increasing indicators of good health and increased longevity in all countries around the world. By justice I mean that the global “good” of health must be fairly distributed both within and among countries. The Lancet Commission report offers a comprehensive roadmap towards realizing the law’s power to make …

Mandating Influenza Vaccinations For Healthcare Workers State By State, Nicolette Guarneri

Health Law Outlook

No abstract provided.

Blockchain Meets Genomics: Governance Considerations For Promoting Food Safety And Public Health, Walter G. Johnson

Journal of Food Law & Policy

Foodborne illness remains an ongoing public health challenge in both the developing and industrialized worlds. In the United States, almost 50 million reported cases of infectious disease occur every year from a food product, resulting in substantial morbidity and mortality with economic burdens to health care and productivity. Despite recognition as a leader in food safety, the U.S. experiences longstanding and novel issues in food safety. Advances in whole genome sequencing (WGS) promise to bolster food safety regulators’ capabilities to identify pathogens and determine their source. However, inefficiencies in tracing food products through the supply chain remain.

Access Before Evidence And The Price Of The Fda’S New Drug Authorities, Erika Lietzan

University of Richmond Law Review

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA’s standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States “gold standard” for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

The Dark Side Of The Pharmaceutical Industry: A Compound Of Issues, Geoffrey A. Marcus

University of Miami Inter-American Law Review

No abstract provided.

Data Re-Use And The Problem Of Group Identity, Leslie Francis, John G. Francis

Utah Law Faculty Scholarship

Reusing existing data sets of health information for public health or medical research has much to recommend it. Much data repurposing in medical or public health research or practice involves information that has been stripped of individual identifiers but some does not. In some cases, there may have been consent to the reuse but in other cases consent may be absent and people may be entirely unaware of how the data about them are being used. Data sets are also being combined and may contain information with very different sources, consent histories, and individual identifiers. Much of the ethical and …

Pharmaceutical Price Gouging: The Need For Direct Regulation On The Gray Market, Nicole Rende

Journal of Civil Rights and Economic Development

(Excerpt)

This Note proposes federal legislation that will ultimately shut down the Pharmaceuticals gray market. The federal government should directly regulate the gray market and the price gouging mechanisms used. Congress should pass the Fair Accountability and Innovative Research Drug Pricing Act of 2016, currently proposed. This Act will increase price transparency and provide a civil penalty for wrong doers. In addition to the passage of this Act, there needs to be a direct attack on the gray market by creating an act that does not allow companies to participate in these distributions and ultimately form monopolies. This act needs …

Beyond The Ethical Boundaries Of Solidarity: Increasing Vaccination Rates Through Mandatory Education To Solidarity, Nili Karako- Eyal Dr.

Texas A&M Law Review

Mandatory vaccination laws require children to be vaccinated against certain communicable diseases to attend school. These laws also provide exemptions to school vaccination requirements.1 All states exempt children from vaccination requirements for medical reasons, and most states also provide an exemption for religious and/or other personal reasons.2 Seven states include an educational component in their religious or philosophical exemption process, requiring that parents receive information regarding the benefits of vaccination and the risks of not being vaccinated.3 Of these seven states, five require that information regarding the social benefits of vaccination will be provided to parents.4

This type of legislation …

Fighting Novel Diseases Amidst Humanitarian Crises, Lawrence O. Gostin, Neil R. Sircar, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

Humanitarian crises are becoming more prevalent and, frequently, more complex, in zones of mis-governance, lack of government presence, and even active conflict, marked by public mistrust and insecurity. The WHO and other health emergency responders lack the capacities and mandate to adequately respond. The current Ebola outbreak in an area of an active insurgency in the Democratic Republic of the Congo is just such a crisis. The State Department has banned U.S. personnel from the outbreak zone due to safety concerns, leaving the population feeling abandoned, potentially increasing the threat to the few brave health workers who remain.

We need …

Disparities In The Use Of Prophylactic Treatments In Reproductive Health Between The Sexes: A Recommendation For The Use Of Hpv Vaccination Schemes Rather Than Surgical Interventions To Reduce Inequities And Threats To The Public's Health, Paul J. Mclaughlin

Library Faculty Publications

On the issue of prophylactic treatment of reproductive diseases, the sexes have historically been treated differently under medical ethics guidelines and the laws of the United States. Women have drawn the focus of medical and legal scrutiny on issues of prophylactic reproductive health. Women were often required to undergo quarantine and forced to recieve treatment for reproductive diseases considered dangerous to public health. Women are now afforded protections against involuntary prophylactic procedures to prevent diseases in reproductive organs. Specifically, women are provided access to vaccinations against the human papillomavirus at a higher rate than males despite the disease's ability to …

Hipaa's Privacy Rule And State Privacy Laws: Roadblocks To Medical Organizations' Self-Policing Expert Medical Testimony, Miles J. Zaremski, Douglas M. Belofsky

Alumni Publications

As part of the wave of medical malpractice reforms over the last several decades, efforts were initiated to ensure the reliability and credibility of expert witness opinion and testimony, which is the sine qua non of necessary proof for any such claim or lawsuit. Governing bodies of professional medical organizations and societies have crafted rules and regulations for their members that wish to provide expert medical witness testimony. Where such testimony does not conform to these organizations’ standards, sanctions can be levied, including membership expulsion. Such self-policing has found favor with courts.

Before sanctions are imposed, however, necessary administrative investigations …

Viral Sovereignty, Intellectual Property, And The Changing Global System For Sharing Pathogens For Infectious Disease Research, Sam Halabi

Annals of Health Law and Life Sciences

No abstract provided.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Foreword, Mary Hannosh

Annals of Health Law and Life Sciences

No abstract provided.

Successes And Failures Of Social Health Insurance Schemes In Africa - Nigeria Versus Ghana And Rwanda: A Comparative Analysis, Obiajulu Nnamuchi, Jirinwayo Jude Odinkonigbo, Uju Beatrice Obuka, Helen Agu

Annals of Health Law and Life Sciences

No abstract provided.

Disparities In The Use Of Prophylactic Treatments In Reproductive Health Between The Sexes: A Recommendation For The Use Of Hpv Vaccination Schemes Rather Than Surgical Interventions To Reduce Inequities And Threats To The Public’S Health

Florida A & M University Law Review

This Article will examine the unequal treatment of the sexes under the law with regard to prophylactic treatments against STDs. The second section of this Article will discuss the ethical and legal issues in the use of prophylactic treatments and the issues involving informed consent regarding their use. The third section of this Article will discuss the historic and current use of prophylactic surgeries on both sexes to prevent disease and the challenges that have been raised against such practices. The fourth section of this Article will discuss the use of the H.P.V. vaccinations in both sexes to reduce the …

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …