Health Law and Policy Commons^™

Paying For Unapproved Medical Products, Kelly Mcbride Folkers, Alison Bateman-House, Christopher Robertson

Faculty Scholarship

This symposium article examines the use of investigational (un-approved) medical products in the United States, with particular focus on who pays for this use. In the United States, the question of who pays for the use of approved medical products for their intended indications is complicated enough, with some expenses borne by private payers, some by public payers, some covered as charity care, and some paid out of pocket by patients. A separate question is off-label use, in which an approved medical product is used for an unapproved indication. In this article, we focus on a narrower issue: what entities …

Covid-19 And Its Impact On America's Retirement System, David M. English

Faculty Publications

There is a long-standing debate over whether America's retirement system is in crisis. The COVID-19 pandemic has resolved the debate. Perhaps the system was merely challenged prior to March 2020, but it is certainly in crisis now. The pandemic has negatively impacted all four of the principal pillars of retirement: Social Security, employer-sponsored retirement programs, earnings from part-time work, and the worker's own savings. This short article will discuss the impact of the pandemic on the retirement system and discuss possible ways to restore the system to health or at least ameliorate the damage.

Striving For The Mountaintop: The Elimination Of Health Disparities In A Time Of Retrenchment (1968-2018), Gwendolyn R. Majette

Law Faculty Articles and Essays

Health disparities in the United States are real. People of color are the adverse beneficiaries of these facts-lower life expectancy, higher rates of morbidity and mortality, and poorer health outcomes in general. This Article analyzes the laws and policies that improve and create barriers to improving people of color's health since the death of Reverend Martin Luther King, Jr. in 1968. The Article builds upon my earlier scholarship and considers the effectiveness of the "PPACA Framework to Eliminate Health Disparities" since the Patient Protection and Affordable Care Act (PPACA) was enacted in 2010.

The Article also explores the impact of …

Habeas Corpus, Conditions Of Confinement, And Covid-19, Allison Wexler Weiss

Washington and Lee Journal of Civil Rights and Social Justice

Incarcerated individuals, worried about contracting the disease in prison without adequate healthcare and often serious health risks, have filed lawsuits challenging their incarceration in the age of COVID-19. Overall, very few have been successful. This virus has changed our world and the reality for those in prison. The traditional legal avenues available to incarcerated individuals to challenge their continued confinement are often ill-equipped to allow for comprehensive and expedited review. The author argues that during these unprecedented times, courts should recognize that the “duty to defend the Constitution” requires them to grant motions for habeas corpus by the most vulnerable …

Health Priorities For Sustainable Development, Lisa E. Sachs, Jeffrey D. Sachs

Columbia Center on Sustainable Investment Staff Publications

The right to health has been repeatedly recognized as one of the core human rights, essential for human functioning, human dignity, economic well-being and development. But the right to health continues to elude hundreds of millions and with Covid-19, perhaps billions of people. Poverty remains the most critical obstacle to the realization of the right to health in developing countries. Achieving universal health coverage, before the additional costs of Covid-19, would require roughly $50 billion per year, approximately 0.1 percent of the GDP of the high-income OECD countries. Yet despite this broad understanding of the vicious cycle of poverty and …

Dirty Johns: Prosecuting Prostituted Women In Pennsylvania And The Need For Reform, Mckay Lewis

Dickinson Law Review (2017-Present)

Prostitution is as old as human civilization itself. Throughout history, public attitudes toward prostituted women have varied greatly. But adverse consequences of the practice—usually imposed by men purchasing sexual services—have continuously been present. Prostituted women have regularly been subject to violence, discrimination, and indifference from their clients, the general public, and even law enforcement and judicial officers.

Jurisdictions can choose to adopt one of three general approaches to prostitution regulation: (1) criminalization; (2) legalization/ decriminalization; or (3) a hybrid approach known as the Nordic Model. Criminalization regimes are regularly associated with disparate treatment between prostituted women and their clients, high …

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Reclaiming Access To Truth In Reproductive Healthcare After National Institute Of Family & Life Advocates V. Becerra, Diane Kee

Michigan Law Review

Crisis Pregnancy Centers (CPCs) are antiabortion organizations that seek to “intercept” people with unintended pregnancies to convince them to forego abortion. It is well documented that CPCs intentionally present themselves as medical professionals even when they lack licensure, while also providing medically inaccurate information on abortion. To combat the blatant deception committed by CPCs, California passed the Reproductive FACT Act in 2015. The Act required CPCs to post notices that disclosed their licensure status and informed potential clients that the state provided subsidized abortion and contraceptives. Soon after, CPCs brought First Amendment challenges to these disclosure requirements, claiming that the …

Japanese Government Actions Against Covid-19 Under The Directives Of Constitutional And Administrative Law, Yuichiro Tsuji

Cardozo International & Comparative Law Review

This paper presents law on the State ofEmergency held jointly on June 16, 2020, by the Asian Law Center of Melbourne University and School of Law, and Vietnam National University, Hanoi.

This paper further elucidates the actions of the Japanese government against COVID-19 during the first five months of 2020. On May 25, 2020, the government fied the emergency declaration passed under the amended Art. 49(2) of the amended Influenza Special Measures Act (ISMA).

This paper argues that the effects of the Japanese government action is not unique, but is instead similar to those of other countries. In 2012, the …

J Mich Dent Assoc October 2020

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story, “Michigan’s New Hypertension Screening Guidelines: What Do They Mean for You?”
• Three feature articles: “The Mask Ask: Understanding and Addressing Mask Resistance”, “An Election-Year Message from Your MDA Dental PAC”, and “How to Respond to Online Reviews Without Violating HIPAA”.
• News you need, Editorial and regular department articles on MDA Foundation activities, …

Genetic Duties, Jessica L. Roberts, Alexandra L. Foulkes

William & Mary Law Review

Most of our genetic information does not change, yet the results of our genetic tests might. Labs reclassify genetic variants in response to advances in genetic science. As a result, a person who took a test in 2010 could take the same test with the same lab in 2020 and get a different result. However, no legal duty requires labs or physicians to inform patients when a lab reclassifies a variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, it offers much-needed guidance to physicians …

Desnatada: Latina Illumination Of Breastfeeding, Race, And Injustice, Jasmine Gonzales Rose

Faculty Scholarship

In Skimmed: Breastfeeding, Race, and Injustice, Andrea Freeman brilliantly explains how racism results in lower breastfeeding rates by Black mothers,¹ which in turn results in poorer health outcomes--including higher mortality rates--for Black babies.² She provides four primary reasons for this phenomenon: (1) the history and legacy of slavery, (2) the imposition of racist gender stereotypes on Black women, (3) racially-targeted formula promotion by manufacturers and hospitals, and (4) government benefits and employment policies that obstruct poor people's ability to breastfeed. The first two of these reasons are particularly devastating: the legacy of slavery and misogynoiristic³ stereotypes …

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

Struggle For The Soul Of Medicaid, Nicole Huberfeld, Sidney Watson, Alison Barkoff

Faculty Scholarship

Medicaid is uniquely equipped to serve low-income populations. We identify four features that form the “soul” of Medicaid, explain how the administration is testing them, and explore challenges in accountability contributing to this struggle. We highlight the work of watchdogs acting to protect Medicaid and conclude with considerations for future health reform.

The Limits Of Medical X-Pertise: Gender Markers In A Pandemic, Heron Greenesmith, Andy Izenson

Faculty Scholarship

The world changed drastically in 2020. The pandemic has far reaching consequences, and so too do the current civil rights movements and the struggle for gender justice and liberation. This Article seeks to describe a moment in time, a moment of doubt of how one 's gender and race will predict one 's ability to survive the pandemic-not simply COVID-19, but the pandemic writ-large and all the wrenches it has thrown into the health-care machine. How do those of us standing at the edge of a gender revolution navigate these waters? Will our health be the price we pay for …

Fostering States As Laboratories, Myrisha S. Lewis

Popular Media

No abstract provided.

Who's Afraid Of Section 1498? A Case For Government Patent Use In Pandemics And Other National Crisis, Charles Duan, Christopher J. Morten

Scholarly Articles in Law Reviews & Journals

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict--indeed, have already begun to conflict--with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government paid compensation under 28 U. S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought …

How The Covid-19 Pandemic Has And Should Reshape The American Safety Net, Gabriel Scheffler, Andrew Hammond, Ariel Jurow Kleiman

Articles

No abstract provided.

(Not The) Same Old Story: Invisible Reasons For Rejecting Invisible Wounds, Jessica Lynn Wherry

Georgetown Law Faculty Publications and Other Works

Thousands of former military servicemembers have been discharged with other-than-honorable discharges due to misconduct that can be traced to a mental health condition. These veterans may request a post-discharge change to their discharge characterization—known as a “discharge upgrade.” Discharge review boards consider discharge upgrade requests and typically (90-99% of the time) deny the requests. In the past few years, the Department of Defense has issued new policy guidance partly in response to the low grant rate and to specifically address the growing understanding of the relationship between misconduct and mental health conditions for military servicemembers. The policy guidance requires the …

Breaking State-Centric Shackles In The Who: Taiwan As A Catalyst For A New Global Health Order, Ching-Fu Lin, Han-Wei Liu, Chien-Huei Wu

Research Collection Yong Pung How School Of Law

After World War II, states established World Health Organization (WHO), recognizing that “the health of all peoples is fundamental to the attainment of peace and security.” This aspiration, embedded in GlobalHealth governance, introduces a paradox vis-à-vis the WHO’s state-centric institutional design. Though Taiwan alerted the WHO to potential human-to-human transmission in the early stage of the pandemic, its participation in the WHO remains limited, contrasting the WHO’s goal of health for all peoples sharply against its outdated emphasis on statehood and power politics.This Essay critically assesses how and why state-centric international health governance neither delivers its goal to “promote and …