Health Law and Policy Commons^™

Legal Strategies For Reining In "Unconscionable" Prices For Prescription Drugs, Michelle M. Mello, Rebecca E. Wolitz

Northwestern University Law Review

Policy discussions about the affordability of prescription drugs in the United States are infused with the theme that drug prices are unconscionably high. Many of the policy interventions proposed in Congress, the White House, and the states adopt this frame, authorizing regulatory action when prices exceed particular thresholds or otherwise constitute “price gouging” on the part of drug companies. Unsurprisingly, such initiatives have prompted legal challenges by the biopharmaceutical industry. State laws in particular are vulnerable to challenges on a number of grounds. In this Article, we focus on one avenue of challenge that has received little scholarly attention in …

Symposium: A Bold Agenda For The Next Steps In Health Reform: Introduction, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Coronavirus, Civil Libertities, And The Courts: The Case Against Suspending Judicial Review, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Introduction: For obvious reasons, local and state orders designed to help “flatten the curve” of novel coronavirus infections (and conserve health care capacity to treat coronavirus disease) have provoked a series of constitutional objections — and a growing number of lawsuits attempting to have those orders modified or overturned. Like the coronavirus crisis itself, much of that litigation remains ongoing as we write this Essay. But even in these early days, the emerging body of case law has rather elegantly teed up what we have previously described as “the central (and long-running) normative debate over emergency powers: Should constitutional constraints …

Works Of Eleanor D. Kinney, Susan David Demaine

Articles by Maurer Faculty

Eleanor D. Kinney was a prolific scholar throughout her thirty-five years as a professor at Indiana University Robert H. McKinney School of Law. She authored or co-authored more than seventy-five journal articles, publishing in numerous peer-reviewed medical and health journals, as well as law reviews. She wrote three books, edited a fourth, and published nine book chapters

Professor Kinney’s work has been cited in at least ten court opinions. Her work has garnered more than 700 citations in law review articles, and nearly 200 in medical and health policy journals. The influence of her work places her within the top …

Fetal Equality, Shaakirrah R. Sanders

Washington and Lee Law Review Online

I join Carliss Chatman’s call to fully consider the equal protection implications of the conception theory and raise an additional right to which a fetus may be entitled as a matter of equal protection: health care, which implicates state laws that provide civil and criminal exemptions to parents who choose religious healing instead of medical care for their children and minor dependents. The evidence of harm to children from religious healing is well documented. Yet, currently, approximately forty-three U.S. states and the District of Columbia have some type of exemption to protect religious healing parents in civil and criminal cases. …

Covid-19, Telehealth, And Substance Use Disorders, Stacey A. Tovino

Faculty Articles

No abstract provided.

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Covid-19 And Individuals With Developmental Disabilities: Tragic Realities And Cautious Hope, Samuel J. Levine

Scholarly Works

The COVID-19 pandemic has cast the United States, along with the rest of the world, into a time of crisis and uncertainty unlike any other in recent memory. Months into the pandemic, there is scant agreement among scientists, government officials, and large segments of the public, both domestic and abroad, as to determining the causes and workings of the virus, designing appropriate and effective responses to the outbreak, and constructing accurate assessments of the future—or even of the present. Indeed, the availability of concrete information about the virus and its effects is grossly inadequate and often replaced by anecdotal or …

Rationing Safe And Effective Covid-19 Vaccines: Allocating To States Proportionate To Population May Undermine Commitments To Mitigating Health Disparities, Harald Schmidt, Parag A. Pathak, Michelle A. Williams, Tayfun Sönmez, M. Utku Ünver, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A central goal in the National Academies of Science, Engineering and Medicine’s (NASEM) framework for equitable COVID-19 vaccine allocation is to mitigate existing inequities, particularly those affecting economically worse-off racial and ethnic minorities. The Advisory Committee on Immunization Practice (ACIP) likewise notes that equity demands to “reduce, rather than increase, health disparities in each phase of vaccine distribution”. A crucial question in this regard is how vaccines should be distributed to states. The default is to allocate proportionate to population size. However, this approach risks increasing scarcity for worse-off populations in states where they represent above-average shares. To avoid lower …

The World Health Organization In Global Health Law, Benjamin Mason Meier, Allyn Taylor, Mark Eccleston-Turner, Roojin Habibi, Sharifah Sekalala, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The World Health Organization (WHO) has sought to bring the world together to respond to a shared threat. This column seeks to examine the central importance of WHO in developing and implementing global health law. Recognizing that global health law requires global governance, the column begins by situating WHO’s role at the forefront of global health governance. WHO’s leadership in global governance for health is supported by an expansive mandate to serve as a forum for the codification of international law, which WHO has exercised sporadically through the evolving development of the International Health Regulations (IHR). Yet, where the IHR …

Pandemic As Opportunity For Competence Restoration Decarceration, Susan A. Mcmahon

Georgetown Law Faculty Publications and Other Works

Before the pandemic, a defendant found incompetent to stand trial was often stranded in jail for weeks or months as she waited for an inpatient bed to open at a psychiatric facility. While there, she usually received no treatment, her mental health deteriorated, and she was astonishingly likely to be abused and neglected. She almost certainly came out of jail in a worse state than she was when she went in.

The pandemic has made this desperate situation even worse. Now that wait in jail is both longer, as many psychiatric facilities stopped accepting new patients as they dealt with …

How Well Does Societal Mobility Restriction Help Control The Covid-19 Pandemic? Evidence From Real-Time Evaluation, Juhwan Oh, Hwa-Young Lee, Khuong Quynh Long, Jeffrey F. Markuns, Chris Bullen, Osvaldo Enrique Artaza Barrios, Seung-Sik Hwang, Young Sahng Seo, Judith Mccool, S. Patrick Kachur, Chang-Chung Chan, Soonman Kwon, Naoki Kondo, Hoang Van Minh, J. Robin Moon, Mikael Rostila, Ole F. Norheim, Myoungsoon You, Mellissa Withers, Mu Lil, Eun-Jeung Lee, Caroline Benski, Soo Kyung Park, Eun-Woo Nam, Katie Gottschalk, Matthew M. Kavanagh, Jong-Koo Lee, Martin Mckee, S. V. Subramanian, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

One of the most widely implemented policy response to the novel coronavirus (SARS-CoV-2) pandemic has been the imposition of restrictions on mobility (1). These restrictions have included both incentives, encouraging working from home, supported by a wide range of online activities such as meetings, lessons, and shopping, and sanctions, such as stay at home orders, restrictions on travel, and closure of shops, offices, and public transport (2-5). The measures constitute a major component of efforts to control the COVID-19 pandemic. Compared to previous epidemic responses, they are unprecedented in both scale and scope (6).

The rationale underpinning these public health …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …

Should I Stay Or Should I Go: Student Housing, Remote Instruction, Campus Policies And Covid-19, Patricia E. Salkin, Pamela Ko

Scholarly Works

In March 2020, as the world scrambled to understand and address myriad public health and economic challenges unfolding from the novel coronavirus labeled COVID-19, higher education was forced into a tailspin. This article examines the legal and policy challenges that result from, among other issues, the congregate housing situations existing for on- and off-campus housing at colleges and universities. The legal issues demonstrate federalism at work and include; at the federal level, regulations and guidance from the White House, the Center for Disease Control (CDC) and the U.S. Department of Education; at the State level from gubernatorial executive orders, state …

Into The Weeds Of The Newest Field In Employment Law: The Oklahoma Medical Marijuana Act, Brennan T. Barger

Oklahoma Law Review

No abstract provided.

The Disability Dilemma: Difficulties Involving Erisa Claims For Subjective-Proof Diseases, Courtney D. Keeling

Oklahoma Law Review

No abstract provided.

Hiv Law And Policy In The United States: A Tipping Point, Scott Skinner-Thompson

Publications

The fight to effectively treat and stop the spread of the human immunodeficiency virus (HIV) has made meaningful progress both in the United States and globally. But within the United States that progress has been uneven across various demographic groups and geographic areas, and has plateaued. While scientific advances have led to the development of medicine capable of both treating and preventing HIV, law and policy dictate who will have ready access to these medicines and other prevention techniques, and who will not. Law and policy also play a crucial role in determining whether HIV will be stigmatized, discouraging people …

Contracts And Covid-19, Andrew A. Schwartz

Publications

No abstract provided.

A Recent Renaissance In Privacy Law, Margot Kaminski

Publications

Considering the recent increased attention to privacy law issues amid the typically slow pace of legal change.

Reproductive Health Care Exceptionalism And The Pandemic, Helen Norton

Publications

No abstract provided.

Taming America's Sugar Rush: A Traffic-Light Label Approach, Alexia Brunet Marks

Publications

Excess added sugar negatively impacts health and can lead to a litany of problems, such as diet-related chronic diseases, e.g., diabetes, cancer, heart disease, and obesity, costing Americans millions in rising medical bills each year. Even more, new studies reveal that individuals with these underlying chronic diseases are at a higher risk of complications from COVID-19 and other viruses compared to those who are deemed healthy. And yet added sugars are difficult to avoid because unlike naturally occurring sugars found in fruits, vegetables, and milk, these sweeteners are added during food processing and preparation.

The problem is that while consumers …

Narrowly Tailoring The Covid-19 Response, Craig Konnoth

Publications

No abstract provided.

Medical Civil Rights As A Site Of Activism: A Reply To Critics, Craig Konnoth

Publications

See Craig Konnoth, Medicalization and the New Civil Rights, 72 Stan. L. Rev. 1165 (2020).

See also Rabia Belt & Doron Dorfman, Response, Reweighing Medical Civil Rights, 72 Stan. L. Rev. Online 176 (2020), https://www.stanfordlawreview.org/online/reweighing-medical-civil-rights/; Allison K. Hoffman, Response, How Medicalization of Civil Rights Could Disappoint, 72 Stan. L. Rev. Online 165 (2020), https://www.stanfordlawreview.org/online/how-medicalization-of-civil-rights-could-disappoint/.

Can You Hear Me Later And Believe Me Now? Behavioral Law And Economics Of Chronic Repeated Ambient Acoustic Pollution Causing Noise-Induced (Hidden) Hearing Loss, Peter H. Huang, Kelly J. Poore

Publications

This Article analyzes the public health issues of Noise-Induced Hearing Loss (“NIHL”) and Noise-Induced Hidden Hearing Loss (“NIHHL”) due to Chronic Repeated Ambient Acoustic Pollution (“CRAAP”). This Article examines the clinical and empirical medical data about NIHL and NIHHL and its normative implications. It applies behavioral law and economics and information economics to advance legal policies to reduce CRAAP. Finally, this Article advocates changing individual and social attitudes about deafness and hearing loss to raise political awareness and social consciousness about NIHL and NIHHL. One way to change our attitudes is by practicing compassion, empathy, and kindness, including Loving-Kindness Mindfulness …

Regulatory De-Arbitrage In Twenty-First Century Cures Act's Health Information Regulation, Craig Konnoth

Publications

Health data regulation can be thought of at two levels. First, the micro- level of regulation has to do with Electronic Health Records (EHRs). Second, the macro-level concerns the networks on which EHRs are transmitted. The micro- and macro-levels of regulation interact. For example, EHRs need to be configured so that they can be transmitted on mandated networks. As a result, the lines do sometimes blur.

That said, the 21st Century Cures Act (Cures) clearly takes a dual approach to regulation. Cures was passed in December 2016 on a bipartisan basis. Its mandate was to address health data regulation at …