Health Law and Policy Commons^™

From Zero-Sum To Economic Partners: Reframing State Tax Policies In Indian Country In The Post-Covid Economy, Pippa Browde

Faculty Law Review Articles

The disparate impact COVID-19 has had on Indian Country
reveals problems centuries in the making from the legacy of
colonialism. One of those problems is state encroachment in
Indian Country, including attempts to assert taxing authority
within Indian Country. The issue of the reaches of state taxing
authority in Indian Country has resulted in law that is both
uncertain and highly complex, chilling both outside investment
and economic development for tribes.
As the United States emerges from COVID-19, to focus only on the
toll exacted on tribes and their peoples ignores the tremendous
opportunities for states to right these historical …

Eviscerating Patent Scope, Shahrokh Falati

Articles & Chapters

The scope of patent claims directed to inventions in the field of pharmaceuticals and biotechnology has been stumped by the Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112. Specifically, the application of a heightened test for enablement of claims to a genus of compounds with functional limitations or a genus of therapeutic antibodies, coupled with an increasingly broader application of the written description doctrine, has resulted in considerable uncertainty in the biopharmaceutical industry. The Federal Circuit’s shift in interpreting 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by splitting the singular …

An Immigration Solution For Improving Rural Healthcare, Kit Johnson

Faculty Articles

If you are one of the more than 249 million people who live in urban areas of the United States, more than 80% of the U.S. population, you’ve likely never thought much about your physical proximity to a doctor. Primary care physicians and medical specialists abound in urban America. But if you are among the more than 59 million people who live in rural areas of the country, you may well know the struggle of finding primary care, a specialist, or a dentist. That is because there is a worrying shortage of medical professionals in rural America. There is a …

Aging, Health, Equity, And The Law: Foreword, Joan C. Foley

Touro Law Review

No abstract provided.

Fertility Care: Essential Or Non-Essential? Lessons From The Covid-19 Pandemic, Rebecca S. Feinberg

Scholarly Works

At the beginning of the COVID-19 pandemic, in an effort to allocate medical resources towards the anticipated influx of patients infected with the novel virus, many non-essential healthcare services were temporarily paused. The American Society of Reproductive Medicine led the move to halt infertility care in all but the most extreme cases. This cessation of infertility care, compounded by the unknown duration of this recommendation, added to the already high level of stress and anxiety that fertility patients experience and in cases of advanced maternal age or diminished ovarian reserve potentially resulted in suboptimal clinical outcomes. There was vocal disagreement …

Safeguarding The Public: Why Workers’ Rights Education Should Be Required Learning For Nurses, Esperanza N. Sanchez

Touro Law Review

Nurses are integral to the delivery of quality health care in this country. They set aside their own needs and fears to provide care and other social services to people across a multitude of settings, taking on the burdens and stresses of others. However, our profit-driven health care system incentivizes employers to maximize productivity at reduced costs by asking nurses to do more with less. Nurses are expected to endure harsh working conditions, proven to be harmful to the nurses’ health and well-being, despite evidence showing that poor working conditions can lead to poor patient outcomes.

There are numerous worker …

How Covid-19 Put The Spotlight On The Emtala, Ikra Kafayat

Touro Law Review

There was a time when those that were unable to afford medical care risked being denied treatment in emergency situations. Before Congress passed Emergency Medical Treatment & Labor Act (EMTALA), patients were being transferred to different hospitals, without being screened, because they did not have insurance and could not afford the treatment. Hospitals are no longer allowed to transport patients without properly screening and stabilizing them. Patients can bring a suit against a hospital if they believe the hospital violated EMTALA, however, in certain circuits the patient will need to prove that hospital had an “improper motive” for failing to …

Compulsory Licensing Of Patents In Times Of Public Health Emergency, Kelsey Truglio

Touro Law Review

In March 2020, the United States shut down to avoid the continued spread of the COVID-19 virus as it spread globally. In December 2020, the first COVID-19 vaccines were granted emergency usage authorization in the United States. Wealthy nations were able to quickly purchase and hoard vaccines for public distribution, leaving many third-world countries and developing nations struggling to continue to survive the pandemic without vaccination.

Compulsory licensing should be allowed on otherwise patented or patentable new technology in times of global health emergency, regardless of which entity creates the technology. This will enable governments of countries spanning all wealth …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

Crisis Pregnancy Centers: An Inherently Unjust Limitation To Reproductive Rights, Rebecca Feinberg, Danielle Pacia

Scholarly Works

This paper’s purpose is two-fold. First, it presents an ethical analysis that details why the current practices of Crisis Pregnancy Centers (CPCs) are unethical and violate women’s reproductive freedom. Second, it proposes policy solutions to mitigate inequities and disinformation caused by the practices of CPCs, in an attempt to protect the women who, fall prey to their services

Viral Injustice, Brandon L. Garrett, Lee Kovarsky

Faculty Scholarship

The COVID-19 pandemic blighted all aspects of American life, but people in jails, prisons, and other detention sites experienced singular harm and neglect. Housing vulnerable detainee populations with elevated medical needs, these facilities were ticking time bombs. They were overcrowded, underfunded, unsanitary, insufficiently ventilated, and failed to meet even minimum health-and-safety standards. Every unit of national and sub-national government failed to prevent detainee communities from becoming pandemic epicenters, and judges were no exception.

This Article takes a comprehensive look at the decisional law growing out of COVID-19 detainee litigation and situates the judicial response as part of a comprehensive institutional …

Hiv No Longer A Death Sentence But Still A Life Sentence: The Constitutionality Of Hiv Criminalization Under The Eighth Amendment, Lauren Taylor

Georgia Law Review

When the HIV/AIDS epidemic began in the 1980s in the United States, there was mass confusion and hysteria regarding HIV transmission and prevention, leading many states to enact HIV criminalization statutes to prosecute persons living with HIV who either exposed another person to HIV or put someone in danger of being exposed to HIV. Yet, almost forty years later, these statutes are still used to criminalize and control the behaviors of people living with HIV, and in some cases, impose lengthy prison sentences hinging on the possibility of exposure. These HIV criminalization statutes and subsequent criminal cases often do not …

Unpacking The Influence Of Islamic Religious Culture And Individual Religious Affiliation On Testing Hiv-Positive, Brittany Hayes, Amy Adamczyk

Publications and Research

The distribution of HIV cases varies cross-nationally. We separate the influences of Islam at the macro-and micro-levels to understand the role of religion in shaping the spread of HIV. Drawing on biomarker data from the Demographic and Health Surveys, we construct a multilevel database (Individual N= 568,476; Country N= 30). We examine a series of national-and individual-level predictors that may mediate the relationship between Islam and testing HIV-positive. Individual religious affiliation and proportion Muslim retained their risk-reducing effects even when accounting for a range of mediators and suppressors. Islam has a sui generis effect on testing HIV-positive.

Review: Wendy A. Bach, Prosecuting Poverty, Criminalizing Care, Anna Arons

Faculty Publications

(Excerpt)

“Lock ’em up, clean ’em up, and start over” (145). This is how a drug treatment coordinator in a court in East Tennessee sums up her approach to provisioning substance use services to poor Tennesseans. If someone needs treatment, the most expeditious route—often, the only route—is through the criminal legal system. First, the court administrator casts about for a criminal charge, hopefully a “little charge,” that the person can be arrested on. Then, once they are arrested, they can be brought to jail where they can detox, with no medical supervision and no medication to ease the detox. And …

Medicare Disadvantaged: A Raft Of Lawsuits Exposes Fraud In Medicare Part C, John J. Locurto

Faculty Articles

Healthcare fraud is a massive and stubborn problem that can be confirmed by examining the annual Health Care Fraud and Abuse Control Program Report that the United States Departments of Justice and Health and Human Services prepare.

One Age Does Not Fit All: Late Career Practitioner Policies And Managed Care, Adella Katz, John J. Locurto

Faculty Articles

A late career practitioner policy (LCPP) is an age-based approach to screening physicians for physical, cognitive, and other limitations that could impact patient care. What makes LCPPs controversial is that they subject physicians to heightened or more frequent screenings based on arbitrary age thresholds, without specific evidence that their skills have diminished, their acuity has declined, or their performance has deteriorated. Supporters justify LCPPs based on data showing that capabilities decline with age. Aging is natural, they contend, and physicians are not immune to its effects. Critics call LCPPs discriminatory, the embodiment of capricious action that stigmatizes older practitioners by …

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

Articles

Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

Pursuing A Right To Genetic Happiness, George P. Smith Ii

Scholarly Articles

With the continued expansion of assisted reproductive technology (ART), and society's inability to regulate it, complex medico-legal issues and ethical and social dilemmas are arising. Although the desire to prevent or limit genetic disease by, for example, gene editing and mitochondrial transfer is noble, what has been termed the "customization" of birth, raises the fundamental issue of procreative liberty, and, more specifically, the extent to which the state is obligated to assist in the use of ART which, in turn, validate the quest for genetic happiness. There is a current notion that reproductive freedom includes, within it, a right to …

Identity By Committee, Scott Skinner-Thompson

Publications

Even in school districts with relatively permissive approaches to defining and embodying gender, the identities of transgender and gender variant students are often governed by complex regulatory protocols. Ensuring that a student is able to live their gender at school can involve input from a host of purported stakeholders including medical providers, mental health professionals, school administrators, the student’s parents, and even the broader community. In essence, trans and gender variant students’ identities are governed by committee, which reduces students’ control over their lives, inhibits self-determination, constricts the scope of permissible gender identities, subjects them to incredible degrees of state …

Non-Consensual Disclosures, Nina Varsava

BYU Law Review

In the course of biomedical research on humans — for example, flu, imaging, and genomic studies — researchers often uncover information about participants that is important to their health and wellbeing. In many cases, the information is not anticipated in advance, and participants did not consent to receiving it. This Article examines the law and policy governing human subjects research, focusing on the set of regulations known as the "Common Rule." I argue that human subjects researchers will often have strong ethical reason s to disclose results even when participants did not consent to the disclosure in advance. I also …

Enhancing Healthcare Professional Practice In The Philippines Toward Asean Integration Through The Continuing Professional Development Law, Kevin T. Crispino, Ian Christopher N. Rocha

ASEAN Journal of Community Engagement

The Republic Act 10912, otherwise known as the Continuing Professional Development (CPD) Act of 2016, was passed into law to promote and upgrade the practice of healthcare professions in the Philippines. Since the establishment of the Association of Southeast Asian Nations (ASEAN) Economic Community (AEC), CPD has been considered an area of development through which Filipino professionals are trained to become globally competitive. The Philippine government upholds several agreements made among ASEAN member-states, including recognizing professionals in every ASEAN country, facilitating the mobility of professions within the region, exchanging expertise on standards and qualifications, promoting best practices, and providing valuable …

Corporate Wealth Over Public Health? Assessing The Resilience Of Developing Countries' Covid-19 Responses Against Investment Claims And The Implications For Future Public Health Crises, Tim Hagemann

Pace International Law Review

In the wake of the Covid-19 pandemic, states around the world swiftly enacted a multitude of far-reaching emergency responses to contain the viruses’ spread and to cope with the economic repercussions of the ensuing crisis. However, these measures detrimentally impacted the operating conditions of many businesses or, at the least, decreased their profitability. As this inevitably affected foreign investments, investors could be tempted to invoke “Investor State Dispute Settlement” (“ISDS”) clauses in International Investment Agreements (IIAs) to initiate proceedings before arbitral tribunals and seek compensation for loss of profit caused by states’ Covid-19 responses. Due to the specific circumstances in …

Punishing Drug Use During Pregnancy: Is It Time To “Just Say No” To Fetal Rights?, Danika E. Gallup

Brooklyn Law Review

In family courts throughout the country, civil neglect and abuse petitions are routinely brought against individuals based on their drug use during pregnancy. While some may be quick to justify such state interventions in the name of child protection based on the presumption that drug use always harms fetuses in utero and the child once it is born, this note questions the propriety of such justifications. While drug use during pregnancy may result in detrimental health outcomes, the theoretical underpinning of this premise has been dramatically distorted due to racist and classist assumptions that permeate child protective schemes. Medical research …

Paging Doctor Robot: Medical Artificial Intelligence, Tort Liability, And Why Personhood May Be The Answer, Benedict See

Brooklyn Law Review

Artificial intelligence (AI) is a part of everyday life. From our phones, to social media accounts, to online shopping, AI is present and enhances our daily experiences. One area where AI has a heavy (and an increasing) presence is the medical industry. Just as humans make mistakes, so does AI. However, when a human doctor makes a mistake, they can be sued for malpractice, but when AI makes a mistake, who is to be held responsible? Because tort law was designed with humans in mind, it may be hard to apply to medical AI, who’s “black box” algorithms make their …

Law School News: Rwu Law Remembers Sarah Weddington 12/30/2021, Michael M. Bowden

Life of the Law School (1993- )

No abstract provided.

Tanggung Jawab Hukum Sumber Daya Manusia Potensi Basarnas Dalam Melakukan Tindakan Medis Terhadap Korban Bencana, Wahyu Andrianto, Nindya Noviani

Jurnal Hukum & Pembangunan

First aid is a basic medical action that can’t be avoided by The Human Resource Potential (HR Potential) of BASARNAS during SAR Operation. Even though it is only categorized as a basic medical act, first aid can determine victims’ life because first aid is done to prevent them from getting more severe injuries or experiencing death. Despite there is no a specific regulation about basic medical action conducted by HR Potential of BASARNAS during SAR operations. This legal research focuses on answering three problems. First, how the legal rules in Indonesia regarding volunteer participation during disasters. Second, how is the …

Keberlakuan Klausula Security Exceptions Dalam Perjanjian Trade-Related Aspects Of Intellectual Property Rights (Trips) Di Masa Pandemi Covid-19, Daniel Nicholas Putra, Yetty Komalasari Dewi Ykd

Jurnal Hukum & Pembangunan

WTO commitments, particularly related to intellectual property rights in the TRIPS Agreement, could potentially hinder efforts to increase access to medicines and vaccines during the Covid-19 pandemic. In time of emergency, these commitments can be overridden using the WTO security exceptions clause. This article compares the WTO security exceptions to general exceptions in Article XX of the GATT 1994 and non-precluded measures in the Argentina-US BIT, India-Germany BIT, and India-Mauritius BIT, and analyses how the Covid-19 pandemic can be a valid reason to waive the obligations under the TRIPS Agreement using the security exceptions clause. In particular, this article discusses …

Eksistensi Perlindungan Paten Atas Vaksin Covid-19, Adzhani Tharifah, Agus Sardjono

Jurnal Hukum & Pembangunan

The Covid-19 vaccine is expected to be a solution to return to normal life. However, the need for vaccines that are global in nature raises several questions in the community, especially regarding the existence of patent protection. For this reason, this paper will answer these questions by discussing the patentability of the Covid-19 vaccine as well as how to implement patent protection in the midst of a pandemic and public concerns about limited access to vaccines. The research method used in the writing of this thesis is normative juridical with a qualitative approach where the data comes from literature studies …

A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day

Duke Journal of Constitutional Law & Public Policy Sidebar

The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …

How To Compromise On Saving The Most Lives: A Commentary On Hellman And Nicholson, “Rationing And Disability”, David Wasserman

Washington and Lee Law Review Online

Deborah Hellman and Kate Nicholson’s “Rationing Disability” is a skillfully integrated analysis of the legal and ethical challenges of avoiding disability discrimination in setting priorities for the allocation of scarce lifesaving resources. Their analysis goes beyond the important but narrow question of what it means to wrongfully discriminate against people with disabilities in this context to the broader question of how to find a principled compromise between the consequentialist goals of public health and the potentially conflicting public value of “equal concern and respect” for each person. I will focus on this broader issue.

I agree with much …