Health Law and Policy Commons^™

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and …

'More Of The Same, But Worse Than Before': A Qualitative Study Of The Challenges Encountered By People Who Use Drugs In Nova Scotia, Canada During Covid-19, Emilie Comeau, Matthew Bonn, Sheila Wildeman, Matthew Herder

Articles, Book Chapters, & Popular Press

Background

To learn about the experiences of people who use drugs, specifically opioids, in the Halifax Regional Municipality (HRM), in Nova Scotia, Canada during the COVID-19 pandemic through qualitative interviews with people who use drugs and healthcare providers (HCP). This study took place within the HRM, a municipality of 448,500 people. During the pandemic many critical services were interrupted while overdose events increased. We wanted to understand the experiences of people who use drugs as well as their HCPs during the first year of the pandemic.

Methodology

We conducted a qualitative study using semi-structured interviews with 13 people who use …

Public Health Law’S Digital Frontier: Addictive Design, Section 230, And The Freedom Of Speech, Matthew B. Lawrence

Faculty Articles

This Article argues that, even if courts are unpersuaded by the broadest arguments in favor of a public health approach to regulation of addictive design, they should nonetheless reject the platforms’ efforts to make addictive design a public-health-law-free zone. The public health and internet paradigms can be reconciled as a policy matter because addictive design threatens both public health and innovation online. The public health and internet paradigms can also be reconciled as a legal matter be-cause even strong theories of section 230 and the First Amendment, properly understood, leave states a safe harbor in which to regulate much addictive …

Climate Security Insights From The Covid-19 Response, Mark P. Nevitt

Faculty Articles

The climate change crisis and COVID-19 crisis are both complex collective action problems. Neither the coronavirus nor greenhouse gas (GHG) emissions respect political borders. Both impose an opportunity cost that penalizes inaction. They are also increasingly understood as nontraditional, novel security threats. Indeed, COVID-19’s human cost is staggering, with American lives lost vastly exceeding those lost in recent armed conflicts. And climate change is both a threat accelerant and a catalyst for conflict—a characterization reinforced in several climate-security reports. To counter COVID-19, the President embraced martial language, stating that he will employ a “wartime footing” to “defeat the virus.” Perhaps …

Addiction And Liberty, Matthew B. Lawrence

Faculty Articles

This Article explores the interaction between addiction and liberty and identifies a firm legal basis for recognition of a fundamental constitutional right to freedom from addiction. Government interferes with freedom from addiction when it causes addiction or restricts addiction treatment, and government may protect freedom from addiction through legislation empowering individuals against private actors’ efforts to addict them without their consent. This Article motivates and tests the boundaries of this right through case studies of emergent threats to liberty made possible or exacerbated by new technologies and scientific understandings. These include certain state lottery programs, addiction treatment restrictions, and smartphone …

Come As You Are?: Democratizing Healthcare Through Black Church - Telehealth Initiatives, Meighan Parker

Scholarly Works

Drawing from the phrase “come as you are,” which is frequently used in Black Churches to encourage and welcome people to church spaces for spiritual restoration and healing irrespective of their various social and economic dispositions, this Article aims to describe how telehealth partnerships with community organizations, such as Black Churches, can help democratize healthcare.

In this project, I develop two models for Black Church-Telehealth Initiatives—a Telehealth Clinic on the Church’s campus and a Designated Telehealth Space with the requisite technology to facilitate telehealth encounters—to argue that Black Church-Telehealth Initiatives can help address certain social determinants of health, such as …

Ada Executive Director Dr. Ray Cohlmia: "We're Focused On The Future, Not The Past", Debra Peters Dds

The Journal of the Michigan Dental Association

In this interview, Dr. Raymond Cohlmia, the Executive Director of the American Dental Association (ADA), reflects on his first year in office and discusses the challenges of overcoming the decline of membership marketshare. He addresses the importance of strategic forecasting, nimbleness, and the role of the ADA team in shaping the future of dentistry. Dr. Cohlmia also highlights the significance of science and research in dentistry and the ADA's commitment to global presence. The interview offers insights into the ADA's evolving strategies and its dedication to serving its members and the dental community.

Ce Requirements For Michigan Dental Licensure, Andrea Sunderman

The Journal of the Michigan Dental Association

The distribution of mandated topics for the 60 hours of CE for dentists and 36 hours for RDHs and RDAs required for each three-year licensure period is presented in this graphic. The ADA, AGD, an accredited dental school, or the Michigan Board of Dentistry must approve courses. The Michigan Dental Association provides access to CE programs necessary for dentists and members of their teams to meet these requirements.

Interagency Dynamics In Matters Of Health And Immigration, Medha D. Makhlouf

Faculty Scholarly Works

When Congress delegates authority to an executive agency, it tells us something important about the expertise that Congress wishes to harness in policymaking on an issue. In the legal literature on interagency dynamics and cooperation, issues at the nexus of health and immigration are largely understudied. This Article extends this literature by examining how delegations of authority on issues at the intersection of health and immigration influence policymaking. In an analysis of how administrative law models apply to three topics in the shared regulatory space of the Department of Health and Human Services (“HHS”) and the Department of Homeland Security …

Privacy For Student-Patients: A Call To Action, Stacey A. Tovino

Emory Law Journal

Consider a law student who has a mental or reproductive health issue that the student wishes to keep private. If the student seeks care at an off-campus health clinic that is not affiliated with the student’s law school or university, the student typically has a number of federally enforceable privacy rights. For example, the federal HIPAA Privacy Rule will typically apply and prohibit the clinic from disclosing the student’s protected health information to professors, parents, and other third parties without the student’s prior written authorization. The law student also will have the right to receive a notice of privacy practices, …

Renewing Faith In Antitrust: Unveiling The Hidden Network Behind Pharmaceutical Product Hopping, Victoria Field

Fordham Journal of Corporate & Financial Law

Patents grant time-limited market exclusivity to drug manufacturers, meaning that other companies are prohibited from copying and selling the patented pharmaceutical. This allows manufacturers to lawfully charge monopoly prices. Generic competition starts at the expiration of the patent. To maintain coveted monopoly power, manufacturers often release an alternative formulation of the drug with a fresh patent that enjoys continued market exclusivity. Manufacturers who can convert their consumer base to the new formulation can continue charging peak prices. This process, called “product hopping,” has been the target of significant antitrust inquiry, with mixed results.

A product hop may be the result …

Prescribing Exploitation, Charlotte A. Tschider

Faculty Publications & Other Works

Patients are increasingly reliant temporarily, if not indefinitely, on connected medical devices and wearables, many of which use artificial intelligence (“AI”) infrastructures and physical housing that directly interacts with the human body. The automated systems that drive the infrastructures of medical devices and wearables, especially those using complex AI, often use dynamically inscrutable algorithms that may render discriminatory effects that alter paths of treatment and other aspects of patient welfare.

Previous contributions to the literature, however, have not explored how AI technologies animate exploitation of medical technology users. Although all commercial relationships may exploit users to some degree, some forms …

Dobbsmacked By The Dobbs Decision: The Need For More Privacy Protection For Personal Health Information, Morgan Vanden Heuvel

Mitchell Hamline Law Review

No abstract provided.

The Surprising Harms Hidden Within The No Surprises Act, Madeleine Amick-Kehoe

Mitchell Hamline Law Review

No abstract provided.

Election Emergencies: Voting In Times Of Pandemic, Michael T. Morley

Washington and Lee Law Review

Over the past century, two global pandemics have struck during American elections—the Spanish Flu of 1918 and COVID-19 in 2020. The legal system’s responses to those pandemics, occurring against distinct constitutional backdrops concerning voting rights, differed dramatically from each other. These pandemics highlight the need for states to address the impact of election emergencies, including public health crises, on the electoral process. States should adopt election emergency laws that both empower election officials to modify an election’s rules as necessary to respond to such disasters and set forth “redlines” to identify certain policies that, even in a disaster, are too …

Supported Decision-Making And Merciful Health Care Access: Respecting Autonomy At End Of Life For Individuals With Cognitive Disabilities, Brenna M. Rosen

Washington and Lee Law Review

Supported decision-making is a relatively new, powerful, and quickly developing alternative to restrictive guardianships and other draconian surrogate decision-making arrangements for individuals with cognitive disabilities. Its power lies specifically in the protection and affirmation of their autonomy, allowing these individuals to remain central in the planning of their lives and affairs. Despite supported decision-making’s theoretical promise, it is often unclear whether and how the model interacts with other legislation presiding over how one may make crucial life choices, such as those at end of life.

This Note attempts to bridge the gap by analyzing how supported decision-making may be a …

Comment: Further Consideration On The Relationship Between The Americans With Disabilities Act, Supported Decision-Making, And Medical Aid In Dying, Amitai Heller

Washington and Lee Law Review

As Ms. Rosen’s Note explains in further detail, the use of supported decision-making creates an opportunity for persons with cognitive impairments to participate more fully in their end-of-life care. While this Comment focuses on the legal requirement for healthcare providers to serve people with cognitive impairments at the end of life, the tenets of patient autonomy, self-determination, and the dignity of risk must be integrated into end-of-life practice to provide guidance where legal requirements are absent or ambiguous. The use of the supported decision-making model in end-of-life care will only succeed when healthcare providers participate in an open-minded manner. It …

Nestlé V. Doe: A Death Knell To Corporate Human Rights Accountability?, Phillip Ayers

Seattle University Law Review

The Supreme Court in Nestlé v. Doe held that foreign plaintiffs who claimed to be victims of overseas tortious conduct by corporate defendants had no jurisdiction to sue in federal courts using the Alien Tort Statute. This Comment looks at the history of the Alien Tort Statute, from its inspiration, long dormancy, and recent reinvigoration beginning in the 1980s. The Comment then explores the background of Nestlé and its issues with child slavery in its cocoa supply chain. From there, the Comment analyzes the Nestlé v. Doe decision, and posits an alternative outcome. Finally, this Comment looks for a new …

Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida

Honors Theses

This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.

Comment: The Project Of Freedom, Alexandra L. Klein

Washington and Lee Law Review

A person’s status may change over time and people should have the right to maximize their autonomy and learn and grow from their experiences. Legal structures must encourage autonomy and growth, rather than producing a static environment that prevents people from challenging external controls imposed upon their lives. Law can create legal structures that sustain an individual’s right to live according to their values. As Ms. Rosen writes, “[i]f an individual is capable of valuing, the wishes stemming from those values should dictate how the individual ought to be treated.” By protecting those values, Ms. Rosen’s Note advises us how …