Health Law and Policy Commons^™

Curing The Cancer Pledge: Three Legal Reforms To Support Employees With Cancer, Hannah R. Weiser, Elizabeth Brown

Lewis & Clark Law Review

The 2023 Super Bowl featured a short film about the #WorkingWithCancer Pledge, a business initiative supporting employees with cancer, to over 100 million viewers. This film highlighted the struggles of a disease that affects a shocking 50% of individuals. It also underscored the need for a broader and more impactful approach ensuring that people with cancer have as full and equitable opportunities to work as other employees. While cancer in the workplace is increasingly common, misconceptions and stigma surrounding cancer exacerbate the gaps in legal protections for both employees with cancer and their employers. Employees with cancer need better legal …

Middlemen At A Price: The Role Of State-Level Laws In Restricting Pharmacy Benefit Managers, Patrick W. Schrader

Lewis & Clark Law Review

Pharmacy Benefit Managers (PBMs) have evolved from simple third-party payors into powerful intermediaries controlling prescription drug access for over 289 million Americans. Operating with minimal federal oversight, just six PBMs dominate 96% of the market, employing practices that systematically increase drug costs while claiming to reduce them. This Comment examines four primary mechanisms through which PBMs exploit the pharmaceutical supply chain: rebate manipulation, spread pricing, step therapy requirements, and formulary control. Federal regulatory efforts remain nascent and ineffective. The Centers for Medicare and Medicaid Services requires only basic reporting without substantive restrictions. Proposed federal legislation has repeatedly stalled, leaving states …

The Legal Ramifications Of Israel’S Destruction Of Gaza’S Healthcare System, Serene Mistkawi

Lewis & Clark Law Review

This Comment argues that Israel’s attacks on the medical infrastructure of Gaza are a violation of international law because hospitals are protected zones and medical personnel are civilians. To Israel’s response that Hamas is attack-ing from hospitals, thereby rendering them legitimate targets, this Comment presents a number of responses: (1) there is little to no evidence that Hamas is doing this; (2) even if Hamas is doing this, the military gains from attacking hospitals are outweighed by the civilian deaths; (3) even if Hamas is doing this and there is significant military gain from attacking hospitals, the interna-tional rules have …

The Alchemy Of Sin: Turning Tobacco Sin Tax Revenue Into Public Health Gold, Audre L. Sylvester

Lewis & Clark Law Review

This Note proposes a reallocation of tobacco excise tax revenue towards health and education programs related to tobacco cessation. Revenue collected from federal excise taxes on tobacco products is currently used to support the daily and long-term operations of the United States while tobacco cessation and education programs remain underfunded and underutilized. This Note examines the history of these “sin taxes,” their modern-day function, and the issues that arise from the current allocation of sin tax revenue to support the argument that revenue from federal sin taxes on tobacco products should be exclusively allocated to a dedicated federal trust fund …

Cause Of Death? -- It's Probably Not What's Reported On The Death Certificate, Lauren R. Roth

Lewis & Clark Law Review

In the age of big data, this country has a data problem—inaccurate and incomplete information in death certificates. The problem has long been hidden by the numbers reported—as have the people whose deaths go uncounted, but the COVID-19 pandemic unveiled the scope of the issue. Since the beginning of the pandemic, “excess deaths” (i.e., any deaths above the number predicted by existing mortality models) have increased significantly. Most of these excess deaths are likely attributable to COVID-19 because the decedent was never tested for COVID-19 or it was one of multiple factors contributing to their death. Other deaths are uncounted …

Medication Abortion And The Mails: The Ghost Of Anthony Comstock Rides Again?, Lars Noah

UF Law Faculty Publications

Mail-order dispensing of the prescription drug mifepristone has become the latest flashpoint in this country’s long-running debate over abortion access. It also has brought back from the dead one of the oldest federal statutes to address that contentious subject. In their fight to limit access to a drug approved by the FDA one quarter of a century ago, abortion opponents have rediscovered the Comstock Act. Although amended on several occasions since 1873, Congress never managed to repeal or clarify its ambiguous language relating to abortion. On its narrowest reading, this provision would have no impact whatsoever on access to mifepristone; …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

Cognitive Decline And The U.S. Presidency: The Case Of Joe Biden, Mark Fisher, Sandy Sanbar

Health Matrix: The Journal of Law-Medicine

This article examines the intersection of cognitive health, medical ethics, and constitutional governance through the lens of President Joe Biden’s medical history and recent cognitive performance. Highlighting the absence of formal neurocognitive testing protocols for presidential candidates and sitting Presidents, it raises critical questions about transparency, accountability, and the statutory and ethical obligations of medical professionals serving in political contexts. The paper discusses Biden’s stroke history, neurosurgical interventions, and subsequent lack of documented cognitive assessments, emphasizing the implications for public trust and the constitutional duty to ensure an executive fit for office. It advocates for the implementation of standardized, objective …

The Chemical Straightjacket: Institutional Over-Use Of Psychotropic Drugs On Children In Lieu Of Therapeutic Community Mental Health Services, Marisa Leib-Neri

Indiana Journal of Law and Social Equality

This Article argues that the abysmal state of children’s mental health in America is in part due to an overreliance on and over prescription of psychotropic drugs inside psychiatric residential institutions in lieu of community based mental health services. This overreliance on residential institutions and psychotropic drugs has allowed a new form of chemical restraint to flourish—the chemical straitjacket. This Article uses the medication lists of twelve children in seven different North Carolina psychiatric residential treatment facilities to demonstrate how the chemical straitjacket operates: the prescription of drugs not approved for pediatric populations, counter to evidence-based practices for particular diagnoses, …

A Bloody Mess: Why Blood Plasma Donation Centers Are Not Public Accommodations Subject To Title Iii Of The Americans With Disabilities Act, Kevin D. Marshall

Indiana Journal of Law and Social Equality

No abstract provided.

A Small Price To Pay For Better Mental Health Crisis Care: Why States Should Be Funding The New 988 Hotline Through Phone Fees, Katherine Menello

Law Student Publications

Mental health care in the United States is uncoordinated, underresourced, and overall insufficient. Mental health crisis care is much the same, but with much higher stakes. The lack of a comprehensive mental health crisis care system across the country has led to law enforcement involvement becoming the default system in most communities. Yet, an overwhelming majority of Americans want a better way; in a survey conducted in summer 2023, “85% of people sa[id] they want a mental health response to someone experiencing a mental health, drug or suicide crisis, not a police response.”...

Disappearing Data At The U.S. Federal Government, Janet W. Freilich, Nicholson Price Ii, Aaron S. Kesselheim

Other Publications

Health data hosted by the U.S. federal government have been disappearing. According to our analysis, between January 21 and February 11, 2025, the Centers for Disease Control and Prevention (CDC) removed 203 datasets (13% of its online datasets, a reduction from 1519 to 1316). The situation is dynamic; various datasets have been removed, restored, manipulated, or not posted as planned.

Prescribing A Balance: Sustaining Environmental Health With Pharmaceutical Interest In Puerto Rico, Derek Warzel

Indiana Law Journal

Puerto Rico, often referred to as the “Medical Cabinet of the U.S.A.,” is a hub for pharmaceutical manufacturing, contributing significantly to the American medical supply chain and Puerto Rico’s economy. However, decades of industrial activity, compounded by climate events like Hurricane Maria, have led to severe environmental damage, particularly through groundwater contamination and damaged Superfund sites. This Note examines the historical intersection of economic incentives and environmental neglect in Puerto Rico, focusing on the pharmaceutical industry’s impact. By critically analyzing the Superfund program and proposing reforms, this Note advocates for a balanced approach: introducing proactive environmental protections and financial incentives …

Federalism, State Action, And Workers’ Medical Privacy, Ani B. Satz

Faculty Articles

Injured workers entering state workers’ compensation systems effectively forego their medical privacy. This is due to widespread judicial misinterpretation of the HIPAA Privacy Rule (HPR) as excluding injured workers from federal medical privacy protections. As a result, medical privacy for workers’ compensation claims is effectively governed by state law. This Article argues that states have failed to protect the medical privacy of injured workers adequately and that there is a pressing need for legislative reform. The Article presents the first comprehensive survey in the legal literature of state action protecting the medical privacy of injured workers. Part I describes the …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Faculty Articles

In her important book, Unwired: Gaining Control Over Addictive Technologies, Gaia Bernstein illustrates the value of a comparative approach, drawing lessons from fights around the regulation of tobacco and ultra-processed food for the regulation of social media. Building on Bernstein’s work, this symposium contribution aims to draw additional insight from experience with drug and gambling regulation for the regulation of social media, video games, AI, and other potentially-addictive technologies.

Specifically, after introducing Bernstein’s book and the foundation it lays, we draw six lessons from the study of psychoactive drugs and gambling. As we elaborate below: Lesson one is that …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

The Interchangeable-Part Structure Of Food And Drug Law, Adam I. Muchmore

FIU Law Review

This Article demonstrates that nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the U.S. Food and Drug Administration. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practices, product standards, marketing authorization requirements, postmarket requirements, and user fees. In each of these areas, Congress or the FDA has engaged in interchangeable-part lawmaking (IPL). IPL occurs when a government takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. …

Unvaccinated By Doubt: How Covid-19 Governance Sparked A Measles Revival, Ellen Black

FIU Law Review

A measles outbreak occurred in the United States this year, with measle cases reaching the highest levels in over two decades, even though the disease had been declared eliminated in 2000. In large part, this measles resurgence can be traced to unvaccinated individuals who have chosen to disregard public health officials' vaccination guidance. Clearly, the public has lost trust in their governmental public health officials. As the next disease outbreak looms, the need for restoration of trust becomes imperative.

This article demonstrates how the government's actions during COVID-19 further led to this lack of trust, by providing conflicting guidance as …

The Hunger Games: Food As A Right, Not A Privilege, Camesha F. Little

FIU Law Review

Despite the United Nations' explicit declaration that all humans have a right to food, food insecurity and hunger remain persistent problems in the United States and around the globe. The dystopian landscapes depicted in novels such as The Hunger Games and Parable of the Sower—societies crippled by poverty, oppression, and pervasive starvation—resonate with sobering contemporary realities. This Article examines existing food laws, food rights, and the current protections safeguarding the United States food supply from a humanitarian perspective. Ultimately, this Article argues that the human right to food must expand to encompass a right to healthy or natural food, and …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Fighting Fgm In Minnesota: Minnesota Legislation Vs. Model Legislation, Molly Rosenfield

Mitchell Hamline Law Review

No abstract provided.

Dobbs V. Brown, Benjamin H. Barton

Dickinson Law Review (2017-Present)

Dobbs v. Jackson Women’s Health Organization1is the most important and impactful Supreme Court decision since at least Roe v. Wade, and potentially since Brown v. Board of Education. Past survey data show that most Americans can only name two Supreme Court opinions: Roe and Brown. Dobbs will surely join that list. This Article compares the history, drafting, and opinions of Dobbs and Brown to show what a missed opportunity Dobbs represents. Regardless of whether you agree or disagree with the opinion, it should be clear that Dobbs was one of those unique times (like that of Brown) where the Court …

Advancing Virtual Care Practices Across The Cognitive Impairment Continuum, Tara Sklar, Kathryn Huber

Health Matrix: The Journal of Law-Medicine

As the population of older adults grows, providing high-quality, costeffective healthcare for those with cognitive impairments is an increasing priority. The COVID-19 pandemic accelerated the shift towards receiving virtual care at home through temporary Medicare flexibilities. However, the uncertainty surrounding the continuing extension of these flexibilities at the federal level and variations in reimbursement policies across the states present challenges for virtual care practices to meet the rising demand for care amid unprecedented workforce shortages. Sustainable, long-term reimbursement at the federal and state levels, a trained and integrated healthcare workforce, and adherence to recognized accreditation standards and guidelines are essential …

J Mich Dent Assoc January 2025

The Journal of the Michigan Dental Association

Each month, the Journal of the Michigan Dental Association provides news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. It is the primary publication reaching Michigan dentists. The January issue sets the tone for February, the observance of Children’s Dental Health Month.

Michigan Academy of Pediatric Dentistry President Jessica Bentoski welcomes readers to this special issue, which features a cover feature on “Approaches to Care for Children with Special Needs in Dental Settings: Desensitization and Teledentistry” and a supporting article on “General Dentists’ Education, Knowledge, Attitudes, and Behavior Concerning the Effects …

Dentistry And The Law: The Difference Between ‘Non-Covered’ Vs. ‘Disallowed’ Services, Daniel Schulte Jd

The Journal of the Michigan Dental Association

The article clarifies the distinction between "non-covered" and "disallowed" services in dental plan audits. Non-covered services are not included in the patient’s dental plan, often due to plan limitations, while disallowed services are covered but deemed non-payable due to issues like claim deficiencies or lack of documentation. Dentists must review their contracts to understand obligations regarding non-covered services and ensure compliance with HIPAA for patient-paid services. For disallowed services, contesting decisions may be possible depending on the agreement with the dental plan.

Integration Over Institutionalization: Addressing Rhode Island’S Institutionalization Of Developmentally Disabled Children Through An Olmstead Compliance Framework, Anna Macgillivray

Roger Williams University Law Review

No abstract provided.

Decision-Making Supports And Cognitive Decline, Rebekah Diller

Articles

For persons with a range of cognitive disabilities, supported decision-making, rooted in a human rights approach to disability, has emerged as a tool that permits them to make legally binding decisions and avoid guardianship. As supported decision-making policy has evolved in the United States, state statutes have primarily focused on formal agreements through which individuals can designate trusted supporters to assist in obtaining information, processing that information, and communicating a decision. This Article argues that supported decision-making has promise for preserving the autonomy of persons living with dementia, but that the model of a supported decisionmaking agreement embodied in the …

Pertanggungjawaban Etik Dokter Dalam Melakukan Aksi Mogok Kerja Di Indonesia, Farel Rifandanu

Jurnal Hukum & Pembangunan

The implementation of strikes by doctors is a complex phenomenon with significant implication that give rise to ethical dilemma. Doctors have a responsibility to provide health services, so that a strike can endanger the health care system. On the other hand, doctors also have the right to fight for fair and decent working conditions. In view of these problems, this study has two (2) problem formulations, how the legal regulations regarding the actions of doctors who go on strike and how the ethical responsibilities of doctors who go on strike. This study uses a normative legal research method that …

Recent Changes In Discretionary Denials Of Drug Patent Challenges, S. Sean Tu, Arti K. Rai, Aaron S. Kesselheim

Faculty Scholarship

Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of “discretionary denials,” invoking a new “settled expectations” rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes …

Ethical Issues In Pandemic Prevention, Preparedness, And Response, Govind Persad

Publications

Pandemic policies raise complex ethical challenges, as well as scientific and technical ones. This chapter examines four critical areas where ethical analysis is essential for effective pandemic prevention, preparedness, and response: spending decisions, clinical research, restrictions on rights and freedoms, and fair allocation of scarce medical resources.

Spending on pandemic prevention, preparedness, and response often involves trade-offs with other societal priorities, such as education, infrastructure, and environment. Navigating these trade-offs requires careful consideration of opportunity costs and distributional impacts.

Rights and freedoms can likewise present difficult trade-offs when pandemic policies restrict individual liberties, requiring clear goals and proportionate responses that …