Health Law and Policy Commons^™

Off-Label Neuroimaging, Jane C. Moriarty

Law Faculty Publications

The growth of neuroimaging evidence in the courtroom is consistent with the increased reliance on technical and machine-based specialties at trial. Litigants routinely seek to introduce neuroimaging evidence in both civil and criminal trials to supplement traditional medical, psychiatric, and psychological opinion testimony. A substantial portion of neuroimaging evidence is still in the developmental stage—what I term “off-label neuroimaging.” Unsurprisingly, evaluating the reliability of developing neuroimaging poses challenging questions for gatekeeping courts. Among the complex evidentiary issues neuroimaging presents for courts and litigants, this Article considers one foundational question: How should courts determine whether neuroimaging evidence is sufficiently reliable for …

The Deregulation Of Cancer, Daniel G. Aaron

Utah Law Faculty Scholarship

Fifty years ago, the U.S. embarked on a radical new path. Under pressure from the environmental movement, Congress passed an array of statutes aimed at regulating carcinogens out of our world. This regulatory experiment sprawled from air and water to food and consumer products.

Legal scholars have paid scant attention to this wave of cancer regulation despite its size and importance and the public’s apparent interest in avoiding carcinogens. But there is a growing literature finding flaws with individual regimes within the framework, such as the Clean Air Act, the Toxic Substances Control Act, and the Tobacco Control Act. In …

The Crisis In U.S. Cancer Care: Law, Markets, And Privatization, Daniel G. Aaron

Utah Law Faculty Scholarship

Cancer is surging among youth and young adults in the U.S., yet instead of public regulation addressing its root causes, we have outsourced the management of cancer to the private sector.  A suite of laws, embodying faith that corporations will cure cancer, has subsidized the cancer biomedical enterprise and transformed quasi-public institutions into marketized, profit-seeking entities.  These changes, across patent law, healthcare law, innovation law, and Food and Drug Administration (FDA) law, have privatized cancer. 

The market failures I describe in U.S. cancer care raise larger questions about who we entrust with managing critical social problems.  This Article provides theoretical …

The Fiduciary Game, Lauren R. Roth

Elisabeth Haub School of Law Faculty Publications

Fiduciary duties are supposed to bridge the gap between public and private law. Private actors who engage in “public or quasi-public” functions (e.g., corporate directors and pension administrators) are often subject to fiduciary constraints to protect vulnerable parties who lack power in relationships with these actors. Recently, scholars have argued that both courts and legislatures have inappropriately expanded the use of fiduciary duties to purely private relationships. But what if the problem is not the expansion of fiduciary duties to private relationships, but the increasing delegation of public powers to private actors whose behavior cannot be adequately constrained by fiduciary …

From Rights To Risks: Mental Health Implications For Pregnant Patients Following The Reversal Of Roe V. Wade, Andrew Murdock, Angelica Arshoun, Eduardo Espiridion

Tower Health Research Day

No abstract provided.

Legal Barriers To Maternal Healthcare Equity, Ashley Keith

Akron Law Faculty Publications

In examining contemporary maternal healthcare inequity in clinical care delivery, we must study the critical role played by the legal institutions in creating and perpetuating this problem. Comprehensive systems within the United States require legal advocacy and judicial enforcement to take shape and maintain their structural integrity. Healthcare in this country is no different. Legal institutions helped form and further, both intentionally and inadvertently, the racial disparities that we currently battle. Legal history plays an integral role in understanding why racial disparities in maternal mortality persist. One way for legal professionals to contribute to the ongoing efforts to achieve maternal …

Venturing Into Health, Rachel Sachs

Scholarship@WashULaw

In recent years, the landscape of venture capital (VC) investment in healthcare technologies has been altered by the introduction of new types of VC firms: those that have emerged from hospital systems and health insurers. However, the legal literature has not yet analyzed these new VC firms, the role they may play in healthcare innovation, and how innovation law and policy ought to consider their involvement. Hospital system and health insurer VC firms operate very differently than do traditional VC firms, even those that have historically developed healthcare specializations. Instead of simply investing capital into start-up firms, hospital system and …

A New Framework For Drug Pricing Law And Policy, Rachel Sachs

Scholarship@WashULaw

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of “the drug pricing problem” into four steps, each of which must be addressed and each of which elevates different institutional actors to key …

Introduction—Bioethics After Dobbs, James Toomey

Pace Law Review

No abstract provided.

Aspek Keperdataan Dalam Upaya Penyelesaian Sengketa Medis Antara Pasien Dengan Tenaga Medis Berdasarkan Undang-Undang Kesehatan, Lintang Zandra Camellia, Adhitya Widya Kartika

Jurnal Hukum & Pembangunan

Medical disputes in the civil field are disputes that can occur between patients and doctor as a medical-professionals and are related to the full fillment of the rights and obligations of the binding relationship as a legal result in the provision of medical services. Medical disputes can lead to losses suffered by patients which can be in the form of limb disability, even death. The emergence of law and health provides a beneficial collaboration, where the health field can be used to face public health challenges and the law can be used to maintain peace and order in society. The …

Public Health Consequences Of Appellate Standards For Hostile Work Environment Claims, Lauren Krumholz

Washington Journal of Social & Environmental Justice

No abstract provided.

Operationalizing Power In Health Law: The Hospital Abolition Hypothesis, Matthew B. Lawrence

Faculty Articles

This symposium Article describes how prison abolitionist arguments also support the hypothesis that a defining goal of health law should be the abolition of hospitals. Like prison abolitionism, the hospital abolition hypothesis can provide a constructive way to shift the focus of legal analysis from substantive dimensions (in health law — cost, quality, access, and equity) to the dimension of power.

Rethinking Health Law Architecture, Ani B. Satz

Faculty Articles

Neither the individualistic regulatory health paradigm nor the vulnerable populations approach of public health can provide the legal structure necessary to address the most pressing problems in health care today. These approaches fail to address conflicts between individuals and populations as well as challenges to qualifying for care and are in inherent conflict with each other, sometimes within the same statute. As health concerns become more global, it is necessary to move past a vulnerable populations approach to a broader population approach that respects individual choice but does not sacrifice community health for liberty interests.

Ella P. Stewart And The Benefits Of Owning A Neighborhood Pharmacy, Randall K. Johnson

Faculty Works

This Essay is the first to explain how and why Ella P. Stewart, who was among the first Black women to earn a doctoral degree in Pharmacy, used her status as a small business owner to protect the limited set of legal rights that were available to African-Americans in the twentieth century. It also describes how Stewart’s early personal and professional experiences informed her subsequent public service career. Additionally, this Essay highlights the various ways that Stewart expanded the real freedoms that Black Americans enjoyed by guaranteeing they received a fair share of public goods or services. It concludes by …

Policy’S Place In Pedestrian Infrastructure, Michael L. Smith

Dickinson Law Review (2017-Present)

Angie Schmitt’s Right of Way: Race, Class, and the Silent Epidemic of Pedestrian Deaths in America delves into the complex, multi-layered phenomenon of how traffic infrastructure and policies systematically disadvantage pedestrians and contribute to thousands of deaths and injuries each year. Despite the breadth of the problem and its often-technical aspects, Schmitt presents the problem in an engaging and approachable manner through a step-by-step analysis combining background, statistics, and anecdotes. While Right of Way tends to focus on infrastructure design, it offers much for legal scholars, lawyers, and policymakers. Schmitt addresses several policy issues at length in the book. But …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

Medicaid Expansion Expectations, Deborah Farringer

Law Faculty Scholarship

Although financial stability in rural hospitals has been a relatively long-standing national problem, in the last decade, hospital closures and the incidence of highly distressed hospitals in rural areas have disproportionately impacted certain states. States that have not expanded their Medicaid programs under the Affordable Care Act, which implemented a program to extend additional federal support to cover adults living below 138% of the federal poverty line (referred to herein as “Medicaid Expansion”), are bearing the brunt of this crisis. Although the reason for hospital closures is multi-faceted and complex, health policy experts have consistently identified the lack of Medicaid …

The Rise Of Concentrated Animal Feeding Operations, Their Effects, And How We Can Stop Their Growth, Andrea Prisco

Dickinson Law Review (2017-Present)

Dramatic changes in the agricultural industry over the last century have led to the rise of concentrated animal feeding operations– industrial facilities that raise a large number of animals in confined spaces. Animals raised in these facilities suffer from poor quality of life and abuse. For humans, these facilities have had adverse effects on the environment and public health, but they are also associated with high productivity and low food costs. This Comment analyzes the effects of concentrated animal feeding operations on animal well-being, the environment, and public health. This Comment also analyzes current federal legislation that helps combat the …

Life After The Covid-19 Pandemic, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

After 2 years of a seemingly relentless pandemic that has upended work, education, and social interactions, the questions many are asking are when will we get back to normal and what will life be like after the COVID-19 pandemic? In truth, science cannot fully predict what SARS-CoV-2 variants will arise and the trajectory of the pandemic. Yet, history and informed scientific observations provide a guide to how—and when—society will return to pre-pandemic patterns of behavior. There will not be a single moment when social life suddenly goes back to normal. Instead, gradually, over time, most people will view COVID-19 as …

More Money, More Problems: Why H.R. 1318 Is An Insufficient Fix To Remedy The Maternal Mortality Crisis

Florida A & M University Law Review

Between 1990 and 2013 maternal mortality has nearly doubled in the United States as opposed to other countries.6 Per every 100,000 live births, there are 26.4 deaths in the United States. In fact, the United States has the highest rate of maternal mortality in the industrialized world. Unfortunately, maternal mortality did not become a political issue until public figures, like Beyonc´e and Serena Williams, began speaking out about near-death experiences while giving birth. For example, T.V. phenomenon Judge Glenda Hatchett’s daughter-in-law, Kira Johnson, died due to pregnancy-related complications in 2016. Stories like Beyonc´e’s, Serena Williams, and Kira Johnson caused a …

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 …

The Role Of State Attorneys General In Improving Prescription Drug Affordability, Michelle M. Mello, Trish Riley, Rachel Sachs

Scholarship@WashULaw

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys general also play a critical role in helping governors and legislatures advance health policies by giving input into their drafting and defending them against legal challenges. State attorneys general have entered the prescription drug affordability arena in both these ways—for example, by initiating lawsuits relating to price fixing by generic drug manufacturers and defending state laws requiring disclosures of pharmaceutical prices. Yet the scope of their collective efforts is not …

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 …

Health Care Civil Rights Under Medicare For All, Valarie K. Blake

Law Faculty Scholarship

The passage of Medicare for All would go a long way toward curing the inequality that plagues our health care system along racial, sex, age, health status, disability, and socioeconomic lines. Yet, while laudably creating a universal right to access to health care, Medicare for All may inadvertently dampen civil rights protections that are necessary to ensure equality in health care delivery, an outcome its creators and supporters surely would not intend.

Federal money is typically requisite for civil rights enforcement. Title VI, Title IX, and the Age Discrimination Act of 1975 all apply to recipients of federal financial assistance. …

“Incident To Service”: Narrowing The Scope Of The Feres Doctrine In Military Medical Malpractice, Thomas A. Campbell

Health Law Outlook

No abstract provided.

The Patient Assistance Problem, John Defuria

Health Law Outlook

No abstract provided.

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Utah Law Faculty Scholarship

This paper examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high schoolers. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to to 3.6 million youth.

This article will review the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by …

Drivers Of Health Policy Adoption: A Political Economy Of Hiv Treatment Policy, Matthew M. Kavanagh, Kalind Parish, Somya Gupta

Georgetown Law Faculty Publications and Other Works

Why do some countries rapidly adopt policies suggested by scientific consensus while others are slow to do so? Through a mixed methods study, we show that the institutional political economy of countries is a stronger and more robust predictor of health policy adoption than either disease burden or national wealth. Our findings challenge expectations in scholarship and among many international actors that policy divergence is best addressed through greater evidence and dissemination channels. Our study of HIV treatment policies shows that factors such as the formal structures of government and the degree of racial and ethnic stratification in society predict …

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

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

Scholarly Articles in Law Reviews & Journals

Introduction: In the aftermath of the largely failed Clinton-era health reform push and the build-up to Obamaera reforms, experts worried that another failed effort could cast a ten-year shadow. The tenth anniversary of the Affordable Care Act offered an opportunity for participants in the 2019 Next Steps in Health Reform conference to reflect. If the ACA proves resilient, what paths will it have paved for the next decade of reforms?