Health Law and Policy Commons^™

Lessons Learned For The Independent Panel For Evidence For Action Against Amr From Previous International Science Panels: Stakeholder Views From The 2025 Lagos Workshop, Iruka N. Okeke, Anthony Mcdonnell, Ayodele A. Akinyele, Javier Guzman, Kevin Outterson

Faculty Scholarship

In September, 2024, the UN General Assembly assigned the Quadripartite Joint Secretariat on Antimicrobial Resistance (AMR) the task of establishing an Independent Panel for Evidence for Action against AMR (IPEA). To promote stakeholder views and input around the constitution and functioning of this Panel, which could feed into the Quadripartite Joint Secretariat’s consultation process, we independently commissioned seven papers to examine the lessons that could be learned from other high-level scientific panels. We then convened 85 stakeholders, primed with the background papers. The Workshop, held in Lagos, Nigeria in April, 2025, drew representation from around the world, particularly low-income or …

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

Escaping Quarantine: Marine Hospitals, The Constitution Act, 1867 And Canada’S First Federal Health Care Program, Dan Dwyre

Dalhousie Journal of Legal Studies

Previous scholarship has argued that the enumeration of marine hospitals as a federal head of power in the Constitution Act, 1867 reflected a national concern over immigration and quarantine. This article disputes that. Using primary sources, this paper demonstrates that Canadian marine hospitals were established in port communities to provide for the general health of itinerant merchant sailors, who would otherwise be a burden on local hospitals and charitable organizations. The article concludes that marine hospitals can be viewed in retrospect as one of Canada’s first federal health care programs.

Access To Justice After Medina V Planned Parenthood South Atlantic, Daniel G. Aaron, Nicole Huberfeld

Faculty Scholarship

Access to justice is “the ability of all people to seek and obtain effective remedies through accessible, affordable, … and culturally competent institutions of justice.”¹ Historically, patients and physicians have worked together to protect the integrity of medical care as well as patients’ rights by challenging unlawful government actions in court. Yet the US Supreme Court recently issued decisions that may impede access to justice, potentially empowering federal, state, and local governments to interfere with evidence-based care. We explore constraints on access to justice that may arise after Medina v Planned Parenthood South Atlantic (PPSA) (606 US 357, 2025), …

Can Legal Knowledge Save Lives? A Randomized Experiment In Preventive Health Screenings, Christopher Robertson, Wendy Netter Epstein

Faculty Scholarship

While the U.S. healthcare system typically imposes significant out-of-pocket costs, the Affordable Care Act (ACA) requires full insurance coverage for certain preventive health services (PHS), including cancer screenings, without cost-sharing. Despite this policy, one in four eligible Americans remains unscreened for breast, colorectal, and cervical cancer, which increases their risk of premature death. We hypothesize that a lack of awareness about the ACA’s free care requirement contributes to this gap and that explicitly informing patients could increase screening uptake. Additionally, we investigate whether prior experiences with medical debt deter individuals from seeking even cost-free care, reflecting a spillover effect of …

Spending Programs And The New Roberts Court, Nicole Huberfeld

Faculty Scholarship

The Supreme Court is poised to place new limits on Congress’s spending power at the urging of states vying for regulatory dominance, particularly in health care and public health. This article is the first to highlight and catalog the throughlines of argumentation, which sparked after states successfully challenged the ACA but have grown into opposing more than Medicaid’s cooperative federalism. This means federal and state programs that heavily rely on federal spending power are at risk, so studying this pattern is imperative. The article begins with a descriptive account of increasing spending power challenges, which make use of converging factors …

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

Indiana Law Journal

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 drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

When Death Is Not Binary, Teneille R. Brown

Indiana Law Journal

There are few dichotomies more recognized than the one between life and death. Given the many legal rights that pivot on this distinction, one would think that the law has exceptionally clear standards for diagnosing death. It may surprise you then to learn that the line between legal life and death is no longer so obvious. That is, in a growing number of cases, there is now disagreement about whether someone is legally dead or alive. This is due to two things: the development of medical devices that can breathe for patients with severe brain injuries, and neuroimaging technology that …

The Power And Peril Of The Aca's Universality At Fifteen, Nicole Huberfeld

Faculty Scholarship

As part of the symposium "15th Anniversary of the ACA: A Health Equity Review," this essay explores the ACA's mix of private law and public law provisions that rendered measurable improvements in health equity and health outcomes, especially for populations that experienced longstanding health disparities before its enactment.  Congress’s central objective was near-universal health insurance coverage, and the ACA employed a variety of mechanisms to reach that goal. The law’s health equity successes grew from establishing a principle of inclusion across federal statutes. This principle, which I have called “universality,” centered a human right to health approach: No longer would …

Opioids And Oblivion: Corporate Bankruptcy And The Erosion Of Accountability In Big Pharma, Ying Yuan

Washington Law Review

In June 2024, the United States Supreme Court ruled in Harrington v. Purdue Pharma that nonconsensual releases for nondebtors are unconstitutional. The decision marked a key development in mass tort litigation involving Purdue Pharma, the company at the center of the opioid crisis. The Sackler family sought to use Purdue’s bankruptcy proceedings to shield themselves from liability, but the Court’s ruling invalidated the use of nondebtor releases to protect third parties from claims without the full consent of affected parties. While the ruling strengthens creditor protections, it creates uncertainty regarding how mass tort bankruptcies can efficiently compensate victims, particularly in …

Seeing Is Believing: Identifying The “Ideal Manifestation Of Hidden Disability” In Ontario’S And Quebec’S Social Benefits Tribunals, Pascale Malenfant

Dalhousie Law Journal

The phenomenon of disability skepticism, especially in relation to “hidden” disabilities like chronic fatigue syndrome (CFS), has fostered a culture of doubt among medical, legal, and public entities. This paper explores the intersection of such skepticism with the social benefits adjudication processes in Ontario and Quebec. In drawing parallels to feminist critiques of the “ideal victim” in sexual assault cases, it argues that the tribunals’ biased framework for believability is based on a claimant’s conformity to stereotypical expectations of what an “ideal” claimant with a hidden disability looks like. By comparatively examining 10 years worth of Ontario and Quebec tribunal …

Bridging The Fair Share Gap For Antibacterial Innovation: An Observational Analysis Of Antibacterial Revenues In The G7 And Eu27, Maple Goh, Matt Mcenany, Rachel Freeman, Max Newton, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

Background

Antimicrobial resistance (AMR) poses an important global health challenge, including insufficient investment in research and development. This study quantifies the required “fair share” contributions from the G7+EU27 countries for an effective set of pull incentives for antibacterial research and development.

Methods

Fair share targets within the G7+EU27 were calculated from GDP data and revenue targets from the literature, adjusted for inflation. Cefiderocol and ceftazidime-avibactam were selected as representative of key antibacterials. Revenues and volumes from IQVIA MIDAS data on these drugs were used to assess alignment with fair share targets. The study period was January 2015–December 2024.

Findings

The …

The Impact Of The Chevron Ruling On Medicare, Sana Sherali

DePaul Journal of Health Care Law

The Supreme Court’s historic decision to overturn the Chevron doctrine in June 2024 received national attention due to its implications for how much power agencies will hold in the years to come. The Chevron doctrine originally comes from the Supreme Court’s 1984 decision in Chevron, U.S.A., Inc. v. Natural Resources Defense Council.Chevron addressed the requirements imposed on states by The Clean Air Act Amendments of 1977. This decision set the precedent that if federal legislation is unclear or leaves an administrative gap, courts have to follow the regulatory agency’s interpretation of the law, as long as the interpretation is …

Heterogeneity In Hospital Consolidation, Christina Depasquale

DePaul Journal of Health Care Law

This paper examines the heterogeneity between two types of hospital consolidations—mergers and system-joinings. I examine changes in admissions, employment outcomes, beds in different medical units, surgeries, costs, case mix, and discharges. I find that hospital mergers and system-joiners are fundamentally different among almost all outcomes examined. Additionally, I extend my analysis by examining those hospitals that, at the time of consolidation, are closer to either their fellow merging hospital or a fellow system-member hospital. I find no meaningful correlation between distance and outcomes.

The Opioid Crisis: How The United States And Countries Abroad Are Making Strides, Maura Mcginnity

DePaul Journal of Health Care Law

The opioid epidemic has been an ongoing problem in the United States since the 1980s. The United States has had a very negative attitude towards individuals suffering from addiction. This attitude is clearly shown through the United States’ handling of the opioid crisis. Hundreds of thousands of individuals have died due to opioids. In the forty years since this epidemic became prevalent, the United States has still failed to implement a country-wide solution to combat the crisis. Certain states, like New York and Illinois, have made strides toward helping individuals suffering from opioid use disorder, but nationally, the country is …

Challenging Race-Based Health Care Discrimination: A New Private Right Of Action, Aaron Pinkett

Northwestern University Law Review

The Hippocratic Oath calls on doctors to “do no harm.” Yet we know from extensive public health research that clinicians repeatedly cause harm to Black patients by dismissing their medical concerns, misdiagnosing them, and undertreating their pain. These practices of differential treatment for Black patients have led to steadily increasing racial disparities in health care outcomes throughout the United States. Title VI of the Civil Rights Act of 1964 prohibits this type of disparate impact, but modern Supreme Court jurisprudence forecloses opportunities for affected parties to seek legal relief—despite the clearly established legislative intent of Title VI. However, another legal …

Sexual And Reproductive Health & Rights: Advances And Setbacks, Aziza Ahmed, Alicia Ely Yamin, Sofia Gruskin

Faculty Scholarship

This article first describes shifts in human rights law that have led to improvements in the realization of sexual and reproductive health and rights (SRHR) over the last decade. The article does so, however, with careful attention to the structural factors beyond formal legal mechanisms that may undermine the ability of governments, even with the best of intentions, to fully develop the necessary robust health and justice systems. Second, this article considers two additional factors: the political economy factors that enable or limit the ability of States to realize SRHR, as well as the growing evidence base that supports positive …

Celebrating 70 Years Of Health Law At Bu, Christopher Robertson, Elizabeth Mccuskey, Aziza Ahmed, Dionne Lomax, Kathryn Zeiler, Dianne Mccarthy, Laura Stephens, Michael Ulrich, Lawrence Vernaglia, Danielle Pelfrey Duryea, Nicole Huberfeld, Kevin Outterson

Faculty Scholarship

This essay celebrates the BU Health Law Program upon its 70th anniversary, offering reflections on the founders of the program, Fran Miller, George Annas, and Wendy Mariner (“FGW,” endearingly), and their contributions to the field.

Current faculty offer reflections, including: Several speak to scholarly research, including Elizabeth McCuskey on health care finance, Aziza Ahmed on human rights, Dionne Lomax on antitrust, Christopher Robertson on trust, and Kathy Zeiler on the marketplace. Other contributors speak to the student experience, with Dianne McCarthy on mentorship, Laura Stephens on demanding excellence, Michael Ulrich on teaching, and Larry Vernaglia on merging law and public …

A Half Century Of Criminalizing Serious Mental Illness: Observations And Considerations, Arthur J. Lurigio

DePaul Journal of Health Care Law

This article describes the difficulties of working with people with serious mental illnesses (PSMIs) at every stage of the criminal justice process—from arrest to post- incarceration release from prison. The needs of PSMI for mental health and social services are complex and require different case management plans and strategies at various points in the process. Severe mental illnesses (SMIs), such as schizophrenia, major depression, and bipolar disorder, stem from abnormalities in the brain structure and neuroprocessing that cause significant distress and dysfunction. People with serious mental illnesses typically suffer from a variety of other related problems (e.g., addiction) that can …

Tug Of War Between Opt-In And Opt-Out Organ Donation Systems, Amna Cehaja

DePaul Journal of Health Care Law

The demand for organ transplants is far greater than the supply of transplantable organs. Every day, twenty people in the United States die as they await an organ transplant; this equates to roughly 7,300 people annually. Whilst organ donation can be highly effective for prospective patients, not all individuals want to take part in such an action. A person’s decision not to partake in organ donation can stem from their ethics, morality, religion, and much more. For individuals that live in the United States and do not want to donate their organs upon death, they do not have to take …

Mental Health Courts: Is There Any Hope For Mental Illness In An Outdated Criminal Justice System?, Brock Imel

DePaul Journal of Health Care Law

Mental health awareness is an ever-growing field of study that has garnered more attention in America after the COVID-19 pandemic. As far back as colonial America, mental illness was considered taboo in society and often reprimanded with punishable crimes. This article seeks to divulge into the history of mental health and its relation to the law, as well as how the creation of mental health courts has led to a decrease in recidivism.

This article aims to provide the reader with an understanding of the evolving field of mental health courts and provide state legislatures foundational knowledge for creating and …

The Healing Power Of Antitrust, Theodosia Stavroulaki

Northwestern University Law Review

Millions of Americans live in hospital deserts—communities where people lack geographic access to hospitals and primary care physicians. People living in these deserts often miss doctor appointments, delay necessary care, and stop adhering to their treatment. In this way, hospital deserts exacerbate the health disparities plaguing America. This Article demonstrates that hospital deserts are not inevitable but the result of several business strategies—including noncompete agreements and merging with competitors—and antitrust enforcers’ unwillingness to recognize these harmful practices as antitrust violations. To cure the issue of hospital deserts, this Article makes three proposals. First, antitrust enforcers and the courts should expand …

Who Decides: The Role Of Parental Rights In Abortion And Gender-Affirming-Care Decisions For Minors, Joanna L. Grossman

Faculty Journal Articles and Book Chapters

The American legal system presumes that children’s interests are best protected by their parents and, secondarily, by the state’s parens patriae authority. Yet this structure falters when parental authority and state power are infused with political and ideological agendas. This Essay examines how these dynamics have distorted decision-making authority in two contexts—minors’ access to abortion and gender-affirming medical care—and allowed children’s welfare and autonomy to be sacrificed to partisan aims. The law is inconsistent on the role of parental rights—typically empowering parents to grant or withhold consent to a minor’s abortion but categorically stripping them of the power to consent …

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. …

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 …

Medicare Drug Price Negotiations: A Blueprint For Ethical Pricing Across The Healthcare System, Jacqueline Fox

FIU Law Review

In a healthcare system with scarce resources, profit that exceeds the value of what is being paid for cries out for justifications. The Medicare Drug Price Negotiation Program, created by the Inflation Reduction Act of 2022, is a new program that allows Medicare to begin negotiating with drug companies to determine the maximum fair price for a small set of drugs. This Article argues that the methods for conducting these negotiations represent a significant step forward in a dramatic and important reordering of how we view the healthcare financing system, allowing us to consider rational, coherent concepts of value without …

Health Law And Democracy, Wendy K. Mariner

Faculty Scholarship

Current political divisions are destabilizing existing laws affecting the health field. Major changes in the field of health law have one thing in common: changes in who holds political power ‒ Congress and state legislatures, governors, presidents, judges, and agency officials. The laws that structure financial, economic, educational, and health care systems, environmental conditions, and civil society are primarily the product of elections that populate our political institutions. These structural determinants of health in turn create laws that influence how ‒ and how well ‒ we live and whether our society functions fairly under the rule of law. Thus, who …

Transplantation And Immortality: A Selective History Of Boston University’S Center For Health Law, Ethics & Human Rights, George J. Annas

Faculty Scholarship

The celebration of the anniversary of the Center for Health Law, Ethics & Human Rights (the “Center”) provides an opportunity to reflect on what defines the field of health law, as well as its conjoined twins of bioethics and human rights. The related fields are vast, and the subjects they encompass are ever-expanding. It is probably impossible to lay out a summary that does justice to their expansive, interdisciplinary scope. Instead, my discussion of the Center examines a subject that barely existed when the Center was formed in 19581 and that continues to make headlines more than sixty–six years later …

Prescription Practices, Anti-Psychotics, And Covid-19: An Intersectional Examination Of The Long-Term Care Home Setting In Canada, Olivia Ramos

Dalhousie Journal of Legal Studies

Public discourse and concern over the state of long-term care homes in Canada has been ongoing over the last two decades. One of the main sources of these concerns is the off-label prescription of anti-psychotic medications to long-term care home residents. Off-label use of pharmaceuticals is common and can be beneficial in certain contexts, however, there is a risk of anti-psychotics being used as an inappropriate means of managing patients chemically in the long-term care home setting. This paper engages in three lines of inquiry: first, the regulatory landscape of on and off-label prescription in Canada; second, the off-label use …

Fighting For Abortion Access In Canada: A Constitutional Analysis, Jordana Borzellino

Dalhousie Journal of Legal Studies

Access to abortion is a controversial matter that creates a labyrinth of polarizing issues. Perspectives on abortion range from anathema to overzealous support, with stakeholders occasionally resorting to legal avenues to control access one way or another. This paper will explore the possibility of protecting and expanding access to abortion through constitutional mechanisms in the Canadian legal landscape. By analyzing Canada's current degree of access, this paper will explain that abortion services for those in need are inadequate. In order to advocate for greater access, this paper examines a multitude of legal tools and doctrines to constitutionally protect access to …