Law Commons^™

Brief For Amici Curiae Legal Scholars Supporting Respondent, Nicole Huberfeld, Timothy S. Jost, Linda C. Mcclain, Wendy E. Parmet, Erwin Chemerinsky, Elizabeth Mccuskey, Danielle Pelfrey Duryea, Gabriel Scheffler, George J. Annas

Faculty Scholarship

QUESTION PRESENTED: Whether the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, preempts Idaho law in the narrow but important circumstance where terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health but the State prohibits an emergency-room physician from providing that care.

Human Rights In Hospitals: An End To Routine Shackling, Neil Singh Bedi, Nisha Mathur, Judy D. Wang, Avital Rech, Nancy Gaden, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Medical students (NSB, NM, JDW) spearheaded revision of the policy and clinical practice for shackling incarcerated patients at Boston Medical Center (BMC), the largest safety net hospital in New England. In American hospitals, routine shackling of incarcerated patients with metal restraints is widespread—except for perinatal patients—regardless of consciousness, mobility, illness severity, or age. The modified policy includes individualized assessments and allows incarcerated patients to be unshackled if they meet defined criteria. The students also formed the Stop Shackling Patients Coalition (SSP Coalition) of clinicians, public health practitioners, human rights advocates, and community members determined to humanize the inpatient treatment of …

Global Pull Incentives For Better Antibacterials: The Uk Leads The Way, Kevin Outterson, John Rex

Faculty Scholarship

The article from Leonard and the team from the National Institute for Health and Care Excellence, NHS England, and NHS Improvement [1] asks the question whether the UK subscription program can restore the antibacterial pipeline, with an insiders’ description of the process and strategy that led to implementation (briefly, a ‘pull incentive’ of reimbursement for new antibacterials that is delinked from volume of sales with payments based on the added value to the whole health and social care system).

Governments [2,3,4,5,6,7,8,9], academics …

Why Money Is Well Spent On Time, Michael Ulrich

Faculty Scholarship

There are a few reasons why incentivizing clinicians to spend more time with patients can improve health outcomes. Doing so affords clinicians time to assess social determinants’ influences on their patients’ health experiences; offers opportunities to identify and respond to patients’ loneliness; and helps motivate patients’ trust in health care, strengthen patient-clinician relationships, and bolster patients’ adherence to clinicians’ recommendations.

Can Moral Framing Drive Insurance Enrollment In The Us?, Christopher Robertson, Wendy Netter Epstein, David Yokum, Hansoo Ko, Kevin Wilson, Monica Ramos, Katherine Kettering, Margaret Houtz

Faculty Scholarship

To encourage health insurance uptake, marketers and policymakers have focused on consumers’ economic self-interest, attempting to show that insurance is a good deal or to sweeten the deal, with subsidies or penalties. Still, some consumers see insurance as a bad deal, either because they rationally exploit private risk information (“adverse selection”), or irrationally misperceive the value due to cognitive biases (e.g., optimism). As a result, about 30 million Americans remain uninsured, including many who could afford it.

At the same time, polling suggests that Americans view health insurance through a moral lens, seeking to protect those with pre-existing conditions especially. …

Addressing Stigma And False Beliefs About Mental Health: A New Direction For Mental Health Parity Advocacy, Claire Sontheimer, Michael Ulrich

Faculty Scholarship

Despite laws designed to protect mental health and substance use parity in the United States, real parity remains an aspiration. Under the current system, insurance companies use multiple tactics to deny coverage for or delay the provision of mental health and substance use disorder (MH/SUD) treatment. The difficulty of enforcing parity creates a barrier to achieving the goal of accessible behavioral health services. Rather than a continued effort to legislate our way out of this conundrum, it may be useful to look further upstream. Critical impediments to achieving such parity include the basic attitudes and beliefs about mental and behavioral …

What The Harm Principle Says About Vaccination And Healthcare Rationing, Christopher Robertson

Faculty Scholarship

Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated …

E-Racing Tobacco & Nicotine-Related Health Disparities, Michael Ulrich

Faculty Scholarship

In the past, tobacco companies used targeted advertising to integrate menthol cigarettes and addict the Black community, generating tobacco-related health disparities. As Juul has come under attack, they have utilized the tobacco playbook to protect itself and deflect criticism by donating to a historically Black medical school and recruiting leaders in the Black community. This helped to create a "Black shield" for menthol cigarettes, which are only now at risk of being regulated, and has the potential to do the same in the vape industry. If proactive steps are not undertaken, health tobacco-related health disparities will continue.

A Code Of Ethics For Gene Drive Research, George J. Annas, Chase L. Beisel, Kendell Clement, Andrea Crisanti, Stacy Francis, Marco Galardini, Roberto Galizi, Julian Grunewald, Greta Immobile, Ahmad S. Khalil, Ruth Muller, Vikram Pattanayak, Karl Petri, Ligi Paul, Luca Pinello, Alekos Simoni, Chrysanthi Taxiarchi, J. Keith Joung

Faculty Scholarship

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species. At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery. A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest …

Paying For Unapproved Medical Products, Kelly Mcbride Folkers, Alison Bateman-House, Christopher Robertson

Faculty Scholarship

This symposium article examines the use of investigational (un-approved) medical products in the United States, with particular focus on who pays for this use. In the United States, the question of who pays for the use of approved medical products for their intended indications is complicated enough, with some expenses borne by private payers, some by public payers, some covered as charity care, and some paid out of pocket by patients. A separate question is off-label use, in which an approved medical product is used for an unapproved indication. In this article, we focus on a narrower issue: what entities …

Setting The Standard: Multidisciplinary Hallmarks For Structural, Equitable And Tracked Antibiotic Policy, Kevin Outterson, Claas Kirchhelle, Paul Atkinson, Alex Broom, Komatra Chuengsatiansup, Jorge Pinto Ferreira, Nicolas Fortané, Isabel Frost, Christoph Gradmann, Stephen Hinchliffe, Steven J. Hoffman, Javier Lezaun, Susan Nayiga, Scott H. Podolsky, Stephanie Raymond, Adam P. Roberts, Andrew C. Singer, Anthony D. So, Luechai Sringernyuang, Elizabeth Tayler, Susan Rogers Van Katwyk, Clare I. R. Chandler

Faculty Scholarship

There is increasing concern globally about the enormity of the threats posed by antimicrobial resistance (AMR) to human, animal, plant and environmental health. A proliferation of international, national and institutional reports on the problems posed by AMR and the need for antibiotic stewardship have galvanised attention on the global stage. However, the AMR community increasingly laments a lack of action, often identified as an ‘implementation gap’. At a policy level, the design of internationally salient solutions that are able to address AMR’s interconnected biological and social (historical, political, economic and cultural) dimensions is not straightforward. This multidisciplinary paper responds by …

Floating Lungs: Forensic Science In Self-Induced Abortion Prosecutions, Aziza Ahmed

Faculty Scholarship

Pregnancy that ends in stillbirth or late miscarriage—particularly where a person gives birth outside of a hospital—raises the specter of criminal behavior. To successfully prosecute a person for the death of a child, however, requires proving that the child was born alive. Prosecutors mobilize forensic science as an objective way to determine life. This Essay focuses on one such forensic method: the hydrostatic lung test (“HLT”), also known as the floating lung test (“FLT”). Although there are debates about the “correct” way to perform the exam, in essence, the test requires that a forensic scientist take pieces of the lung …

Pedagogy And Policy: A Tribute To Karen Rothenberg’S Contributions To Health Law, Michael Ulrich

Faculty Scholarship

Professor Karen Rothenberg has had a significant influence on my life, impacting my education, my career, and the way I think. Professor Rothenberg has been a pillar in the health law community, but perhaps her most lasting impact for myself was creating the health law program at the University of Maryland, Francis King Carey School of Law. This nationally recognized program grew from her passion, expertise, and recognition of the importance of health, and is the reason I chose to attend the University of Maryland. The curriculum, faculty, and experience made it one of the best decisions of my life …

Is Tort Law The Tool For Fixing Reproductive Wrongs?, Christopher Robertson

Faculty Scholarship

In his 2019 book, Birth Rights and Wrongs: How Medicine and Technology are Remaking Reproduction and the Law, Dov Fox offers a compelling argument for new torts allowing recovery for wrongful reproduction. These torts would include three sorts of cases, those where wrongdoing (whether negligent, reckless, or intentional) caused undesired reproduction; stymied desired reproduction; or confounded reproduction, causing birth of a child different than that intended by the parents. The likely defendants in these torts are gynecologists, urologists, sperm banks, and IVF clinics.

Federalism, Erisa, And State Single-Payer Health Care, Erin C. Fuse Brown, Elizabeth Mccuskey

Faculty Scholarship

While federal health reform sputters, states have begun to pursue their own transformative strategies for achieving universal coverage, the most ambitious of which are state-based single-payer plans. Since the passage of the Affordable Care Act in 2010, legislators in twenty-one states have proposed sixty-six unique bills to establish single-payer health care systems. This paper systematically surveys those state legislative efforts and exposes the federalism trap that threatens to derail them: ERISA's preemption of state regulation relating to employer-sponsored health insurance. ERISA's expansive preemption provision creates a narrow, risky path for state regulation to capture the employer health care expenditures crucial …

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

Us Military Medical Ethics In The War On Terror, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Military medical ethics has been challenged by the post-11 September 2001 ‘War on Terror’. Two recurrent questions are whether military physicians are officers first or physicians first, and whether military physicians need a separate code of ethics. In this article, we focus on how the War on Terror has affected the way we have addressed these questions since 2001. Two examples frame this discussion: the use of military physicians to force-feed hunger strikers held in Guantanamo Bay prison camp, and the uncertain fate of the Department of Defense’s report on ‘Ethical Guidelines and Practices for US Military …

Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson

Faculty Scholarship

Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …

Rural Health, Universality, And Legislative Targeting, Nicole Huberfeld

Faculty Scholarship

Health disparities are persistent and worsening for rural communities, which have smaller patient populations with higher rates of uninsurance and greater incidence of the diseases and deaths of despair. Hospital closures and provider shortages are more common than in urban areas, also contributing to worsening population health and crises in maternal and infant health. This paper posits that these disparities are tied to the unique rural features of space and population. Efforts to address persistent problems in health care through universal legislation, such as the ACA, have given rural communities important tools to address some long-standing health problems by improving …

Race And Assisted Reproduction: Implications For Population Health, Aziza Ahmed

Faculty Scholarship

This Article emerges from Fordham Law Review's Symposium on the fiftieth anniversary of Loving v. Virginia,¹ the case that found antimiscegenation laws unconstitutional. ² Inspired by the need to interrogate the regulation of race in the context of family, this Article examines the diffuse regulatory environment around assisted reproductive technology (ART) that shapes procreative decisions and the inequalities that these decisions may engender. ³ ART both centers biology and raises questions about how we imagine our racial futures in the context of family, community, and nation. ⁴ Importantly, ART demonstrates how both the state and private actors shape family …

On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey

Faculty Scholarship

This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

Informed Consent: Charade Or Choice, George J. Annas

Faculty Scholarship

The physicians of ancient Greece valued conversation with their patients. Conversation, however, did not apply to slaves, whose minds and opinions did not matter. More than 2000 years later, slavery has been abolished and the law has joined ethics in setting standards for the doctor-patient relationship. The most important doctrine, in both medical ethics and health law, is the doctrine of informed consent (better termed "informed choice"), including its corollary, the right to refuse treatment. Today this doctrine is under attack. The attack is direct from business models that see genuine doctor-patient conversations as inefficient (and a waste of time), …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Abortion In A Post-Truth Moment: A Response To Erwin Chemerinsky And Michele Goodwin, Aziza Ahmed

Faculty Scholarship

In Abortion: A Woman’s Private Choice, Erwin Chemerinsky and Michele Goodwin respond to the crisis of abortion rights in our current political moment. While preserving the right to abortion is an ongoing challenge for reproductive-justice advocates and lawyers, the arrival of a new Republican administration led by Donald Trump and a Republican majority in the House and Senate heightens these concerns. In the face of ongoing and new threats to abortion access, Chemerinsky and Goodwin argue that abortion should be treated as a woman’s private choice. I agree with Chemerinsky and Goodwin, as all supporters of abortion rights should. …

Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim

Faculty Scholarship

In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …