Digital Commons Network^™

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 …

Minding Ps And Qs: The Political And Policy Questions Framing Health Care Spending, William M. Sage

Faculty Scholarship

Tracing the evolution of political conversations about health care spending and their relationship to the formation of policy is a valuable exercise. Health care spending is about science and ethics, markets and government, freedom and community. By the late 1980s the unique upward trajectory of post-Medicare U.S. health care spending had been established, recessions and tax cuts were eroding federal and state budgets, and efforts to harness market forces to serve policy goals were accelerating. From the initial writings on “managed competition,” through the failed Clinton health reform effort in the early 1990s, to the passage of the Affordable Care …

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 …

Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma E. Marouf

Faculty Scholarship

In the Affordable Care Act (“ACA”), passed in 2010, Congress provided that only “lawfully present” individuals could obtain insurance through the Marketplaces established under the Act. Congress left it to the Department of Health and Human Services (“HHS”) to define who is “lawfully present.” Initially, HHS included all individuals with deferred action status, which is an authorized period of stay but not a legal status. After President Obama announced a new policy of Deferred Action for Childhood Arrivals (“DACA”) in June 2012, however, HHS amended its regulation specifically to exclude DACA recipients from the definition of “lawfully present.” The revised …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …

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 …

Vaccines And Airline Travel: A Federal Role To Protect The Public Health, Christopher Robertson

Faculty Scholarship

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority — especially under the Commerce Clause — to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could …

Ebola And Human Rights: Post-9/11 Public Health And Safety In Epidemics, George J. Annas

Faculty Scholarship

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism …

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, …

Assembled Products: The Key To More Effective Competition And Antitrust Oversight In Health Care, William M. Sage

Faculty Scholarship

This Article argues that recent calls for antitrust enforcement to protect health insurers from hospital and physician consolidation are incomplete. The principal obstacle to effective competition in health care is not that one or the other party has too much bargaining power, but that they have been buying and selling the wrong things. Vigorous antitrust enforcement will benefit health care consumers only if it accounts for the competitive distortions caused by the sector’s long history of government regulation. Because of regulation, what pass for products in health care are typically small process steps and isolated components that can be assigned …

Regulating Employment-Based Anything, Brendan S. Maher

Faculty Scholarship

Benefit regulation has been called “the most consequential subject to which no one pays enough attention.” It exhausts judges, intimidates legislators, and scares off theorists. That need not be so. Reality is less complicated than advertised.

Governments often consider intervention if markets fail to make some socially desirable Good X — such as education, health care, home mortgages, or pensions, for example — sufficiently available. One obvious fix is for the government to provide the good itself. A less obvious intervention is for the government to regulate employment-based (EB) arrangements that provide Good X as a benefit to employees and …

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

An International Legal Framework To Address Antimicrobial Resistance, Kevin Outterson, Steven J. Hoffman, John-Arne Rottingen, Otto Cars, Charles Clift, Fiona Rotberg, Göran Tomson, Anna Zorzet, Zain Rizvi

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Health Care And The Myth Of Self-Reliance, Nicole Huberfeld

Faculty Scholarship

Both pillars of the Affordable Care Act that are designed to facilitate universal coverage — the low-income tax subsidy and Medicaid expansion — have been subject to high-profile Supreme Court cases. While in King v. Burwell the Court saved the ACA’s low-income subsidy, in NFIB v. Sebelius the Court frustrated Medicaid expansion, at least temporarily. We argue that there is a deeper story about health care access for the poor. Drawing from the history of the American health care system, vulnerability theory, and demographic data, we demonstrate that all Americans lead subsidized lives and could find themselves quickly moving from …

Avoiding Overtreatment At The End Of Life: Physician-Patient Communication And Truly Informed Consent, Barbara A. Noah, Neal R. Feigenson

Faculty Scholarship

This Article considers how best to ensure that patients have the tools to make informed choices about their care as they near death. Informed decision making can help reduce excessive end-of-life care and unnecessary suffering, and result in care that aligns with patients’ well-considered values and preferences. The many factors that contribute to dying patients receiving too much therapy and life-prolonging care include: the culture of denial of death, physicians’ professional culture and attitudes toward treatment, physicians’ fear of liability, physicians’ avoidance of discussions about prognosis, and the impact of payment incentives that encourage overutilization of medical technologies.

Under the …

Stopping Deceptive Health Claims: The Need For A Private Right Of Action Under Federal Law, Diane Hoffmann, Jack Schwartz

Faculty Scholarship

This is the accepted version of the article. The final published version is available at

https://journals.sagepub.com/doi/abs/10.1177/0098858816644715

Contract Development In A Matching Market: The Case Of Kidney Exchange, Kimberly D. Krawiec, Wenhao Liu, Marc L. Melcher

Faculty Scholarship

We analyze a new transplant innovation — Advanced Donation, referred to by some as a kidney “gift certificate,” “layaway plan,” or “voucher — as a case study offering insights on both market and contract development. Advanced Donation provides an unusual window into the evolution of the exchange of a single good — a kidney for transplantation — from gift, to simple barter, to exchange with a temporal separation of obligations that relies solely on trust and reputational constraints for enforcement, to a complex matching market in which the parties rely, at least in part, on formal contract to define and …

Does Medical Malpractice Law Improve Health Care Quality?, Michael D. Frakes, Anupam B. Jena

Faculty Scholarship

Despite the fundamental role of deterrence in justifying a system of medical malpractice law, surprisingly little evidence has been put forth to date bearing on the relationship between medical liability forces on the one hand and medical errors and health care quality on the other. In this paper, we estimate this relationship using clinically validated measures of health care treatment quality constructed using data from the 1979 to 2005 National Hospital Discharge Surveys and the 1987 to 2008 Behavioral Risk Factor Surveillance System records. Drawing upon traditional, remedy-centric tort reforms — e.g., damage caps — we estimate that the current …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Law In The Shadow Of Violence: Can Law Help To Improve Doctor-Patient Trust In China?, Benjamin L. Liebman

Faculty Scholarship

Can law help to address the lack of trust in doctor-patient relationships in China? This essay examines the role that law, on the books and in practice, has played in the rise and resolution of patient-doctor disputes and conflict in China. Law has generally played a secondary role in medical disputes: most patient claims never make it to court, and there is little evidence that negotiated outcomes are influenced by legal standards. Yet a legal framework weighted in favor of hospitals and doctors almost certainly exacerbated doctor-patient conflict in the 2000s. Patients facing legal procedures and rules that appeared to …

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …

Progress In The Fight Against Multidrug Resistant Bacteria?: A Review Of Fda-Approved Antibiotics 2010-2015, Kevin Outterson

Faculty Scholarship

A weak antibiotic pipeline and the increase in drug-resistant pathogens have led to calls for more new antibiotics. Eight new antibiotics were approved by the U.S. Food and Drug Administration (FDA) between January 2010 and December 2015: ceftaroline, fidaxomicin, bedaquiline, dalbavancin, tedizolid, oritavancin, ceftolozane-tazobactam, and ceftazidime-avibactam. This study evaluates the development course and pivotal trials of these antibiotics for their innovativeness, development process, documented patient outcomes, and cost. Data sources were FDA approval packages and databases (January 2010 to December 2015); the Red Book (Truven Health Analytics); Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA); and supplementary information …

International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Kevin Outterson, Christine Årdal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen

Faculty Scholarship

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms …

Beyond Lifestyle: Governing The Social Determinants Of Health, Wendy K. Mariner

Faculty Scholarship

Non-communicable and chronic diseases have overtaken infectious diseases as the major causes of death and disability around the world. Despite recognition that reduction in the chronic disease burden will require governance systems to address the social determinants of health, most public health recommendations emphasize individual behavior as the primary cause of illness and the target of intervention. This Article argues that focusing on lifestyle can backfire, by increasing health inequities and inviting human rights violations. If States fail to take meaningful steps to alter the social and economic structures that create health risks and encourage unhealthy behavior, health at the …

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Introduction To Thinking About A Post-Aca World: Litigation, Cost Shifting And Enforcement Of Statutory Rights, Maria O'Brien

Faculty Scholarship

At its annual gathering in 2016, members of the Employee Benefits and Executive Compensation and Law, Medicine and Healthcare Sections of the Association of American Law Schools (AALS) jointly sponsored a discussion of the future of the Affordable Care Act (ACA) following the Supreme Court's decision in King v. Burwell.' What follows are the papers generated for the panel discussion. The panelists² were asked to evaluate the future of the ACA from a distinct perspective.

Instrumental And Transformative Medical Technologies, Nicole Huberfeld

Faculty Scholarship

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (A CA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health …

Criminal Laws On Sex Work And Hiv Transmission: Mapping The Laws, Considering The Consequence, Aziza Ahmed, Sienna Baskin, Anna Forbes

Faculty Scholarship

Lawmakers historically justify the mobilization of criminal laws on prostitution and HIV as a means of controlling the spread of disease. Over time, however, public health research has conclusively demonstrated that criminal laws on prostitution and HIV significantly impede the ability of sex workers to access services and to live without the stigma and blame associated with being a transmitter of HIV. In turn, mainstream public health approaches to sex work and HIV emphasize decriminalization as a way to improve the lives of sex workers in need of care, treatment, and services. Our current legal system, which criminalizes both prostitution …

Hiv/Aids Care And Prevention Infrastructure In The U.S. Deep South, Susan S. Reif, Kristen Sullivan, Elena Wilson, Miriam Berger, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.