Law Commons^™

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 …

Furthering The Fiduciary Metaphor: The Duty Of Providers To The Payers Of Medicare, Isaac ("Zack") D. Buck

Scholarly Works

Five years and two near-death experiences later, the Patient Protection and Affordable Care Act of 2010 (ACA) has restructured the delivery of American health care. It has provided coverage to millions of Americans who previously did not have it, outlawed discrimination in the insurance marketplace, and armed the patient with consumer-based tools to streamline their care. Its positive impact is being seen throughout the country. But it can only go so far. Separate from the goal of providing access, the most daunting challenge facing American health care, and particularly, Medicare, is controlling expenditures and utilization in an era of unprecedented …

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 …

Disrupting The Path From Childhood Trauma To Juvenile Justice: An Upstream Health And Justice Approach, Yael Cannon, Andrew Hsi

Georgetown Law Faculty Publications and Other Works

A groundbreaking public health study funded by the U.S. Centers for Disease Control and Prevention (CDC) and the Kaiser Foundation found astoundingly high rates of childhood trauma, including experiences like abuse, neglect, parental substance abuse, mental illness, and incarceration. Hundreds of follow-up studies have revealed that multiple traumatic adverse childhood experiences (or “ACEs”) make it far more likely that a person will have poor mental health outcomes in adulthood, such as higher rates of depression, anxiety, suicide attempts, and substance abuse. Interestingly, the original ACE Study examined a largely middle-class adult population living in San Diego, but subsequent follow-up studies …

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, …

Overtreatment And Informed Consent: A Fraud-Based Solution To Unwanted And Unnecessary Care, Isaac ("Zack") D. Buck

Scholarly Works

According to multiple accounts, the administration of American health care results in as much as $800 billion in wasted spending due largely to the provision of overly expensive, inefficient, and unnecessary services. Beyond inflicting fiscal pain on the nation’s pocketbook, this waste has no clinical benefit — and often results in unnecessary hospital stays, cascading follow-up procedures, and time-wasting inconvenience for American patients. But aside from the mere annoyance of unnecessary care, the administration of overtreatment — that is, unnecessary care in and of itself — causes harm to the patient. Excessive care is deficient care. Unnecessary care risks potential …

What Is (And Isn't) Healthism, Jessica L. Roberts, Elizabeth Weeks Leonard

Scholarly Works

What does it mean to discriminate on the basis of health status? Health is, of course, relevant in a number of ways. It can speak to the length of our lives, our ability to perform mentally and physically, our need for health care, and our risk of injury and incapacity. But the mere relevance of a particular attribute does mean that considering it should be legally permissible. Moreover, the potential harms that may result from health-status discrimination raise important moral questions. This Essay explores when differentiating on the basis of health is socially acceptable and, by contrast, when it is …

Adverse Childhood Experiences In The New Mexico Juvenile Justice Population, Yael Cannon, George Davis, Andrew Hsi, Alexandra Bochte

Georgetown Law Faculty Publications and Other Works

Faculty from the University of New Mexico (UNM) School of Law and the UNM School of Medicine, and New Mexico’s Children, Youth and Families Department (CYFD) initiated a joint project to look at the prevalence of Adverse Childhood Experiences (ACEs) nationally and in New Mexico. The study was intended to better establish the association between early childhood trauma and delinquency, as well as to explore the role that law and medicine can play in ensuring better health and juvenile justice outcomes for children who have experienced ACEs.

From Patient Rights To Health Justice, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

Models emphasizing professional autonomy, patient rights, market power, and health consumerism are no longer adequate to address the increasingly social, collective nature of health law institutions, instruments, and norms. What is needed is a new model that expressly recognizes the public-alongside the patient, the provider, and the payer-as an important stakeholder and active participant in decisions about medical treatment, health care coverage, and allocation of scarce resources. In a previous article, the author looked to the environmental justice, reproductive justice, and food justice movements for inspiration in developing a "health justice" approach to eliminating social disparities in health. This Article …

Gambling Disorder, Vulnerability, And The Law: Mapping The Field, Stacey A. Tovino

Scholarly Works

This Article seeks to descriptively map the sub-field of gambling disorder and the law and ask whether individuals with gambling disorder are vulnerable under the law. Like other scholarship that descriptively maps ethical, legal, and social implications of lesser known conditions and developments, this Article seeks to describe the treatment of individuals with gambling disorder in a variety of illustrative, but not exhaustive, legal contexts, to identify the limited scholarship assessing the application of the law to individuals with gambling disorder, and to invite members of the health law academy to bring their significant expertise to bear on these issues …

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 …

Instrumental And Transformative Medical Technology, Nicole Huberfeld

Law Faculty Scholarly Articles

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (ACA), 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 care; in …

Reimagining The Risk Of Long-Term Care, Allison K. Hoffman

All Faculty Scholarship

U.S. law and policy on long-term care fail to address the insecurity American families face due to prolonged illness and disability — a problem that grows more serious as the population ages and rates of disability rise. This Article argues that, even worse, we have focused on only part of the problem. It illuminates two ways that prolonged disability or illness can create insecurity. The first arises from the risk of becoming disabled or sick and needing long-term care, which could be called “care-recipient” risk. The second arises out of the risk of becoming responsible for someone else’s care, which …