Health Law and Policy Commons^™

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), …

Can They Do That?: The Limits Of Governmental Power Over Medical Treatment, Paul Mclaughlin

Scholarly Works

No abstract provided.

Side Effects Of The Abortion Wars, Maya Manian

Scholarly Articles in Law Reviews & Journals

Over the last several decades, as part of the movement against abortion rights, abortion has become increasingly stigmatized and isolated in women's health. The current segregation of abortion from the rest of women's medical needs brings us full circle back to questions raised by Roe v. Wade. Although Roe was rightly criticized as over-medicalizing the abortion decision and empowering doctors rather than women, we have now shifted to the opposite extreme of severing abortion completely from the realm of women's health. While it remains important to understand abortion access as necessary to sustaining women's right to equal citizenship, the public's …

Trial And Error: Legislating Adr For Medical Malpractice Reform, Lydia Nussbaum

Scholarly Works

The U.S. healthcare system has a problem: hundreds of thousands of people die each year, and over a million are injured, by medical mistakes that could have been avoided. Furthermore, over ninety percent of these patients and their families never learn of the errors or receive redress. This problem persists, despite myriad reforms to the medical malpractice system, because of lawmakers' dominant focus on reducing providers' liability insurance costs. Reform objectives are beginning to change, however, and the vehicle for implementing these changes is alternative dispute resolution ("ADR"). Historically, legislatures deployed ADR to curb malpractice litigation and restrict patients' access …

On Health, Law, And Religion, Stacey A. Tovino

Faculty Articles

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman's Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court's recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a wide …

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. …

Why Some Religious Accommodations For Mandatory Vaccinations Violate The Establishment Clause, Hillel Y. Levin

Scholarly Works

All states require parents to inoculate their children against deadly diseases prior to enrolling them in public schools, but the vast majority of states also allow parents to opt out on religious grounds. This religious accommodation imposes potentially grave costs on the children of non-vaccinating parents and on those who cannot be immunized. The Establishment Clause prohibits religious accommodations that impose such costs on third parties in some cases, but not in all. This presents a difficult line-drawing problem. The Supreme Court has offered little guidance, and scholars are divided.

This Article addresses the problem of religious accommodations that impose …

A Mental Health Checkup For Children At The Doctor’S Office: Lessons From The Medical-Legal Partnership Movement To Fulfill Medicaid’S Promise, Yael Cannon

Georgetown Law Faculty Publications and Other Works

Traumatic childhood events and the stress they cause can negatively affect health over a lifetime. For children with Medicaid coverage, visits to the doctor’s office present an opportunity to improve this trajectory. Medicaid’s Early Periodic Screening Diagnostic and Treatment (EPSDT) mandate requires that children receive more than a basic physical when they see a doctor for regular “well-child checks.” As part of a comprehensive look at their development, they should receive mental health check-ups that could identify childhood trauma, its impacts, and the interventions that could help improve health and mental health. Data suggests that many children do not receive …

Redefining Medical Care, Lauren R. Roth

Scholarly Works

President Donald J. Trump has said he will replace the Affordable Care Act (ACA) with health savings accounts (HSAs). Conservatives have long preferred individual accounts to meet social welfare needs instead of more traditional entitlement programs. The types of “medical care” that can be reimbursed through an HSA are listed in § 213(d) of the Internal Revenue Code (Code) and include expenses “for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.”

In spite of the broad language, regulations and court interpretations have narrowed this definition substantially. …

Reproductive Selection Bias, Lauren R. Roth

Scholarly Works

Decades after the advent of assisted reproductive technology (ART) that allows prospective parents to deselect embryos with grave genetic illnesses – a procedure called preimplantation genetic diagnosis (PGD) – it remains a tool largely of upper class whites. In the wake of the Supreme Court’s decision in Whole Woman’s Health v. Hellerstedt, I argue that the time has come to focus on access in this area of reproductive rights. The next logical step is to rebut the presumption that reproductive liberty is only a negative right that prevents government interference with decisions about whether and how to procreate or not …

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 …

Corporate Power Unbound: Investorstate Arbitration Of Ip Monopolies On Medicines—Eli Lilly V. Canada And The Trans-Pacific Partnership Agreement, Brook K. Baker, Katrina Geddes

Journal of Intellectual Property Law

No abstract provided.

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

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, …

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 …

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 …

Classification Standards For Health Information: Ethical And Practical Approaches, Craig Konnoth

Washington and Lee Law Review Online

Secondary health information research requires vast quantities of data in order to make clinical and health delivery breakthroughs. Restrictive policies that limit the use of such information threaten to stymie this research. While the Notice of Proposed Rulemaking (NPRM) for the new Common Rule permits patients to provide broad consent for the use of their information for research, that policy offers insufficient flexibility. This Article suggests a flexible consenting system that allows patients to consent to a range of privacy risks. The details of the system will be fleshed out in future work.

Selected Issues Concerning The Ethical Use Of Big Data Health Analytics, Lieke Jetten, Stephen Sharon

Washington and Lee Law Review Online

No abstract provided.

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.

The Legal And Medical Ethical Entanglements Of Infant Male Circumcision And International Law, Paul Mclaughlin

Scholarly Works

The practice of infant male circumcision has been debated by legal and medical experts for years. The practice, once seen as a social norm, has come under opposition by children’s rights, legal, and medical organisations around the world. In order to meet the requirements of international treaty law and allow infant male children the fullest opportunity for self determination, infant male circumcision must be treated under the law and by medical practitioners with the same degree of opposition that female genital mutilation has received.

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 …

Wage Theft As Public Larceny, Elizabeth J. Kennedy

Brooklyn Law Review

Home care for the elderly and disabled is a rapidly expanding industry in which structural and regulatory factors contribute to worker vulnerability and exploitation. Systemic exclusion from core federal employment and labor laws, as well as many state and local regulations, results in minimal consequences for employers who violate standards. Despite recent movement at the federal level to create a “new mindset” of rights and regulations, home care workers must be equipped with creative ways to enforce these new rights and to challenge existing gaps in enforcement. With the understanding that two-thirds of the home care industry is financed by …

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, Christine Årdal, Kevin Outterson, 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 …

Health Information Ownership: Legal Theories And Policy Implications, Lara Cartwright Smith, Elizabeth Gray, Jane H. Thorpe

Vanderbilt Journal of Entertainment & Technology Law

This Article explores the nature and characteristics of health information that make it subject to federal and state laws and the existing legal framework that confers rights and responsibilities with respect to health information. There are numerous legal and policy considerations surrounding the question of who owns health information, including whether and how to confer specific ownership rights to health information. Ultimately, a legal framework is needed that reflects the rights of a broad group of stakeholders in the health information marketplace, from patients to providers to payers, as well as the public's interest in appropriate sharing of health information.

From Patient Rights To Health Justice, Lindsay Wiley

Scholarly Articles in Law Reviews & 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 …

On Health Status, Choice, And Immunity, Elizabeth Weeks Leonard

Popular Media

This article by Professor Elizabeth Weeks Leonard in JOTWELL on July 22, 2015, discusses discrimination on health status.

Remarks: Neuroscience, Gender, And The Law, Stacey A. Tovino Jd, Phd

Akron Law Review

n my recent research, I have been exploring the legal impact of advances in the neuroscience of gender, such as whether and how stakeholders are using recent studies finding structural and functional differences between male and female brains in an attempt to influence the law. I also have been examining whether and how stakeholders are using the neuroscience of both gender-specific and gender-prevalent health conditions to influence the interpretation of civil and regulatory health law. Today, I am going to explore how stakeholders are using advances in the neuroscience of three gender-specific and genderprevalent conditions (the postpartum mood disorders, premenstrual …