Health Law and Policy Commons^™

Unconsented Educational Pelvic Exams On Anesthetized Patients: The Collapse Of Legal And Ethical Safeguards For Patient Consent, Rachel Beth Cohen

Maine Law Review

It is a troubling reality that medical students in some U.S. teaching hospitals perform pelvic examinations on anesthetized surgical patients without their explicit knowledge or consent. These unconsented educational pelvic examinations raise serious ethical and legal concerns. Although professional medical societies agree that specific and voluntary consent is a fundamental ethical prerequisite for conducting such examinations, this standard has been frequently disregarded in practice. The law offers little practical deterrence to this violation of patient autonomy. Tort law provisions on battery and informed consent are ineffective in addressing the issue, while state legislatures have largely failed, or outright refused, to …

Buyer, Beware Of Addiction, Erin E. Meyers, Clayton J. Masterman

Cardozo Law Review

Addictive products kill more than 700,000 people in the United States every year. Despite the large-scale risks that addiction poses, the law requires manufacturers of addictive products to disclose little-to-no information about the risk of addiction—the single most consequential characteristic of a class of products contributing to mass death every year.

While consumers understand that addictive products are, in fact, addictive, they generally do not understand the magnitude of the addiction risks that they face. Metaphorically, consumers understand that they are playing a game of “Russian roulette” when they consume an addictive product—but they play without knowing how many bullets …

The End(S) Of Bankruptcy Exceptionalism: Purdue Pharma And The Problem Of Social Debt, Jonathan C. Lipson, Pamela Foohey

Cardozo Law Review

The Supreme Court’s recent 5-4 decision in the controversial chapter 11 bankruptcy reorganization of opioid-maker Purdue Pharma ends the use of nonconsensual third-party “releases,” which discharge (eliminate) liabilities of nondebtors who may share liability with a corporate debtor. Although the majority opinion is correct that the Bankruptcy Code does not permit this, it failed to recognize the problematic exceptionalism of the lower courts which approved those releases or the “social” qualities of Purdue Pharma’s mass tort liability.

Bankruptcy exceptionalism has been a contested concept since it emerged over fifteen years ago and reflects a willingness to bend the rule of …

Unvaccinated By Doubt: How Covid-19 Governance Sparked A Measles Revival, Ellen Black

FIU Law Review

A measles outbreak occurred in the United States this year, with measle cases reaching the highest levels in over two decades, even though the disease had been declared eliminated in 2000. In large part, this measles resurgence can be traced to unvaccinated individuals who have chosen to disregard public health officials' vaccination guidance. Clearly, the public has lost trust in their governmental public health officials. As the next disease outbreak looms, the need for restoration of trust becomes imperative.

This article demonstrates how the government's actions during COVID-19 further led to this lack of trust, by providing conflicting guidance as …

A One-Egg Wonder: Working To Cure Judicial Gender Bias And Increase Access To Pre-Embryos For Infertile Parties, Nicole Marks Kaufman

Cardozo Law Review

The first live birth of a child conceived from in vitro fertilization (“IVF”) happened in 1978. Today, over eight million children have been born through IVF procedures. The first dispute over the resulting pre-embryos was in 1990 when the Tennessee Supreme Court outlined a balancing approach with a presumption favoring non-use of the pre-embryos for courts to follow when resolving these matters. Numerous states have taken differing approaches—some have taken a contractual approach, others an approach requiring contemporaneous mutual consent before there can be a departure from the status quo, and very few state legislatures have directly addressed how to …

Safeguarding The Pandemic Agreement From Disinformation, Alexandra Finch, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Complicating the negotiation of a global pandemic treaty has been a sustained disinformation campaign worldwide to undermine the agreement by making and amplifying spurious assertions about what it intends to accomplish and how it will do so. Central to the disinformation campaign are erroneous claims about national sovereignty and forcible takings of pandemic countermeasures. Further, legitimate and unfounded unease concern weakened intellectual property (IP) and speech rights. Having followed the negotiations and provided technical assistance to the World Health Organization's (WHO's) leadership, we set the record straight in several key areas.

Emotionally Harmed? It Might Not Matter: An Analysis Of Cummings V. Premier Rehab Keller And Its Implications For Title Ii Of The Americans With Disabilities Act Of 1990, Sotir Zhupa

Cardozo Law Review

On April 28, 2022, the U.S. Supreme Court handed down an opinion that shocked the disability rights community. In Cummings v. Premier Rehab Keller, P.L.L.C., the Court ruled that compensatory damages for emotional distress may not be recovered by claimants who sue for disability discrimination under section 504 of the Rehabilitation Act of 1973 (section 504) and section 1557 of the Patient Protection and Affordable Care Act of 2010..

Cummings involved a woman, Jane Cummings, who is both deaf and legally blind. Because of her disabilities, she communicates through American Sign Language (ASL)—her first and primary language—and cannot communicate …

Education, Employment, And Healthcare: Personal And Societal Strategies For Transitioning Servicemembers' Fiscal Sustainability, Kan Samuel

Faculty Scholarship

No abstract provided.

Dying In Isolation: Public Health Implications Of Transportation And Burial Of Human Remains During A Pandemic A Fifty State Survey, Christopher Ogolla

Faculty Scholarship

No abstract provided.

Medical-Legal Partnership As A Model For Access To Justice, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The United States is plagued with a “justice gap” that leaves many Americans with unmet civil legal needs. Americans with low income do not receive the legal help they require for as many as 92% of their substantive civil legal problems. The justice gap requires many legal aid agencies to triage, becoming “emergency rooms” for clients with unmet legal needs. This national crisis calls for new innovations so that access to justice (A2J) can function more like primary care, promoting better use of resources and preventing legal crises that can cause long-lasting harm.

Medical-Legal Partnerships (MLPs) embed lawyers in healthcare …

The Commerciality Of Non-Profit Hospitals Requires Them To Be Taxed: Bringing The Debate To A Conclusion, Edward A. Zelinsky

Articles

It is now time to conclude our prolonged debate about the tax-exempt status of nonprofit hospitals. The contemporary nonprofit hospital is a commercial enterprise, materially indistinguishable for tax purposes from its profit-making, taxed competitor. The federal income tax and the states’ income, sales and property taxes should treat all hospitals alike, regardless of whether such hospitals are nonprofit or for-profit enterprises. In the interests of equity and efficiency, these similar institutions should be taxed similarly.

As a political matter, nonprofit hospitals will continue to defend their tax-exempt status. Like any other lucrative, vested interest, nonprofit hospitals will continue to fight …

The Global Health Architecture: Governance And International Institutions To Advance Population Health Worldwide, Lawrence O. Gostin, Eric A. Friedman, Alexandra Finch

Georgetown Law Faculty Publications and Other Works

Policy Points Global health institutions and instruments should be reformed to fully incorporate the principles of good health governance: the right to health, equity, inclusive participation, transparency, accountability, and global solidarity. New legal instruments, like International Health Regulations amendments and the pandemic treaty, should be grounded in these principles of sound governance. Equity should be embedded into the prevention of, preparedness for, response to, and recovery from catastrophic health threats, within and across nations and sectors. This includes the extant model of charitable contributions for access to medical resources giving way to a new model that empowers low- and middle-income …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

Corrupt Or Charitable? Patient Assistance Programs And The Case For Narrowing The Breadth Of The Federal Anti-Kickback Statute, Isaac Strauss

Cardozo Law Review

No abstract provided.

Why A New Deal Must Address The Readability Of U.S. Consumer Contracts, Michael L. Rustad

Cardozo Law Review

United States companies are increasingly drafting consumer contracts that are complex and unreadable, thus making it difficult for many Americans to comprehend terms of use that apply to goods and services. Many U.S. companies are creating terms of use that are, in effect, rights-foreclosure schemes. Many consumer agreements cap damages at a nominal amount, disclaim all warranties, limit remedies, and impose mandatory arbitration clauses and class action waivers. U.S. courts enforce these unfair mass-market contracts with few exceptions. My proposal for a New Deal for Consumer Contracts, as described in this Article, would impose a more exacting readability standard, enforcing …

The Academic Medical-Legal Partnership: Training The Next Generation Of Health & Legal Professionals To Work Together To Advance Health Justice, Vicki W. Girard, Deborah F. Perry, Lisa P. Kessler, Yael Cannon, Prashasti Bhatnagar, Jessica Roth

Georgetown Law Faculty Publications and Other Works

As the national medical-legal partnership (MLP) movement grows, the need for doctors, nurses, social workers, other health professionals, and lawyers who have the knowledge, skills, and experience to collaborate effectively in this holistic healthcare approach is increasing. Given the unique role that institutions of higher education play in training students as they develop their professional identities, members of the Georgetown University Health Justice Alliance sought to build on prior efforts to define the MLP model by focusing on MLPs that exist in academic settings as a specific type of MLP. This report is based on the results of an environmental …

United States V. Safehouse: The Future Of Supervised Consumption Sites In Maine And Beyond, Jeff P. Sherman

Maine Law Review

People who use drugs are dying at an unprecedented rate. However, many of these deaths can be prevented. When a person experiencing an opioid overdose is timely treated with naloxone and oxygen the overdose is reversed. Access to a supervised consumption site—a place where people can use pre-obtained drugs in the safety and presence of others—ensures that when a person overdoses, they receive this life-saving treatment. In response to a proposed supervised consumption site in Philadelphia, the Department of Justice sued to prevent it from opening. The government claimed that the facility, called “Safehouse,” would violate 21 U.S.C. § 856(a)(2) …

No-One Receives Psychiatric Treatment In A Squad Car, Judy A. Clausen, Joanmarie Davoli

Faculty Scholarship

No abstract provided.

Reparations For A Public Nuisance? The Effort To Compensate Survivors, Victims, And Descendants Of The Tulsa Race Massacre One Hundred Years Later, Adam Coretz

Cardozo Law Review

No abstract provided.

Patient Decision Aids Improve Patient Safety And Reduce Medical Liability Risk, Thaddeus Mason Pope

Maine Law Review

Tort-based doctrines of informed consent have utterly failed to assure that patients understand the risks, benefits, and alternatives to the healthcare they receive. Fifty years of experience with the doctrine of informed consent have shown it to be an abject catastrophe. Most patients lack an even minimal understanding of their treatment options. But there is hope. Substantial evidence shows that patient decision aids (PDAs) and shared decision making can bridge the gap between the theory and practice of informed consent. These evidence-based educational tools empower patients to make decisions with significantly more knowledge and less decisional conflict than clinician-patient discussions …

The First 2 Years Of Covid-19: Lessons To Improve Preparedness For The Next Pandemic, Jennifer B. Nuzzo, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On December 31, 2019, the World Health Organization (WHO) Country Office in China reported novel “viral pneumonias of unknown cause” in Wuhan, but China did not confirm case clusters until January 3, 2020. Two years later, more than 285 million cases and 5.4 million deaths have been reported. As of December 2021, more than 800 000 COVID-19 deaths have occurred in the US, surpassing the 675 446 total deaths that occurred during the great influenza pandemic of 1918. The COVID-19 pandemic reduced global economic growth by an estimated 3.2% in 2020, with trade declining by 5.3%; an estimated 75 million …

Beyond Data Ownership, Ignacio Cofone

Cardozo Law Review

Proposals for data ownership are widely misunderstood, aim at the wrong goal, and would be self-defeating if implemented. This Article, first, shows that data ownership proposals do not argue for the bundle of ownership rights that exists over property at common law. Instead, these proposals focus on transferring rights over personal information solely through consent.

Second, this Article shows the flaws of a property approach to personal information. Such an approach magnifies well-known problems of consent in privacy law: asymmetric information, asymmetric bargaining power, and leaving out inferred data. It also creates a fatal problem: moral hazard where corporations lack …

No Future But A Shared Future, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to …

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

Pediatric Covid-19 Vaccines: What Parents, Practitioners, And Policy Makers Need To Know, William J. Moss, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The US Food and Drug Administration (FDA) granted Emergency Use Authorization for Pfizer-BioNTech’s mRNA COVID-19 vaccine (BNT162b2) for children 5 to 11 years of age on October 29, 2021. The Centers for Disease Control and Prevention recommended use of the vaccine among children in this age group on November 2, 2021. Approximately 28 million children are now eligible for vaccination, with only those younger than 5 years remaining excluded from vaccine eligibility. The benefits of pediatric COVID-19 vaccines are clear. Vaccinations protect children, decrease spread to families and communities, and ensure educational continuity. What do parents, practitioners, and policy makers …

Twenty Years After The Anthrax Terrorist Attacks Of 2001: Lessons Learned And Unlearned For The Covid-19 Response, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The 20th anniversary of the terrorist attacks on September 11, 2001, resulted in deep national reflection. Less remembered are the events that began to unfold 7 days later as anonymous letters laced with deadly anthrax (Bacillus anthracis) spores began arriving at postal facilities, media companies, and congressional offices. The first death from inhaled anthrax exposure occurred on October 5, with an additional 4 deaths and 17 infections over the ensuing months.

The anthrax attacks exposed a health system ill-equipped to respond to acute emergencies. This article explores the lessons learned, and unlearned, from the anthrax attacks, through to …

Covid-19 Vaccine Mandates—A Wider Freedom, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

President Biden has required COVID-19 vaccinations across much of the US workforce, reaching nearly 100 million workers. Opponents call it unconstitutional, a violation of personal freedom, and even “un-American.” The truth is that vaccine mandates are lawful and deeply entrenched in US history and values. They constitute a “wider freedom” so that everyone in society can feel safer where they work, learn, worship, and live.

Introductory Essay For The Issue Devoted To The Appointment Of Amy Coney Barrett To The U.S. Supreme Court, David Rudenstine

Cardozo Law Review

No abstract provided.

Suffering Uncompounded: Civilizing Healthcare Standards For Gender Dysphoric Prisoners, Julian S. Cohen

Cardozo Law Review

No abstract provided.

The Supreme Court, The Texas Abortion Law (Sb8), And The Beginning Of The End Of Roe V Wade?, I. Glenn Cohen, Eli Y. Adashi, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Thirteen states have enacted so-called “fetal heartbeat” laws banning abortions once embryotic cardiac activity can be detected. Courts have enjoined their enforcement as unconstitutional. However, on September 1, 2021, the Supreme Court declined to block a Texas fetal heartbeat law, which virtually eliminates access to abortion services. Texas Governor Greg Abbott signed SB8 into law on May 19th, with an effective date of September 1st. The law essentially prohibits abortion after 6 weeks of gestational age, before most women know they are pregnant.

Texas’ fetal heartbeat law has a unique feature. It empowers private individuals to bring civil lawsuits not …