Law Commons^™

Designing And Developing A Medical-Legal Partnership To Address Cancer Patients' Health-Harming Legal Needs, Allison B. Dowling, Vicki W. Girard, Megan E. Gordon, Abigail Sweeney, Christopher M. Gallagher, Amy D. Ly, Lisa Kessler, Deborah F. Perry

Georgetown Law Faculty Publications and Other Works

The Georgetown University's Cancer Legal Assistance and Well-being Project launched in 2020 as a medical-legal partnership that works with health care providers at a Washington, D.C. safety-net hospital to treat the health-harming legal needs of historically and intentionally marginalized patients with cancer.

Hatch-Waxman’S Renegades, John R. Thomas

Georgetown Law Faculty Publications and Other Works

No intellectual property rights impact society more forcefully than patents on pharmaceuticals. But as a practical matter, only a handful of jurists resolve disputes involving them. Two neighboring federal districts, Delaware and New Jersey, adjudicate the vast majority of patent contests between brand-name drug companies and generic manufacturers. And in contrast to Eastern Texas, which has been persistently derided as a renegade jurisdiction, the authority of the mid-Atlantic courts has seldom been questioned. The complex workings of the Hatch-Waxman Act, the compromise legislation that governs pharmaceutical patent litigation, go a long way to explaining such distinct shareholder reactions to highly …

Leveraging Academic-Medical Legal Partnerships To Advance Health Justice, Vicki W. Girard, Yael Cannon, Deborah F. Perry, Eileen S. Moore

Georgetown Law Faculty Publications and Other Works

Unmet legal needs contribute to housing, income, and food insecurity, along with other conditions that harm health and drive health inequity. Addressing health injustice requires new tools for the next generations of lawyers, doctors, and other healthcare professionals. An interprofessional group of co-authors argue that law and medical schools and other university partners should develop and cultivate Academic Medical-Legal Partnerships (A-MLPs), which are uniquely positioned to leverage service, education, and research resources, to advance health justice.

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

The Stellenbosch Consensus On Legal National Responses To Public Health Risks: Clarifying Article 43 Of The International Health Regulations, Roojin Habibi, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Margherita Cinà, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to global health emergencies such as the ongoing COVID-19 pandemic. Countries are permitted to exercise their sovereignty in taking additional health measures to respond to such emergencies if these measures adhere to Article 43 of this legally binding instrument. Overbroad measures taken during recent public health emergencies of international concern, however, reveal that the provision remains inadequately understood. A shared understanding of the measures legally permitted by Article 43 is a necessary step in …

The Stellenbosch Consensus On The International Legal Obligation To Collaborate And Assist In Addressing Pandemics: Clarifying Article 44 Of The International Health Regulations, Margherita Cinà, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Roojin Habibi, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to potential global health emergencies such as the ongoing covid-19 pandemic. While Article 44 of this binding legal instrument requires countries to collaborate and assist each other in meeting their respective obligations, recent events demonstrate that the precise nature and scope of these legal obligations are ill-understood. A shared understanding of the level and type of collaboration legally required by the IHR is a necessary step in ensuring these obligations can be acted upon …

The Great Coronavirus Pandemic Of 2020—7 Critical Lessons, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The world is experiencing a once-in-a-lifetime pandemic, causing untold human suffering and death, unraveling of social relationships, and robbing individuals of livelihoods and countries of prosperity. The coronavirus pandemic has strained health systems, revealed unconscionable inequalities, and upended international institutions. Here are 7 critical lessons.

Tuberculosis, Human Rights, And Law Reform: Addressing The Lack Of Progress In The Global Tuberculosis Response, Matthew M. Kavanagh, Lawrence O. Gostin, John Stephens

Georgetown Law Faculty Publications and Other Works

In 2018, the United Nations General Assembly convened the first-ever high-level meeting (HLM) on tuberculosis (TB). Since that time news on the world’s most lethal infectious disease is not good—the 2019 WHO TB report shows 1.2 million people died from TB, a number that has fallen just 11% since 2015, less than one-third of the way towards the End TB Strategy milestone of a 35% reduction (to about 850 million deaths) by 2020. The same number of people, 10.0 million, are estimated to have fallen ill with TB in 2018 as in 2017. The stubborn persistence of TB is attributable …

Kicked Out, Kicked Again: The Discharge Review Boards’ Illiberal Application Of Liberal Consideration For Veterans With Post-Traumatic Stress Disorder, Jessica Lynn Wherry

Georgetown Law Faculty Publications and Other Works

In recent years, the Department of Defense (DoD) has responded to the growing awareness of mental health issues for military servicemembers during and after service. This Article focuses on veterans who have already been discharged from service, and specifically those who have been discharged under other-than-honorable conditions for misconduct that is likely the result of a mental health condition, including post-traumatic stress disorder (PTSD), traumatic brain injury, sexual assault, or sexual harassment. Thousands of former servicemembers have been kicked out of the military for misconduct rather than treated for mental health conditions they experienced due to their military service. When …

(Not The) Same Old Story: Invisible Reasons For Rejecting Invisible Wounds, Jessica Lynn Wherry

Georgetown Law Faculty Publications and Other Works

Thousands of former military servicemembers have been discharged with other-than-honorable discharges due to misconduct that can be traced to a mental health condition. These veterans may request a post-discharge change to their discharge characterization—known as a “discharge upgrade.” Discharge review boards consider discharge upgrade requests and typically (90-99% of the time) deny the requests. In the past few years, the Department of Defense has issued new policy guidance partly in response to the low grant rate and to specifically address the growing understanding of the relationship between misconduct and mental health conditions for military servicemembers. The policy guidance requires the …

Universal Masking In The United States: The Role Of Mandates, Health Education, And The Cdc, Lawrence O. Gostin, I. Glenn Cohen, Jeffrey P. Koplan

Georgetown Law Faculty Publications and Other Works

The Centers for Disease Control and Prevention (CDC) recommends cloth face coverings in public settings to prevent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). Face coverings decrease the amount of infectious virus exhaled into the environment, reducing the risk an exposed person will become infected.1 Although many states and localities have ordered mask use, considerable variability and inconsistencies exist. Would a national mandate be an effective COVID-19 prevention strategy, and would it be lawful? Given the patchwork of state pandemic responses, should the CDC have enhanced funding and powers to …

Brief Of Amicus Curiae 290 Criminal Law And Mental Health Law Professors In Support Of Petitioner's Request For Reversal And Remand, Kahler V. Kansas, 18-6135 (U.S. June 6, 2019), Paul F. Rothstein

Georgetown Law Faculty Publications and Other Works

Amici curiae are a group of philosophically and politically diverse law school professors and scholars in the fields of criminal law and mental health from a variety of disciplines who have been teaching and writing about the insanity defense and related issues throughout their careers. They include the authors of leading criminal law and mental health law treatises and casebooks and numerous important scholarly books and articles.

Amici believe this case raises important questions about principles of criminal responsibility, the integral role of the insanity defense in Anglo-American law, and the inadequacy of the “mens rea alternative” to the traditional …

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

Medical Malpractice Liability Crisis Or Patient Compensation Crisis?, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

This Article is organized as follows. Part II summarizes the common rhetoric in tort reform debates that places the blame for rising premiums on the liability system and touts tort reform as the cure-all for ailing insurance markets. It then summarizes empirical results, produced using Texas closed claims data and other data, which suggest not only that Texas tort reform advocates wrongly placed blame on the liability system, but also that noneconomic damages caps passed in 2003 have caused more harm than good. Part III describes results that suggest that the widely used tactic of pointing to jumbo jury verdicts …

Justice Blackmun, Abortion, And The Myth Of Medical Independence, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

In this article I test this conventional wisdom by explicitly placing medicine at the center of the analysis of Justice Blackmun's opinions on abortion, and then interrogating the connection between law and medicine. Using the Blackmun papers opened to the public in 2004 and augmented by other documents and sources, I examine four critical periods in Blackmun's life: his years at Mayo; his participation in a series of medicine-related cases prior to Roe; the period of intra-Court dynamics in Roe; and the post-Roe period in which a split developed between Blackmun and Roe's critics over the use of medical rhetoric. …

Race, Money And Medicines, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. The literature on race as a classifying tool in clinical research poses this core dilemma: On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. On the other hand, racial distinctions have social mean­ ings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. Our country's troubled past in this regard and the persistence of race-related disadvantage should keep us …

Deliberate Extinction: Whether To Destroy The Last Smallpox Virus, David A. Koplow

Georgetown Law Faculty Publications and Other Works

The target problem to be examined is smallpox. Specifically, what should we (the United States and the entire world) now do with the last known residual samples of the virus that causes this uniquely horrific disease? The illness itself has virtually disappeared from the catalogue of human afflictions: due to a stunningly imaginative, concerted, and resolute campaign of the World Health Organization (WHO) through the 1970s, no one has contracted this deadly impairment for twenty-five years. Yet the causative element, an insidious scourge known as the variola virus, still remains, housed for now in high-security freezers at the U.S. Centers …

That Wonderful Year: Smallpox, Genetic Engineering, And Bio-Terrorism, David A. Koplow

Georgetown Law Faculty Publications and Other Works

The thesis of this Article is that the United States, Russia, and by extension, the world as a whole, are pursuing a fundamentally sound strategy in retaining, rather than destroying, the last known remaining samples of the variola virus. For now, those samples are housed in secure, deep-freeze storage at the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia and at the comparable Russian facility, known as Vector, near Novosibirsk, Siberia. But that basic decision is about the only correct move we are making at this time - and even it is animated by fundamental misapprehensions about …

Trust And Betrayal In The Medical Marketplace, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author argues in this Comment that disingenuity as first resort is an unwise approach to the conflict between our ex ante and our later, illness-endangered selves. Not only does rationing by tacit deceit raise a host of moral problems, it will not work, over the long haul, because markets reward deceit's unmasking. The honesty about clinical limit-setting that some bioethicists urge may not be fully within our reach. But more candor is possible than we now achieve, and the more conscious we are about decisions to impose limits, the more inclined we will be to accept them without experiencing …

Embryonic Stem Cell Research As An Ethical Issue: On The Emptiness Of Symbolic Value, Kevin P. Quinn

Georgetown Law Faculty Publications and Other Works

The debate over human embryonic stem cell research-scientific and clinical prospects as well as ethical implications-became front-page news only after two teams of university researchers reported in November 1998 that they had isolated and cultured human pluripotent stem cells. The discovery caused a flurry of excitement among patients and researchers and drew attention from President Clinton, who instructed the National Bioethics Advisory Commission (NBAC) to "conduct a thorough review of the issues associated with. .. human stem cell research, balancing all medical and ethical issues.”

Caretakers And Collaborators, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

A chilling subplot in the twentieth-century saga of state-sponsored mass murder, torture, and other atrocities was the widespread incidence of medical complicity. Nazi doctors’ human “experiments” and assistance in genocidal killing are the most oft-cited exemplar, but wartime Japanese physicians’ human vivisection and other grotesque practices rivaled the Nazi medical horrors. Measured by these standards, Soviet psychiatrists’ role in repressing dissent, Latin American and Turkish military doctors’ complicity in torture, and even the South African medical profession’s systematic involvement in apartheid may seem, to some, almost prosaic. Yet these and other reported cases of medical complicity in human rights abuse …

Liberalism And Abortion, Robin West

Georgetown Law Faculty Publications and Other Works

First in a groundbreaking book, Breaking the Abortion Deadlock: From Choice to Consent, published in 1996, then in various public fora, from academic conference panels to Christian radio call-in shows, and now in a major law review article entitled My Body, My Consent: Securing the Constitutional Right to Abortion Funding, Eileen McDonagh has sought to redefine drastically our understanding of the still deeply contested right to an abortion, and hence, of the nature of the constitutional protections which in her view this embattled right deserves. Her argument is complicated and subtle, but its basic thrust can be readily …

Beyond Autonomy: Coercion And Morality In Clinical Relationships, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

This article considers the problem of line-drawing between autonomy-preserving and autonomy-negating influence in clinical relationships. The author’s purpose is not to propose particular boundaries, either with respect to reproductive decisions by HIV-infected women or for other clinical choices. Rather, he attempts to shed some light on what drives our disputes about whether one or another influence method is compatible with autonomous choice.

The author argues that such disagreements reflect underlying conflicts between normative commitments, and that resolving these conflicts is essential to settling controversies over whether particular influences unduly interfere with autonomous choice. Alternative understandings of the prerequisites for autonomous …

Bioethics And Law: The Second Stage – Balancing Intelligent Consent And Individual Autonomy, Judith C. Areen

Georgetown Law Faculty Publications and Other Works

The principle that government rests on the consent of the governed eventually spread beyond the political arena to alter such private behavior as the relationship between physician and patient. This Article examines the successive transformations of the principle of consent as it has developed in the field of law and bioethics from bare consent to informed consent, and then, more strikingly, to beyond informed consent. This most recent form of the principle may prove to be every bit as revolutionary as the idea of popular sovereignty in 17th century England.