Health Law and Policy Commons^™

The Rise And Fall Of A Reproductive Right: Dobbs V. Jackson Women’S Health Organization, Carol Sanger

Faculty Scholarship

Although the phrase “Post-Roe Era” is still used by those who want to underscore the loss wrought last June by Dobbs v. Jackson Women’s Health Organization, it is only a matter of time before the present state of reproductive constitutionalism solidifies into the more authoritarian “Dobbs Era.” In these early days of transition, states are still figuring out what they want the legal status of abortion to be, ever since Dobbs overruled both Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, thus tossing the issue of abortion’s legality back to the states for …

Disposable Lives: Covid-19, Vaccines, And The Uprising, Matiangai Sirleaf

Faculty Scholarship

Two French doctors appeared on television and publicly discussed potentially utilizing African subjects in experimental trials for a tuberculosis vaccine as an antidote to the novel coronavirus (COVID-19). Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization (WHO), denounced these kinds of racist remarks as a “hangover from ‘colonial mentality’” and maintained that “Africa can’t and won’t be a testing ground for any vaccine.” The fallout on social media was similarly swift, with Samuel Eto’o, a Cameroonian football legend, referring to the doctors as “[d]es assasins” and several others questioning the motives behind testing a vaccine on the African …

Extending Postpartum Medicaid: State And Federal Policy Options During And After Covid-19, Jamie R. Daw, Emily Eckert, Heidi Allen, Kristen Underhill

Faculty Scholarship

The United States is facing a maternal health crisis with rising rates of maternal mortality and morbidity and stark disparities in maternal outcomes by race and socioeconomic status. Among the efforts to address this issue, one policy proposal is gaining particular traction: extending the period of Medicaid eligibility for pregnant women beyond 60 days after childbirth. The authors examine the legislative and regulatory pathways most readily available for extending postpartum Medicaid, including their relative political, economic, and public health trade-offs. They also review the state and federal policy activity to date and discuss the impact of the COVID-19 pandemic on …

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping …

Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher

Faculty Scholarship

Background Unprecedented numbers of physicians are practicing past age 65. Unlike other safety-conscious industries, such as aviation, medicine lacks robust systems to ensure late-career physician (LCP) competence while promoting career longevity.

Objective To describe the attitudes of key stakeholders about the oversight of LCPs and principles that might shape policy development.

Design Thematic content analysis of interviews and focus groups.

Participants 40 representatives of stakeholder groups including state medical board leaders, institutional chief medical officers, senior physicians (>65 years old), patient advocates (patients or family members in advocacy roles), nurses and junior physicians. Participants represented a balanced sample from …

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 …

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 …

We Have The Tools To End Hiv: Benefits, Barriers, And Solutions To Expanded Utilization Of Pre-Exposure Prophylaxis (Prep) In The Us Deep South, Jason Ervin, Allison Weller Tikare, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Just Compensation: A No-Fault Proposal For Research-Related Injuries, Leslie Meltzer Henry, Megan E. Larkin, Elizabeth R. Pike

Faculty Scholarship

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been …

Whose Duty Is It Anyway?: The Kennedy Krieger Opinion And Its Implications For Public Health Research, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

In this article, the authors discuss the Maryland Court of Appeals decision in the case of Grimes v. Kennedy Krieger Institute, Inc. and its implications for the tort duty owed by researchers, in particular public health researchers, to their subjects. The Opinion resulted from two lawsuits alleging lead poisoning of children enrolled in a study conducted by the Kennedy Krieger Institute, a world renown pediatric research and treatment facility. The opinion shocked the research establishment with its scathing characterization of researchers and its apparent holding that in Maryland a parent cannot consent to the participation of a child in "nontherapeutic …

Colloquium - Gender, Law And Health Care: New Perspectives For Teaching And Scholarship: The Role Of Gender In Law And Health Care, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.