Health Law and Policy Commons^™

Protecting Patients From Physicians Who Inflict Harm: New Legal Resources For State Medical Boards, Elizabeth Pendo, Tristan Mcintosh, Heidi Walsh, Kari Baldwin, James M. Dubois

All Faculty Scholarship

State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians.

Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary …

What Covid-19 Laid Bare: Adventures In Workers’ Compensation Causation, Michael C. Duff

All Faculty Scholarship

This essay performs a close analysis of workers’ compensation coverage of COVID-19 and arrives at the conclusion that it should not be “impossible” to prove in a legal sense that an employee’s COVID-19 was caused by work. Scientific proof is not the same as legal proof: workers’ compensation law has never required that claims must be supported by irrefutable scientific proof of workplace causation. Yet repeatedly one heard this suggestion during public discussion on workers’ compensation coverage of employees.

Still, there is good evidence that even when workers’ compensation undisputedly covers work-related disease employers seldom pay benefits (and states do …

The Criminal Legal System Doesn’T Care About Your Mental Illness, Fredrick E. Vars

Cardozo Law Review de•novo

Why would a beloved small-town doctor with no history of violence suddenly strangle his father to death? The Other Dr. Gilmer is a gripping account of the search for an answer to this question. It turns out the doctor has a rare neurological disorder that likely caused the killing. If only the diagnosis had come before trial, the author believes, the doctor would not have been convicted of first-degree murder and sentenced to life without parole. That belief is appealing, but naïve. Jails and prisons are full of people with mental illness. Misdiagnosis is not the reason. A close examination …

Recommendations On Mature Minors, Constance Macintosh

Reports & Public Policy Documents

Recommendation: The Committee should remove the requirement from the Criminal Code that candidates for Medical Assistance in Dying (MAID) be at least 18 years old. This is for the following reasons, elaborated upon below.

1.The MAID regime should always turn on the actual capacity of any person requesting MAID

2.The MAID regime’s approach to consent and capacity should be consistent with Canadian law on health care decision-making by minors

3.The MAID regime will likely be found unconstitutional if it maintains an age-based bar

4.The vulnerability of youth may require a different approach but does not justify an age-based bar

5.Removing …

Evaluation Of Risk Perception Of Smoking After The Implementation Of California’S Tobacco 21 Law, Joanna K. Sax, Neal Doran

Faculty Scholarship

Decreasing smoking initiation remains a public health priority. In 2016, California, in the United States, enacted the Tobacco 21 law, which raised the minimum age for the purchase of tobacco products from age 18 to age 21. This paper evaluates whether the enactment and implementation of the Tobacco 21 law changed how young adults perceive the risk(s) of smoking. Data were drawn from a cohort of emerging adults (n = 575) in California who were non-daily smokers at enrollment and followed quarterly for 3 years. Data were collected during 2015–2019. Piecewise multilevel regression models were used to test for changes …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

Honoring The Public Trust: Curbing The Bane Of Physician Sexual Misconduct, Rebecca H. Allensworth, K. S. Sindhu, Et Al.

Vanderbilt Law School Faculty Publications

The Federation of State Medical Boards defines physician sexual misconduct as any "behavior that exploits the physician-patient relationship in a sexual way." Although several attempts have been made in recent years to clarify its incidence in the United States, physician sexual misconduct is almost certainly underreported. Physician sexual misconduct represents a severe and irreversible violation of the compact underlying the patient–physician relationship and can have far-reaching consequences on the lives of patients and their families. In addition, the credibility of and trust in physicians, both essential to the provision of medical care, could well erode in the eyes of the …

The Role Of State Attorneys General In Improving Prescription Drug Affordability, Michelle M. Mello, Trish Riley, Rachel Sachs

Scholarship@WashULaw

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys general also play a critical role in helping governors and legislatures advance health policies by giving input into their drafting and defending them against legal challenges. State attorneys general have entered the prescription drug affordability arena in both these ways—for example, by initiating lawsuits relating to price fixing by generic drug manufacturers and defending state laws requiring disclosures of pharmaceutical prices. Yet the scope of their collective efforts is not …

New Innovation Models In Medical Ai, W. Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg

Scholarship@WashULaw

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …

Why The Equal-Protection Case For Abortion Rights Rises Or Falls With Roe's Rationale, Sherif Girgis

Journal Articles

From the Post

For nearly 50 years, legal scholars who favor Roe v. Wade’s outcome but scorn its rationale have tried to find firmer footing for a constitutional abortion right. Roe and its follow-on case, Planned Parenthood v. Casey, claimed to derive such a right from the Due Process Clause. That proved deeply controversial, for reasons laid out in Dobbs v. Jackson Women’s Health Organization. Most prochoice critics of Roe would have relied instead on the Equal Protection Clause. Scores of essays on abortion rights have endorsed, developed, and refined the equality arguments over decades. A book of proposals about …

Misreading And Transforming Casey For Dobbs, Sherif Girgis

Journal Articles

From the Article

In Dobbs, Mississippi has asked the Supreme Court to uphold a 15-week abortion ban by overturning Roe and Casey. Some have proposed that the Court could instead uphold the ban under Casey’s undue-burden test, on the ground that a law that leaves women a fair opportunity to choose whether to abort (here, up to the 15th week) creates no undue burden. Many have noted that this proposal would flout Casey’s rejection of undue burdens until viability, which comes long after 15 weeks. This essay focuses on another problem: that the proposal would transform the meaning of the …

'The Perfect Shouldn't Be The Enemy Of The Good' — What Canada Can Do Today, Tomorrow & Next Week To Enhance Equitable Access To Covid-19 Biopharmaceutical Interventions, Matthew Herder

Reports & Public Policy Documents

There is overwhelming evidence of inequitable access to a range of COVID-19 targeting biopharmaceutical interventions, including not only vaccines but also anti-viral drug therapies, diagnostic tests, and various materials that are incorporated into these products. As recently explained by Yamey et al. in the British Medical Journal, inequitable access is baked into every phase of the biopharmaceutical system—from production and allocation to affordability and deployment. Yet, it is still possible to improve access to these critically important biopharmaceutical interventions in low and middle-income countries (LMICs). Intellectual property (IP) rights are one crucial site where policy intervention can make an immediate …

Psychosocial Factors Of Covid-19 Impact Oral Health, Neeru Ramaswami Bds, Ms, Mph

The Journal of the Michigan Dental Association

The impact of psychosocial factors on oral health during the COVID-19 pandemic necessitates an interdisciplinary approach to patient care. This article, part of National Children’s Dental Health Month, focuses on adolescent oral health and eating disorders, authored by experts from the University of Michigan. With a dramatic increase in eating disorders among Michigan adolescents during the pandemic, especially affecting transgender and diverse youth, identifying such issues is crucial. General dentists, in an ideal position for interaction, can play a vital role in addressing these challenges, emphasizing the need for continued education and collaboration.

J Mich Dent Assoc January 2022

The Journal of the Michigan Dental Association

Monthly, The Journal of the Michigan Dental Association brings news, information, and feature articles to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists! In this January 2022 issue, the reader will find the following original content:

• A cover feature, “Eating Disorders in Adolescents: Facts and Recommendations for the Oral Health Team”
• An introduction to the Pediatric Health Series, “Psychosocial Factors of COVID-19 Impact Oral Health”
• A DEI Feature, “Inclusion of the Mobility Impaired in Our Community”
• A 10-Minute EBD, “Factors Impacting Gingival Margin Position Following Esthetic Crown Lengthening”
• News you need, an …

Assistance In Dying: A Comparative Look At Legal Definitions, Jocelyn Downie, Mona Gupta, Stefano Cavalli, Samuel Blouin

Articles, Book Chapters, & Popular Press

Euthanasia, assisted suicide, medical assistance in dying, death with dignity: these and many other different terms are used around the world to capture various types of assistance in dying. This diversity in terminology can create confusion both in academic debates and in policy-making if it is unclear what type of action or inaction is intended to be captured, by whom, and under what circumstances. By defining and contrasting several terms and legal status of assistance in dying in jurisdictions authorizing it, this comparative glossary aims to lay a foundation that prevents linguistic and conceptual confusion.

Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder

Articles, Book Chapters, & Popular Press

Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …

Protecting Expert Advice For The Public: Promoting Safety And Improved Communications, Julia M. Wright, Wendy Hui Kyong Chun, Amanda Clarke, Matthew Herder, Howard Ramos

Articles, Book Chapters, & Popular Press

The drivers of the harassment and intimidation of researchers are complex, widespread, and global in their reach and were being studied across many disciplines even before COVID-19. This policy briefing reviews some of the scholarship on this wide-ranging problem but focuses on what can be done to help ensure that Canadians fully benefit from the work of Canada’s researchers while also preserving the security and safety of those researchers. It identifies policies and actions that can be implemented in the near term to gather information on the problem, better frame public research communications, and ensure that mechanisms are readily available …

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

Abortion Rights Beyond The Medico-Legal Paradigm, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

Abortion rights in international law have historically been framed within a medico-legal paradigm, the belief that regulated systems of legal and medical control guarantee safe abortion. However, a growing worldwide practice of self-managed abortion (SMA) supported by feminist activism challenges key precepts of this paradigm. SMA activism has shown that more than medical service delivery matters to safe abortion and has called into question the legal regulation of abortion beyond criminal prohibitions. This article explores how abortion rights have begun to depart from the medico-legal paradigm and to support the novel norms and practices of SMA activism in a transformation …

Essential But Ignored: Covid-19 Litigation And The Meatpacking Industry, Alexia Brunet Marks

Publications

The spread of the novel coronavirus SARS-CoV-2 (COVID-19) among meatpacking employees forced closures and slowdowns at many plants across the United States. As the meatpacking giants JBS, Smithfield, and Tyson became hotbeds for COVID-19, national meat production plummeted. To forestall further supply chain disruptions, former President Trump passed an Executive Order compelling plants to continue operating as “essential businesses.” As work continued, employees reported that social distancing and mask-wearing were not being enforced, managers were pressuring sick employees to work and not revealing co-worker’s infections, and an overall lack of Personal Protective Equipment (PPE) or training to reduce the risk …

Survival Voting And Minority Political Rights, Douglas M. Spencer, Lisa Grow Sun, Brigham Daniels, Chantel Sloan, Natalie Blades

Publications

The health of American democracy has literally been challenged. The global pandemic has powerfully exposed a long-standing truth: electoral policies that are frequently referred to as "convenience voting" are really a mode of "survival voting" for millions of Americans. As our data show, racial minorities are overrepresented among voters whose health is most vulnerable, and politicians have leveraged these health disparities to subordinate the political voice of racial minorities.

To date, data about racial disparities in health has played a very limited role in assessing voting rights. A new health lens on the racial impacts of voting rules would beneficially …

Jail Health And Early Release Practices, Brandon L. Garrett, Deniz Ariturk, Jessica Carda-Auten, David L. Rosen

Faculty Scholarship

Local jails in the United States incarcerate millions of people each year. The COVID-19 pandemic made jail health a pressing public health concern nationally, where releasing individuals from jails occurred across the country in order to prevent pandemic spread. But releases also faced substantial resistance and exposed long-standing challenges in delivering adequate healthcare in jail settings. People in jail have substantially higher levels of medical need than individuals in the general population, with large numbers having serious mental illnesses and substance use disorders. Further, overcrowded conditions and poor healthcare standards and delivery make jails harmful to those already-vulnerable people. What …

Viral Injustice, Brandon L. Garrett, Lee Kovarsky

Faculty Scholarship

The COVID-19 pandemic blighted all aspects of American life, but people in jails, prisons, and other detention sites experienced singular harm and neglect. Housing vulnerable detainee populations with elevated medical needs, these facilities were ticking time bombs. They were overcrowded, underfunded, unsanitary, insufficiently ventilated, and failed to meet even minimum health-and-safety standards. Every unit of national and sub-national government failed to prevent detainee communities from becoming pandemic epicenters, and judges were no exception.

This Article takes a comprehensive look at the decisional law growing out of COVID-19 detainee litigation and situates the judicial response as part of a comprehensive institutional …

A Pandemic Instrument Can Start Turning Collective Problems Into Collective Solutions By Governing The Common-Pool Resource Of Antimicrobial Effectiveness, Isaac Weldon, Kathy Liddell, Susan Rogers Van Katwyk, Steven J. Hoffman, Timo Minssen, Kevin Outterson, Stephanie Palmer, A. M. Viens, Jorge Viñuales

Faculty Scholarship

To address the complex challenge of global antimicrobial resistance (AMR), a pandemic treaty should include mechanisms that 1) equitably address the access gap for antimicrobials, diagnostic technologies, and alternative therapies; 2) equitably conserve antimicrobials to sustain effectiveness and access across time and space; 3) equitably finance the investment, discovery, development, and distribution of new technologies; and 4) equitably finance and establish greater upstream and midstream infection prevention measures globally. Biodiversity, climate, and nuclear governance offer lessons for addressing these challenges.

Righting A Reproductive Wrong: A Statutory Tort Solution To Misrepresentation By Reproductive Tissue Providers, Yaniv Heled, Hillel Y. Levin, Timothy D. Lytton, Liza Vertinsky

Scholarly Works

Fraud, misrepresentation, and other unfair trade practices plague the market for human reproductive tissue. The sale of sperm, eggs, and embryos is virtually unregulated in almost all states, and courts have been inhospitable to victims. As a result, children are born with genetic disorders that impose extreme financial and personal hardship. Proposals for direct government oversight have, for the most part, failed to gain traction, and litigation has yielded inadequate remedies.

This Article assesses these problems and proposes model legislation that would eliminate doctrinal obstacles to holding unscrupulous reproductive tissue providers liable. By making it easier for parents to bring …

A Cost To Bear—Environmental Contamination And Eminent Domain, Evan C. Heaney

Seattle University Law Review

This Note advocates for Washington courts to adopt a system that universally allows evidence of environmental contamination on the private property taken in eminent domain proceedings. Part I of this Note discusses the history and progression of eminent domain and the broader constitutional roots of the Takings Clause. Part II explores Washington’s environmental remediation statute. Part III details the various approaches jurisdictions around the county have formulated to deal with this issue. Part IV argues Washington courts should adopt the inclusionary approach, which allows the introduction of environmental evidence in eminent domain proceedings.

Introduction: Amr Belongs In The Pandemic Instrument, Susan Rogers Van Katwyk, Kevin Outterson

Faculty Scholarship

In the wake of COVID-19, the World Health Organization established an Intergovernmental Negotiating Body to negotiate a new instrument for pandemic prevention, preparedness, and response. This special issue of the Journal of Law, Medicine & Ethics brings together multidisciplinary scholarship to address the question of whether antimicrobial resistance should be included in this new instrument. Drawing from disciplines including law, anthropology, history, public health, public policy, economics, and veterinary medicine, this special issue explores the inclusion of AMR within the Pandemic Instrument from three perspectives: first, through the lens of global AMR governance, second, from the perspective of technical governance …

Abortion Experts, Aziza Ahmed

Faculty Scholarship

The COVID-19 pandemic, and the overturning of Roe v. Wade,¹ has intensified the fight for access to medication abortion. ² As state governors put emergency orders into place limiting health care provisions to essential services, some also limited access to abortion, designating it a nonessential service. ³ In the face of these challenges, women's health advocates, in keeping with prior advocacy, have called for greater access to medication abortion.⁴ The increased reliance on telemedicine during the COVID-19 pandemic provides new possibilities for the provision of abortion medication that do not rely on a patient engaging in-person at a …