Health Law and Policy Commons^™

Owning Health Equity Entrepreneurship, Capital, And Community-Owned Health, Thomas Williams

Scholarly Articles in Law Reviews & Journals

There is a long history of recognized health disparities affecting marginalized communities in the United States. These disparities have complicated and deep roots, but multiple factors can be controlled in the short term, such as access to high-quality medical care. Public and private institutions often use incentives to focus the efforts of private actors towards specified goals; incentives can also be calibrated to mitigate health disparities through a health equity entrepreneurial model.

To understand the possibilities and complications of this model of health equity-focused entrepreneurship, this Article uses the Black and American Indian maternal mortality and morbidity crises as a …

Patient Access To At-Home Health Care Device Data Toward A Legal Framework, Charles Duan, Christopher J. Morten

Contributions to Books

No abstract provided.

Facts On Trial: Alliance For Hippocratic Medicine V. Fda And The Battle Over Mailed Medication Abortion, Rachel Rebouché .

University of Colorado Law Review

No abstract provided.

Consumer Privacy And The Dobbs Disruption, Mason R. Clark

Faculty Articles

The right to reproductive privacy is under attack in the United States, and it is losing ground. Dobbs v. Jackson Women's Health Organization, the Supreme Court's 2022 decision that overruled Roe v. Wade's constitutional protection of abortion and jeopardized privacy rights by proxy, reflects this losing posture. Scholarship in reproductive privacy varyingly critiques federal privacy initiatives, evaluates regulatory interventions, and proposes civil rights frameworks in response to Dobbs. This Article, however, pinpoints how Dobbs created a gaping hole in state consumer privacy laws even as they propagated across the United States. Currently, there are no state consumer privacy laws that …

Locating Liability For Medical Ai, W. Nicholson Price Ii, I. Glenn Cohen

Articles

When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed …

Rethinking Innovation At Fda, Rachel E. Sachs, Nicholson Price, Patricia J. Zeitler

Articles

In several controversial drug approval decisions in recent years, the Food & Drug Administration (“FDA”) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of …

What Recent Scrutiny Surrounding New Jersey's Newborn Screening Program Is Missing: Comment On The Reproductive And Social Justice Issues The Program Illuminates, Dylan Blanchard

Cardozo Arts & Entertainment Law Journal

The note critiques New Jersey's Newborn Screening Program, highlighting its constitutional and social justice implications. While the program is a vital public health measure, its retention of newborn blood samples without informed consent and subsequent use by law enforcement raises significant Fourth Amendment concerns. The analysis argues that the program disproportionately impacts minorities and perpetuates systemic racism in the criminal legal system, as biometric data from these samples can be used to bypass probable cause requirements.

Ai Renaissance: Pharmaceuticals And Diagnostic Medicine, Ty J. Feeney, Michael S. Sinha

All Faculty Scholarship

The explosive growth of Artificial Intelligence (AI) in the modern era has led to significant advancements in the world of medicine. In drug discovery, AI technology is used to classify proteins as drug targets or non-targets for specific diseases, more accurately interpret and describe pharmacology in a quantitative fashion, and predict protein structures based on only a protein sequence for input. AI methods are used in drug development to generate predictive models for drug screening purposes, refine and modify candidate structures of drugs to optimize compounds, and predict a drug’s physiochemical properties, bioactivity, and toxicity. For medical devices, the advancement …

Reproductive Rights And Medico-Legal Education Post-Dobbs: A Fireside Chat, Michael S. Sinha, Anna Krotinger, Maya A. Phan, Louise P. King

All Faculty Scholarship

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization was a pivotal moment that reshaped the landscape of abortion policy and delivery of abortion care in the United States. To create a space for critical reflection on the implications of Dobbs for the teaching and learning of abortion care in both medical and legal education, the authors engage in a dialogue highlighting the varied perspectives of professionals and professionals-in-training in both the medical and legal professions. As new attacks on reproductive autonomy continue at both state and federal levels, we foreshadow a tumultuous landscape for abortion policy …

Physician Decision Making Under Uncertainty In A Post-Dobbs America, Molly J. Walker Wilson, Michael S. Sinha

All Faculty Scholarship

Following the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization and a series of restrictive state laws post-Dobbs, physicians in many states now face difficult choices between evidence-based practice and criminal penalties. Previously, when deciding whether to provide abortion care, concern for the health of the patient was paramount. Now, fear of criminal penalties drives decision-making for physicians practicing in many areas of the country, including our home state: Missouri. For certain life-threatening complications, termination of pregnancy is warranted, but since Dobbs, physicians have been delaying these potentially lifesaving procedures for fear of criminal repercussions. Behavioral research on …

Economic And Social Rights, Corruption, And Covid-19: The Indian And South African Experiences, Anashri Pillay

National Law School of India Review

India and South Africa have been at the forefront of debates about economic and social rights for many decades. Whilst the apex courts in these states have led the way in interpreting and handing down remedies stemming from these rights, vast social and economic inequalities persist. This article uses the responses to Covid-19 as a basis to consider how corruption has affected the realisation of economic and social rights in each of these countries. The article goes on to address broader arguments about the value of international human rights in tackling corruption. A human rights perspective is a relatively recent …

Body. Freedom. Choice: Creating Artwork In Post-Roe America, Erin Sedra

Graduate Theses/Dissertations

I knew from a young age that I never wanted children. Whenever I expressed my disinterest in motherhood, I was often met with bewilderment, disapproval, and hostility. The church I was raised in taught me that my value and worth as a woman directly correlated with the power of my birthing hips. This fundamentalist upbringing has significantly shaped my relationship with my femininity, my body, and my artwork. When I feel powerless, turning to my art gives me a sense of control and self-expression. This body of work began as a reaction to the overturning of Roe v. Wade and …

Wipo Negotiations On Intellectual Property, Genetic Resources And Associated Traditional Knowledge, Peter K. Yu

Faculty Scholarship

At the 2000 General Assembly, the World Intellectual Property Organization (WIPO) established the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) to address intellectual property issues relating to genetic resources, traditional knowledge (TK) and traditional cultural expressions (TCEs). Although the IGC initially focused its work on studying these issues, it obtained a new mandate to accelerate its work in October 2009 and began text-based negotiations on an international instrument, or international instruments, a few months later. These negotiations paved the way for WIPO to convene a diplomatic conference to conclude an International Legal Instrument Relating …

Psychedelics, Psychosocial Support, And Psychotherapy: Why It Matters For The Law, Ethics, And Business Of Medical Psychedelic Use, I. Glenn Cohen

Fordham Law Review

No abstract provided.

Tele-Induction Of Buprenorphine For Opioid Use Disorder: Regulatory Flux And Public Confusion, Stacey A. Tovino

Fordham Law Review

No abstract provided.

A Bayesian Analysis Of E-Cigarette Risk Perceptions In The United Kingdom, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Public Health England has communicated that e-cigarettes provide at least a 95% risk reduction compared to conventional cigarettes. This article's survey evidence indicates that adults in the United Kingdom believe that e-cigarettes are only 30%–40% safer overall and that they reduce lung cancer risks and total mortality risks by a similar percentage. A Bayesian analysis of risk beliefs finds that e-cigarette risk perceptions are anchored on prior cigarette risk beliefs. The public, especially smokers, underestimates the magnitude of the risk reduction being communicated by public health officials. Those who are aware of e-cigarette messages from Public Health England assess lower …

Students For Fair Admissions: Affirming Affirmative Action And Shapeshifting Towards Cognitive Diversity?, Steven A. Ramirez

Seattle University Law Review

The Roberts Court holds a well-earned reputation for overturning Supreme Court precedent regardless of the long-standing nature of the case. The Roberts Court knows how to overrule precedent. In Students for Fair Admissions v. Harvard (SFFA), the Court’s majority opinion never intimates that it overrules Grutter v. Bollinger, the Court’s leading opinion permitting race-based affirmative action in college admissions. Instead, the Roberts Court applied Grutter as authoritative to hold certain affirmative action programs entailing racial preferences violative of the Constitution. These programs did not provide an end point, nor did they require assessment, review, periodic expiration, or revision for greater …

Empirically Assessing 510(K) Device Safety, George Horvath

Akron Law Faculty Publications

Innovations in medical device technology hold the potential to improve health outcomes across the populace. Nearly half of all medical devices that enter the U.S. market each year are regulated by the Food and Drug Administration (FDA) under the 510(k) pathway. If FDA regulation of 510(k) devices stifles innovation, health outcomes will suffer over time because beneficial devices would not reach patients; on the other hand, if regulation facilitates innovation, health outcomes could improve. Most discussions of innovation under the 510(k) pathway have been either excessively reductionist (such as claims that the pathway stifles innovation) or wholly pessimistic (notably, the …

Flattening Breast Cancer By Removing The Breasts: Protecting A Woman's Right To Choose Reconstruction Of An Aesthetic Flat Chest After A Mastectomy, Amelia Landenberger

Akron Law Faculty Publications

Breast cancer takes away women’s choices. Many women decide to regain control of their bodies and prevent future cancer or follow-up surgeries by having a double mastectomy without any reconstruction, leaving a fat chest. When their doctors refuse to perform this surgery or their insurers refuse to cover this form of chest reconstruction, women are traumatized by their loss of choice in a system that clings to the outdated idea that women cannot be feminine without breasts. The Women’s Health and Cancer Rights Act of 1998 was intended to protect women facing cancer from the second trauma of being unable …

What I Talk About When I Talk About Charity Scott, Elizabeth Weeks

Scholarly Works

This essay pays tribute to Professor Charity Scott’s transformative impact on health law, legal education, and medical-legal partnerships. Reflecting on personal experience and Scott’s pioneering work, It highlights Scott’s integrity, compassion, and dedication to improving individual and community well-being through law. Scott’s role in establishing the Health Law Partnership (HeLP) and advancing the medical-legal partnership model is situated within the broader evolution of health justice, social determinants of health, and interprofessional collaboration. The essay underscores her legacy as a scholar, mentor, and innovator whose work continues to shape health law and inspire future generations of advocates, educators, and practitioners

Challenging The Criminalization Of Undocumented Drivers Through A Health-Justice Framework, Jason A. Cade

Scholarly Works

States increasingly use driver’s license laws to further policy objectives unrelated to road safety. This symposium contribution employs a health justice lens to focus on one manifestation of this trend—state schemes that prohibit noncitizen residents from accessing driver’s licenses and then impose criminal sanctions for driving without authorization. Status-based no-license laws not only facilitate legally questionable enforcement of local immigration priorities but also impose structural inequities with long-term health consequences for immigrants and their family members, including US citizen children. Safe, reliable transportation is a significant social determinant of health for individuals, families, and communities. Applying a health justice lens …

Standing In The Way Of Environmental Justice, Lauren Cormany

Utah Law Review

Private citizens need an avenue for justice through the judicial system on the siting of hazardous facilities. The health impacts of exposure to toxic facilities—like cancer, respiratory illnesses, and birth defects—are severe and victims deserve their day in court. While initiatives by government agencies and grassroots organizations provide influential roads to improvement, the judiciary stands to only bolster the efficacy of the work in the environmental justice field. The most effective way to include the courts is through the legislature creating a cause of action targeting the issues that communities face. Solutions to the issue of citizen standing in challenging …

Public Primacy In Corporate Law, Dorothy S. Lund

Seattle University Law Review

This Article explores the malleability of agency theory by showing that it could be used to justify a “public primacy” standard for corporate law that would direct fiduciaries to promote the value of the corporation for the benefit of the public. Employing agency theory to describe the relationship between corporate management and the broader public sheds light on aspects of firm behavior, as well as the nature of state contracting with corporations. It also provides a lodestar for a possible future evolution of corporate law and governance: minimize the agency costs created by the divergence of interests between management and …

Stakeholder Governance As Governance By Stakeholders, Brett Mcdonnell

Seattle University Law Review

Much debate within corporate governance today centers on the proper role of corporate stakeholders, such as employees, customers, creditors, suppliers, and local communities. Scholars and reformers advocate for greater attention to stakeholder interests under a variety of banners, including ESG, sustainability, corporate social responsibility, and stakeholder governance. So far, that advocacy focuses almost entirely on arguing for an expanded understanding of corporate purpose. It argues that corporate governance should be for various stakeholders, not shareholders alone.

This Article examines and approves of that broadened understanding of corporate purpose. However, it argues that we should understand stakeholder governance as extending well …

The Limits Of Corporate Governance, Cathy Hwang, Emily Winston

Seattle University Law Review

What is the purpose of the corporation? For decades, the answer was clear: to put shareholders’ interests first. In many cases, this theory of shareholder primacy also became synonymous with the imperative to maximize shareholder wealth. In the world where shareholder primacy was a north star, courts, scholars, and policymakers had relatively little to fight about: most debates were minor skirmishes about exactly how to maximize shareholder wealth.

Part I of this Essay discusses the shortcomings of shareholder primacy and stakeholder governance, arguing that neither of these modes of governance provides an adequate framework for incentivizing corporations to do good. …

The Structure Of Corporate Law Revolutions, William Savitt

Seattle University Law Review

Since, call it 1970, corporate law has operated under a dominant conception of governance that identifies profit-maximization for stockholder benefit as the purpose of the corporation. Milton Friedman’s essay The Social Responsibility of Business is to Increase Its Profits, published in September of that year, provides a handy, if admittedly imprecise, marker for the coronation of the shareholder-primacy paradigm. In the decades that followed, corporate law scholars pursued an ever-narrowing research agenda with the purpose and effect of confirming the shareholder-primacy paradigm. Corporate jurisprudence followed a similar path, slowly at first and later accelerating, to discover in the precedents and …

Corporate Law In The Global South: Heterodox Stakeholderism, Mariana Pargendler

Seattle University Law Review

How do the corporate laws of Global South jurisdictions differ from their Global North counterparts? Prevailing stereotypes depict the corporate laws of developing countries as either antiquated or plagued by problems of enforcement and misfit despite formal convergence. This Article offers a different view by showing how Global South jurisdictions have pioneered heterodox stakeholder approaches in corporate law, such as the erosion of limited liability for purposes of stakeholder protection in Brazil and India, the adoption of mandatory corporate social responsibility in Indonesia and India, and the large-scale program of Black corporate ownership and empowerment in South Africa, among many …

Robo-Voting: Does Delegated Proxy Voting Pose A Challenge For Shareholder Democracy?, John Matsusaka, Chong Shu

Seattle University Law Review

Robo-voting is the practice by an investment fund of mechanically voting in corporate elections according to the advice of its proxy advisor— in effect fully delegating its voting decision to its advisor. We examined over 65 million votes cast during the period 2008–2021 by 14,582 mutual funds to describe and quantify the prevalence of robo-voting. Overall, 33% of mutual funds robo-voted in 2021: 22% with ISS, 4% with Glass Lewis, and six percent with the recommendations of the issuer’s management. The fraction of funds that robo-voted increased until around 2013 and then stabilized at the current level. Despite the sizable …

Stakeholder Governance On The Ground (And In The Sky), Stephen Johnson, Frank Partnoy

Seattle University Law Review

Professor Frank Partnoy: This is a marvelous gathering, and it is all due to Chuck O’Kelley and the special gentleness, openness, and creativity that he brings to this symposium. For more than a decade, he has been open to new and creative ways to discuss important issues surrounding business law and Adolf Berle’s legacy. We also are grateful to Dorothy Lund for co-organizing this gathering.

In introducing Stephen Johnson, I am reminded of a previous Berle, where Chuck allowed me some time to present the initial thoughts that led to my book, WAIT: The Art and Science of Delay. Part …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents