Health Law and Policy Commons^™

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Pertanggungjawaban Etik Dokter Dalam Melakukan Aksi Mogok Kerja Di Indonesia, Farel Rifandanu

Jurnal Hukum & Pembangunan

The implementation of strikes by doctors is a complex phenomenon with significant implication that give rise to ethical dilemma. Doctors have a responsibility to provide health services, so that a strike can endanger the health care system. On the other hand, doctors also have the right to fight for fair and decent working conditions. In view of these problems, this study has two (2) problem formulations, how the legal regulations regarding the actions of doctors who go on strike and how the ethical responsibilities of doctors who go on strike. This study uses a normative legal research method that …

The Value Of A Statistical Life: From Skin In The Game To Vision Zero, Michael C. Duff

All Faculty Scholarship

This essay discusses justice issues surrounding occupational safety and health and assesses the ethical legitimacy—the justice—of regulatory cost benefit analysis when the costs in question involve the risks and realization of workplace injury and fatalities. The current “value of a statistical life” for legal-regulatory purposes is 13.1 million dollars. While economists are careful to say that this figure does not “really” represent an attempt to value any particular life, the purpose of even calculating the number is to provide an “aggregated” statistical justification for saying “no” to rules requiring safer work. This seems acceptable until you, or someone you love, …

Public Patent Powers, Laura E. Dolbow

Publications

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Corporate Scenarios: Drawing Lessons From History, Madison Condon

Seattle University Law Review

As corporations are increasingly pressed to reveal information about their exposure to climate-related risks, they are often asked to undertake and disclose the outcome of “scenario analysis.” In this exercise, corporations, including financial institutions, examine how their business would fare under different pathways the future may take. One oft-used scenario, for example, is the International Energy Agency’s “Net-Zero by 2050: A Roadmap for the Energy Sector.” This Essay presents a history of the use of scenarios as a corporate planning tool, particularly in the oil industry, arguing that it is key for understanding our present moment and the role of …

Shareholder Expression In A Time Of Heightened Political Tension, Aaron A. Dhir

Seattle University Law Review

In this article, I provide context for my forthcoming research project on shareholder proposals and racial equity audits. Since the murder of George Floyd in May of 2020, progressive shareholder actors have increasingly used the proposal mechanism to advance diversity, equity, inclusion, and justice-related goals. These proposals have frequently gone beyond requesting the usual corporate fare of diversity trainings, intersectionality workshops, affinity groups, etc. Instead, a more ambitious type of proposal asks corporate America to conduct racial equity audits, defined as “an independent, objective and holistic analysis of a company’s policies, practices, products, services and efforts to combat systemic racism …

Corporate Governance Speech, Sarah C. Haan

Seattle University Law Review

The State has always regulated the intra-firm communications that make corporate governance possible, most commonly by mandating disclosures of information by a corporation to its shareholders. Some such laws are labeled “securities regulation,” but securities regulation is a broad category that extends to speech by actors who are outside the corporate enterprise as well. Also, the conventional securities regulation category does not capture all such laws; other examples, including informationforcing mandates, can be found in state corporate law. This Article uses the term “corporate governance speech” to describe the communications among shareholders, directors, and officers through which corporate governance is …

Dark Accounting Matter, Colleen Honigsberg

Seattle University Law Review

Physicists calculate that approximately 85% of the matter in the universe is composed of “dark matter” that “does not absorb, reflect, or emit electromagnetic radiation and is therefore difficult to detect.” The S&P 500 currently trades at a price-to-book value of 4.2, suggesting that book value accounts for less than 20% of the S&P 500’s market value. The remaining 80% appears nowhere in these firms’ balance sheets—it is invisible to contemporary accounting techniques and constitutes “dark accounting matter.”

Some “dark accounting matter” is composed of factors commonly described as components of “ESG.” Human capital, for example, is an intangible asset …

The Employees’ Dilemma: Balancing Internal Reporting, Whistleblowing, And Insider Trading Risks, Geeyoung Min

Seattle University Law Review

The Essay examines how recent developments in insider trading regulations and whistleblower reward programs can lead to unintended and counterproductive results of discouraging employees from using internal reporting channels within corporate compliance programs. While the presence of a robust and well-functioning corporate compliance program is a critical factor both in mitigating the level of public enforcement actions against companies and in protecting corporate managers from liability in private litigation, these programs often provide little incentive for employees to report potential misconduct internally.

Corporate compliance programs are designed to promote the upward information flow within the company, which is essential for …

How The Antidiscrimination Law Of Commercial Transactions Really Works, Helen Norton

Seattle University Law Review

A variety of businesses now cite 303 Creative when seeking First Amendment protection for their refusal to serve certain customers based on those customers’ protected class status. How this litigation will play out remains to be seen. But future courts need not, and should not, repeat the 303 Creative Court’s misunderstanding of how the antidiscrimination law of commercial transactions actually works.

Part I of this Essay explains the Court’s longstanding understanding of the antidiscrimination law of commercial transactions, and then describes the Court’s failure to engage with this precedent in 303 Creative. Part II then identifies the 303 Creative decision’s …

Understanding The Big Three’S Wavering Support Of Environmental And Social Shareholder Proposals, Jeff Schwartz, Jefferson Jensen

Seattle University Law Review

Because of their substantial equity portfolios, BlackRock, Vanguard, and State Street (the Big 3) are central players in corporate governance. It is, therefore, critical to understand how they vote. One puzzle is that their support for shareholder proposals on environmental and social matters appears to waiver. In 2020, for instance, BlackRock supported 11.1% of environmental proposals at S&P 500 firms. In 2021, it seemingly reversed course, supporting 55.2%. It then flipped again, supporting 32.1% in 2022. Such statistics suggest that the Big 3 are constantly changing their views on these topics. This Article seeks to better understand whether this is …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Ghost Guns: A Case Study On The Tension Between Public Exigencies And Statutory Construction, Bradley Krause

Catholic University Law Review

Administrative agencies often navigate public policy issues while simultaneously handling complex and highly technical matters. When facing a public emergency, how should courts interpret these agencies’ authorizing statutes? What rules of thumb exist to guide the courts? This Comment answers these questions through a case study on ongoing litigation pertaining to a recent ATF (Bureau of Alcohol, Tobacco, and Firearms) regulation. The regulation, targeted towards ghost guns (also known as “privately manufactured firearms”), seeks to incorporate these weapons within pre-existing definitions in the ATF’s authorizing statute, the Gun Control Act of 1968 (GCA). In spite of challenges to the regulation, …

Is Hipaa Dead? How Recent Developments In Ftc Section 5 Enforcement May Impact Traditional Notions Of Health Privacy, Brian Patrick

University of Cincinnati Law Review

No abstract provided.

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

All Faculty Scholarship

Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of …

A Local Option: How Medicare Patients In Rural States Could Obtain Coverage For Weight Loss Medications, Emily Blackburn

West Virginia Law Review

There are currently three options when it comes to managing obesity: (1) making nutritional and activity changes; (2) weight loss medications; and (3) weight loss surgery. The existing limited options for managing obesity are even more restricted for Medicare patients. Making lifestyle changes might not be effective for a variety of reasons, including persistent food cravings and experiences of weight stigma from healthcare providers. To qualify for weight loss surgery, Medicare patients must satisfy several criteria in addition to the already specific weight loss surgery requirements. Additionally, weight loss surgery might not be the most viable option for the Medicare …

Diabetes Management Of Incarcerated Individuals: Is The Federal Bureau Of Prisons Contributing To Worsening Diabetic Conditions?, Mariam Antony

Journal of the National Association of Administrative Law Judiciary

There are many issues related to noncommunicable disease care in federal prisons, which fall under the management of the U.S. Bureau of Prisons, a federal agency. Although there are many noncommunicable diseases, this comment specifically focuses on diabetes because of its prevalence (how common it is in individuals), especially in incarcerated individuals. Prison and incarceration are not conducive to the management of diabetes because diabetes may not even show symptoms until an individual mismanages the disease for a long time. An individual could first appear normal and then suffer a diabetic emergency, which could lead to consequences like heart attack …

The Modern Energizer Bunny - Hopping Into The Nuclear Energy Revolution: The Tenth Circuit's Analysis In New Mexico Ex Rel. Balderas V. U.S. Nuclear Regulatory Commission, Jack A. Mansur

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Leading The Way: The Ninth Circuit Orders Reconsideration Of Lead-Based Paint Hazard Regulations In A Community Voice V. Environmental Protection Agency, Bae-Corine Schulz

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Empirically Assessing Medical Device Innovation, George Horvath

Minnesota Journal of Law, Science & Technology

No abstract provided.

Shots Fired, Shots Refused: Scientific, Ethical & Legal Challenges Surrounding The U.S. Military's Covid-19 Vaccine Mandate, Shawn Mckelvy, L. William Uhl, Armand Balboni

St. Mary's Law Journal

The COVID-19 pandemic provided uncertain and challenging circumstances under which to lead a nation and the military that protects it. Those in charge and in command faced unique challenges—scientific, ethical, and legal—at our various levels of government to both keep people safe while keeping government and society functioning. While there were many successes to celebrate, there are also many criticisms for how this “whole-of-government approach” may have degraded some of our most cherished liberties along the way. The authors focus on the U.S. military’s vaccine mandate and propose military leaders may have failed to fully consider the evolving science, weigh …

Pursuing The Exemption: The Makah's White Whale, Sarah Van Voorhis

Washington Journal of Social & Environmental Justice

No abstract provided.

Affirmatively Furthering Health Equity, Mary Crossley

Brooklyn Law Review

Pervasive health disparities in the United States undermine both public health and social cohesion. Because of the enormity of the healthcare sector, government action, standing alone, is limited in its power to remedy health disparities. This article proposes a novel approach to distributing responsibility for promoting health equity broadly among public and private actors in the healthcare sector. Specifically, it recommends that the Department of Health and Human Services issue guidance articulating an obligation on the part of all recipients of federal healthcare funding to act affirmatively to advance health equity. The Fair Housing Act’s requirement that recipients of federal …

From Precedent To Policy: The Effects Of Dobbs On Detained Immigrant Youth, Ciera Phung-Marion

Washington Law Review

In June 2022, the United States Supreme Court released the historic decision Dobbs v. Jackson Women’s Health Organization, holding that the U.S. Constitution does not protect an individual’s right to an abortion. Dobbs overturned many cases, including J.D. v. Azar, which previously protected abortion rights for unaccompanied migrant youth in federal detention facilities. Post-Dobbs, the Office of Refugee Resettlement (ORR)—the agency responsible for caring for detained immigrant children—still protects abortion rights as part of its own internal policy. Without judicial precedent, however, this policy lacks the stability to truly protect the rights of the children in its …

What Can State Medical Boards Do To Effectively Address Serious Ethical Violations?, Tristan Mcintosh, Elizabeth Pendo, Heidi A. Walsh, Kari A. Baldwin, Patricia King, Emily E. Anderson, Catherine V. Caldicott, Jeffrey D. Carter, Sandra H. Johnson, Katherine Matthews, William A. Norcross, Dana C. Shaffer, James M. Dubois

Articles

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

No Need To Reinvent The Wheel: The Positive Relationship Between Green Technology And Patent Enforcement, Addison S. Fowler

Villanova Environmental Law Journal (1991 - )

No abstract provided.

A History Of Corporate Law Federalism In The Twentieth Century, William W. Bratton

Seattle University Law Review

This Article describes the emergence of corporate law federalism across a long twentieth century. The period begins with New Jersey’s successful initiation of charter competition in 1888 and ends with the enactment of the Sarbanes-Oxley Act in 2002. The federalism in question describes the interrelation of state and federal regulation of corporate internal affairs. This Article takes a positive approach, pursuing no normative bottom line. It makes six observations: (1) the federalism describes a division of subject matter, with internal affairs regulated by the states and securities issuance and trading regulated by the federal government; (2) the federalism is an …

Stakeholder Capitalism’S Greatest Challenge: Reshaping A Public Consensus To Govern A Global Economy, Leo E. Strine Jr., Michael Klain

Seattle University Law Review

The Berle XIV: Developing a 21st Century Corporate Governance Model Conference asks whether there is a viable 21st Century Stakeholder Governance model. In our conference keynote article, we argue that to answer that question yes requires restoring—to use Berle’s term—a “public consensus” throughout the global economy in favor of the balanced model of New Deal capitalism, within which corporations could operate in a way good for all their stakeholders and society, that Berle himself supported.

The world now faces problems caused in large part by the enormous international power of corporations and the institutional investors who dominate their governance. These …