Law Commons^™

Evaluating The Case Against Fda Independence, Patricia J. Zettler, Rachel E. Sachs

Utah Law Review

Many former FDA officials, both politically-appointed leaders and those from the career ranks, as well as numerous FDA scholars have advocated for increased FDA independence in varied forms, and for good reason. At the same time, there are advantages to FDA’s current structure, and there may be ways to insulate career scientific experts’ decisions from political influence and to address other problems by generating independence, without overhauling the agency’s design. Policymakers should consider all options, as particular independence features may, or may not, be the best way, to address concerns about FDA’s capacity to carry out its vital public health …

Fda In 2050: Best- And Worst-Case Scenarios, Michael S. Sinha

Utah Law Review

In 2025, the Trump administration disrupted many critical aspects of the biomedical research infrastructure in the United States. The Food and Drug Administration (FDA) was not spared. Robert F. Kennedy, Jr., a known vaccine denier with no health care experience, was confirmed as Secretary of the U.S. Department of Health and Human Services (HHS) in February 2025, followed by the confirmation of Dr. Martin Makary as Commissioner of the FDA in April. Departures of long-time FDA scientists, coupled with appointments of key personnel, seemingly because of their public stances on COVID-19 mRNA vaccines, have resulted in a tumultuous year for …

A Primer Of Medical Device Regulation: How To Go From Reactive To Proactive To Better Protect Patient Safety, Sneha Dave, Rita F. Redberg

Utah Law Review

FDA oversight of medical devices has too often been reactive, following preventable disasters rather than based on a proactive commitment to patient safety. The history of the device framework, the expansion of expedited pathways, weak postmarket surveillance, broad preemption, and conflicted patient advocacy together create a perfect storm of a regulatory environment that tolerates uncertainty and externalizes costs onto patients. Reforms such as time‑limited breakthrough status, mandatory and enforceable postmarket studies, requirements for more robust safety and efficacy data, and strengthened reporting duty for clinicians would move device regulation closer to FDA’s statutory mandate to protect public health. It would …

Fireproofing The Fda: Power, Politics, And Public Health, Daniel G. Aaron

Utah Law Review

On September 26, 2025, the S.J. Quinney College of Law hosted the Lee E. Teitelbaum Utah Law Review Symposium — Fireproofing the FDA: Power, Politics, and Public Health. The symposium is available on YouTube. Participants discussed problems longstanding and new in an attempt to chart a path for this vital agency. Topics included (1) What is the purpose of FDA?; (2) In what ways are the current Administration’s actions precedented or unprecedented?; (3) What is the current and ideal relationship between law and politics?; (4) How can law serve as an agent of public health?; and (5) How do we …

Fda Policymaking In The Trump Deregulation Era, Jordan Paradise J.D.

Utah Law Review

This Article endeavors to contribute to and continue the conversation about how the Trump deregulatory agenda is impacting a vital national public health agency, the FDA, and our national collective public health in ways that deviate from longstanding agency policy and practice. Various other FDA policy actions deserve concerted attention by legal scholars, including the agency’s recent moves in the direct-to-consumer marketing (DTC) drug space through targeted warning letters and publicity about reforming the “adequate provision” standards, food additives and generally recognized as safe (GRAS) listing processes and directives to industry, adjustments to the biosimilar interchangeability requirements through guidance document, …

Medical Device Regulation: We Can’T Just Go Back (Nor Should We), George Horvath

Utah Law Review

For much of the twentieth century, the federal Food and Drug Administration maintained its reputation as the preeminent regulatory agency, renowned for providing vigilant and scientifically rigorous oversight that ensured the safety and effectiveness of drugs and medical devices. But a former FDA commissioner recently lamented that “[t]he FDA as we’ve known it is finished.” Many commentators have raised concerns that reductions in force will leave the Agency understaffed, that these shortages will prolong review times, and that the standards applied to premarket evaluations of medical products will allow unsafe and ineffective products to reach the market. But in the …

The Fda’S New Clinical Decision Support Software Guidance And Its Implications For Artificial Intelligence, Sara Gerke

Utah Law Review

Artificial Intelligence (AI) is transforming healthcare. While the U.S. Food and Drug Administration (FDA) has authorized the marketing of more than 1,400 AI-based products classified as devices under Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act, many other AIbased products, including certain clinical decision support (CDS) software tools that provide recommendations to health care professionals about diagnosis, treatment, or prevention of a disease or condition, have been placed on the U.S. market without FDA premarket review. On January 6, 2026, the FDA issued a revised CDS Guidance, which superseded the September 28, 2022 CDS Guidance. Shortly after, the …

Post-Approval Problems, Anjali D. Deshmukh M.D., J.D.

Utah Law Review

Sitting across from 4-year-old Jessica’s parents, I whispered the truth: the most promising drug to fight their daughter’s disease was a therapy approved for adults, not for children her age. We could estimate the dose, monitor her organs, and hope the toxicity would not outpace the benefits, but there was no high-quality clinical trial data proving it was safe for kids like her yet, despite congressional mandates. Unexpected safety issues are often identified after drugs are approved and used outside of a closely controlled clinical trial, especially in understudied populations like children, the elderly, and pregnant women. When I asked …

What Matters For Bar Success: Doctrinal Performance, Coursework Exposure, And First-Time Bar Passage, Jason Scott, Rob Hunter, Andrea Pals

AccessLex Institute Research

This study examines how enrollment and academic performance in doctrinal law courses relate to first-time bar passage. Drawing on a large, multi-institutional data set, we estimate the associations between doctrinal GPA, course completion, credit accumulation, and first-time bar passage using regression adjustment and doubly robust methods designed to reduce selection bias. Across all models, performance in doctrinal coursework emerges as the strongest and most consistent predictor of first-time bar passage, far outweighing the influence of credit accumulation or course completion. Although greater exposure to doctrinal and skills-based coursework is positively associated with bar passage, these effects are comparatively modest, reinforcing …

Decolonial Human Rights Practice: Tactics, Obstacles, And Futures, Sarah Knuckey, Anjli Parrin, Gulika Reddy

Faculty Books

Human rights advocacy takes place within a deeply unequal world. As activists seek to protect rights, they struggle against the global economic and political power imbalances that drive violations. Movements for human rights are engaged in an internal struggle as well: against a human rights ecosystem that has long favored Global North organizations at the expense of civil society in the Global South. Decolonial Human Rights Practice: Tactics, Obstacles, and Futures explores the ongoing struggle of human rights organizations to confront and dismantle the coloniality of human rights advocacy.

Through a granular study of everyday advocacy practice which builds upon …

A Sign Of Our Times: Cities, Protest And Public Space, Susan Drucker

Proceedings of the New York State Communication Association

The U.S. is a country born out of protest, a nation which enshrined in its Constitution the right to assemble and petition the government, which includes the right to protest peacefully. Cities are spatial media and the site of much current contentiousness and controversy in the Trump administration’s America.  Cities can be symbols of protest such as sanctuary cities. Appropriation of everyday urban spaces and activities has been key to opposition politics. City streets have historically been the site of sign toting protesters watched o masked members of U.S. Immigration and Customs Enforcement (ICE). This paper explores the historical and …

Economic Costs And Rhetoric Of Resisting Diversity, Bill Petkanas

Proceedings of the New York State Communication Association

This paper examines the history of group exclusion in various occupations and the rhetoric used to support programs in diversity, equity, and inclusion. Examples include the Manhattan Project, the Discovery of the structure of DNA, and sports. Rhetorical possibilities are suggested based on the economic advantages of DEI.

Prosecutorial Guidance And Non-Prosecution Policies: A Pragmatic Path Forward For Ai In Legal Services, Jessica Bednarz, Ericka Byram, Kelli M. Raker, Jeff Ward

Duke Center on Law & Technology

No abstract provided.

Analysis Of The Impacts Of Propositions 41 And 42 On California Public Finance, David Gamage, Brian D. Galle, Darien Shanske

Faculty Publications

This memorandum discusses the possible collateral damage that Propositions 41 and 42 (on the ballot in California on November 3, 2026) might cause.  The two propositions were concocted very quickly by billionaires in order to trick voters that will vote for Proposition 40 (the billionaire tax) also to vote for these propositions that are designed to undermine the billionaire tax.

The basic trick is that these propositions have plausible seeming veneers but hide a poison pill that aims to frustrate the functioning of the billionaire tax.  The veneers are “plausible seeming” because they address problems that are not problems.  For …

Department Of Health Exerts Strong Control Over Cbct In Dental Offices: Regulations, Adopted Over Objection From Nysda, Take Effect Immediately., Lance Plunkett Jd, Llm

The New York State Dental Journal

On July 22, the New York State Department of Health finally adopted an entire set of new regulations covering all aspects of ionizing radiation. Contained in Article 16 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York (10 NYCRR), the new regulations repealed and replaced the old Article 16. It is important to note that the new regulations are in effect only in counties outside of New York City. Dentists in New York City should still rely on guidance from the city Department of Mental Health and Hygiene. The regulations contain …

Status Quo Bias Dalam Reformasi Hukum Acara Pidana Di Indonesia: Kegagalan Penguatan Pengawasan Pengadilan (Judicial Scrutiny) Yang Lebih Optimal, Choky Risda Ramadhan, Abni Nur Aini, Dheliana Khairunisa

The Indonesian Journal of Socio-Legal Studies

Pretrial proceedings (Praperadilan), as a form of judicial scrutiny, function as a control mechanism over the actions of law enforcement officials to prevent abuses of power. This mechanism was introduced in the 1981 Criminal Procedure Code (Kitab Undang-Undang Hukum Acara Pidana, KUHAP) and re-regulated in the 2025 KUHAP. However, numerous studies and focus group discussion with legal scholars and law enforcement officers have documented structural weaknesses in Praperadilan, prompting calls to reform judicial scrutiny in order to more effectively limit law enforcement authority and protect the human rights of individuals involved in criminal proceedings. During the Reform era (2004–2025), proposals …

Comparative Legal Study On Corruption In The Construction Sector: Indonesia And China, Seng Hansen, Liang Qi

The Indonesian Journal of Socio-Legal Studies

This study aims to compare the legal approaches to corruption in the construction sector in Indonesia and China. The construction sector in both countries is often fertile ground for corruption, which harms the economy and creates social inequality. This study employs a comparative legal analysis method to examine regulations, policies, and the effectiveness of law enforcement in combating corruption within the construction sector in both countries. The primary focus of this study is a comparison of applicable anti-corruption laws and the roles of law enforcement agencies, such as the Corruption Eradication Commission (KPK) in Indonesia and the Central Commission for …

Beyond Regulatory Compliance: Reorienting Indonesia's Post-Mining Governance Through Ecological Justice, Suryaningsi Suryaningsi, Rosmini Rosmini, Andi Luthfi, Muhammad Sayyidus Cakrawala

Hasanuddin Law Review

Post-mining governance in coal-producing regions is often unable to translate regulatory compliance into actual ecological recovery, as evidenced by East Kalimantan's environmental challenges. Therefore, this study aimed to examine implementation gaps in Indonesia's legal framework for reclamation and propose legal reforms grounded in ecological justice. A socio-legal method was used to integrate normative analysis, semi-structured interviews with 12 multi-level stakeholders, and comparative assessments of Australia, South Africa, and India. The results identified four critical gaps, namely discrepancies between administrative compliance and ecological outcomes, inadequate financial assurance, uncertain land transfer, and fragmented institutional oversight. This study showed that regulatory compliance without …

Dentistry And The Law - Understanding ‘Rollover Equity’ When Selling Your Practice, Daniel Schulte Jd

The Journal of the Michigan Dental Association

Daniel J. Schulte, MDA Legal Counsel, addresses the legal and tax implications of 'rollover equity' when dentists sell their practices to private equity-backed buyers. The article outlines typical shareholder and buy-sell agreement restrictions, noting how equity is often subject to vesting and employment covenants. Schulte explains the critical importance of making an Internal Revenue Code Section 83(b) election within 30 days of closing. Failing to file this election results in taxation at high ordinary income rates as the stock vests, whereas a timely election accelerates tax payments but secures lower capital gains tax rates upon eventual sale.

Patient-Centered Imaging In Dentistry, Erika Benavides Dds, Phd, Fabiana Naomi Soki, James R. Geist Dds, Ms, Angela M. Hoikka, Dds, Ms

The Journal of the Michigan Dental Association

This clinical feature discusses joint guidelines by the ADA and AAOMR for patient-centered dental radiography and cone-beam computed tomography (CBCT), emphasizing individual risk-based needs rather than routine schedules. It covers the principles of radiation safety: justification, optimization (ALARA/ALADA), and dose limitation. The article maps out specific imaging modalities recommended for caries, periodontal disease, endodontics, orthodontics, implants, and TMJ disorders. Additionally, it summarizes Michigan's administrative rules for X-ray installation shielding, equipment alignment, stable mechanical support, operator positioning, and the mandatory radiography training program requirements for dental assistants.

A Bibliography Of Faculty Scholarship, Kathryn J. Dufour Law Library

Scholarly Articles

The purpose of this bibliography is to record in one place the substantial body of scholarship produced by the current faculty at the Catholic University, Columbus School of Law. From its humble beginnings under the tutelage of founding Dean William Callyhan Robinson, through its adolescent period when, like so many other American law schools, it was trying to define its pedagogical niche, to its eventual merger with the Columbus University Law School in 1954, the law school at Catholic University has always retained a scholarly and remarkably productive faculty. The sheer quantity of writing, the breadth of research and the …

Rebutting 38 False Claims About Solar, Wind, Electric Vehicles, And Battery Storage, Andrew Kieffer

Sabin Center for Climate Change Law

Achieving the United States’ ambitious emissions reduction goals depends in large part on the rapid adoption of wind and solar energy and the electrification of consumer vehicles. However, misinformation and coordinated disinformation about renewable energy is widespread and threatens to undermine the transition. In this report, the Sabin Center identifies and examines 38 of the most pervasive false claims about solar energy, wind energy, and electric vehicles, with the aim of promoting a more informed discussion.

W&L Law Library Annual Report 2025-2026, The Law Library At Washington And Lee University School Of Law

Law Library Annual Reports

No abstract provided.

Scientific Uncertainty As Political Aggression: A Manifesto For Those Who Value Science And Want To Save It From State And Corporate Control, Stephen Demeo

Publications and Research

A manifesto is an opportunity to publicly express strongly held beliefs about a topic that is personally important to an author. It is analytical as it is creative. “Scientific Uncertainty as Political Aggression” is a manifesto that intersects science and politics. It urges those interested in science to examine two different but related topics: scientific uncertainty in measurement—what it is, how it is determined, why it’s important— and the magnification of uncertainty through legal and linguistic tactics used by right-wing politicians and politically supported corporations.

For some time now, the Republican Establishment has cast excessive doubt on scientific findings through …

The Nusantara Capital City (Ikn) Relocation: Autocratic Legalism And The Marginalization Of Local Communities, Imam Syafi'i, Dian Aulia

The Indonesian Journal of Socio-Legal Studies

The first phase (2022–2024) of the Nusantara Capital City (IKN) relocation prioritizes the construction of the city's physical infrastructure under the “Nusa Rimba Raya” concept. During this phase, the massive development of supporting infrastructure, including government buildings, official residences, toll roads, ports, and the VVIP airport, has driven increased demand for materials and land, impacting areas beyond the delineation of IKN. However, the power-driven approach in the capital relocation policy has led to socio-ecological injustices for indigenous and local communities by disregarding meaningful public participation and environmental sustainability. Land acquisition through the Land Bank (Bank Tanah), which prioritizes investment, along …

Medical Liability In The Age Of Ai-Driven Healthcare: Ethical Challenges And Legal Framework Recommendations, Rani Tiyas Budiyanti, Roro Isyawati Permata Ganggi, Penggalih Mahardika Herlambang

The Indonesian Journal of Socio-Legal Studies

The integration of artificial intelligence (AI) in healthcare is progressing rapidly and is applied to various aspects of medical practice, including diagnosis, treatment planning, and patient care. However, the integration of AI in healthcare raises complex legal and ethical issues, particularly regarding medical liability. The growing development of AI technology is blurring the concepts of responsibility and accountability in medical practice. Furthermore, with AI systems becoming increasingly autonomous in their decision-making processes, it becomes increasingly difficult to determine responsibility in cases of medical errors or actions that harm patients. In view of this situation this article argues that it is …

Mengadili Kepentingan Umum: Korporatisme Pengadilan Dalam Proyek Strategis Nasional (Psn), Agung Wardana, I Kadek Sudiarsana, Yogi Paramitha Dewi

The Indonesian Journal of Socio-Legal Studies

The implementation of National Strategic Projects (NSP) often leads to conflict. Projects that are claimed to be developments in the public interest are challenged by affected communities and civil society organisations in various ways, including through litigation. However, in the legal studies literature, studies on NSP issues tend to be analysed through a normative analysis focusing on development for the public interest. The article examines court decisions concerning NSP to understand how courts provide their deliberations of the cases, a perspective that enriches knowledge about NSP. This article shows how the corporatist relationship between the executive power and the judiciary, …

When Protection Becomes Predation: Militarized Masculinity And Sexual Violence In Northeastern Nigeria, Tosin Osasona

Dignity: A Journal of Analysis of Exploitation and Violence

The study investigates the structural and situational drivers of conflict-related sexual violence (CRSV) perpetrated by state security actors in the context of Nigeria’s counterinsurgency campaigns in Borno State. Drawing on militarized masculinity and strain and deprivation theories, and using a qualitative, interpretive research design, the study argues that CRSV is not an isolated or episodic form of deviance by individual soldiers and security personnel but is embedded in routine military–civilian interactions. Advancing an interactionist explanation of CRSV in Nigeria’s Islamist counterinsurgency operations, the study demonstrates that the likelihood of sexual violence increases through the interaction of gendered institutional norms, operational …

Reforming The Mississippi Criminal Code Part V: Justification, Judith J. Johnson

MC Law Review

No abstract provided.

Invoking The Protection Of Pupil Rights Amendment ("Ppra") To Safeguard Student Privacy Rights: My Three-Year Battle To Enforce The Ppra Against An Intractable New Jersey School District, Patricia Montana

MC Law Review

No abstract provided.