Digital Commons Network^™

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 …

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 …

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 …

Defending The Quasi-Employee Doctrine In Singapore In The Aftermath Of Bird V Dp, Yu Han Lam, Suan Yeong Amelita Sim

Research Collection Yong Pung How School Of Law

The rule that an organisation may be held vicariously liable for a tort committed by a tortfeasor who is not its traditional employee, but whose relationship is nonetheless "akin to employment" (commonly known as the "quasi-employee doctrine"), has been accepted only in obiter dicta in Singapore. In Bird v DP, the High Court of Australia rejected the quasi-employee doctrine. Bird may therefore provide impetus for the Singapore courts to do the same. This article argues, however, that the quasi-employee doctrine should be retained for four reasons. First, it enables unincorporated associations to be appropriately held vicariously liable. Second, the Singaporecourts …

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.

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 …

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.

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 …

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 …

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 …

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 …

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 …

International Law And Power Politics: On Koskenniemi's Perceptions Of Justice, Monica Hakimi

Faculty Scholarship

Martti Koskenniemi wrote ‘Perceptions of Justice’ against the backdrop of the 2003 Iraq War. The piece draws a stark distinction between American and European conceptions of justice – and approaches to international law. Over twenty years later, his distinction might still (or again) resonate. This retrospective analyses it in light of his other work and more contemporary events, arguing that it is a mix of misguided and confused. The United States and Europe have for decades, if not centuries, been profoundly entwined; each has significantly shaped and been shaped by its relationship with the other. The urgent question now is …

Police Surveillance And The Perils Of Techno-Solutionism, Prithika Balakrishnan

Faculty Scholarship

This Article charts domestic law enforcement’s use of video surveillance, beginning in the backlash to the Civil Rights movement in the late 1960s, continuing through the War on Terror and, more recently, in the context of the post-George Floyd public critiques of policing. The undergirding philosophy of policing’s embrace of surveillance technology is techno-solutionism, the view that all complex social situations can be simplified to measurable data primed for quick-fix, unbiased, algorithmic answers. While technology may have initially been adopted by police to respond to specific problems, it has changed the problems themselves, altered the array of potential solutions, and …

The Normative Status Of States' Obligations To Mitigate The Climate Crisis: Implications For The Right To Adequate Housing, Erna Dyah Kusumawati, Sasmini Sasmini

Padjadjaran Jurnal Ilmu Hukum (Journal of Law)

The convergence of the global climate crisis, pursuant to the UNFCCC Paris Agreement and its implementing protocols as well as the fundamental right to housing has fundamentally disrupted established legal paradigms, necessitating a rigorous re-examination of the normative status of state obligations. This paper examines the scope of governmental responsibility to mitigate climate-induced threats to housing security. Drawing upon international human rights frameworks and contemporary legal discourse, the study interrogates the complex friction emerging at the intersection of environmental mandates and housing protections. Through a systematic analysis of the existing literature and recent developments in the international climate change framework, …

Territorial Representation In Fiscal Governance: A Comparative Constitutional Analysis Of Indonesia's Regional Representative Council And South Africa's National Council Of Provinces, Endah Yuniningsih, Deden Rafi Syafiq Rabbani

Padjadjaran Jurnal Ilmu Hukum (Journal of Law)

This article examines the institutional role of territorial chambers in fiscal governance through a comparative constitutional analysis of Indonesia's Regional Representative Council (DPD) and South Africa's National Council of Provinces (NCOP). While the DPD was established to strengthen regional representation following Indonesia's decentralization reforms, its legislative role in fiscal policymaking remains institutionally constrained. Existing scholarship has primarily focused on the DPD's constitutional status in debates on bicameralism, with comparatively little attention to how constitutional design shapes the role of territorial chambers in fiscal governance and intergovernmental fiscal relations. Using a normative legal research method that combines statutory, conceptual, and comparative …

Geoengineering And Criminal Liability Comparative Lessons For Penal Reform, Zico Junius Fernando, Deviana Yuanitasari, Chairul Huda, Muhammad Yamani, Arimbi Fajari Furqon

Padjadjaran Jurnal Ilmu Hukum (Journal of Law)

Geoengineering has emerged as a controversial climate technology involving large-scale interventions such as cloud seeding, weather modification, and unregulated carbon capture. While these practices are promoted as solutions to climate change, they also generate significant ecological risks that remain largely unaddressed within criminal law frameworks. This article examines the absence of explicit criminal liability for geoengineering-related harms and explores how comparative legal experiences can inform future penal reform. This research uses normative research methods with several approaches, including comparative, conceptual, and futuristic approaches. The collected legal materials are analysed qualitatively, and content analysis is employed to classify and interpret relevant …

The Expansive Power Of The House Of Representatives As A Precondition For Constitutional Rot, Isnawati Isnawati, Adam Setiawan

Padjadjaran Jurnal Ilmu Hukum (Journal of Law)

This study examines how the expansive powers of the Indonesian House of Representatives have contributed to constitutional rot because those powers no longer operate effectively or proportionately. It identifies dysfunction in the House of Representatives through weak legislative performance, inadequate oversight of the executive branch, and transactional political practices in appointment processes. Using a doctrinal legal method and contemporary constitutional theory as its analytical framework, this study argues that the expansive powers of the House of Representatives constitute a precondition for constitutional rot, evidenced by the poor exercise of legislative authority and institutional intervention through amendments to the Rules of …

Reconstructing Legal Certainty In Legacy Oil Well Management: A Systemic Model For Resource Governance, Azhar Azhar, Bagaskara Sagita Wijaya, Siti Darwinda Mohamed Pero, Cynthia Azhara Putri

Padjadjaran Jurnal Ilmu Hukum (Journal of Law)

Legacy oil wells present persistent legal and institutional challenges in resource-dependent regions, where ageing infrastructure, informal extraction, environmental risk, and fragmented public authority intersect. This article examines how legal certainty is weakened in the management of legacy oil wells and how it may be reconstructed through a systemic model for resource governance. Using interdisciplinary socio-legal research, the study combines doctrinal legal analysis of Indonesia's oil and gas regulatory framework with qualitative field insights from Musi Banyuasin, a subnational setting in which formally recognised legacy wells coexist with community-operated wells. The analysis shows that legal uncertainty does not arise merely from …

Bank Indonesia's Floating Rate Notes (Bi-Frn) And Federal Reserve Instruments: A Comparative Analysis From An Institutional-Legal Perspective, Abdul Madjid Podungge

Padjadjaran Jurnal Ilmu Hukum (Journal of Law)

This paper analyses the legal validity of Bank Indonesia's Floating Rate Notes (BI-FRN) following the Law Number 4 of 2023 on the Development and Strengthening of the Financial Sector (P2SK Law) from a public law viewpoint. Doctrinal legal research utilises statutory, conceptual, and comparative methodologies, augmented by literature network visualisation, to pinpoint structural deficiencies. The network analysis reveals a significant divide between technical financial transactions and administrative legal oversight. The findings indicate that Article 11 of the P2SK Law enforces a stringent priority clause that centres monetary policy solely on Rupiah stability. This legal barrier prohibits abuse of power by …

How U.S. Legal Stagnation Can Be Aided By Decolonization, Marquel Gardner

McNair Summer Research Program

Decolonization is a term often used to present a simple shift from colonial thinking, heavily maintaining the establishment of colonial systems today. However, this usage oversimplifies and overshadows the word’s key purpose. Common proclamations of the term forgo the fundamental indigenous essence behind the word. Doing so, we not only strip the word of its inherent power, but obstruct further possibilities for actual decolonization to appear in our world. Many argue that the U.S. legal system, a product of colonial factors, has reached an alarming state. Our current legal, political atmosphere gears not towards justice or morality, but fascism and …

Two Paths Of Criminal Law Reform: From Shared Colonial Legacies To Divergent Legal Trajectories In Indonesia And Malaysia, Ade Adhari, Charisse Evania Tansir

Indonesia Law Review

Despite sharing colonial legacies in the development of their criminal law systems, Indonesia and Malaysia have pursued markedly different paths of criminal law reform, reflecting their distinct legal traditions and legislative philosophies. This article examines how these divergent reform trajectories are manifested through a comparative analysis of Indonesia's Law Number 1 of 2023 on the Criminal Code and Malaysia's Penal Code (Act 574). Focusing on three analytical dimensions—the principle of legality, criminal responsibility, and sentencing policy—the study adopts a normative legal research method supported by statutory, conceptual, and comparative approaches. Legal materials were collected through library-based research and analysed qualitatively …

The Eu’S Copyright Legislation For Generative Ai: Relevant To Indonesia?, Yolanda Simbolon

Indonesia Law Review

Tremendously copyrighted works are used to train Generative AI (Gen-AI) at the epicenter of current sectors. In many countries, there is a dilemma as to whether the amount of data used may infringe copyright. The EU is the one that has regulations on the use of copyrighted works as text and data mining (TDM) to train GenAI.  Meanwhile, Indonesia does not yet have a regulation, even though Gen-AI has been massively developed in Indonesia. Data has been used freely to train Gen-AI, even to modify works and damage the author’s reputation. This article investigates whether the EU’s copyright of Gen-AI …