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Breakthrough or Breakaway Innovation?
No full textThis article argues that expedited regulatory review programs for innovative products, like the Food and Drug Administration’s (FDA) Breakthrough Devices Program (BDP), should not be paired with immunity from tort liability for those products and their developers. Doing so both limits the ability of regulators to manage the risks of new products while simultaneously undermining incentives for their developers to adopt internal systems that address those risks. In non-emergency contexts, expedited review and liability immunity together could elevate innovation as a policy goal in the short-term above the more fundamental principles of safety and effectiveness for those new products over time and across populations. At minimum, if these two policies are deployed at once, they should only occur in the context of heightened regulatory supervision over those products both during and after review, backed up by a strong legal mandate for the regulator and adequate resources to conduct supervision.
To make this argument, the article provides an in-depth analysis of the FDA’s Breakthrough Devices Program, an initiative from the 21st Century Cures Act for promoting innovation in medical devices by reducing scrutiny of their safety and effectiveness. The analysis applies doctrinal and empirical approaches to explore the Program’s legal foundations, current operations, and implications of liability preemption for patients and device manufacturers. Some patients have already been harmed by breakthrough devices and, while the Cures Act leaves some legal uncertainty, doctrinal analysis shows those patients appear likely to have limited remedies in tort law against some of these devices due to federal liability preemption. The article argues for loosening the current federal preemption of state-level tort liability for medical devices that were approved through the BDP, paired with greater regulatory supervision by the FDA both during and after the Program. While innovation remains an important policy goal, it should never surpass safety as a core regulatory imperative for novel products
Pharmaceutical Mergers: Do We Have The Right Cure?
No full textFew federal agencies wield tools more powerful than the Federal Trade Commission’s authority to review—and deny—proposed mergers between companies. This authority is powerful for a reason: Large mergers can be uniquely harmful to the United States economy, potentially reducing competition, undercutting consumer choice, and inflating prices.
The pharmaceutical industry is particularly sensitive to merger harms, given the limited number of competitors and the inelasticity of demand for prescription drugs. As a result, when pharmaceutical companies seek to merge, the FTC often requires that one of the companies divest ownership of certain drugs not yet on the market—so-called “pipeline” drugs––to a third party.
FTC evaluations deem the pipeline divestiture program a complete success. But does it really work? As a client once said when asked this question, “It depends on what you mean by ‘it’ and ‘work.’” In prior research, the FTC determined the success of a divestiture based solely on whether it occurred––rather than whether it meaningfully preserved competition post-merger. Our first-of-its-kind study reveals that pipeline divestitures have not in fact worked. Using conservative measures, our analysis shows that 81% of divested pipeline products fail to attain even a 1% share of their relevant markets.
But all is not lost: With a few key changes, drug divestiture can indeed achieve its intended effects. We recommend that the FTC require either a “crown jewel divestiture” (selling the on-market product, not the pipeline product) or a “skin in the game divestiture” (if the pipeline product fails, the company divests its on-market product)
Forget Me Not? Machine Unlearning's Implication for Privacy Law
No full textGenerative AI systems are increasingly relied on and are already actively reshaping how we think about privacy and data protection law. Models ingest and process vast amounts of personal and sensitive data, challenging assurances of compliance with legal frameworks like the General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA) with increasing intensity. Machine unlearning is an emerging tool in practitioners’ attempts to address these challenges: the act of selectively removing or suppressing specific data, such as personal data that a data subject requests be deleted, from AI models as means of complying with legal obligations or policy goals. This Article’s much-needed analysis of unlearning’s technicalities and uses builds on recent critical scholarship that examines unlearning’s limitations at the technical and policy level. It delves deeper into machine unlearning’s implications for privacy and data protection law by situating it within privacy law’s broader ecosystem and proposing actionable pathways for integrating unlearning into enforcement and policy. Specifically, this Article evaluates whether privacy laws’ legal, remedial, and normative aspirations can be reconciled with the technical realities of machine unlearning in generative AI systems. It also contributes to the privacy profession by proposing a framework for integrating machine unlearning into broader privacy-preserving interventions. In doing so, the Article positions machine unlearning as both a vital new tool as well as a site of contestation in the evolving landscape of privacy and AI governance while providing a forward-looking roadmap for aligning machine unlearning with privacy law’s goals
Hiding in Plain Sight: An Empirical Study of Prosecutorial Bias in AI Legal Analysis
No full textArtificial intelligence is beginning to shape the criminal justice system, but scholars have largely overlooked its impact on prosecutors—the system’s most powerful actors. This gap is significant because large language models are particularly well-suited to legal work, where analysis and writing are central. Companies now market AI tools that prepare “a first draft of potential charges” and legal memos, promising to “turn 1 day” of work “into 1 hour.” With heavy caseloads and few guardrails, prosecutors may be quick to adopt them, and some offices already report using AI to draft charging documents and analyze evidence.
We conducted a large-scale experiment examining how AI might influence prosecutorial decision-making. Using real police reports from common low-level offenses, we asked a widely used ChatGPT model to generate over 140,000 legal memos. While we anticipated signs of racial bias, we discovered a more foundational issue: the model exhibits a prosecutorial default bias. It systematically recommends prosecution–even when prompted from a defense perspective, confronted with minimal evidence, or presented with clear constitutional violations.
These findings raise urgent questions about the integration of AI into legal workflows. We explore the role of automation bias—the pattern, even among highly trained professionals, to defer to algorithmic suggestions—and how it may anchor human decision-making toward harsher outcomes. We also examine how systems that fail to recognize Fourth Amendment violations risk eroding constitutional protections in ways that efficiency gains alone cannot justify. Finally, we argue that prosecution-oriented AI tools raise democratic concerns: America’s prosecutors are accountable to voters and local values, but AI systems may transfer key aspects of criminal justice policymaking from elected officials who answer to their communities to private companies optimizing for different objectives. We conclude by identifying areas for further research, and suggest evaluation protocols, enhanced professional responsibility standards, and regulatory safeguards—particularly relevant given recent federal mandates for “unbiased” and ideologically neutral AI—to help ensure that AI tools serve justice rather than subvert it
The “Lamp of Hind” in Cairo: How an Indian Jurist Became the Chief Hanafi Judge of the Mamluk Sultanate in the Fourteenth Century
No full textThis article explores scholarly exchange across the Arabian Sea in the fourteenth century with respect to Islamic law. It connects legal contexts from the Delhi Sultanate to the Cairo Sultanate and shows how the Sunni legal schools (madhhabs) and the recently emergent system of legal pluralism shaped transoceanic exchanges of scholarship. In particular, this article focuses on the career of Sirāj al-Dīn al-Hindī (d. 773/1372), an Indian scholar who traveled from Delhi via Mecca to Cairo, and then built an accomplished career that culminated with him as chief Hanafi judge in Cairo. It examines his relationships with Turkish mamluks and sultans as well as his prolific writings to uncover their shared investment in the Hanafi madhhab and the significance of ongoing transregional debates between the Hanafi and Shafiʿi legal schools. In so doing, this article sheds light on a missing history of how Mamluk initiatives towards expanding legal pluralism between the madhhabs created new opportunities across the Indian Ocean for Hanafi jurists like Sirāj al-Dīn. Hence, it widens our understanding of premodern Islamic intellectual exchange between South Asia and the Middle East, showing how South Asia also served as an exporter of Islamic scholarship and legal expertise rather than its peripheral recipient
The Protectionist Bar Against Foreign Lawyers in Japan, China, and Korea: Domestic Control in the Face of Internationalization
Full text linkWith the advent of the new millennium and a rapidly changing international outlook, Japan, China, and Korea' have been at the forefront of recent media attention, focused primarily on the rapidly gaining influence and power that these countries wield on a level no longer limited to Asia. Some observers argue that these countries have untapped economic potential, especially with regard to China, which is in the position to become a global economic powerhouse as its economy continues to grow and expand internationally. Furthermore, participation in the World Trade Organization and other multilateral agreements, such as GATS, has created the need for a global standardization of services offered to support and safeguard the rights of foreign investors.
The gradual opening of these three major players in East Asia to international organizations and standards suggested to many observers that the legal services market, under the same premise, would also be opened to foreigners who wished to practice the law of their home countries abroad. However, the current trend suggests otherwise. Recent revisions to China's Lawyers Law put stricter standards and compliance measures on foreign lawyers and foreign law firms, while Japan still prevents Japanese lawyers (bengoshi) from being hired by non-Japanese firms. Korea won't even permit foreign law firms to set up shop in their country. What force is behind the protectionist nature of the largest East Asian economies regarding legal services and the relationship between domestic and foreign lawyers?
One important difference between these three countries' legal systems is the role of the lawyer within the system, and more specifically, the number of "lawyers" currently existing within the system. China, with over 110,000 lawyers, has structured a very different legal community than Japan, where the exceedingly strict pass rate on the Japanese bar exam means that only 1,000 Japanese can become lawyers each year. This number does not, however, include the separate positions of patent agent (benrishi), tax agent (zeirishi), in-house corporate attorneys, drafters of private legal documents (shiho shoshi) and document drafters for administrative agencies (gyosei shoshi), which greatly increases the number of the legal community if the definition of "lawyer" is an open one.
Another fundamental difference in the legal systems of these three countries lies in the structure of their bar associations. While China's Ministry of Justice ("MOJ") has actively played the functional role of China's bar association, Japan's tiered bar system and Korea's independent bar association have remained separate from each country's Ministry of Justice, creating at times inconsistent policy decisions between the bars and the governments. The differing connections between the state and the lawyer population for each of the three countries might also suggest something about the level of strictness with which each country chooses to regulate its foreign lawyer population. For example, a more tightly controlled, government-regulated community might implicate a different set of regulations and barriers than a country where there is a more loosely structured relationship between the state actor and the private community.
This paper argues that the interplay between each country's Ministry of Justice and its local bar association creates a pervasive protectionist atmosphere surrounding the legal profession, with strongly perpetuated domestic worries over job security being the driving factor behind the stringency of recent changes to the regulations. While the degree and means of protectionism vary by country due to individual characteristics inherent to each nation, the uniform concept of state management and involvement in the private legal sector shared between these countries helps to create pervasive protectionist control over the legal profession in all three. With the government and, in certain cases, the local bar associations having so much pull over regulations dealing with foreign lawyers, this effectively creates a lockout for foreign lawyers in certain crucial sectors of the legal services market. While cooperation with the WTO and other multinational standards is likely, at least more openly than before, the protectionist force in each of these countries will be hard to unseat through the simple threat of defaulting on international agreements
The Mental Health of Indonesian Male Breadwinners: Family Harmony as a Moderator Between Perceived Stress and Psychological Well-Being
Full text linkThese days, despite the increasing attention directed to mental health, men are typically placed on the back burner of these discussions due to the social stigma that men are supposed to be strong breadwinners. Multiple studies have found a negative association between perceived stress and psychological well-being, ergo, it is important to expand these studies to include the well-being of male breadwinners. Other literature has also suggested that the presence of a harmonious family might help buffer the effects of stress on well-being. Therefore, this study consisting of 304 participants aimed to understand the relationship between perceived stress and psychological well-being, and whether family harmony can moderate this relationship in male breadwinners. Results from linear regression models found that perceived stress predicted psychological well-being in male breadwinners (R² = .30, p < .01), and the moderated regression models also showed family harmony to be a significant moderator between perceived stress and psychological well-being in male breadwinners (R² = .40, β = -.04, p < .001, 95% CI [-.06, -.02]). Aside from adding to the body of research on stress and family psychology, the practical implications of this study highlight the need for family-centered therapy and workplace policies that support the well-being of male breadwinners