TortsProf Blog

Editor: Christopher J. Robinette
Southwestern Law School

Tuesday, May 21, 2024

Goldberg & Trask on No-Injury and Piggyback Class Actions

Phil Goldberg & Andrew Trask have published No-Injury and Piggyback Class Actions:  When Product-Defect Class Actions Do Not Benefit Consumers.  The abstract provides:

Class counsel are more frequently filing product-based class actions that, whether
successful or not, offer few practical benefits to real consumers or class members.
These no-benefit class actions cause the unnecessary expense of the courts’ time and
resources, and they often fail to provide actual value to class members while still
producing substantial attorneys’ fees. This article explores why strategic vagueness in
plaintiffs’ filings and a lack of vigorous analysis by the courts have allowed no-benefit
class actions to unnecessarily consume court resources. The article concludes by
offering suggestions for how courts can alleviate some of this pressure, primarily by
requiring judges to follow and enforce Federal Rules of Civil Procedure Rule 23(b)(3)
as the rule was written and intended.

May 21, 2024 in Legislation, Reforms, & Political News, Scholarship | Permalink | Comments (0)

Monday, May 20, 2024

Concluding the Restatement (Third) of Torts Papers Available

Last year, Southwestern Law School, in conjunction with the Panish Civil Justice Program and ALI, held a symposium on Concluding the Restatement (Third) of Torts.  Papers and transcripts from the symposium are now available on the Southwestern Law Review's website.  Special thanks to Elena Cordonean, the editor-in-chief, for all her work on the project.

i Table of Contents (PDF
 351

Concluding the Restatement (Third) of Torts: An Introduction (PDFByron G. Stier and Christopher J. Robinette 

358

A Brief Introduction to the American Law Institute and the Restatements of Torts (PDFHon. Goodwin H. Liu

364

The American Law Institute and the Restatement (Third) of Torts: Presentation of Michael Green (PDFMichael D. Green

369

Tort Theory and the Restatement, in Retrospect (PDFKeith N. Hylton

399

Is the Third Restatement of Design Defect a Defective Product? (PDFGregory C. Keating

428

The Role of Tort Theory in the Third Restatement of Torts: An Explanation and Defense (PDFKenneth W. Simons

444

Tort Theory and the Restatements: Presentation of Catherine Sharkey (PDFCatherine M. Sharkey

450

Informed Consent in the Restatement of Medical Malpractice (PDFMark A. Hall

465

Modernizing the Medical Malpractice Standard of Care (PDF) Philip G. Peters, Jr.

478

Informed Consent in the New Restatement on Medical Malpractice: A Friendly Critique (PDFNina A. Kohn

484

Keynote Symposium Presentation of Brian Panish and Jesse Creed (PDFBrian Panish and Jesse Creed

493

The Equity of Tort Claims for Medical Monitoring (PDFMark A. Geistfeld

512 The Restatement (Third) of Torts Proposes Abandoning Tort Law’s Present Injury Requirement to Allow Medical Monitoring Claims: Should Courts Follow? (PDFVictor E. Schwartz and Christopher E. Appel
543

Trauma Damages (PDFMartha Chamallas

580

Why Courts Should Continue to Reject Innovator Liability Theories that Seek to Hold Branded Drug Manufacturers Liable for Generic Drug Injuries (PDFMark A. Behrens and Christopher E. Appel

607 Damages: Symposium Presentation of Anthony Sebok (PDFAnthony J. Sebok
615

Damages: Symposium Presentation of Ibiere Seck (PDFIbiere N. Seck

618

Damages and Trial Practice: Symposium Presentation of Judge Kevin Brazile (PDFHon. Kevin C. Brazile

May 20, 2024 in Conferences, Scholarship | Permalink | Comments (0)

Wednesday, May 15, 2024

JOTWELL Torts: Engstrom on Parikh on Mass-Tort Financing

At JOTWELL, Nora Freeman Engstrom reviews Samir Parikh's Opaque Capital and Mass-Tort Financing.

May 15, 2024 in Scholarship, Weblogs | Permalink | Comments (0)

Monday, May 13, 2024

Abraham on Free Speech and Liability Insurance

Ken Abraham has posted to SSRN Free Speech, Breathing Space, and Liability Insurance.  The abstract provides:

In New York Times v. Sullivan (1964), the Supreme Court began adopting First Amendment restrictions on liability for defamation and other speech torts (invasion of privacy and intentional infliction of emotional distress), so as to create “breathing space” -- additional protection against liability for speech that has no constitutional value in itself. The idea was that the threat of tort liability should not have a “chilling effect” on constitutionally protected speech.

Alongside the rules affording breathing space for the exercise of free-speech rights is a little-known but highly important liability insurance regime that also affords breathing space, by covering defendants against liability for harm caused by unprotected speech. The theory of constitutionally required breathing space, however, takes no account of the role that this insurance against speech-tort liability plays in the operation of free speech, in theory and in practice. There have been decades of extensive legal scholarship about the First Amendment’s restrictions on speech-tort liability. Yet this scholarship wholly ignores the fact that all of the liability for the speech torts that the First Amendment does permit can be and often is covered by liability insurance. In the last few years, Supreme Court Justices Clarence Thomas and Neil Gorsuch have separately criticized existing constitutional limitations on liability for defamation as too broad, without any mention of the widespread existence and availability of insurance protecting against liability for defamation. The Justices’ criticisms of defamation law garnered a lot of attention and a barrage of responses, which have also omitted any reference to the possible relevance and significance of liability insurance to the debate about the proper scope of defamation liability.

This Article takes insurance against speech-tort liability out of the shadows, bringing First Amendment theory and doctrine into the orbit of thinking about liability insurance and its operation in practice. The Article identifies and analyzes the sources and scope of the coverage that insurance provides against speech-tort liability, combining insights about the complex and intertwined consequences of the threat of speech-tort liability with what we know about how liability insurance both creates breathing space and attempts to mitigate excess risk-taking by those who are insured. Finally, the Article considers the relevance of liability insurance to analysis of the speech torts, arguing that, with an awareness of the breathing space that liability insurance provides on the table, we cannot avoid what would amount to a wholesale review of the proper scope of constitutional protections against speech-tort liability.

May 13, 2024 in Scholarship | Permalink | Comments (0)

Thursday, May 9, 2024

Tort Law & Social Equality Project: Dagan & Dorfman on the Value of Personal Rights of Action

On Friday, May 17, at noon (EST), Hanoch Dagan & Avihay Dorfman will present "The Value of Personal Rights of Action."

The paper claims claim that contemporary champions of personal rights of action do not explain why and when these rights matter. Moreover, contemporary critics of these rights do not explain why all such rights should be replaced with other alternatives to the traditional system of common-law litigation, such as collective litigation. Their core thesis is that some personal rights of action can be valuable in and of themselves – that is, they carry freestanding value, beyond their contribution to vindicating plaintiffs’ substantive rights. On other cases, personal rights of action are legal technologies that are rightly dispensable with others if these replacements can better ensure the vindication of private plaintiffs’ rights. The key question, therefore, is not only whether personal rights of action are intrinsically valuable, but rather when. Dagan and Dorfman employ the normative framework of relational justice to address these questions. 

The flyer (with a Zoom link) is here:  Download Dagan & Dorfman

May 9, 2024 in Conferences, Scholarship | Permalink | Comments (0)

Tuesday, May 7, 2024

Rozenshtein on Section 230

Alan Rozenshtein has posted to SSRN Interpreting the Ambiguities of Section 230.  The abstract provides:

As evidenced by the confusion expressed by multiple Justices in last Term’s Gonzalez v. Google, there is little consensus as to the scope of Section 230, the law that broadly immunizes internet platforms from liability for third-party content. This is particularly striking given that no statute has had a bigger impact on the internet than Section 230, often called the “Magna Carta of the internet.”

In this essay I argue that Section 230, despite its simple-seeming language, is a deeply ambiguous statute. This ambiguity stems from a repeated series of errors committed by Congress, the lower courts, and the Supreme Court in the drafting, enactment, and early judicial interpretation of the statute.

This diagnosis, which I lay out in Part I, sets the stage for Part II, in which I consider three potential paths forward for the judicial interpretation of Section 230. In particular, I focus on a novel interpretative approach, by which courts would interpret Section 230 immunity narrowly in order to spur large technology companies to lobby Congress to act, thereby forcing Congress to clarify the scope of platform intermediary liability. But this approach carries substantial risks of disrupting the internet in the time between the judicial reinterpretation of Section 230 and Congress’s response, and thus represents at best an imperfect solution to the legislative and judicial mistakes that attended Section 230’s origins.

May 7, 2024 in Scholarship | Permalink | Comments (0)

Thursday, May 2, 2024

Engstrom et al. on Protective Orders

Nora Freeman Engstrom, David Freeman Engstrom, Jonah B. Gelbach, Austin Peters, and Aaron Schaffer-Neitz have posted to SSRN Secrecy by Stipulation.  The abstract provides:

GM Ignition Switch. Dalkon Shield. Oxycontin. For decades, protective orders—court orders that require parties to maintain the confidentiality of information unearthed during discovery—have hid deadly defects and pervasive abuse from the public, perpetuating unnecessary harm.

But how worrisome are these protective orders, really? Under Rule 26(c)’s plain language, protective orders are to be granted only upon a showing of “good cause.” Doesn’t that adequately cabin the orders’ entry? Prominent judges and scholars have long insisted it does and that, under Rule 26(c), the day-to-day grant of protective orders is careful, not cavalier. Critics disagree. They charge that parties frequently agree to sidestep Rule 26(c)’s “good cause” requirement and that judges, although formally duty-bound to protect the public interest, uncritically acquiesce to their demands. Worried about judicial rubber-stamping, some, in fact, have spent decades pushing to tighten Rule 26(c)’s standards—while others have, just as vigorously, opposed these efforts, insisting that the status quo works well enough.

This debate has raged since the late 1980s. But until now, it’s mostly run aground on the shoals of basic, but unanswered, factual questions: Are stipulated protective orders really de rigueur? Are they becoming more prevalent? And are joint motions for protective orders actually meticulously scrutinized?

Using state-of-the-art machine-learning techniques, this Article analyzes an original dataset of over 2.2 million federal cases to answer these persistent and profoundly important questions. Along the way, we find that stipulated protective orders are surprisingly prevalent. Grant rates for stipulated protective orders are sky high. And even though many insist that judges are scrupulous in the entry of such orders, over our entire study period, a majority of federal judges never ever rejected a joint protective order request.

We offer the first comprehensive accounting of stipulated protective orders in federal litigation. In so doing, we aim not only to revitalize—and discipline—the perennial and consequential debate surrounding Rule 26(c). We also offer a fortified empirical foundation on which to ground inquiry into broader questions, including the role of transparency and privacy in a system ostensibly committed to “open courts,” tort law’s vital information-forcing function, adversarialism as a procedural cornerstone of American litigation, and trial-court discretion and fidelity to higher law.

May 2, 2024 in Scholarship | Permalink | Comments (0)

Tuesday, April 30, 2024

Fox-Decent on the Moral Authority of Rulings

Evan Fox-Decent has posted to SSRN The Moral Authority of Rulings.  The abstract provides:

In Rights, Wrongs, and Injustices, Steve Smith argues that substantive legal rules, sanctions for breaking them, and judicial remedial orders are fundamentally distinct. A remedial order consists in a specific command addressed to a particular defendant, with the expectation that the defendant will comply voluntarily. One puzzle raised by remedial orders is why courts bother with them at all, since it seems they could simply right the wrong by skipping directly to a sanction when the relevant rule has failed to motivate. Smith suggests that practical considerations resolve the puzzle. His argument, roughly, is that it would be too costly to use public institutions to transfer property or take other action to right every judicially recognized private wrong. Were the direct imposition of sanctions costless (or of negligible cost), remedial orders would appear anachronistic and, by hypothesis, under-motivated. I suggest a complementary resolution to the puzzle. I argue that remedial orders can be understood as courts’ attempt to allow wrongdoers to redeem themselves and reassert their moral standing as equals. While remedial orders correct the injustices plaintiffs have suffered and thereby restore plaintiffs’ moral equality, they also allow wrongdoers to publicly acknowledge their transgressions and affirm their commitment to equal justice under law. This moralized account of orders sits congenially with Smith’s otherwise moralized account of private law. And importantly, on the moral account, even if the practice of issuing judicial orders were shown to be more costly than direct sanctions, there would still be reason, however defeasible, to maintain the practice.

April 30, 2024 in Scholarship | Permalink | Comments (0)

Thursday, April 25, 2024

Bublick on the Art of the Treatise

Ellie Bublick has posted to SSRN In Praise of the Treatise Writer:  Law's Special Knowledge.  The abstract provides:

What is the special knowledge that law has? In this paper, Professor Bublick lauds the work of her late colleague, tort law treatise writer Dan B. Dobbs (1932-2024).

April 25, 2024 in Scholarship | Permalink | Comments (0)

Tuesday, April 23, 2024

BNSF Railway Liable in Asbestos-Related Deaths of Two in Libby, MT

Yesterday, a federal jury found that BNSF Railway is liable in the deaths of two Libby, MT residents and awarded their estates $4 million each.  The jury concluded that a spill of abestos-contaminated vermiculite in the Libby Railyard was a substantial factor in the illnesses and deaths of the pair.  Libby is known for being adjacent to a vermiculite mine operated by W.R. Grace; the mine was closed in 1990.  Grace has paid significant settlements to victims in Libby.  Another suit against the railroad for the death of a Libby resident is scheduled for federal court in Missoula next month.  News 5 Cleveland has the story.  Thanks to Louis Mowers for the tip.

April 23, 2024 in Current Affairs | Permalink | Comments (0)

Monday, April 22, 2024

Sharkey on Platform Liability and Deterrence

Cathy Sharkey has posted to SSRN The Irresistible Simplicity of Preventing Harm.  The abstract provides:

In Loomis v. Amazon.com, the California Court of Appeal confronts the most pressing products liability issue of our time: the extent to which an online marketplace is liable for injuries caused by defective products sold on its platform. In a trailblazing concurrence destined to enter the torts canon, Justice John Wiley highlights Amazon’s ability to influence the safety of the products it makes available for sale, and uses the case to remind us that the “deep structure of modern tort law” is built to “minimize the social costs of accidents.” Similarly, Justice Wiley cuts a clear path through the thicket of the economic loss rule, institutional (or vicarious) liability and punitive damages cases by following the torts lodestar: the irresistible simplicity of preventing harm.

April 22, 2024 in Products Liability, Scholarship | Permalink | Comments (0)

Friday, April 19, 2024

Swan on Public Duties for the New City

Sarah Swan has posted to SSRN Public Duties for the New City.  The abstract provides:

The first job of a government is to protect its people, and, in the United States, the government ostensibly performs this job through the police. But policing in America is deeply dysfunctional, as the police not only provide inadequate protection from violent crime, but simultaneously engage in outright acts of brutality against the citizenry. As awareness of these practices has swept across the nation, legal scholars and policymakers have offered numerous reforms and remedies to help solve policing’s problems. The responses have tended to focus on the top of the legal pyramid, using the big hammers of the federal government, the Constitution of the United States, the federal remedies of Section 1983, and the qualified immunity doctrine of federal courts as the requisite tools for reform. More recently, as these efforts have faltered, scholars and policymakers have begun to explore the possibilities for change at the state and local level.

This Article, too, begins at the bottom. While the proposed fixes to the federal framework are indeed important, this Article argues that changes at the lower, foundational level of cities, local governments, and common law duties of care are equally so. Policing is, after all, a fundamentally local matter, with thousands of municipal and county governments responsible for its administration. And duties of care are the most basic articulation of the norms and obligations flowing between members of our society, shaping not just private relations, but the government-constituent relationship as well. This Article argues that attending to these roots offers an opportunity to reorient the police-citizen relationship and recast the relational norms between local government actors and their constituents more generally. In particular, this Article argues that the “public duty doctrine”—a no-duty rule that immunizes municipalities from civil liability arising from police violence and failures to protect—has contributed to a profoundly unbalanced and perverse local-constituent relationship. To reestablish just relations, localities should bear, and indeed embrace, a legally
enforceable duty of care to protect their constituents.

Such a duty would not open the liability flood gates, nor impose catastrophic expenses on cities, nor expand the already oversized footprint of policing. Such a duty would, however, achieve the usual tort goals of compensation and deterrence, significantly reduce the harms that police and other governmental actors visit on city constituents through both their action and inaction, align with corrective justice principles, enhance democratic accountability, advance the constitutional principle of equal protection, and accord with the thick conception of the city-constituent relationship that cities themselves put forward in the affirmative litigation context.

Further, implementing this duty on the ground would not be difficult. Neither courts nor legislatures need do anything at all; many cities could simply choose to not avail themselves of the public duty defense and instead accept an owed duty. Doing so would not only reorient the city-constituent relationship in a profoundly more positive way; adopting this duty would also serve cities’ broader self-interest. As cities increasingly vie for political recognition and acknowledgement as independently legitimate polities on both the domestic and international stage, this Article draws on the burgeoning sovereignty-as-responsibility literature to argue that by embracing a duty to protect, cities can advance their own status as credible, politically important actors in the wider American democratic project.

April 19, 2024 in Scholarship | Permalink | Comments (0)

Wednesday, April 17, 2024

Rabin on Stand Alone Emotional Harm

Bob Rabin has posted to SSRN Stand Alone Emotional Harm:  Old Wine in New Bottles.  The abstract provides:

In their contribution to the 2023 Clifford Symposium on Tort Law and Social Policy, Professors Kenneth Abraham and G. Edward White advance the interesting thesis that the ancient tort of offensive battery, initially recognized under the writ of trespass, and later substantiated in the three iterations of the Restatement of Torts, has experience newfound popularity in its linkage to federal statutory claims of sex discrimination under Title VII of the Civil Rights Act of 1964 and constitutional deprivation of civil rights in Section 1983 cases.

In Part I of this essay, I provide a broader context on the long history of misconduct generating a claim for “offensive” behavior without physical harm. Then, in Part II, I address the many pathways of a far more expansive conception of recoverable stand-alone emotional harm that rests on cultural change in a distinctly modern-day setting. Finally, I offer some concluding observations.

April 17, 2024 in Scholarship | Permalink | Comments (0)

Monday, April 15, 2024

Tyco Fire Products Agrees to Settle "Forever Chemicals" Lawsuit for $750M

On Friday, Tyco Fire Products, a subsidiary of Johnson Controls, announced it had reached a $750 million settlement with some U.S. public water systems.  Plaintiffs alleged that a firefighting foam manufactured by Tyco contained forever chemicals that contaminated their water supplies.  The contaminants, per- and polyfluoralkyl substances ("PFAs),:

are a class of chemicals used in thousands of consumer and commercial products, including firefighting foams, non-stick pans and stain-resistant fabrics. They have been tied to cancers and other diseases, and are often called forever chemicals because they do not easily break down in nature or the human body.

The cases have been centralized in an MDL in South Carolina.  Reuters has the story.

April 15, 2024 in MDLs and Class Actions | Permalink | Comments (0)

Thursday, April 11, 2024

Bennett: Principles of the Law of Agency (2d ed.)

Howard Bennett has published Principles of the Law of Agency (2d ed.) with Bloomsbury.  The blurb provides:

The 2nd edition of this successful book provides a fully updated, succinct examination of the principles of agency law.

The book explores the rules of attribution, the rights and obligations arising within the agency relationship, the impact of agency in the fields of contract and tort, and the termination of an agent's authority. Throughout the book, full consideration is given to the issues arising under the Commercial Agents (Council Directive) Regulations 1993. The discussion is informed not only by common law authority that constantly nourishes the development of agency law principle, but also by international soft law instruments and the Restatement of the Law, Third: Agency.

Discount Price: £31.99

Order online at www.bloomsbury.com  – use the code GLR AT5 to get 20% off!

April 11, 2024 in Books | Permalink | Comments (0)

Wednesday, April 10, 2024

Tort Law and Social Equality Speakers Series: Koshan & Sowter on Family Violence

 On Friday, April 19 from 12pm-1:30pm (EST), Jennifer Koshan (Calgary) and Deanne Sowter (Osgoode) will speak on the tort of family violence.  The Zoom link is in the attached poster:   Download Koshan & Sowter

“The Tort of Family Violence and its Potential to Remediate the Consequences of Abuse”
 
Torts – even intentional torts – were not traditionally conceived of as a means of redressing intimate partner violence (IPV). Within the last fifty years, Canadian tort law (and related limitations laws) have evolved to allow IPV survivors to seek tort-based remedies. However, these remedies have been sought rarely and have been largely limited to existing categories of intentional torts such as assault, battery, and the intentional infliction of emotional distress. These torts do not always encompass the myriad harms sustained by survivors of IPV, particularly the harms of economic abuse and coercive control. In Ahluwalia v Ahluwalia, a 2022 family law decision, Justice Renu Mandhane responded to this gap in the law by recognizing a new tort of family violence, but her decision was overturned by the Ontario Court of Appeal in 2023. Our presentation will provide an intersectional feminist analysis of the role of tort law in providing remedies for survivors of IPV, situating tort remedies within the wider context of Canadian IPV laws as well as tort theory and critiques. This wider context raises issues about access to justice and socio-economic responses to IPV for members of marginalized groups in particular.
 
Jennifer Koshan is a Professor in the Faculty of Law and Research Excellence Chair at the University of Calgary. Jennifer’s research and teaching focus on equality and human rights, legal responses to interpersonal violence, and access to justice. With a number of colleagues across the country, she recently completed a project on Domestic Violence and Access to Justice Within and Across Multiple Legal Systems that was funded by the Social Sciences and Humanities Research Council. Research from the project includes work published here and here. Jennifer has also been working with colleagues in Nursing and Social Work at the University of Calgary on an interdisciplinary course module on gender-based violence using virtual gaming simulation. She blogs on domestic violence and other issues on ABlawg.ca, and regularly presents her research to judges, lawyers, and other academic and professional audiences. Jennifer also sits on the National Association of Women and the Law’s Violence Against Women Working Group, and regularly works with the Women’s Legal Education and Action Fund (LEAF) on its projects.
 
Deanne Sowter is a doctoral candidate and Vanier Scholar at Osgoode Hall Law School. She is also a Research Fellow with the Winkler Institute for Dispute Resolution. Deanne’s research focuses on gender-based violence, family law, and legal ethics, and it has been supported by SSHRC and several prestigious fellowships and scholarships including the Honourable Willard Z Estey Teaching Fellowship and the OBA Foundation Chief Justice of Ontario Fellowship in Legal Ethics and Professionalism Studies.
 
Deanne’s work has been published in several peer-reviewed journals and it has been cited by the Supreme Court of Canada. She has taught as an Instructor at the University of Calgary and as an Adjunct Professor at Western Law. Deanne has a JD from Osgoode Hall Law School, an LLM from the University of Toronto.

April 10, 2024 in Conferences, Scholarship | Permalink | Comments (0)

Tuesday, April 9, 2024

Goldberg on the Need for Early Vetting in MDLs

The Federal Rules Advisory Committee is considering a new rule of civil procedure to govern MDLs.  Several years ago, the Committee issued a report estimating that approximately 20%-30% of claims in MDLs are unsupportable.  Phil Goldberg, citing specific incidents, argues that the Committee needs to address early vetting of MDL claims in the new rule.  The piece (behind a paywall) is at Law.com.

April 9, 2024 in Current Affairs, MDLs and Class Actions | Permalink | Comments (0)

Monday, April 8, 2024

JOTWELL Torts: Sebok on Abraham & Sharkey on Insurance and Tort Theory

At JOTWELL, Tony Sebok reviews Ken Abraham & Cathy Sharkey's The Glaring Gap in Tort Theory.

April 8, 2024 in Scholarship, Weblogs | Permalink | Comments (0)

Friday, April 5, 2024

Sharkey on Products Liability and AI

Cathy Sharkey has posted to SSRN A Products Liability Framework for AI.  The abstract provides:

A products liability framework, drawing inspiration from the regulation of FDA-approved medical products—which includes federal regulation as well as products liability—holds great promise for tackling many of the challenges artificial intelligence (AI) poses. Notwithstanding the new challenges that sophisticated AI technologies pose, products liability provides a conceptual framework capable of responding to the learning and iterative aspects of these technologies. Moreover, this framework provides a robust model of the feedback loop between tort liability and regulation.

The regulation of medical products provides an instructive point of departure. The FDA has recognized the need to revise its traditional paradigm for medical device regulation to fit adaptive AI/Machine Learning (ML) technologies, which enable continuous improvements and modifications to devices based on information gathered during use. AI/ML technologies should hasten an even more significant regulatory paradigm shift at the FDA away from a model that puts most of its emphasis (and resources) on ex ante premarket approval to one that highlights ongoing postmarket surveillance. As such a model takes form, tort (products) liability should continue to play a significant information-production and deterrence role, especially during the transition period before a new ex post regulatory framework is established.

April 5, 2024 in Products Liability, Scholarship | Permalink | Comments (0)

Thursday, April 4, 2024

Sharkey & Kenny on the Role of the FDA

Cathy Sharkey & Daniel Kenny have posted to SSRN FDA Leads, States Must Follow.  The absract provides:

As deference to administrative agencies has steadily come under attack, the FDA is a desert oasis. Courts have long deferred to the agency’s scientific expertise, particularly on matters of drug safety and effectiveness. But now, post-Dobbs, the FDA faces what this Article frames as two distinct types of legal challenges: (1) direct challenges to FDA actions, including drug approval decisions, and (2) indirect challenges to the primacy of FDA actions that arise in the context of preemption disputes over the extent to which state regulations conflict with federal regulatory schemes. Direct challenges to FDA actions are relatively rare and almost never succeed. Indirect challenges posed by state bans or restrictions on FDA-approved drugs amount to a new preemption frontier facing courts.

Where Congress has not definitely addressed the federal-state regulatory interaction, this Article marshals the longstanding record of judicial deference to the FDA’s scientific expertise; the "agency reference model" drawn from existing implied preemption doctrine; principles embedded in the statutes and regulations governing FDA approval of drugs; and normative arguments about the need for national uniformity to build a novel preemption framework to be enforced by courts in which the FDA’s risk calculus leads and the states must follow.

Under our framework, states cannot ban FDA-approved drugs, whether due to health and safety or political or moral objections. State restrictions that subvert the FDA’s risk calculus, such as bans of abortion-inducing drugs or telehealth proscriptions, cannot withstand preemption. But, where the FDA has not acted, states can fill the void either with gap-filling drug safety regulation, or—as the proliferation of gender-affirming care bans forewarns—the bootstrapping of politically-motivated decisions under the guise of health and safety.

Our framework whereby FDA leads and states must follow not only promotes national regulatory uniformity but—equally significantly—it harnesses the FDA’s capacity to incentivize the generation of high-quality clinical data about drugs’ safety and effectiveness.

April 4, 2024 in Scholarship | Permalink | Comments (0)