Law Commons^™

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Atlantic Richfield Company V. Montana Second Judicial District Court, Molly Kelly

Public Land & Resources Law Review

Landowners in Opportunity, Montana sought restoration damages from ARCO, Anaconda Copper Mining Company’s successor, to their property from over a century of processing ore at the Anaconda Smelter. ARCO argued that CERCLA preempted and barred any claim for restoration damages. The Montana Supreme Court held: landowners could bring their state common law claims seeking restoration damages; the state district court had subject matter jurisdiction; and landowners’ proposed restoration fund did not challenge EPA’s selected remedy under CERCLA.

Time To Act: Correcting The Inadequacy Of Youth Concussion Legislation Through A Federal Act, Lance K. Spaude

Marquette Law Review

Concussions in sports are inevitable. Although an increased focus on concussions in youth sports has improved understandings, the prevalence of concussions in youth sports, the health and safety dangers they pose, and the legal liability they create are still relative unknowns. Despite remaining unknowns, a greater understanding of the long-term effects of concussions and the increased dangers in head impacts in youth athletics in recent years has resulted in lawsuits against the youth coaches, schools, and state athletic associations for athlete injuries suffered as a result of repetitive head trauma and concussions.

This Comment focuses on the need for federal …

Discrimination And Business Regulation, Eileen Kaufman

Touro Law Review

No abstract provided.

"A Distinction Without A Difference"?: Bartlett Going Forward, Steven A. Schwartz

Fordham Law Review

This Note addresses the question of whether federal law preempts state design defect claims against generic drug manufacturers regardless of which test state law uses to determine whether a drug is defective. This issue, arising out of the U.S. Supreme Court's interpretation of preemption jurisprudence and fundamental tort law as stated in Mutual Pharmaceutical Co. v. Bartlett, is significant because it plays a large role in determining to what extent generic drug manufacturers are immune to civil liability arising out of injuries caused by their generic drugs. In an age of rising medical costs and jury awards, both plaintiff …

Too Many Cooks In The Climate Change Kitchen: The Case For An Administrative Remedy For Damages Caused By Increased Greenhouse Gas Concentrations, Benjamin Reese

Michigan Journal of Environmental & Administrative Law

Recent federal and state court decisions have made clear that federal common law claims against emitters of greenhouse gases are not sustainable; however, those same courts seem to have given state common law tort claims the green light, at least if the claims are brought in the state where the polluters are located. This Note contends that such suits are not an adequate remedy for those injured by climate change because they will face nearly insurmountable barriers in state court, and because there are major policy-level drawbacks to relying on state tort law rather than a federal solution. This Note …

Everything Is Presumed In Texas, Benjamin Walther

Benjamin Walther

As this Article will reveal, the Fifth Circuit has traditionally been loath to apply the presumption against preemption in most cases. Texas courts, on the other hand, have consistently employed a particularly strong application of the presumption to all types of preemption cases. This inconsistency between these two jurisdictions creates an incentive for forum shopping. Generally, the courts rely on a defendant’s ability to remove a case to the federal courts to counteract the plaintiff’s exclusive power to decide the forum. This ability, however, is not available to a defendant within the context of preemption cases. As such, there is …

Surviving Preemption In A World Of Comprehensive Regulations, Kyle Anne Piasecki

University of Michigan Journal of Law Reform Caveat

The Clean Air Act imposes a federal regulatory regime on a number of sources of air pollution. It does not, however, provide a ready means of relief to individuals harmed by air polluters. Nevertheless, many courts have held that the Clean Air Act preempts state common law tort claims that do provide a means to such relief. The disparate benefits of the Clean Air Act and common law tort claims may indicate different purposes and make court imposed preemption of common law tort claims improper. This Comment argues that the Savings Clause in the Clean Air Act and in parallel …

Mutual Pharmaceutical Co. V. Bartlett: A Need For “Explicit” Congressional Action And State Tort Law Reform, Kara A. Ritter

Kara A Ritter

No abstract provided.

Mutual Pharmaceutical Co. V. Bartlett And Its Implications, Brian Wolfman, Anne King

Georgetown Law Faculty Publications and Other Works

The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Bartlett, which generally shields generic drug manufacturers from state-law damages liability for design-defect claims, may also have broader implications for preemption jurisprudence. In this article they describe the Supreme Court’s decision in Mutual and evaluate how it may affect future products-liability litigation.

Part I provides an overview of the case’s factual background and of federal generic drug regulation, while Part II discusses the Court’s majority opinion and the dissents. Part III analyzes the implications of the decision, offering ideas on how plaintiffs injured by …

Navigating Between Scylla And Charybdis: Preemption Of Medical Device “Parallel Claims”, Jean Eggen

Jean M. Eggen

The scope of federal preemption of state common law medical device claims has been vigorously debated since the Medical Device Amendments were enacted in 1976. Currently, a hot-button topic is the extent to which either express or implied preemption may bar state device claims that parallel duties imposed by the federal government’s Food, Drug, and Cosmetic Act. The author analyzes a selection of recent lower court cases in light of Congressional intent and Supreme Court precedent. This article provides some guiding principles to achieve greater consistency and predictability in parallel claim preemption decisions. The author then concludes that preemption doctrine …

Medtronic, Inc. V. Lohr: Is Federal Pre-Emption A Heartbeat Away From Death Under The Medical Device Amendments?, Mark E. Gelsinger

Pepperdine Law Review

No abstract provided.

Federalism And Preemption In October Term 1999, Jonathan D. Varat

Pepperdine Law Review

No abstract provided.

An Economic Perspective On Preemption, Keith N. Hylton

Faculty Scholarship

This Essay has two goals. The first is to present an economic theory of preemption as a choice among regulatory regimes. The optimal regime choice model is used to generate specific implications for the court decisions on preemption of products liability claims. The second objective is to extrapolate from the regime choice model to consider its implications for broader controversies about preemption.

Federal Preemption Of Claims Based On Cell Phone Hazards: Farina V. Nokia And The Road To The U.S. Supreme Court, Jean Eggen

Jean M. Eggen

No abstract provided.

The Case Against Preemption: Vaccines & Uncertainty, Mary J. Davis

Law Faculty Scholarly Articles

This article begins with a brief recap of the state of current preemption doctrine and how it governs the interaction of federal regulation of product manufacturers and state tort actions related to the actions of those manufacturers. Second, the article provides observations on how that doctrine might apply to vaccine injury litigation. Bruesewitz v. Wyeth, Inc. involves the preemptive scope of the Vaccine Act and the unique compensation system Congress created to respond to vaccine injuries. Bruesewitz was decided on February 22, 2011, and held that design defect claims are expressly preempted by the Vaccine Act. This article endeavors …

"What Do I Do About This Word, 'Unavoidable'?": Resolving Textual Ambiguity In The National Childhood Vaccine Injury Act, Jason Lafond

Michigan Law Review First Impressions

The quote in the title of this Essay comes from Justice Breyer, expressing his frustration with the language of section 22(b)(1) of the National Childhood Vaccine Injury Act. Justice Breyer made this comment during the October 12, 2010, oral argument in Bruesewitz v. Wyeth, Inc., a case about the availability of state tort claims based on vaccine design defects. The question before the Court was whether that section expressly preempts such claims against vaccine manufacturers "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions …

Access To Courts And Preemption Of State Remedies In Collective Action Perspective, Robert L. Glicksman, Richard E. Levy

Robert L. Glicksman

Preemption of common law remedies for individual injuries such as harm to health raises fundamental questions about the proper allocation of authority between the federal and state governments and about the role of courts in interpreting statutes and providing remedies for those who suffer injuries. Developing a workable framework for analyzing what we call “remedial preemption” issues can help to ensure an appropriate accommodation of the federal and state interests at stake and promote consistent application of preemption doctrine to state judicial remedies.

This article applies a “collective action” framework for preemption analysis to the issue of remedial preemption. Our …

Coordinating Sanctions In Torts, Kyle D. Logue

Articles

This Article begins with the standard Law and Economics account of tort law as a regulatory tool or system of deterrence, that is, as a means of giving regulated parties the optimal ex ante incentives to minimize the costs of accidents. Building on this fairly standard (albeit not universally accepted) picture of tort law, the Article asks the question how tort law should adjust, if at all, to coordinate with already existing non-tort systems of regulation. Thus, if a particular activity is already subject to extensive agency-based regulation (whether in the form of command-and-control requirements or in the form of …

Equal Accountability Through Tort Law, Jason M. Solomon

Faculty Publications

No abstract provided.

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

Tort Experiments In The Laboratories Of Democracy, Alexandra B. Klass

William & Mary Law Review

This Article considers the broad range of "tort experiments" states have undertaken in recent years, as well as the changing attitudes of Congress and the Supreme Court toward state tort law. Notably, while states have limited tort rights and remedies in the products liability and personal injury areas in recent years, they have at the same time increased tort rights and remedies to address new societal problems associated with privacy, publicity, consumer protection, and environmental harm. At the same time, however, Congress has eliminated state tort law entirely in targeted areas without replacing it with corresponding federal remedies. The Supreme …

The Truth About Torts: Rethinking Regulatory Preemption And Its Impact On Public Health, William Buzbee, William Funk, Thomas Mcgarity, Nina A. Mendelson, Sidney Shapiro, David Vladeck, Matthew Shudtz

Other Publications

As consumers, we assume that the automobiles, pharmaceuticals, medical devices, and other products we purchase are generally safe for their intended uses. We rely on manufacturers to design and produce safe products, and we assume that federal regulators are conscientious watchdogs of the marketplace. In most instances, our assumptions are valid and we safely go about our lives. But the regulatory system is now frayed to the point that dangerous products sometimes slip through the cracks. Vioxx, Firestone/ATX tires, and toxics-laden children’s toys have endangered and harmed millions. In these cases, society depends on the state courts as a venue …

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller

Michigan Telecommunications & Technology Law Review

Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …

On Restating Products Liability Preemption, Mary J. Davis

Law Faculty Scholarly Articles

This Article provides a brief explanation of the state of preemption doctrine and explains how the Court altered, quite dramatically, its treatment of preemption of common law tort actions in the last two decades. The Court's almost exclusive focus on the interpretation of express preemption provisions, which never specifically address common law tort claims one way or the other, turned "traditional" preemption analysis of common law tort claims on its head. The Court then, almost as suddenly, signaled a retreat from the emphasis on express preemption analysis and returned, awkwardly, to implied preemption doctrine. The Court has only recently begun …

The Mature Product Preemption Doctrine: The Unitary Standard And The Paradox Of Consumer Protection, Jean M. Eggen

Jean M. Eggen

The history of the U.S. Supreme Court's product preemption doctrine has been characterized by inconsistency and confusion. Product regulation and common-law product liability actions are primarily concerned with assuring the health and safety of the consuming public, and it is not surprising that the Court's product preemption decisions have focused substantially on medical devices and drugs. Recent government studies have shown, however, that the FDA is hampered in reaching its safety goals by insufficient resources and increasing demands. This article reassesses the Court's product preemption doctrine in the light of a triad of new decisions issued in 2008 and 2009. …

The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis

Law Faculty Scholarly Articles

A mere five years ago, the Food and Drug Administration (the "FDA") began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The U.S. Supreme Court has contributed to this debate with several …

Law Casebook Description And Table Of Contents: Constitutional Environmental And Natural Resources Law [Outline], Jim May, Robin Craig

The Future of Natural Resources Law and Policy (Summer Conference, June 6-8)

6 pages.

"James May, Widener University School of Law" -- Agenda