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Mixed Preemption Rulings in Products Liability Cases

By Robert C. Rodriguez, Litigation News Associate Editor – August 30, 2011

Given the limited caseload of the U.S. Supreme Court, it may be surprising that the Court decided two products liability cases involving federal preemption during its 2010–2011 term. The preemption doctrine generally requires that, when a state statute or common-law cause of action conflicts with federal law or stands as an obstacle to congressional objectives, the state law must be preempted. Two recent rulings in the products arena—one finding preemption and the other declining to find preemption—suggest that the Court will decide these cases on narrow, fact-dependent grounds.

Williamson v. Mazda: State Law Claims Can Proceed
In Williamson v. Mazda, the Supreme Court found no preemption of Federal Motor Vehicle Safety Standard (FMVSS) 208. Williamson arose out of an automobile accident. The decedent’s estate alleged that the decedent died because the inner rear seat of the Mazda minivan in which she was riding had a lap belt instead of a lap-and-shoulder belt. Mazda, relying on the Supreme Court’s earlier decision in Geier v. Honda, argued that FMVSS 208, a later version of the regulation at issue in Geier, gives manufacturers the choice to have lap-and-shoulder or lap belts on inner rear seats.

In Geier, the Court had held that the regulation preempted state tort claims seeking to hold a manufacturer liable for the failure to install airbags. According to the Court in Williamson, the Geier Court determined that “the federal regulation preempted a state tort suit that, by premising tort liability on a failure to install airbags, would have deprived the manufacturers of the choice that the federal regulation had assured them.” Relying on Geier, Mazda argued that it chose lap belts in reliance on FMVSS 208 and that the plaintiff’s claim, therefore, should be preempted.

The Supreme Court disagreed. Justice Breyer’s majority opinion explained that, in Geier, “the regulation’s history, the agency’s contemporaneous explanation, and its consistently held interpretive views indicated that the regulation sought to maintain manufacturer choice in order to further significant regulatory objectives.” Those significant objectives included ensuring that manufacturers would “retain a choice of installing any of several different passive restraint devices.”

In contrast, the portion of FMVSS 208 at issue in Williamson did not have the same type of regulatory objective. Unlike the choice to install airbags, it was not a “significant regulatory objective” of FMVSS 208 to permit manufacturers to choose between lap belts and lap-and-shoulder belts.

The Court also relied on U.S. Department of Transportation (DOT) regulatory history and the Solicitor General’s representation of DOT’s views. According to the Court, there was no indication in the rule-making record that DOT had a “pre-emptive intent” to bar state tort claims based on a manufacturer’s failure to install lap-and-shoulder belts for inner rear seats. Although DOT may not have required such lap-and-shoulder belts due to concerns about cost-effectiveness, the Court concluded that the rule-making record still did not disclose sufficient “pre-emptive intent.”

“I have a problem with the Court saying in Geier that a manufacturer cannot be sued in state court by exercising a choice which the federal law allows, and then turning around in Williamson and allowing such a lawsuit to go forward,” says Nathaniel Cade Jr., Milwaukee, WI, cochair of the Section of Litigation’s Products Liability Committee. “Consumers have options when buying a vehicle, and if having lap-and-shoulder belts on every seat in the vehicle is important to a consumer, then that consumer should buy a vehicle that has such an option,” says Cade.

Bruesewitz v. Wyeth: Vaccine Design Defect Claims Are Preempted
In Bruesewitz v. Wyeth, the Supreme Court held that the National Childhood Vaccine Injury Act of 1986 preempts design defect claims alleging vaccine side effects against vaccine manufacturers. Justice Scalia’s majority opinion analyzed the language of 42 U.S.C. § 300aa-22(b)(1) and concluded that the statute’s “silence regarding design-defect liability was not inadvertent.” “It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the Food and Drug Administration (FDA) and the National Vaccine Program rather than juries.”

The Court stated that the act contained a “structural quid pro quo.” In exchange for avoiding “costly tort litigation and the occasional disproportionate jury verdict,” it provides that “vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries.”

“This opinion is limited to vaccines, which already have a fund in place to provide redress to alleged victims, as the Court points out,” says Lori B. Leskin, New York City, cochair of the Section’s Products Liability Committee. Due to the existence of the fund, the majority’s opinion was not a surprise to many, explains Leskin.

Justice Sotomayor’s dissent criticized the majority for leaving “a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.” “Yet there are plenty of factors that guide drug manufacturers’ behavior other than lawsuits, and no drug manufacturer thinks it is good business to put an unsafe drug on the marketplace,” says Leskin.

A Muddled Record on Preemption and Products Liability
Whether litigators agree or disagree with these decisions, the Supreme Court has clearly signaled that preemption in the products liability context will be decided on the facts of each case. Williamson and Bruesewitz follow Wyeth v. Levine, a 2009 ruling in which the Court rejected preemption in a case involving prescription drugs and failure-to-warn claims, and Riegel v. Medtronic, Inc., a 2008 ruling in which the Court found preemption of state law claims in a medical device case.

Another ruling is expected in the near future. The Supreme Court heard oral arguments in March in a third products liability case this term involving preemption claims, Pliva, Inc. v. Mensing. At issue in Mensing is whether the Food, Drug, and Cosmetic Act’s requirement that the labeling for generic drugs be the same as FDA-approved labeling for branded drugs preempts state claims alleging failure to warn.

Respondent Mensing argues that drug manufacturer Pliva, Inc., was required to offer additional warnings on its labels because Congress clearly did not intend the act to preempt state law. Petitioner Pliva counters that the FDA’s regulation of the drug approval and labeling process preempts state law tort actions.

Rather than closing the book on preemption in products cases, the Supreme Court’s recent decisions guarantee that both pro- and anti-preemption advocates will continue to litigate the issue. “The doctrine of preemption will continue to be a hot legal battleground for years to come,” predicts Cade.

Keywords: litigation, preemption, products liability

Related Resources

  • » PLIVA v. Mensing, ---S. Ct.----, 2011 U.S. LEXIS 4793 2011).
  • » Williamson v. Mazda, 131 S. Ct. 1131 (2011).
  • » Bruesewitz v Wyeth, 131 S. Ct. 1068 (2011).


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