Warner-Lambert Co., LLC v. Kent

Preemption: FDA Approval / State Consumer Remedy

Traditional state tort law allows a manufacturer, alleged to have sold a defective product, to use compliance with federal standards or regulations as evidence that the product was not defective or that the manufacturer acted non-negligently. In most states, such evidence is not controlling. However, in 1995, Michigan enacted a statute providing that, with respect to drug manufacturers, federal approval and compliance with Food and Drug Administration approval requirements generally precludes liability for injuries caused by their products. The Michigan legislature chose not to extend this defense to situations in which it lacked confidence that the federal approval could be relied on as dispositive evidence that the manufacturer satisfied state-law duties of care. Accordingly, the statute also provides an exception to the defense such that, if a drug manufacturer did not comply with FDA disclosure requirements and the noncompliance affected the FDA’s approval decision, the statutory defense does not apply.

The question before the Supreme Court is whether the exception to the statutory defense is impliedly preempted.

The decision below was affirmed by an equally divided Supreme Court. Allison Zieve of Public Citizen argued for the respondents.