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.
In this case, four individuals in Michigan who had been seriously harmed by the drug Rezulin sued the manufacturer. The district court granted the company’s motion to dismiss based on the Michigan statute, holding that the exception in the Michigan statute was impliedly preempted by federal regulation. On appeal, the Second Circuit reversed, holding that the exception was not impliedly preempted. The company then sought review in the U.S. Supreme Court.
Public Citizen served as lead counsel for the plaintiffs in the Supreme Court, which affirmed the court of appeals’ decision in favor of the plaintiffs by a 4-4 vote.