Conklin v. Medtronic, Inc.Annotate this Case
The Supreme Court held that an Arizona common law failure-to-warn claim based on a medical device manufacturer’s failure to submit adverse event reports to the United States Food and Drug Administration (FDA) is impliedly preempted.
Plaintiff and his wife sued Defendant alleging several common law tort claims, including strict liability and negligence claims for failure to provide adequate and timely warnings. Defendant moved to dismiss under Ariz. R. Civ. P. 12(6)(b), asserting that Plaintiff’s claims were expressly and impliedly preempted under federal law. The superior court granted the motion and dismissed the action with prejudice. The court of appeals vacated the dismissal of Plaintiff’s failure-to-warn claim, finding it neither expressly nor impliedly preempted, and otherwise affirmed. The Supreme Court disagreed with the court of appeals and affirmed the superior court’s judgment, holding that because only federal law, not state law, imposes a duty on Defendant to submit adverse event reports to the FDA, Plaintiff’s failure-to-warn claim was impliedly preempted under 21 U.S.C. 337(a).