Express Preemption for a de novo Device with Special Controls Should Have Been the End

Litigation attorney Eric Alexander published a blog for Drug & Device Law examining Higginbottom v. Dexcom Inc., a decision from the U.S. District Court for the Southern District of California addressing express preemption in litigation involving a Class II medical device cleared through the U.S. Food and Drug Administration's (FDA) de novo process and subject to special controls. The court determined that the plaintiffs' claims were expressly preempted because Wyoming law does not recognize a duty to warn the FDA of adverse events, leaving no viable parallel state law claim to avoid preemption. Eric notes that the ruling adds to a growing body of case law recognizing express preemption protections for certain de novo devices with device-specific special controls, but he questions the court's choice to grant the plaintiffs another opportunity to amend their complaint after multiple unsuccessful attempts to plead around preemption.

READ: Express Preemption for a de novo Device with Special Controls Should Have Been the End