STORY FROM: Drugs & Medical Devices

Minn. Judge Dismisses Pain Pump Action Without Prejudice on Preemption Grounds

MINNEAPOLIS — Claims based on Medtronic’s alleged failure to comply with federal regulations in its manufacture of an infusion pain pump device are preempted because the plaintiffs failed to specify which requirements the manufacturer violated, thereby causing the alleged injuries, a Minnesota judge has ruled.

In dismissing the claims without prejudice on July 25, Judge M. Jacqueline Regis of the Hennepin County District Court explained that the plaintiffs cannot simply rely on certain FDA actions taken in connection with the device, such as warning letters. Rather, they must plead with specificity the premarket approval regulations Medtronic violated, how it caused ...

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