The U.S. Court of Appeals for the 9th Circuit grants en banc rehearing to determine if federal law pre-empts a personal injury lawsuit filed against medical device company Medtronic over claims that its SynchroMed EL pain pump left an Arizona man paralyzed.
This week, the U.S. Court of Appeals for the 9th Circuit granted en banc rehearing to determine if federal law pre-empts a personal injury lawsuit filed by Richard Stengel. In April, the same court upheld a lower court ruling dismissing Stengel's claims that the company's SynchroMed EL pain pump left him paralyzed, on grounds of preemption.
Preemption holds that patients can't sue medical device makers in state courts over products that went through the FDA's most stringent review process, called pre-market approval. But the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.