SIMS PETITION ON PMA PREEMPTION OF TORT CLAIMS COULD RECEIVE SUPREME COURT RULING IN EARLY JANUARY; FDA DRAFT RULE REITERATES NARROW INTERPRETATION
This article was originally published in The Gray Sheet
Executive Summary
The U.S. Supreme Court could announce as early as Jan. 12 whether to O.K. or deny a writ of certiorari for a case, Kernats v. Sims, that raises the issue of whether FDA's premarket approval application and investigational device exemption processes preempt state common law tort claims.