The US Supreme Court has ruled that the US Food and Drug Administration (FDA) pre-market approval (PMA) process for medical devices preempts state tort lawsuits approved through that process.
The court ruled 8 to 1 that Congress has granted the FDA the exclusive authority to assess the proper balance in its pre-market review of the medical device in the case, Riegel V. Medtronic.
The decision of the Court is the first ever to rule on the legal effect of FDA pre-market device approval on tort lawsuits.
A Syllabus of the decision prepared by the Reporter of Decisions (of court decisions) for the convenience of the reader described Riegel v. Medtronic as follows: ...