Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted.  After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.”  Id. at 323.  Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:Continue Reading PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

There has been a veritable pandemic of posts about Covid-19 regulations (vaccine mandates, restrictions on indoor gatherings, etc.) on the DDL blog as of late, so we thought we’d take a break from the craziness and report on a good, old-fashioned medical device preemption case. And yet we still found ourselves encountering a loathsome disease

Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed “parallel” violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a “Current Good Manufacturing Practice” or “CGMP”)

We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic.  That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA.  As we have said here