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We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count.  This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.”  Id. at 558.  While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation.  Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.”  Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)

Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).Continue Reading Preemption, Plausibility, and Parallel Claims

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…

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Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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