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We write a lot of briefs involving federal preemption and Class III medical devices with premarket approval (or “PMA”).  Many of those briefs are in support of motions to dismiss lawsuits brought by attorneys who don’t regularly practice in the pharmaceutical and medical device product liability space. 

The complaints filed by such attorneys often are

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Sometimes there’s a little something for everyone.  Today’s case has personal jurisdiction, corporate veil piercing, PMA preemption, statute of limitations, and learned intermediary.  Not every decision on these issues goes the way we think it should, and perhaps the thorns outnumber the roses, but it caught our attention nonetheless.

The case is Franks v. Coopersurgical

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In Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016) (initially discussed here), the Supreme Court drove a stake through the heart of the misbegotten “presumption against preemption” in express preemption cases.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on

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The Dearinger case in the Western District of Washington provided a lot of defense friendly blog fodder. It made its way to the Washington Supreme Court for a certified question whether Washington would recognize a direct to consumer exception to the learned intermediary rule. The Washington Supreme Court answered that question with a resounding no.  Following that decision, the district court dismissed some of plaintiffs’ claims on an initial motion for summary judgement.  We blogged about that decision here.  The latest decision in Dearinger v. Eli Lilly & Co., 2024 WL 416848 (W.D. Wash. Feb. 5, 2024) serves up some nice defense nuggets applying the Washington Product Liability Act (WPLA) and refusing to let a sham affidavit create a fact issue.Continue Reading Last Nail in the Coffin for Dearinger

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The FDA has taken recent steps that may, or may not, affect product liability litigation.  We’re discussing the “may” aspect.  For purely regulatory analysis, plenty of other commentary is available.

These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices.  Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).Continue Reading Tort-Related Implications of Recent FDA Device Draft Guidances

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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