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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

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Long before the Supreme Court decided Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022), Bexis was concerned that FDCA preemption would be dragged into the country’s culture wars by the abortion issue.  He hoped the Supreme Court would adhere to long-established precedent and thus keep FDCA preemption out of politics and in product liability litigation where it belonged.  Dobbs extinguished that hope (and many others), so Bexis decided that he might as well embrace the inevitable.

He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute.  FDLI accepted the proposal, and now, over a year later, the article is now published:  Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Post-Dobbs Reproductive Freedom Frontier,” 78(2) Food & Drug L.J. 109 (2023).  The article is available to the public at the journal’s website, here.  Bexis hardly did this alone, being ably assisted by three (then) Reed Smith colleagues, Philip W. Danziger, Sarah B. Johansen, and Andrew R. Hayes.Continue Reading Bexis Publishes Article Applying FDCA Preemption to Medication Abortions

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We say today’s case is about SIRVA (shoulder injury related to vaccine administration), but plaintiff tried her best to run from that allegation in her opposition to defendants’ motion to dismiss.  That’s because a SIRVA case runs up against not only a preemption obstacle, but also serious duty and causation barriers.  But since the court