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This post is only from the non-Butler Snow part of the Blog.

As our 50-state survey of the learned intermediary rule demonstrates, the rule now applies in all fifty states.  That includes statutes or high court decisions from 38 states and the District of Columbia, intermediate state appellate decisions from four more states, and federal appellate Erie predictions from seven more states and Puerto Rico.  All told, only three states lack binding appellate precedent approving of the learned intermediary rule:  Rhode Island, South Dakota, and Vermont.  All three of those states have federal district court precedent, and Rhode Island has unpublished federal appellate authority in addition.

Then there’s Oregon.  That state was an early adopter of the learned intermediary rule, see McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974), but a subsequent decision held that the Oregon product liability statute, which basically adopted Restatement §402A in toto, meant that the rule did not apply in strict liability cases, because §402A did not reference the rule.  Griffith v. Blatt, 51 P.3d 1256, 1262 (Or. 2002).

But in Oregon strict liability litigation, or anywhere else that some plaintiff argues that for some reason the rule doesn’t apply, there is a backup argument – implied preemption.Continue Reading Preemption as a Backup for the Learned Intermediary Rule

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For readers noticing the new byline, let me introduce myself.  I am Susanna Moldoveanu, and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group.  I am excited to join the Drug & Device Law Blogging Team.  The best group of legal wonks there is.

Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co., 2023 WL 8717570 (W.D. Wash. Dec. 18, 2023).  A prior opinion in this case earned the top spot on the Blog’s Ten Best Prescription Drug/Medical Device Decisions of 2022.  This opinion is short and sweet, but a good one too.Continue Reading W.D. Wash. Nixes Failure to Warn Claim Under Learned Intermediary Doctrine

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The Fifth Circuit gave the plaintiff in Bruno v. Biomet, Inc., 2023 U.S. Dist. LEXIS 213826 (E.D. La. Dec. 1, 2023) a second chance, but it was short lived.  This case had been dismissed on statute of limitations grounds.  On appeal, the Fifth Circuit reversed that holding and remanded the case for the district

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The Granuflo/Naturalyte MDL (“G/N”) was created a decade ago, in 2013.  In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, 935 F. Supp. 2d 1362 (J.P.M.L 2013).  Notwithstanding a settlement in 2016, it’s still up and running, it appears.  Over the past decade, the G/N MDL had distinguished itself for – not much, really.  We wrote a grand total of one post about it during that time, which collected several one-off state-law rulings, but zero preemption, expert admissibility, or core product liability issues decided.

Until a little while ago.Continue Reading GranuFlo/NaturaLyte MDL Substantive Rulings – Better Late Than Never

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A plaintiff lawyer recently filed a case against our client in North Carolina.  He has made a settlement demand that any rational observer would regard as ambitious to the point of outrageous.  Despite that crazy number, we are on fairly friendly terms with the plaintiff lawyer. We jawbone at each other in a generally good

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When we last visited the Zostavax MDL last December, over a thousand plaintiffs, all claiming shingles as an injury, had been dismissed because none of them could produce results from the only medical test that could establish causation.  We ended that post with:

The only claims left allege that Zostavax caused a hodge-podge of other injuries.  But it’s safe to say the nucleus of this MDL pretty much self-destructed.

Continue Reading Zostavax − Dredging the Dregs

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That seems like it should be an obvious statement.  FDA regulations draw important distinctions between brand drugs and generic drugs.  A manufacturer seeking FDA approval of a new drug must prove safety and efficacy involving expensive and lengthy clinical trials.  Once approved, that drug becomes the reference list drug.  If a manufacture wants to market