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We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight.  A learned intermediary case before the California Supreme Court?  For your ever-vigilant DDL bloggers, that is like Thanksgiving and Christmas wrapped into one! 

Who will be

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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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Plaintiffs love sales representatives.  They love to use them to try to keep cases in state court—naming them as non-diverse defendants.  They love to try to use them to get around preemption—claiming a direct duty from the rep to the plaintiff.  And they certainly love making sales representative statements and conduct a focal point of

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A potential top-ten case came across our desks the other day, and even better, it comes out of our home state of California.  In Amiodarone Cases, No. A161023, 2022 WL 16646728 (Cal. Ct. App. Nov. 3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine.  Along the way, the Court disabused several harmful misconceptions on California’s learned intermediary doctrine and held that fraud claims based on journal articles and decades-old statements were bunk. 

The FDA approved amiodarone in 1985 as a last-resort treatment for ventricular fibrillation, and a few years later—in 1989 and 1992—the agency notified the manufacturer of statements that it considered false and misleading, including purported promotion for an unapproved use.  Id. at *1.  Fast forward a few decades, and hundreds of plaintiffs in a coordination proceeding in California have alleged that they experienced side effects after their doctors prescribed amiodarone off label.  Id. at *2. 

You read that correctly.  These plaintiffs were reaching back to alleged misstatements made 30 years ago.  Moreover, amiodarone has been available in generic forms since 1998, so the plaintiffs ginned up claims against generic manufacturers, too—that all defendants (branded and generic) failed adequately to warn plaintiffs of potential risks because they did not ensure that patients received FDA-approved Medication Guides with their prescriptions. 

This is not a new idea.  Amiodarone patients in other jurisdictions have made similar Medication Guide/warnings claims, and some have survived challenges to the pleadings, including in Wisconsin and Illinois.  You can see our take on these orders here and here.  Long story short, we disagreed with those results, especially the short shrift that those orders gave to implied preemption. Continue Reading California Appellate Court Reaffirms Federal Preemption, Learned Intermediary Doctrine in Amiodarone Cases

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We are trying very hard not to bore everyone silly with endless discussion of our puppy-to-be, almost certainly interesting only to us.  But we are failing.  So, briefly, we comment that we met the whole spectacular litter last week – eight gorgeous butterballs. Five are white, and three are now black but will probably end

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The plaintiff in Salinero v. Johnson & Johnson, __ F.3d __, No. 20-10900, 2021 WL 1681237 (11th Cir. Apr. 29, 2021), tried a new twist to get around the learned intermediary rule—and it did not work.  The district court rejected the plaintiff’s attempt to graft a “financial bias” exception onto Florida’s learned intermediary rule,

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Kelly v. Ethicon, Inc., 2020 U.S. Dist. LEXIS 191665 (N.D. Iowa Oct. 16, 2020), is a remanded pelvic mesh case. The complaint included the usual panoply of causes of action for negligence, strict liability, fraud, and breach of warranty. Failure to warn, as usual, was central to the plaintiff’s case.

During the years while