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We write a lot about the learned intermediary rule. It’s a fundamental aspect of the defense of drug and device cases, it’s grounded in the realities of the physician-patient relationship, and it tends to produce a lot of cases worth blogging about. We also refer to it as a rule (e.g., here, here, here, and here), rather than a doctrine, because that’s what it is.  We particularly like it when courts dismiss warnings claims based on the learned intermediary rule at the pleadings stage.   Today’s case is one of those. Plaintiff filed a shoddy complaint, was able to amend in response to an initial motion to dismiss, and then saw his warnings claims dismissed with prejudice under Alabama’s learned intermediary rule.

In McCrackin v. Rex Medical L.P., 2026 WL 66797 (N.D. Ala. Jan. 8, 2026), the plaintiff alleged he received an Option retrievable IVC filter in 2012. Twelve years later, he allegedly suffered complications when a “leg” from the filter fractured and penetrated a vein, with the further allegation that his spine grew around the fractured leg. He sued based on allegations that the device was marketed as permanent when it should have been temporary, and that there were not adequate warnings about the risk of “tilt, fracture, migration and/or perforation.” Id. at *1. Plaintiff previously obtained leave to file an amended complaint in response to an initial motion to dismiss, so this was his second bite at the apple. The defendant who marketed and distributed the device moved to dismiss.Continue Reading Learned Intermediary Success at the 12(b) Stage in Alabama (plus a Double Whammy)

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Today’s post is our second installment about a case in the District of Massachusetts alleging injury from a Class III medical device. We blogged about it this spring when the court dismissed plaintiff’s claim that an implanted defibrillator and associated leads caused her numerous, unnecessary shocks. The court dismissed that complaint based on straightforward, premarket approval preemption. But the court granted plaintiff leave to amend, and she moved to file an amended complaint.  Today’s decision, Summers v. Medtronic, Inc., 2025 WL 2201110 (D. Mass. Aug. 1, 2025), denied plaintiff’s motion for leave based on the learned intermediary rule in Massachusetts. It’s a helpful decision because it applies the learned intermediary rule at the 12(b)(6) stage in the context of a device recall.Continue Reading Summers Round 2: Learned Intermediary Rule Applies to Claim Based on Device Recall

We posted earlier this year about the failure to warn causation decision from the California Supreme Court in Himes v. Somatics, 549 P.3d 916 (Cal. 2024), and the potential parade of horribles that might ensue.  Here comes the grand marshal of the parade.Continue Reading California District Court Punts on Learned Intermediary Causation Post-Himes

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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

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