The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant.
Fluid allegedly worked its way into the device and caused a short‑circuit and device
Nevada courts have long applied the learned intermediary rule to pharmacists filling prescriptions, and now another federal district court has ruled that the doctrine applies to drug manufacturers, too. This is not surprising, since other federal judges have similarly predicted that Nevada’s Supreme Court would apply the learned intermediary rule to drug and medical device
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.
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 RecallWe 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
We have a couple of updates on the learned intermediary rule in California. We reported to you three months ago on the California Supreme Court’s tweaking of the learned intermediary rule in Himes v. Somatics, and the tweaks were not good. As we wrote back then, the Court did not make any fundamental
The California Supreme Court issued its widely anticipated opinion on the learned intermediary rule the other day, and the opinion is worth the wait. Based on the oral argument (which we reported on here), we did not expect the Supreme Court to enact a fundamental change to the learned intermediary doctrine, and the Court
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
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