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
This post comes from the non-RS side of the Blog.
Prescription medications for psychiatric conditions fill an important role in modern healthcare. They tend to have labels with lots of information about the risks of various emotional, psychological, and neuroreceptor-mediated conditions, including worsening of the underlying conditions being treated, interactions with other medications or substances
Not too long ago one of our bloggers (McConnell) critiqued a p-side law review article he had received from a lawyer on the other side with whom he was friendly. Bexis isn’t as friendly with opposing counsel – Paul Rheingold being a rare exception. But probably due to his activity in the American Law Institute
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 case, Hartney v. Zoetis, Inc., 2025 WL 2924661 (D.N.J. Oct. 15, 2025), is about a canine medicine allegedly gone wrong. But lest you think the DDL blog has gone to the dogs, this case addresses issues such as preemption and learned intermediary that are key in cases with thumbed, supposedly sapient, biped plaintiffs.
Mind you
You know it’s going to be an interesting ride when the appellate brief reads like a conspiracy theory starter pack. Which is how we read the issues raised on appeal in Thelen v. Somatics, LLC, — F4th –, 2025 WL 2749888 (11th Cir. Sep. 29, 2025): erroneous entry of summary judgment on design
Today’s guest post is from Dechert’s Brooke Meadowcroft who brings us her take on an unfortunate learned intermediary ruling out of Illinois. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter.
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The learned intermediary doctrine is the elegant legal principle
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