No, your DDL bloggers are not offering a money-back guarantee—although we suppose offering one would not cost us anything, since reading the blog is free. For enterprises that actually sell products though, the story is sometimes different, and many product sellers do guarantee satisfaction—or your money back. Moreover, when those guarantees are unrestricted, we
The plaintiff in Kha v. Tilray Brands, Inc. tried to use California’s Sherman Law to do an end run around the Food, Drug, and Cosmetic Act in a case involving hemp products, but it did not work. The district court correctly saw the case as an attempt to impose additional, state-law requirements on food labeling
We’ve re-read Monsanto Co. v. Durnell, No. 24-1068, 609 U.S. ___, 2026 LX 336645, 2026 WL 1825691 (June 25, 2026) (“Durnell”), a few times over the past few weeks. As Bexis noted in his quick-out-of-the gate (and great) analysis, there is a lot in there to use in our medical device
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
A federal judge in California filed an important OTC preemption decision earlier this month, and it’s important because it applied federal preemption to shut down (for now) one of the many recent benzene-related consumer class actions. The case is Daugherty v. Padagis US LLC, No. 24-cv-02066, 2025 WL 2243622 (N.D. Cal. Aug. 6, 2025)
Today’s decision, Croci v. Zoll Medical Corp., 2025 WL 2307728 (S.D.N.Y. Aug. 11, 2025), is a straightforward, preemption-based 12(b)(6) dismissal of a complaint involving a Class III medical device. The case involves claims about a Life Vest, which is worn externally and monitors the wearer’s heart rate. The device is able to detect ventricular tachycardia and ventricular fibrillation, and it can deliver a therapeutic shock to restore the wearer’s heart rate to a normal rhythm. The complaint alleged that the decedent experienced problems with the Life Vest, and that a representative of the Life Vest’s manufacturer visited the decedent’s home to “desensitize the device.” Id. at *1. Shortly after the alleged visit from the representative, the decedent experienced a cardiac arrest and died.
Continue Reading PMA Preemption in the Southern District of New York
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
It might seem that we talk about preemption incessantly on this blog, but a pretty good opinion from a pretty important jurisdiction went unremarked by us last September. We’ll rectify that right now. Call it an end of year clean up session.
The decision in Howard v. Alchemee, LLC, 2024 U.S. Dist. LEXIS 169359
Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting—at least to us. We lamented just yesterday that many judges reflexively deny motions to dismiss on preemption, but others see the light from the get
As regular blog readers know, we love a clean grant of a motion to dismiss on preemption grounds. They are relatively common, so it sometimes puzzles us that the plaintiffs’ bar keeps filing plainly preempted claims.
Perhaps some of these plainly preempted lawsuits get filed because the express preemption provision of the FDCA related to