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)
Express preemption
PMA Preemption in the Southern District of New York
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
Summers Round 2: Learned Intermediary Rule Applies to Claim Based on Device Recall
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
C.D. Cal. Dismisses Acne OTC/Benzene Claims as Preempted
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…
Medical Device Claims Preempted in Ohio
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…
Another Preemption Win Involving An Economic Loss Class Action And An OTC Drug
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…
It’s Hip To Be Preempted, Again
We are celebrating an anniversary today: We wrote our first blogpost on July 26, 2013. Eleven years and hundreds of posts later, we have two observations. First, we seriously need to update our blog profile photo. Or maybe we will just ride out our blogging years promoting the fiction that we are younger and fitter…
SDNY Dismisses Economic Injury Class Action Based on Express OTC Preemption
Patora v. Vi-Jon, LLC, 2023 U.S. Dist. LEXIS 153421 (S.D.N.Y. Aug. 30, 2023), is a typical express preemption decision resulting in dismissal of a typical consumer protection-based purely economic loss class action against an over the counter (OTC) product. The plaintiffs, suing on behalf of a putative class, alleged that they purchased an OTC…
A Dismissal Trifecta: Personal Jurisdiction, Preemption, and Twombly Doom Product-Liability Claims in the Northern District of Ohio
Today we report on Farson v. Coopersurgical, Inc., 2023 WL 5002818 (N.D. Ohio 2023), a product-liability decision that dismissed all claims against all defendants based on lack of personal jurisdiction, preemption, and Twombly.
Claiming that she was injured when an implantable medical device migrated in her body, the plaintiff brought suit in Ohio…
California Supreme Court Issues Landmark Opinion On Express Preemption
We do not often see state court opinions strongly endorsing federal preemption, or even weakly endorsing federal preemption. That is why we took notice last week when the California Supreme Court ruled unanimously that the Medicare Act expressly preempted state common-law and statutory claims against a health maintenance organization and a healthcare plan administrator. Most…