This post is from the non-RS side of the Blog.
Consider the following scenario. A fifty-two-year-old woman has end-stage left ventricular heart failure despite medical care and the latest medications. Her prospects for a heart transplant or the implantation of a left-ventricular assist device to prolong her life are limited, including by financial considerations. She
In the drug and device product liability world, we love our acronyms and our short-hand phrases. The MDAs to the FDCA. Class III. PMA. 510(k).
Today’s acronym is CGMP, which sometimes you will see written as “cGMP”. The GMP stands for Good Manufacturing Practices, and the “C” (or “c”) has, since a 1996 Final Rule
About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered. The diabetic using the pump then spoke with a representative of the manufacturer who confirmed that the pump was not delivering insulin and that the user should replace the insulin cartridge. The user of the pump died later the same day, and his estate filed a lawsuit. As discussed in our prior post, the court dismissed with prejudice most of the estate’s claims, but it granted plaintiff leave to file a second amended complaint (SAC) that included a claim for negligent defective design and wrongful death. Today’s decision, Gallego v. Tandem Diabetes Care, Inc., 2026 WL 1130316 (E.D.N.Y. Apr. 27, 2026), applies another robust preemption analysis and dismisses the plaintiff’s remaining claims with prejudice.
Continue Reading Preemption Round Two in the Eastern District of New York
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
If ever there were a case that reads like a checklist for how not to plead around preemption, it’s Dunham v. Boston Scientific Corp., — F.Supp.3d–, 2026 WL 539533 (W.D. Mich. Feb. 24, 2026). Plaintiff alleged that his spinal cord stimulator—a Class III, premarket approved device—implanted to treat his chronic back pain caused him
Not quite three years ago, we co-authored a chapter in a Digital Health guide put out by International Comparative Legal Guides. It bore the pithy title “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health.” We continue to tinker with the principles of product liability law
In case our title was too subtle, we think that a stack of purported inferences should neither state a claim for strict liability with a prescription medical device nor sidestep express preemption in the case of a Class III device. We have long been dubious of the idea of a true parallel claim as articulated
There is a documentary out on the actor Charlie Sheen and it reminded us that, long before the current denizen of the White House crowed about “winning,” that was a staple of many bizarre rants by Sheen.
We’re not ranting, whether bizarrely or sanely, but it is nice to post about yet another defense win
The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.
Every time we see a case that does that—upholds preemption on summary judgment—we wonder
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