Search results for: pma preemption scorecard

There’s a certain romance to the idea that if one courthouse door closes, another—perhaps with better lighting and more favorable precedent—must surely be open somewhere else. But as one group of particularly determined preemption refugees recently learned, civil procedure is not a game of judicial Whac-A-Mole.

The story begins in Utah, where 50 plaintiffs brought…

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

Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted.  After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.”  Id. at 323.  Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:

Continue Reading PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

As evidenced by our PMA Preemption Score Card, on which today’s case became the 651st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions.  But plaintiffs keep filing PMA medical device complaints, so we’ll keep posting about them. 

Which brings us to today’s case, Arnold v.

It’s unusual when the same defendant wins two unrelated cases involving the same product in the same week – and on the same issue.  But it does happen, and recently, in both Benn v. Medtronic, Inc., 2023 WL 3966000 (D.N.J. June 13, 2023), and Warmoth v. Medtronic, Inc., 2023 WL 3938464 (W.D. Okla. June 9, 2023), express medical device preemption carried the day, in decisions issued only four days apart.

That’s worth a blogpost – and two cheers.  Hip hip!

Continue Reading A Preemption Two-Fer

We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:

[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light

…

If preemption had a family tree, the drug and device branch would be heavy.  And, as our scorecards and cheat sheets demonstrate, there are obvious sub-branches that sprouted out of major Supreme Court decisions.  We have the Wyeth v. Levine, 555 U.S. 555 (2009) pharmaceutical branch; the Medtronic, Inc. v. Lohr, 518 U.S.…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book