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
Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on the defendant because it approved “hundreds of premarket supplements” rather than requiring “a new PMA application.” Supposedly “[b]y utilizing the [premarket approval] supplement process instead of filing a new PMA application, [the defendant] avoided the rigorous scientific review, public comment and clinical trial requirements.”
That’s barnyard excrement. This plaintiff isn’t just wrong s/he is loud wrong – which, for plaintiffs, is unfortunately rather common.Continue Reading Supplemental Authority
A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation. The end results weren’t horrible (p-side motions were denied), but th0se Rule 702 opinions completely ignored the changes wrought by the 2023 amendments to that Rule. It was so striking that we went on PACER to see whether defense counsel was to blame for any of that – they weren’t.
Well, today we’re cheering the latest decision(s) in the same litigation. Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2005) (“Bulox I”), adopted, 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025) (“Bulox II”), is as good a PMA medical device preemption decision as a defendant has a right to expect. This Bulox decision should go a long way towards defeating the other side’s latest campaign to deprive women of contraceptive choice.Continue Reading Clip, Clip Hooray
Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.Continue Reading No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted
And patience is a virtue…all great achievements require time…trust the process. All easier said than done. Waiting can be a breeding ground for discouragement or frustration—like in litigation where, unfortunately for defendants that waiting usually comes at the significant cost of having to defend against and conduct discovery. Especially when the result after all
Today we report on the court’s order granting Defendant’s motion to dismiss in Keim-Bacon v. Stryker Corp., No. 4:22-CV-00383-WPJ-MTS, 2024 WL 4886051, at *1 (N.D. Okla. Nov. 25, 2024). It is a straightforward application of Riegel preemption that gets it right on all fronts.
The Scandinavian Total Ankle Replacement System (“STAR”) is a Class
Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).
This decision involved the Scandinavian Total Ankle Replacement device (“STAR”). The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a). This was Plaintiff’s second bite at the apple: The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim. See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023). After striking out in round one, Plaintiff fared no better in round two.Continue Reading Slam-Dunk Express Preemption Decision from the District of Arizona