At this time we report on the court docket’s order granting Defendant’s movement 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’s a easy utility of Riegel preemption that will get it proper on all fronts.
The Scandinavian Whole Ankle Alternative System (“STAR”) is a Class III medical system—one of many small share of medical units so extremely regulated that Congress included an specific preemption provision within the Medical System Amendments of 1976, 21 U.S.C. § 360k(a) (“MDA”), barring any state regulation claims imposing necessities completely different from or along with federal necessities. Due to this specific preemption provision, the one claims that could be introduced are so-called “parallel claims” underneath Riegel v. Medtronic, 552 U.S. 312 (2008).
In Keim-Bacon, the court docket held the strict legal responsibility and negligence claims have been expressly preempted by the MDA in a traditional Riegel preemption evaluation. A plaintiff can’t state a parallel declare in conclusory phrases, however quite “should present that the defendant deviated from a specific pre-market approval or different FDA requirement relevant to the Class III medical system.” Keim-Bacon, 2024 WL 4886051, at *3. Furthermore, the plaintiff should “particularly establish a state regulation declare that’s parallel to the federal necessities and . . . causally join the simultaneous violations of federal and state regulation and to the alleged damage.” Id. The court docket famous as persuasive the Skinner choice we reported earlier this 12 months, the place an Arizona district court docket held claims associated to the identical STAR system preempted. Just like the grievance in Skinner, the grievance right here failed “to allege that Defendant violated or deviated from any PMA or different FDA necessities, both throughout the PMA course of or after.” Id. at *4. Merely referencing an FDA security communication concerning higher-than-expected charges of breakage is just not sufficient. Nowhere within the security communication did the FDA point out that this challenge has something to do with a violation of PMA or different FDA necessities. “[A]s the court docket held in Skinner, a plaintiff can’t merely allege a defect in a medical system and assume that the existence of the defect within the system alone establishes a parallel declare.” Id. In different phrases, there isn’t a res ipsa loquitur for parallel claims.
Plaintiff’s negligence per se declare failed Twiqbal as a result of Plaintiff’s grievance didn’t establish a specific statute or regulation that Defendant allegedly breached. And even when Plaintiff had recognized such a statute or regulation, the declare would nonetheless be preempted—both expressly or impliedly—underneath the MDA. It might be expressly preempted as a result of Plaintiff didn’t plausibly allege a violation of FDA necessities. And it could be impliedly preempted to the extent the declare sought to implement the MDA quite than any parallel obligation.
Lastly, the court docket held that modification of the grievance can be futile. Plaintiff’s conclusory allegations didn’t set up a parallel declare. And their argument the STAR system was adulterated by unauthorized modifications to the inner-pouch packaging was contradicted by the FDA’s approval of this modification through a supplemental PMA, of which the court docket took judicial discover.
We give this choice on the STAR system 5 stars.