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 III medical device—one of the small percentage of medical devices so highly regulated that Congress included an express preemption provision in the Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) (“MDA”), barring any state law claims imposing requirements different from or in addition to federal requirements. Because of this express preemption provision, the only claims that may be brought are so-called “parallel claims” under Riegel v. Medtronic, 552 U.S. 312 (2008).  

In Keim-Bacon, the court held the strict liability and negligence claims were expressly preempted by the MDA in a classic Riegel preemption analysis. A plaintiff cannot state a parallel claim in conclusory terms, but rather “must show that the defendant deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.” Keim-Bacon, 2024 WL 4886051, at *3. Moreover, the plaintiff must “specifically identify a state law claim that is parallel to the federal requirements and . . . causally connect the simultaneous violations of federal and state law and to the alleged injury.”  Id. The court noted as persuasive the Skinner decision we reported earlier this year, where an Arizona district court held claims related to the same STAR device preempted. Like the complaint in Skinner, the complaint here failed “to allege that Defendant violated or deviated from any PMA or other FDA requirements, either during the PMA process or after.” Id. at *4. Simply referencing an FDA safety communication regarding higher-than-expected rates of breakage is not enough. Nowhere in the safety communication did the FDA indicate that this issue has anything to do with a violation of PMA or other FDA requirements. “[A]s the court held in Skinner, a plaintiff cannot simply allege a defect in a medical device and assume that the existence of the defect in the device alone establishes a parallel claim.” Id. In other words, there is no res ipsa loquitur for parallel claims.

Plaintiff’s negligence per se claim failed Twiqbal because Plaintiff’s complaint did not identify a particular statute or regulation that Defendant allegedly breached. And even if Plaintiff had identified such a statute or regulation, the claim would still be preempted—either expressly or impliedly—under the MDA. It would be expressly preempted because Plaintiff did not plausibly allege a violation of FDA requirements. And it would be impliedly preempted to the extent the claim sought to enforce the MDA rather than any parallel duty.

Finally, the court held that amendment of the complaint would be futile. Plaintiff’s conclusory allegations did not establish a parallel claim. And their argument the STAR device was adulterated by unauthorized changes to the inner-pouch packaging was contradicted by the FDA’s approval of this modification via a supplemental PMA, of which the court took judicial notice.

We give this decision on the STAR device five stars.