We have been saying for a long time that parallel violation claims that avoid preemption under 21 U.S.C. § 360k pursuant to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), may nonetheless be preempted by 21 U.S.C. § 337(a)’s ban on private actions to enforce the FDCA. It took the judiciary a little time to get this, but the light bulb has gone off, and the good decisions keep rolling in. Bass v. Stryker Corp., 2010 U.S. Dist. LEXIS 90226 (N.D. Tex. Aug. 31, 2010), is the latest example.
Bass claimed his Trident System hip prosthesis failed and filed suit alleging numerous claims, including products liability, negligence, breach of warranty, and violation of the Texas Deceptive Practices Act. Defendants moved to dismiss, arguing that each of the claims is preempted.
The first issue was whether the FDA’s premarket approval to the Trident System as a whole meant that the particular component that failed, the Trident ASL Acetubular Shell, had received premarket approval. The court said that it did, following the decision in Lewkut v. Stryker Corp., 2010 U.S. Dist. LEXIS 38345 (S.D. Tex. Apr. 16, 2010), which we discussed here, and other decisions. 2010 U.S. Dist. LEXIS 90226 at *6-*12.
The more substantial issue was whether Bass had stated viable parallel claims. His complaint included conclusory allegations of “manufacturing deficiencies” and “material deviations” and passing references to a voluntary recall and an FDA warning letter, but no supporting facts, much less facts connecting the alleged problems to his injuries. The complaint therefore failed to plead parallel claims. Id. at *13-*14. Score another for Twombly and Iqbal.
But there’s more. The court said that plaintiff’s putative parallel private pleadings were preempted by 21 U.S.C. § 337(a). Following one of our fave decisions, In re Medtronic, Inc., 592 F. Supp. 2d 1147 (D. Minn. 2009), the court said that “a plaintiff’s characterizing his claims as parallel would be no response to a preemption argument under § 337(a).” 2010 U.S. Dist. LEXIS 90226 at *14-*15. And Bass was skeptical of potential exceptions recognized by the District of Minnesota. Although In re Medtronic said that a plaintiff could avoid preemption under Riegel by alleging a failure to adhere to premarket approval specifications, Bass said that such a claim would be preempted by § 337(a)’s language giving the United States the exclusive right to enforce the FDCA, and in any event Bass did not plead facts supporting such a claim. 2010 U.S. Dist. LEXIS 90226 at *15.
The Bass court said that In re Medtronic recognized a second exception for claims under state statutes that create a cause of action for FDCA violations, but the court said that Bass did not rely on any such statute, so that exception did him no good. Id. at *16. We would add that any such state statute would also be preempted by § 337(a) – federal law giving the United States the exclusive right to enforce the FDCA should preempt any state statute purporting to give some private plaintiff the right to enforce the FDCA, as that’s the whole idea behind preemption – but Bass didn’t have to go that far.
Bass concluded that plaintiff’s claims are preempted by § 360k and any alleged parallel claims that escaped § 360k preemption are preempted by § 337(a). Id. at *17. Motion to dismiss granted. Case over. Preemption works.