Patient who underwent hip replacement surgery sued company that designed, manufactured, and marketed hip prosthesis that malfunctioned under number of theories including products liability, negligence, and breach of warranty, as well as the Texas Deceptive Trade Practices Act. “In summary, Bass pleaded: (1) he received a Shell implant; (2) the FDA had previously warned Stryker of bioburden in excess of FDA regulations in its final rinse of the Shells; (3) after Bass’s surgery, Stryker ultimately voluntarily recalled those Shells, including the Shell specifically used in Bass’s implant; (4) Bass suffered from a loose Shell due to a lack of bony ingrowth; and (5) the lack of bony ingrowth is a known effect of an excess of bioburden and manufacturing residuals on Shells.” The District Court found that even if the plaintiff’s claims were not preempted by §360k, they were preempted by 21 U.S.C. §337(a), which provides that “all such proceedings for the enforcement, or to restrain violations, of this Act … shall be by and in the name of the United States.” 21 U.S.C. §337(a). The Fifth Circuit said: “We agree with the courts that hold that an implied warranty claim is not preempted if the plaintiff alleges that the defendant violated federal requirements and can ultimately show a causal link between the violation and the breach of the implied warranty. If, however, the plaintiff claims that the defendant breached the implied warranty despite its compliance with FDA requirements, that claim is clearly preempted, as it would be different from, or in addition to, the requirements imposed by federal law. Here, the issue is whether Bass sufficiently pleaded that his breach of implied warranty claims are causally related to Stryker’s alleged violations of the FDA’s requirements. To the extent that he bases his breach of implied warranty claims on violations of federal requirements, those claims survive. To the extent he alleges that Stryker complied with the FDA requirements, his implied warranty claims are preempted.” Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012).
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