. Specifically, Plaintiff alleges that he bases this claim on the contention that Smith & 3The FDA has mandated “current good manufacturing practices,” or CGMP, which are outlined in 21 C.F.R. § 820.30. 9 6:15-cv-00545-TMC Date Filed 02/16/16 Entry Number 52 Page 9 of 15 A9 Case 1:16-cv-00712-LPS Document 11-2 Filed 02/03/17 Page 10 of 16

Accordingly, as in Norman, De La Paz, McLaughlin, and Richardson, Plaintiff’s claims fail. Plaintiff’s only attempt to link manufacturing deficiencies with her alleged injuries is the attenuated and conclusory claim that failure to “conform to the CMP design controls enumerated in 21 C.F.R. § 820.30,” Am. Compl. ¶¶ 137, 154, resulted in “ongoing and systematic failures related to the control of non-conforming materials” that somehow caused her device to become “unpassivated,” which in turn somehow caused the device to break.

id. ¶ 16 (“The BHR . . . was designed and/or manufactured in 3 Plaintiffs’ Complaint lists 21 C.F.R. § 820.30(f)-(g); 21 C.F.R. § 820.80(c)-(d); 21 C.F.R. § 820.100; and 21 C.F.R. § 820.198. Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 13 of 26 PageID #: 41 10 violation of the Federal Food, Drug and Cosmetic Act (the ‘Act’) and regulations promulgated pursuant to it.”).) Because Plaintiffs’ claims are expressly predicated on Smith & Nephew’s alleged failure to comply with the FDCA and because the FDA retains sole authority to enforce such purported violations, Plaintiffs’ claims are preempted.