Riegel, 522 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). The statute likewise “forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). FDA may demand additional information from the manufacturer at any time, see 21 U.S.C. § 360e(c)(1)(H), and may require revisions to any component of the application, see 21 C.F.R. § 814.44(c). Only upon successfully “running the gauntlet of the PMA Case 8:16-cv-01958-MWF-MRW Document 18 Filed 12/08/16 Page 11 of 32 Page ID #:184 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES process,” Medtronic, Inc. v. Lohr, 518 U.S. 470, 494 (1996), may a Class III device lawfully be marketed in the United States. A device manufacturer’s obligations under federal law do not end with pre- market approval.

Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are “substantially equivalent” to pre-existing devices to avoid the PMA process. See 21 U.S.C. § 360e(b)(1)(B). Medtronic, Inc. v. Lohr, 518 U.S. 470, 477–478, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).

Riegel, 522 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. § 814.39(c)). The statute likewise “forbids the manufacturer to make, without FDA permission, changes Case 2:16-cv-06822-MWF-MRW Document 15 Filed 10/04/16 Page 13 of 36 Page ID #:2017 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4 NOTICE OF MOTION AND MOTION TO DISMISS; MEMORANDUM OF POINTS AND AUTHORITIES in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). FDA may demand additional information from the manufacturer at any time, see 21 U.S.C. § 360e(c)(1)(H), and may require revisions to any component of the application, see 21 C.F.R. § 814.44(c). Only upon successfully “running the gauntlet of the PMA process,” Medtronic, Inc. v. Lohr, 518 U.S. 470, 494 (1996), may a Class III device lawfully be marketed in the United States.

“Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in . . . labeling … that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. §360e(d)(6)(A)(i)). “If the applicant wishes to make such a change, it must submit, and the FDA must approve, and application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application.”

Following approval, “the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). The FDA may also require post- approval studies as a condition of approval under 21 C.F.R. § 814.82(a)(2). On December 12, 2003, Mentor submitted a PMA application for its MemoryGel Silicone Breast Implants.

And the revocation of PMA requires explicit FDA action pursuant to a specific statutory and regulatory procedure. See, e.g., 21 U.S.C. §§ 360e(e)(2), 360e(g)(1)(A); 21 C.F.R. §§ 10.45, 16.

As a result, the Court granted summary judgment in favor of Mentor. Id. at 4; see also Gomez, 442 F.3d 919 (holding that patient’s defective design, failure -to-warn, failure-to-train and breach of implied and express warranty claims were preempted but manufacturing defect claims were not, to the extent that patient alleged that the device was defectively manufacture because it did not comply with FDA specifications); Hearn v. Advanced Bionics Corp., 2008 WL 3896431 (S.D. Miss.) (acknowledging Reigel, 128 S.Ct. 999); Betterton v. Evans, 351 F.Supp.2d 529 (N.D.Miss 2004) (holding that state law tort claims of strict liability, negligence and breach of warranties were preempted where pacemaker system and components were approved through the Product Development Protocol as provided in 21 U.S.C. § 360e(f)(3)(B)(I)-(viii)); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001) (holding that state common law products liability claims, for manufacturer’s breach of duty in connection with its design, labeling and manufacture of pacemaker which had already been subject to rigorous premarket approval were preempted by MDA). B. The Plaintiff has failed to establish the essential elements of her claims. Alternatively, if this Honorable Court should find that any of the Plaintiff’s claims are not preempted by federal law, BSC is nonetheless entitled to summary judgment as a matter of law as she has not established the essential elements of her strict liability, negligence or breach of warranty claims.

If the agency is not satisfied with the information provided, it can demand more. See id. (citing 21 U.S.C. § 360e(c)(1)(G)). The FDA may also refer the application to a panel of outside experts.

(citing 21 U.S.C. § 360e(d)(6)(A)(i)). FDA may demand additional information from the manufacturer at any time, see 21 U.S.C. § 360e(c)(1)(H), and may require revisions to any component of the application, see 21 C.F.R. § 814.44(c).

Once premarket approval has been granted, “the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). Moreover, approved devices are also subject to ongoing reporting requirements related to the device’s health and safety.