........................20 Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007) .................................................................................................................12 Williams v. E.I. du Pont de Nemours & Co., 154 F. Supp. 3d 407, 411 (M.D. La. 2015) ........................................................................11, 13 Williamston v. Medtronic, Inc., 2014 WL 2042004 (W.D. La. May 15, 2014) ...................................................................26, 29 Williard v. Humana Health Plan of Texas, 336 F.3d 375 (5th Cir. 2003) .....................................................................................................9 Statutes 21 U.S.C. §360c ...............................................................................................................................8 21 U.S.C. § 360e(c)..........................................................................................................................8 21 U.S.C. § 360i(a) ..........................................................................................................................6 Food, Drug and Cosmetics Act ....................................................................................................1, 8 La. C.C. Arts. 2315-2317, 2317.1, 2320, 2322, and 2324 ................................................. 10, 18-19 La.C.C. Art. 2520, et seq. ........................................................................................................10, 18 La. R.S. 9:2800.52 .........................................................................................................................18 La. R.S. 9:2800.54 .........................................................................................................................18 Louisiana Products Liability Act, La. R.S. 9:2800.51, et seq. ............................................... passim Other Authorities 21 C.F.R. §20.63 ..........................................

The Court will, however, grant Plaintiffs leave to amend as to these claims. Plaintiffs also seek to pursue a parallel claim based on Defendants' failure to report adverse events associated 2015 U.S. Dist. LEXIS 43141, *53 Case 3:17-cv-00294-ARC Document 13-1 Filed 05/08/17 Page 59 of 69 Page 18 of 20 Pamela Sandillo with use of the R3 metal liner in hip replacement procedures to the FDA, in violation of 21 U.S.C. § 360i, 21 C.F.R. § 803.50, and other FDA regulations.

Page 19 of 32 Page ID #:351 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 11 DEFENDANTS’ NOTICE OF MOTION AND MOTION TO DISMISS 8:16-CV-2174 JLS (KESx) 388690 V1 Here, plaintiffs generally allege that the Subject ICD “was in violation of the FDCA, Manufacturing Guidelines, FDA Premarket Approval requirements, Reporting Requirements, Notification Requirements,” but the alleged “violations” are: (1) “concealing data from the FDA that premature battery depletion may cause the ICDs already implanted in patients to fail, in violation of 21 U.S.C. §§ 351 (e), (f), and (h)”; (2) failing to implement appropriate quality controls in its manufacturing process in violation of 21 C.F.R. 820; (3) failing to report adverse events associated with the ICDs, “as evidenced by the failure to report the failure Plaintiff’s Subject ICD and previous such failures . . . , in violation of 21 U.S.C. § 360i”; (4) “failing to implement effective recall communications to get the defective product out of the stream of commerce, in violation of 21 C.F.R. § 7, et seq., as evidenced by the fact [that] no notice was ever provided to Plaintiff . . . .” (See, e.g., FAC ¶ 35.)

Further, the manufacturer is under a continuing duty to report the results of new studies or Case 2:08-cv-00079-KS-MTP Document 39 Filed 01/16/09 Page 8 of 20 Page 9 of 20 investigations and adverse events possibly resulting from use of or malfunctioning of the device. Id. (citing 21 U.S.C. § 360i; 21 CFR §§ 814.84 (b)(2), 803.50(a)).

63, 21 C.F.R. 20.111 and in federal statutory law including 21 U.S.C. 360i. The FDA has strongly stated that “its success in encouraging health professionals to participate in the voluntary adverse event reporting system depends substantially on the guarantee of confidentiality given the identity of the reporter under FDA regulations.”