Nor do plaintiffs allege how any conduct violated any particular provision. Plaintiffs cite to 21 U.S.C § 351 (e), but this subdivision governs devices not in conformity with performance standards, not purportedly concealing information from the FDA. Plaintiffs have not identified any particular performance standards applicable to the device that were violated, let alone alleged such violations caused plaintiffs’ injuries.

Case 1:14-cv-01923-BAH Document 22-1 Filed 11/18/14 Page 15 of 59Case 1:14-cv-01923-BAH Document 3 Filed 1 /18/14 Page 15 of 59 12 Form FDA 483, but that response did not adequately address FDA’s concerns. On September 16, 2008, FDA issued a Warning Letter to Ranbaxy stating that, based on the violations observed during FDA’s January-February 2008 inspection at Dewas and taking into account Ranbaxy’s written response, the sterile and non-sterile finished drug products and APIs manufactured at Dewas were adulterated under section 501(a)(2)(B) of the FDCA, 21 U.S.C. § 351(a)(2)(B), because they were manufactured in violation of CGMP. The Warning Letter stated that, “[u]ntil all corrections have been completed and FDA can confirm your firm’s compliance with CGMP, this office will recommend disapproval of any new applications or supplements listing your firm as a manufacturing location of finished dosage forms and [APIs].”

As part of the XR “test market,” Synthes and Norian directed the Synthes Spine sales force to gather clinical data about surgeries that the “test market” surgeons performed, so that Synthes and Norian could document the results of surgeries to treat VCFs, in order to assess the risk level of using Norian XR to treat VCFs, and determine whether that risk level was too high. This unauthorized clinical testing of Norian XR for the treatment of VCFs violated 21 U.S.C. § 351(f)(1) because such testing of a significant risk device required the prior approval of the FDA, through an IDE. Plea Agreement, Doc.

A parallel provision of the statute imposes cGMP requirements by establishing that a drug is “adulterated” if “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.” 21 U.S.C. § 351(a)(2)(B). FDA has established implementing regulations to enforce these cGMP requirements.

Case: 4:09-cv-00588-SNLJ Doc. #: 77 Filed: 12/15/11 Page: 2 of 14 PageID #: 757 -3- 21 U.S.C. § 351(a)(2)(B). As a condition of their settlement with the FDA, Defendants issued a retail level recall covering all then existing inventories of the Medication in January 2009.

An ANDA applicant seeking approval of drug for which there is a USP monograph must generally show that the proposed product’s strength, quality and purity meet the standards in the monograph. See 21 U.S.C. § 351. Case 1:17-cv-00180-RDM Document 25 Filed 03/29/17 Page 25 of 50 - 16 - specific, multi-factor analysis that considered the timing of the change as well as myriad other facts equally important to causation under the statute.

Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 25 of 27 26 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 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 CONCLUSION For the foregoing reasons, this Court should dismiss Plaintiff’s complaint. 6 Nor is it at all clear how adulteration under 21 U.S.C. § 351 concerns Plaintiff, as neither the complaint nor the Petition raises any issue concerning adulteration. Case 3:16-cv-01214-H-BLM Document 6-1 Filed 09/26/16 Page 26 of 27 27 Kripke v. U.S. Food and Drug Administration et al., Case No. 3:16-cv-1214-H-BLM 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 Dated: September 26, 2016 Respectfully Submitted, MARGARET M. DOTZEL Acting General Counsel U.S. Dept. of Health & Human Services ELIZABETH H. DICKINSON Chief Counsel ANNAMARIE KEMPIC Deputy Chief Counsel, Litigation ARIEL Z. SEELEY Associate Chief Counsel U.S. Dept. of Health & Human Services Office of the General Counsel Food and Drug Division 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 (301) 796-8738 (phone) ariel.seeley@fda.hhs.

Charges that may be brought against unapproved drugs include, but are not limited to, violations of 21 U.S.C. 355(a) and 352(f)(1) of the FD&C Act. Other charges may also apply based on, among others, violations of 21 U.S.C. 351(a)(2)(B) (CGMP), 352(a) (misbranding), or 352(o) (failure to register or list). 12 Firms are reminded that this CPG does not create any right to a grace period; the length of the grace period, if any, is solely at the discretion of the Agency.

................... 38 United Savings Ass’n v. Timbers of Inwood Forest Associates, 484 U.S. 365 (1988) ................ 29 United States Dep’t of Treasury v. Fabe, 508 U.S. 491 (1993) .................................................... 25 United States v. Mead Corp., 533 U.S. 218 (2001) ................................................................ 18, 24 Washington Legal Clinic for the Homeless v. Barry, 107 F.3d 32 (D.C. Cir. 1997) ............. 38, 39 Statutes and Regulations Administrative Procedure Act 5 U.S.C. § 704 ............................................................................................................................... 43 5 U.S.C. § 706(2)(A)............................................................................................................... 15, 16 Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 331 ......................................................................................................................... 7, 40 21 U.S.C. § 351(a)(2)(B). ......................................................................................................... 7, 40 21 U.S.C. § 355(a) .......................................................................................................................... 6 21 U.S.C. § 355(b).

No claim to original U.S. Government Works. 9 Under the FDCA, “a ... device shall be deemed to be adulterated” with respect to an intended use if it is a Class III device which has not received premarket approval or § 510(k) clearance with respect to that intended use. See 21 U.S.C. § 351(f). The FDCA provides that “a ... device shall be deemed to be misbranded” unless its labeling bears “adequate directions” for the intended use of the device including indications, effects, relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purposes for which it is intended.