The FDCA grants the following rights to the FDA: (1) to recommend the initiation of an action for seizure of products to the Department of Justice (21 Case: 4:09-cv-00588-SNLJ Doc. #: 31 Filed: 08/26/09 Page: 20 of 39 PageID #: 393 - 13 - U.S.C. § 334); (2) to recommend pursuant of injunctions against companies and individuals alleged to have violated the FDCA (21 U.S.C. § 332(a)); (3) to recommend criminal charges (21 U.S.C. § 333(a)); and (4) in some situations, to assess civil monetary penalties (21 U.S.C. §§ 333(b) & (f), 335a, 360pp). It does not authorize the FDA to recommend to the Justice Department that it seek economic damages on behalf of consumers who, like Mr. Lefaivre and the members of the Class, purchased adulterated (and, thereafter, valueless) prescription drugs.1 If Congress had intended to foreclose consumers from pursuing claims for damages suffered as a result of purchasing adulterated drugs (adulterated as defined in the FDCA) by granting the FDA the sole right to pursue the enforcement provisions of the statute, it would either have given the FDA the right to pursue damages claims or it would have expressly provided that damages caused by FDCA violations are not recoverable.

at 18. This factual assertion (even if true) is of no moment because intent is not required for a violation of the FDCA or the Sherman Law.21 See 21 U.S.C. § 333(a); Cal. Health & Safety Code 20 To the extent Defendant argues that certain other packages of Thomas’ Bagel Thins may not have contained an “excellent source of fiber” claim, this only raises questions of fact.

But the fact that the FDCA Case 1:11-cv-00289-RJL Document 15 Filed 06/03/11 Page 24 of 58 – 14 – DC1 2025010v.1 is silent as to when the government must prosecute violations of the FDCA does not mean that the Heckler court found the word “shall” in 21 U.S.C. § 333 to be lacking its usual mandatory meaning. Even after Heckler, it remains the case that if a person is convicted of a violation of the FDCA, then that person must be sentenced in accordance with 21 U.S.C. § 333. The government’s error is well illustrated by its reliance on United States v. Clarke, 628 F. Supp. 2d 1 (D.D.C. 2009).

Case: 4:09-cv-00588-SNLJ Doc. #: 23 Filed: 07/07/09 Page: 19 of 37 PageID #: 167 - 12 - U.S.C. § 333(a)); and (4) in some situations, to assess civil monetary penalties (21 U.S.C. §§ 333(b) & (f), 335a, 360pp). It does not authorize the FDA to recommend to the Justice Department that it seek economic damages on behalf of consumers who, like Mr. Lefaivre and the members of the Class, purchased adulterated (and, thereafter, valueless) prescription drugs.4 If Congress had intended to foreclose consumers from pursuing claims for damages suffered as a result of purchasing adulterated drugs (adulterated as defined in the FDCA) by granting the FDA the sole right to pursue the enforcement provisions of the statute, it would either have given the FDA the right to pursue damages claims or it would have expressedly provided that damages caused by FDCA violations are not recoverable.

Therefore, McKesson cannot alter the Eliquis label without facing federal civil and criminal penalties. 21 C.F.R. § 314.71(a); 21 U.S.C. § 333. In Mensing, the Supreme Court found that a generic manufacturer of a pharmaceutical could not be held liable for state failure-to-warn claims based on the following deductive analysis: (1) federal law permits only the NDA holder to alter the label; (2) state failure-to-warn claims would require a generic manufacturer (i.e., non-NDA holder) to alter the label; and, therefore, (3) the state failure-to-warn claims were necessarily preempted by federal law, pursuant to the Supremacy Clause, because it would be “impossible” for the generic manufacturer to abide by both federal and state laws. Mensing, 564 U.S. at 618.

. BIPI would have violated federal law (i.e., Jardiance would have been misbranded) if, upon approval, BIPI instead had marketed Jardiance with labeling and warnings other than what the FDA approved. See 21 U.S.C. §§ 331(c), 333(a), 352(a), (c). Thus, as the First Circuit has explained, Wyeth and Mensing drew a line that “lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops.” In re Celexa, 779 F.3d at 41. Plaintiff’s state law claim that a different warning should have been provided when BIPI commenced marketing Jardiance is therefore preempted. Allowing state law tort juries to find otherwise—i.e., that from the time the drug was first marketed, it was “unreasonably dangerous” as a result of the drug’s FDA-approved labeling—would invariably conflict with the FDA’s considered judgment regarding the same.

Threat of criminal prosecution also prevents distribution of violative drugs. See 21 U.S.C. § 333(a). FDA typically utilizes these other enforcement mechanisms, instead of withdrawal of approval, to prevent distribution of a violative drug.

Buckman, 531 U.S. at 349; see also 21 U.S.C. §§ 332, 333, 334. B. Factual Background 1.

Buckman, 531 U.S. at 349; see also 21 U.S.C. §§ 332, 333, 334. B. Factual Background 1. FDA’s Approval of Essure Since 2002, FDA has recognized that Essure is a safe and effective method of permanent contraception for women.

The FDCA includes its own enforcement mechanism, entrusting FDA with authority to investigate violations of the FDCA, 21 U.S.C. § 372, and to pursue a variety of sanctions for any fraud it discovers, including withdrawing approval of a drug, 21 U.S.C. § 355(e), 21 C.F.R. § 314.150(a)(2)(iv); injunctive relief, 21 U.S.C. § 332; civil monetary penalties for submission of false and misleading information, 21 U.S.C. § 333(f)(3)(A); and criminal prosecution of the manufacturer, 21 U.S.C. § 333(a).3 FDA, in turn, has instituted an administrative policy regarding appropriate measures for responding to false or misleading statements submitted by drug manufacturers. 56 Fed. Reg.