1. Federal Statutory and Regulatory Background Congress enacted the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. in 1938 (“FDCA”). The FDCA generally prohibits misbranding of food.

The FDCA’s version of the common carrier exemption is arguably even clearer than the CSA’s. Section 373(a) expressly provides that “carriers shall not be subject to the other provisions of this Act [21 U.S.C. §§ 301 et seq.] by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers,” except in circumstances not applicable here. U.S. v. FedEx Corp. et al.

The Mentor MemoryGel Silicone Breast Implants implanted in Plaintiff are Class III medical devices as defined by 21 C.F.R. § 878.3530. The most stringent controls apply to Class III devices under the Medical Device Amendments, 21 U.S.C. §§ 360 et seq., to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq. See Riegel, 552 U.S. at 316. Because of its Class III status, the commercial sale of Mentor MemoryGel Silicone Breast Implants to healthcare professionals was conditioned upon the device receiving premarket approval from the FDA.

should be dismissed with prejudice for the reasons set forth in the instant Motion. Smith & Nephew reserves, and specifically does not waive, its right to seek dismissal of Plaintiffs’ Complaint on this additional ground. 2 This Court may take judicial notice of the BHR System approval documents because they are located on an official government website (the FDA’s website) at: http://www.accessdata.fda. gov/cdrh_docs/pdf4/P040033A.pdf. See, e.g., Scanlon v. Medtronic Sofamor Danek USA Inc., 61 F. Supp. 3d 403, 413 n.16 (D. Del. 2014) (taking judicial notice of document available on Case 1:16-cv-00712-LPS Document 7-1 Filed 11/11/16 Page 7 of 26 PageID #: 35 4 that the BHR System has been deemed safe and effective by the FDA, pursuant to the requirements of the MDA, 21 U.S.C. § 301, et. seq. (See Ex. A.) ARGUMENT I. PLAINTIFFS’ CLAIMS ARE EXPRESSLY PREEMPTED BY THE MEDICAL DEVICE AMENDMENTS A. Federal Regulatory Scheme Applicable to the BHR System The MDA, 21 U.S.C. § 301, et. seq., governs FDA-approved medical devices such as the BHR System. The FDA groups prescription medical devices into three classes.

007(a). It is undisputed that the Eliquis label was “approved by [FDA] . . . under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.),” Tex. Civ. Prac. & Rem.

III. THE FDA REGULATORY PROCESS FOR PRESCRIPTION DRUGS AND REQUIREMENTS FOR DRUG LABELING AND WARNINGS An analysis of conflict preemption requires an understanding of the drug approval process, the manner in which FDA regulates prescription drugs and their labeling, and the scope of such regulation. Congress, through the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., charged FDA with the authority and responsibility to regulate every aspect of the safety, effectiveness, labeling, marketing, and promotion of prescription drugs. See 21 U.S.C. § 393(b) (stating that FDA must “promote the public health by promptly and efficiently reviewing clinical research” and “protect the public health by ensuring that . . . drugs are safe and effective”).

Under the FDCA, the FDA has virtually exclusive authority to regulate medical devices. 21 U.S.C § 301 et seq; Delaney v. Stryker Orthopaedics, No. CIV.A.

FDA has regulatory jurisdiction over drugs and medical devices. Congress has carefully delineated the distinction between a drug and a device in the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq. As a matter of law, DSW is a device and must be regulated by FDA as such.

D. Plaintiffs’ State-Law Claims Stand as an Obstacle to the Full Purposes and Objectives of Congress Plaintiffs’ claims also stand as an obstacle to Congress’s intent that FDA exclusively regulate prescription drugs sold in the United States. See FDCA, 21 U.S.C. § 301, et seq. Congress created a regulatory structure that grants FDA exclusive authority and responsibility for resolving complex scientific and public health issues related to prescription drug labeling.

Third, Plaintiffs’ assertion that they never received the FDA-approved medication guide with their amiodarone prescriptions fails as a matter of law because: (1) Upsher-Smith’s obligations regarding distribution of the medication guide exist only under the federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., which does not provide a private right of action, so such a claim is impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), as an impermissible attempt to enforce the FDCA; (2) Plaintiffs have not plausibly alleged that the distributor to whom Upsher-Smith allegedly failed to provide medication guides was the distributor of the amiodarone allegedly purchased by Mr. Bennett and Mr. Smith; and (3) Plaintiffs have not plausibly alleged that Upsher-Smith failed to comply with the medication guide regulations. Fourth, Plaintiffs’ claims of “off-label” promotion to use amiodarone to treat conditions other than those approved by FDA, like the medication guide claims, are impliedly preempted under Buckman because private litigants cannot enforce FDA regulations.