Herron
Herron v. Smith & Nephew, Inc.
Opinion
Lead Opinion
Karlton, J.
ORDER
Defendant moves to dismiss the amended complaint, asserting that it is preempted by federal law, and that it fails to state a claim. For the reasons that follow, the amended complaint will be dismissed with leave to amend.
I. BACKGROUND
Defendant, Smith & Nephew, Inc., is the manufacturer of the Birmingham Hip Resurfacing System (“BHR System”), a medical device. 1 FAC ¶ 6. Defendant sought pre-market approval (“PMA”) of the device, which was granted, with conditions, on May 9, 2006. FAC ¶ 8. See Approval Letter (ECF No. 29-3), Exhibit A to the Declaration of Litsa Georgantopoulous in support of Defendant’s motion to dismiss. 2 “Pre-Market Approval” is part of a federal regulatory process created by the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq.
The Approval Letter states that “[f]ail-ure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA,” and that “[cjommercial distribution of a device that is not in compliance with these conditions is a violation” of the federal Food, Drug, and Cosmetic Act. Approval Letter at 7.
On July 11, 2009, plaintiff underwent surgery to replace a BHR System. FAC ¶ 10.…