United States District Court, E.D. California
Decided March 21, 2014
For Paul Herron, Jr., Plaintiff: R. Parker White, LEAD ATTORNEY, Poswall White & Cutler, Sacramento, CA.
For Smith & Nephew, Inc., a Delaware Corporation, Defendant: David O'Quinn, PHV, LEAD ATTORNEY, PRO HAC VICE, Irwin Fritchie Urquhart & Moore LLC, New Orleans, LA; John W. Shaw, LEAD ATTORNEY, Morris Polich & Purdy LLP, Los Angeles, CA; Litsa Georgantopoulos, LEAD ATTORNEY, Morris Polich & Purdy, LLP, Los Angeles, CA.
LAWRENCE K. KARLTON,
SENIOR UNITED STATES DISTRICT JUDGE.
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.
Defendant, Smith & Nephew, Inc., is the manufacturer of the Birmingham Hip Resurfacing System (" BHR System" ), a medical device. 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. " 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]ailure to comply with any postapproval requirement constitutes a ground for withdrawal of approval of a PMA," and that " [c]ommercial 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. Unbeknownst to plaintiff at the time, the BHR System leaks metal ions into the tissues, causing various types of serious injury. FAC ¶ 14. As a result, plaintiff suffered pain and symptoms of cobalt poisoning. Id. On May 10, 2012,
plaintiff's BHR System was removed, and he was told that the device had failed. FAC ¶ 12. On June 1, 2012, a component of the BHR System (the " acetabular component" ) was subject to a market recall. FAC ¶ 13.
On June 20, 2012, plaintiff filed a complaint in state court alleging that defendant was strictly liable for the BHR System, under a " Product Liability" cause of action. ECF No. 1 at 15-16 (original complaint). Defendant answered, asserting, among other things, that the complaint was preempted by the Medical Device Amendments of 1976 (" MDA" ) to the Federal Drug and Cosmetic Act (the " Act" ), 21 U.S.C. § § 321, et seq., and federal regulations. Id., at 59-60.
Defendant removed the action to this court on December 19, 2012. Id., at 1. After defendant moved to dismiss the case based upon federal preemption, plaintiff amended his complaint. The amended complaint contains two common-law claims. The first claim alleges " Negligence," asserting that the device was designed or manufactured in violation of the MDA and its implementing regulations. The second claim alleges " Strict Products Liability," asserting, in addition to the negligence claims, that the device was " defective" and " unreasonably dangerous" when it entered the stream of commerce, due to defendant's alleged failures to comply with the MDA and regulations.
Defendant now moves to dismiss the amended complaint based upon preemption, and failure to state a claim.