Part Of Plaintiff’s Failure To Warn Claim Is Preempted; Part Is Not.

Defendant manufactures a medical device, Infuse, used in surgery to strengthen the spines of individuals with degenerated vertebral discs. The Food and Drug Administration [FDA] granted approval for certain types of uses, but not for the type of use performed upon plaintiff, which was a posterior fusion. After plaintiff’s surgery, he suffered numbness and pain, and CT scans showed the collagen sponge had leaked, resulting in unwanted bone growth that encased the nerves in plaintiff’s spine. Plaintiff’s complaint alleges defendant “promoted the off-label use of Infuse while downplaying the risk of complications, violating both state and federal laws.” The trial court sustained defendant’s demurrer without leave to amend because his claims are preempted by federal law. The appellate court noted that FDA regulations prohibit a device manufacturer from promoting the use of a device in a manner inconsistent with premarket approval, and stated: “To avoid preemption, a plaintiff must state a cause of action based on state law that parallels a federal requirement. [] Here, because the requirements imposed by state law do not parallel the federal requirements, [plaintiff’s] off-label promotion failure to warn claim is expressly preempted.” The appellate court ruled: “The judgment is affirmed to the extent the trial court sustained the demurrer . . .as to the causes of action for fraud, intentional misrepresentation, violation of Business and Professions Code section 17200, concealment, and strict liability failure to warn on a theory of off-label promotion. The judgment is reversed to the extent the trial court sustained the demurrer . . . as to the causes of action for (1) strict liability failure to warn based on a failure to warn the FDA theory, (2) negligence, and (3) design defect. We remand the case for further proceedings.  (Coleman v. Medtronic, Inc. (Cal. App. Second Dist., Div. 5; January 27, 2014) (As mod. February 3, 2014) 223 Cal.App.4th 413, [167 Cal.Rptr.3d 300].)