Daily Blast January 27, 2014

The California Court of Appeal, Second Appellate District, Division Five (Los Angeles) issued an opinion in Coleman v. Medtronic, Inc., et al. (Jan. 27, 2014, B243609) __ Cal.App.4th ___, analyzing whether plaintiffs claims involving the off-label use of a medical device were preempted by federal law. The Court of Appeal held that plaintiff could allege causes of action for negligence and strict liability in a manner that avoids federal preemption. (Slip opn., p. 2.)

Plaintiff Coleman sued defendant Medtronic alleging he suffered painful complications after a spinal surgery in which Infuse, Medtronic’s federally-approved bone fusion medical device, was used in an “off-label” manner. (Slip opn., p. 2.) The FDA granted Infuse premarket approval for certain types of surgeries, including Anterior Lumbar Interbody Fusion. Posterior Lumbar Interbody Fusion is an alternate form of spinal fusion surgery and is considered an off-label use of Infuse. (Id. at pp. 2-3.) Coleman contended that Medtronic defectively manufactured Infuse, promoted off-label uses of Infuse without adequately warning of the associated risks, and failed to take available steps to warn Coleman of the risks of such uses. The trial court sustained Medtronic’s demurrer to Coleman’s third amended complaint without leave to amend on the ground that each cause of action was preempted by federal law. (Id. at p. 2.)

The Court of Appeal reversed the judgment as to Coleman’s causes of action for (1) strict liability failure to warn, (2) negligence, and (3) design defect. (Slip opn., p. 24.) The court held that Coleman’s failure to warn claim based on Medtronic’s failure to file adverse event reports with the FDA was not subject to express or implied preemption because California law imposes a parallel adverse event reporting requirement under the common law strict liability tort of failure to warn as is imposed under federal law. (Id. at p. 14.) The court then held that Coleman’s failure to warn claim based on Medtronic’s alleged promotion of off-label use was expressly preempted because federal regulations preventing device manufacturers from promoting off-label use of FDA-approved devices are substantively different than the requirements imposed by California common law in the failure to warn context. (Id. at p. 16.) Further, the court held that Coleman’s negligence cause of action based on Medtronic’s failure to report adverse events to the FDA was not preempted. According to the court, there is “no preemption of state law claims based on negligence per se.” (Id. at p. 19.) Additionally, Coleman’s negligence cause of action based on the theory of off-label promotion was not preempted because it paralleled the federal requirements prohibiting misbranding and adulteration. (Id. at p. 20.) Finally, the court held that Coleman sufficiently alleged facts sufficient to state a cause of action for manufacturing defect. At the pleading stage, he was not required to identify the specific manner in which Medtronic violated the federal requirements. Rather, the issue of preemption as to the manufacturing defect could be addressed after Coleman had some opportunity to conduct discovery. (Id. at p. 24.)

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