On January 27, 2014, the California Court of Appeal for the Second Appellate District published its opinion in Coleman v. Medtronic, Inc., et al. The Court of Appeal evaluated certain claims made relating to Medtronic’s federally-approved bone fusion medical device, when used in an off-label manner, eventually holding the claims were not federally preempted.
Medtronic manufactures and sells Infuse, a medical device used in surgery to strengthen the spines of individuals with degenerated vertebral discs. In 2009, John Coleman underwent Posterior Fusion surgery, an alternative form of spinal fusion surgery. His surgeon used Infuse. The Food and Drug Administration (“FDA”) has only approved Infuse for Anterior Fusion, thus use of the device in Coleman’s surgery was considered an “off-label” use. Coleman experienced complications following his surgery and in 2011, filed suit against Medtronic. Coleman alleged Medtronic promoted the off-label use of Infuse while downplaying the risk of complications, in violation of both state and federal laws. The trial court sustained Medtronic’s demurrers to both Coleman’s first and second amended complaints with leave to amend. The trial court ruled that Coleman’s subsequent third amended complaint was sufficient, with the exception of Coleman’s manufacturing defect claim, and ordered Coleman to file a third amended complaint without the manufacturing defect claim.
Just days later, the Ninth Circuit Court of Appeals held that a state law negligence cause of action based on a failure to report adverse information about an FDA-approved medical device as required by federal regulations was preempted by federal law. (Stengel v. Medtronic, Inc. (9th Cir. 2012) 676 F.3d 1159 (“Stengel I”).) Based on this decision, Medtronic demurred to Coleman’s third amended complaint and the trial court sustained it without leave to amend. Thereafter, the Ninth Circuit agreed to rehear Stengel I (“Stengel II”). On January 10, 2013, the Ninth Circuit issued a unanimous decision holding that the plaintiff’s state law negligence claims for failure to warn were not preempted by federal law. (Stengel v. Medtronic, Inc. (9th Cir. 2013) 704 f.3d 1224 (“Stengel III”).)
Coleman appealed. In his appeal, Coleman asserted his failure to warn, negligence and manufacturing defect claims were not preempted based on state law duties that parallel requirements under federal law.
The Court of Appeal found that in order “to survive both express and implied preemption, a state law cause of action must be premised on conduct that both (1) violates the Federal Food, Drug and Cosmetic Act (“FDCA”); and (2) would give rise to recovery under state law even in the absence of the FDCA. (Riley v. Cordis (D. Minn. 2009) 625 F.Supp.2d 769, 777).” Coleman’s state law claim for failure to warn was expressly preempted to the extent it was based on the theories that: (1) Medtronic should have given warnings different than those approved by the FDA; and (2) Medtronic promoted the off-label use of Infuse in Posterior Fusion. These claims would impose requirements different from or in addition to federal requirements and do not adequately parallel federal law.
The Court held, however, that Stengel III guided other aspects of Coleman’s claims and Coleman may continue with his failure to warn claim under the theory that Medtronic failed to report adverse information about Infuse to the FDA after FDA approval. As for his negligence claims, the Court found that because they were based on Medtronic’s failure to file adverse event reports as well as Medtronic’s off-label promotion, they were cognizable under California law, parallel to federal requirements, remedies available under state law, and therefore not federally preempted. The Court also held it was premature to make a determination with regard to the manufacturing defect claim. The issue of preemption as to this cause of action will be addressed after Coleman has conducted discovery; at the pleading stage, the complaint alleged sufficient facts to state this cause of action.
The Court of Appeal ultimately concluded that Coleman may allege causes of action for strict liability, negligence and design defect in a manner that avoids federal preemption, but his remaining causes of action were preempted by federal law.
Product manufacturers should be aware that the Coleman court’s holding (clarifying Stengel III) limits defendant medical device manufacturers from defeating certain claims involving their devices based on federal preemption.
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