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From Products Liability Law Daily, January 28, 2014

Claims for strict liability and negligent failure to warn FDA of risks of spinal implant not preempted

By John W. Scanlan, J.D.

A spinal implant patient could proceed with claims for negligence and for strict liability based on a theory that the device’s manufacturer failed to warn the FDA of adverse events, a California Court of Appeal held. However, the patient’s strict liability claim for failure to warn based on the theory that the manufacturer should have warned of the dangers of off-label uses was preempted. (Coleman v. Medtronic, Inc., January 27, 2014, Kriegler, S.)

Background. Medtronic manufactures and sells Infuse, a medical device used to strengthen the spines of individuals with degenerated medical discs. The Federal Drug Administration (FDA) granted it premarket approval for use in certain types of spinal surgeries, including Anterior Lumbar Interbody Fusion, in which the incision is made in the patient’s abdomen. In 2009, John Coleman underwent Posterior Lumbar Interbody Fusion, which is an alternate spinal surgery in which the incision is made in the patient’s back. Because the FDA has not approved the use of Infuse for Posterior Fusion, it is an off-label use. Coleman began experiencing numbness and pain, and tests revealed that the device had leaked a protein that caused the nerves in his spine to be encased in unwanted bone growth. Coleman brought claims in California state court for, inter alia, failure to warn, negligence, and defective manufacturing against Medtronic. A series of demurrers and amended complaints followed, after which the trial court ordered him to file a complaint without the manufacturing defect claim because it was insufficient.

A three judge panel of the U.S. Court of Appeals for the Ninth Circuit then held in Stengel v. Medtronic, 676 F.3d 1159 (9th Cir 2012) (Stengel I) that a state law negligence cause of action based on a failure to report adverse information to the FDA was preempted by federal law, after which the trial court sustained Medtronic’s demurrer to Coleman’s third amended complaint. Then, the Ninth Circuit decided to rehear Stengel I en banc (Stengel v. Medtronic, Inc., 686 F.3d 1121 (9th Cir 2012)) (Stengel II), and a unanimous en banc Ninth Circuit panel reversed itself, finding that a state law negligence claim based on a failure to report was not preempted by federal law. (Stengel v. Medtronic, 704 F.3d 1224 (9th Cir 2013)) (Stengel III). Medtronic petitioned the U.S. Supreme Court for a writ of certiorari on May 10, 2013. Coleman filed his appeal of the demurrer to this third amended complaint prior to Stengel III.

Failure to warn. The patient’s failure to warn claim was expressly preempted to the extent that it was based on a theory that Medtronic should have given different warnings than the warnings approved by the FDA. Furthermore, to the extent the claim was based on Medtronic’s alleged promotion of off-label uses for Infuse, specifically its use in Posterior Fusion surgery, it was expressly preempted. Including a theory of off-label promotion is impliedly claiming that Medtronic had a duty to warn the patient and his doctors of the dangers of off-label uses, according to the court. This would constitute a state law requirement to provide warnings different from and in addition to federal requirements and, thus, is preempted. State and federal laws are not parallel in this situation because federal regulations prevent manufacturers of FDA-approved devices from promoting off-label uses, whereas strict liability under California common law imposes a requirement to warn of a particular risk that was known or knowable in light of the best scientific and medical knowledge available at the time. Noting that there was no case law recognizing a failure to warn based on allegations that the manufacturer had a duty to refrain from marketing, the court found the requirements of federal and state law to be distinct.

However, the patient’s failure to warn claim was not preempted to the extent it was based upon his theory that Medtronic violated state common law and parallel federal requirements by failing to report adverse information about Infuse to the FDA after receiving FDA approval. Noting that Stengel III was not binding on it, the appellate court nevertheless found its reasoning persuasive and used its framework for its analysis, noting that there was no distinction between it and the present case except that Stengel III involved a negligence claim under Arizona law. California’s common law regarding strict liability failure to warn imposed a parallel requirement to federal law’s requirement that manufacturers filed adverse event reports with the FDA. Although Medtronic argued that failure to warn the FDA is not cognizable under California law because a device manufacturer had a duty to warn only doctors, who then warn their patients, the court said that the duty to warn should not be defined so narrowly as to exclude filing adverse event reports with the FDA if that is the only way to warn doctors and patients.

Negligence. The patient’s negligence claim against Medtronic was not preempted, whether based on a failure to warn the FDA theory or an off-label promotion theory. Regarding the failure to warn the FDA claim, although courts were divided on whether negligence per se claims were subject to preemption, the court agreed with those cases that found that these claims were not preempted. The only reason to dismiss a negligence per se cause of action is if the claim is not cognizable under state law, the court stated, and California recognizes its applicability in cases involving a violation of federal law. Federal regulations were designed to limit the risk inherent in medical devices, and the patient, as a recipient of a regulated medical device, is among the class of persons the regulations were designed to protect. The patient’s claim, as based on Medtronic’s alleged failure to file adverse event reports, was cognizable under California law and was parallel to federal requirements.

Similarly, the patient’s negligence claim based on a theory of off-label promotion was not preempted because it paralleled federal requirements on misbranding and adulteration. Unlike his failure to warn claim based on off-label promotion, this claim was premised on a state requirement that was parallel to a federal requirement: that Medtronic violated a duty of reasonable care, which paralleled the federal duty to comply with the misbranding and adulteration requirements. The claim was premised in traditional California tort law and would exist even without the Federal Food, Drug and Cosmetic Act (FDCA) and its regulations because the manufacturer of a medical device would still owe consumers a duty of reasonable care.

Manufacturing defect. The court declined to rule at this stage of the litigation whether the patient’s manufacturing defect claim was preempted. The court was persuaded by case law from the Seventh and Eighth Circuits that the patient needed to be given some opportunity for discovery to identify a specific federal requirement of the FDA’s premarket approval process that allegedly was violated because this information was available only to the FDA and the manufacturer.

The case number is B243609.

Attorneys: Martin N. Buchanan (Law offices of Martin N. Buchanan) for John Coleman. Andrew E. Tauber (Mayer Brown LLP) for Medtronic, Inc.

Companies: Medtronic, Inc.

MainStory: TopStory PreemptionNews WarningsNews DesignManufacturingNews MedicalDevicesNews CaliforniaNews

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