RSSColeman v. Medtronic, Inc., (Second District, January 27, 2014, as modified February 3, 2013) 223 Cal.App.4th 413, 167 Cal.Rptr.3d 300.
A man who suffered painful complications following spinal surgery to implant a bone fusion device, filed suit against the manufacturer, asserting, inter alia, causes of action for strict liability failure to warn and negligence. The plaintiff further alleged that the defendant had violated state common law and parallel federal requirements by (1) failing to report adverse information about the product to the FDA after approval and (2) promoting the off-label use of the product while downplaying the risk of complications.
The trial court sustained the defendant’s demurrer without leave to amend, finding that the claims were preempted by the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act, § 2 et seq., 21 U.S.C.A. § 360c et seq. However the court of appeal reversed. Although the court held that the failure to warn claim was expressly preempted to the extent it was based on the theory that the defendant should have given warnings different than those approved by the FDA, the court held that the failure to warn claim based upon failure to file adverse events reports was not preempted. The court also held that although the claim was preempted to the extent it was based upon promoting off-label uses, the plaintiff could pursue such a claim under a theory of negligence per se:
We agree with Coleman that the duty to warn should not be so narrowly defined as to exclude a requirement to file adverse event reports with the FDA if that is the only available method to warn doctors and consumers. As the concurrence pointed out in Stengel III construing this duty in that way creates a causation hurdle that plaintiffs would not otherwise face. “To prevail, they will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the plaintiff’s] doctors in time to prevent his injuries.”…
[B]ecause the requirements imposed by state law do not parallel the federal requirements, Coleman’s off-label promotion failure to warn claim is expressly preempted by section 360k(a)….Our analysis of Coleman’s negligence cause of action based on the theory of off-label promotion is again slightly different….Assuming the truth of Coleman’s factual allegations, his negligence claim based on the theory of off-label promotion is neither expressly nor impliedly preempted, because it “parallels” the federal requirements prohibiting misbranding and adulteration. …Unlike his failure to warn claim, Coleman’s negligence claim is premised on a state requirement that is parallel to the federal requirement to refrain from off-label marketing. In pursuit of a state negligence claim, Coleman is arguing that Medtronic violated its duty of reasonable care, which would parallel the federal duty to comply with the regulations prohibiting misbranding and adulteration….
We conclude that Coleman’s negligence claim is not preempted. The claim is rooted in traditional state tort law and exists regardless of the FDCA and its regulations because the manufacturer of a medical device owes a duty of reasonable care to the consumer of such a device even in the absence of FDA regulations. … The doctrine of negligence per se simply directs the trier of fact to the federal requirements to establish the applicable standard of care. … Coleman uses the negligence per se doctrine, well recognized in California tort law, to ensure that the state law duty he alleges directly parallels federal law; however, he is pursuing a remedy under state law, not federal law.
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