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Failure to Warn About Dangers of Off-Label Use of Medical Device Preempted Under Federal Law

March 25, 2015

In Thorn v. Medtronic Sofamor Danek, USA, the Honorable Janet T. Neff dismissed the plaintiff’s state law claims of failure to warn and negligence as preempted under the Medical Device Amendments of 1976 (“MDA”), 28 U.S.C. § 360c, et seq., to the federal Food, Drug, and Cosmetics Act. The lawsuit involved Medtronic’s “Infuse” bone graft device, a bio-engineered bone-filling material used in lieu of grafting bone from the patient’s hip or other sources in certain spinal surgeries. In 2002 the FDA approved Infuse for anterior-approach lumbar surgery (performed through the abdomen). The plaintiff had spinal surgery in March 2010 using the infuse device in an off-label manner, specifically in a posterior-approach lumbar surgery performed through the patient’s back. The plaintiff alleged that Medtronic failed to accurately explain the risks of off-label use of the Infuse device to his surgeon and suffered significant physical and emotional damages as a result of complications associated with the off-label of the Infuse device.

The court began its analysis by noting that so-called “off-label” uses of medical devices for purposes other than those for which the device was approved by the FDA is “an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Op. at 6 (citing Buckman Co. v. Pls’ Legal Comm., 531 U.S. 341, 350 (2001)). Section 337(a) of the MDA provides that all actions to enforce FDA requirements “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court has interpreted this provision to mean that even state law claims that run parallel to federal regulatory requirements are impliedly preempted, unless they are ground in traditional state tort law and do not depend exclusively on a federal requirement, such that they would have given rise to liability under state law even if the Food, Drug & Cosmetic Act had never been adopted.

After noting that the MDA includes a number of specific requirements for off-label use and promotion of medical devices, the court concluded that “off-label promotion is governed by federal law, which sets the parameters and occupies the field for deciding whether a representation is false or misleading.” Op at 15. Accordingly, because there is no state law duty to abstain from off-label promotion, the plaintiff’s failure to warn and negligence claims must be dismissed, as the “‘gravamen’ of these claims . . . is that Medtronic should have made ‘different’ or ‘additional’ statements about Infuse, i.e., warnings beyond those specified by the FDA.” Op at 17.

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