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From Products Liability Law Daily, August 12, 2013

Federal law preempts product liability claims against spinal fusion device maker by patient allegedly harmed by off-label use

By Georgia D. Koutouzos, J.D.

State-law product liability claims against the makers of a medical device approved by the Food and Drug Administration for certain types of spinal fusions by a surgical patient who had been implanted with part of the device in an off-label usage were preempted by federal law, a South Carolina federal court concluded, dismissing the patient’s claims (Dawson v. Medtronic, Inc., August 9, 2013, Anderson, J.). The claims were based upon the premise that the off-label promotion of the device by the manufacturer was illegal under the Food Drug and Cosmetic Act, which it is not, the court instructed.

Background. Diane Dawson underwent spinal fusion surgery on her C5 – C7 cervical vertebrae during which her surgeon implanted one of the three components of an Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device manufactured by Medtronic, Inc., in an off-label use of that device (which had received U.S. Food and Drug Administration approval for use in Anterior Lumbar Interbody Fusion procedures involving a single level fusion in the L4 – S1 region of the lumbar spine). Soon after the surgery, Dawson began to experience severe, chronic, and persistent numbness and pain in her back, right leg, and hands, as well as neck discomfort and acute pressure in her head that led to blurred vision and severe headaches. She also experienced poor balance, which required that she use a walker to move around without falling.

Dawson brought suit against Medtronic, Inc., and its sister companies (hereinafter “Medtronic”) alleging, among other things, manufacturing defect, failure to warn, design defect, negligence, strict liability, breach of warranty, and fraud. Because Dawson could not fault Medtronic for the off-label use of her device, she based her claims on Medtronic’s alleged active promotion of the Infuse Device for off-label use, which she claimed that Medtronic had done without adequately having disclosed the alleged risks, including the severe bone growth that Dawson alleged was the cause of her injuries.

The parties’ contentions. Medtronic moved to dismiss Dawson’s suit, arguing that all of her claims were expressly preempted by the Medical Device Amendments of 1976 to the Food Drug and Cosmetic Act (FDCA) and pursuant to U.S. Supreme Court precedent because all of the claims required a finding that the Infuse Device should have been manufactured, designed, or labeled differently from the manner that had been approved by the FDA. The claims also were impliedly preempted because: (1) they still required that Medtronic add or change the FDA-mandated warning label of the Infuse Device even though it is prohibited from doing so by federal law; and (2) they attempted to pursue a private right of action, which is barred by the FDCA and prior case law.

Dawson responded to the express preemption defense by stating that her arguments clearly and succinctly stated that Medtronic had breached its duty to the FDA by promoting the Infuse Device for uses not directly dictated in the Premarket Approval Process, thereby violating federal laws and resulting in harm to her.

Off-label promotion. Addressing those of Dawson’s claims that were based upon the defendants’ alleged off-label promotion of the Infuse Device, the court said that the claims’ survivability was based upon the premise that off-label promotion is illegal under the FDCA. That premise was unsupported, however, given Dawson’s failure to identify exactly which provisions such conduct violates. Regulations that once controlled off-label promotion have lapsed, and the Medical Device Amendments otherwise do not mention off-label promotion, the court instructed, adding that it was not convinced that off-label promotion violates the FDCA. As a consequence, any state laws proscribing off-label promotion would establish requirements “different from, or in addition to, any requirement” under the MDA and would be expressly preempted by that statute’s federal preemption provision, the court advised. Moreover, to the extent that off-label promotion does violate the FDCA, claims based upon such conduct still would be impliedly preempted under applicable case precedent, the court determined.

The case number is 3:13-cv-663-JFA.

Attorneys: Carl L. Solomon (Solomon Law Group) for Dawson. Clarence Davis (Greenberg Traurig) and Michael K. Brown (Reed Smith) for Medtronic, Inc. Elizabeth Graham Minerd (Reed Smith LLP) for Medtronic Sofamor Danek USA, Inc.

Companies: Medtronic, Inc.; Medtronic Sofamor Danek USA, Inc.; Medtronic Vertelink, Inc.; Warsaw Orthopedic, Inc.

MainStory: TopStory PreemptionNews MedicalDevicesNews SouthCarolinaNews

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