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From Health Law Daily, June 4, 2014

State law claims concerning Medtronic spinal fusion products not preempted by federal law

By Bryant Storm, JD

A products liability complaint survived defendant Medtronic’s motion to dismiss on the grounds that the claim was either expressly or impliedly preempted by federal law. Preemption did not apply to the claims in the complaint, which alleged misrepresentation and unlawful use of Medtronic’s spinal fusion products, because Medtronic allegedly promoted and marketed its spinal fusion products in a manner not approved by the FDA (Hornbeck v Medtronic, June 2, 2014, Kendall, V).

Background. Under the district court’s spotlight was Medtronic’s InFUSE® Bone Graf and t/LT-CAGETM Lumbar Tapered Fusion Device. According to the court, the two devices consist of “a tapered metallic spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone.” When Medtronic sought approval from the FDA for the Class III medical devices, the FDA considered the design of the two devices as a pair and approved their use together.

Despite the fact that the FDA only approved the products use as a combination, according to the Donna Hornbeck’s complaint, Medtronic nevertheless marketed and promoted those products to be used separately. During Hornbeck’s spinal surgery, Dr. Richardson, who was also a named defendant, implanted the InFUSE® Bone Graft component and not the LT-CAGETM Lumbar Tapered Fusion Device. Hornbeck subsequently experienced radiating pain, numbness, and tingling in her left leg. Hornbeck was forced to undergo surgical procedures to correct those issues.

Federal Law. Class III medical device manufacturers are granted significant protections from civil liability when they subject their devices to pre-market approval by the FDA. Specifically, the Food Drug and Cosmetics Act (FDCA), preempts state and local laws regarding medical devices that are “different from, or in addition to” the FDCA. In other words, as long as the medical device manufacturer complies with federal law, they cannot be held liable for failure to provide additional warnings or protections that were not called for by the FDA approval process or other federal requirements.

Lack of preemption. Donna Hornbeck brought seven state law claims against two Medtronic defendants and Dr. Richardson. The claims alleged, fraud, misrepresentation, four kinds of products liability, failure to warn, and breach of warranty, which were premised on Medtronic’s violation of the FDCA. Donna’s husband, John Hornbeck, also brought a claim for loss of consortium. The court held that each of those claims derived from Medtronic’s FDCA violations and that none imposed requirements different from those imposed by the FDCA. Had Medtronic used the InFUSE® Bone Graf together with the t/LT-CAGETM Lumbar Tapered Fusion Device as the FDA had approved them, the court reasoned that the Hornbeck’s claims would have been preempted. The court held that by promoting and marketing its products outside of the scope of their FDA approval, Medtronic lost the preemption protections of the FDCA and opened itself to civil liability.

Exceeding approval. Medtronic’s argument that plaintiff’s claims would require warnings that exceeded those required by the FDCA was rejected by the court because the warnings that the FDA required were designed specifically for the combined use of Medtronic’s InFUSE® Bone Graf with the t/LT-CAGETM Lumbar Tapered Fusion Device. By using those products separately, or in a way different from the way the FDA had approved them, the court reasoned, different warnings would be needed for those additional uses. The court held that the FDCA preemption only applied to uses that the FDA has already deemed safe; any additional uses fell outside the scope of the FDCA protections. Thus, the Hornbeck’s claims survived the defendant’s motion to dismiss on preemption grounds.

Other grounds. The Medtronic defendants also attempted to dismiss several of the Hornbeck’s claims through use of the learned intermediary doctrine. While the court acknowledged that medical device manufacturers typically have no duty to warn physicians of dangers posed by medical devices that the medical community is aware of, the court held, in the instant case, the alleged misinformation campaign conducted by Medtronic tipped the scales on that analysis. The court reasoned that the medical community could not have truly appreciated the risks posed by the Medtronic devices given the misinformation Medtronic allegedly had spread surrounding their use.

The case number is 13 C 7816.

Attorneys: Andrew T. Hays (Hays Firm LLC) for Donna Hornbeck. Daniel Leslie Ring (Mayer Brown LLP) for Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc.

Companies: Medtronic, Inc.; Medtronic Sofamor Danek, USA, Inc.

MainStory: TopStory CaseDecisions MDeviceNews PreemptionNews IllinoisNews

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