Products Liability Law Daily Failure-to-warn claim against medical device manufacturer not preempted
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Thursday, September 21, 2017

Failure-to-warn claim against medical device manufacturer not preempted

By Lindsey Firnbach, J.D.

Strict liability and negligent failure to warn claims brought by a patient who sustained injuries as a result of a medical device implantation were not preempted by federal law, an Illinois appellate court ruled in finding that the lower court had erred in dismissing the claims with prejudice. Although not all of the claims survived, her failure-to-warn state-law claim based on manufacturer misbranding was parallel to federal law and, therefore, not preempted. However, because the complaint did not adequately plead that the manufacturer’s actions were the proximate cause of the injuries, the claims should have been dismissed without prejudice and, thus, the case was reversed and remanded (Norabuena v. Medtronic, Inc., September 20, 2017, Cobbs, C.).

Medtronic Inc. (Medtronic) created the Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device (Infuse) for use in spinal fusion surgeries. The device was granted premarket approval by the FDA in 2002, and the approval included a label on the device indicating the device was for one spine level, and stated an anterior approach should be used when implanted. It warned of "ectopic or exuberant bone function" when the posterior approach was used and the metal cage was not used. The patient underwent surgery in 2012, and the Infuse was implanted at multiple levels of her spine in a posterior approach, and the cage was not used. She continued to have pain and it was later discovered that a heterotopic bone had formed to the left of her spine, which was explained to her as the likely cause of pain.

In 2015, the patient and her husband filed suit against Medtronic, asserting strict liability claims for defective warnings, negligence claims for failure to warn, and a loss of consortium claim. They alleged that the company had promoted using the device contrary to the label through its advertisements and a royalty program that it established with physicians and surgeons. In turn, Medtronic filed a motion to dismiss, alleging that the claims presented by the patient and her husband were preempted by federal law and that the complaint failed to demonstrate that Medtronic’s actions were the proximate cause of the injuries. The trial court did not address the issue of failure to state a claim, and dismissed the claims with prejudice, finding that the claims were preempted expressly and impliedly by federal law. The patient and her husband appealed.

Preemption claim. The court found that the failure-to-warn claim presented by the patient and her husband on the basis of misbranding by Medtronic was parallel to federal law, and therefore the lower court erred in finding preemption. However, the claim based on a requirement to submit the reports of adverse events to the FDA was preempted because Illinois law on failure to report is different from federal law.

Failure to state a claim. The court reviewed the non-preempted claim and noted that although the patient and her husband alleged numerous instances of Medtronic having withheld information regarding the risks of using the product "off-label," the complaint failed to show specific facts that the doctor who performed the surgery encountered these instances or relied on any of the marketing. Therefore, the patient and her husband failed to demonstrate that Medtronic’s actions were the proximate cause of the injuries. The court dismissed the claim, without prejudice, noting that it was not clear that the patient and her husband could not prove any set of facts for recovery and that they should be given an opportunity to amend their complaint.

The case is No. 1-16-2928.

Attorneys: Goldstein Fishman Bender for Senayda Norabuena. Anderson Rasor & Partners for Northwestern Memorial Healthcare. Mayer Brown LLP for Medtronic Sofamor Danek USA, Inc. and Medtronic Inc.

Companies: Northwestern Memorial Healthcare; Medtronic Sofamor Danek USA, Inc.; Medtronic Inc.

MainStory: TopStory PreemptionNews WarningsNews MedicalDevicesNews IllinoisNews

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