CA Judge Denies Medtronic’s Preemption Claims on Bone Device
A California judge ruled that a product liability lawsuit against Medtronic Inc. can proceed despite the company’s claim the case should be dismissed under preemption, a legal doctrine in which victims cannot sue medical device makers over a product approved by the Food and Drug Administration (FDA).
Judge Michael Linfield denied a motion for summary judgment from Medtronic and a subsidiary, according to Law360 (subscription required). The ruling is thought to be the first case involving Medtronic’s Infuse Bone Graft to address preemption on summary judgment.
"Plaintiff's claim is not based on allegations that Medtronic's device violated state tort law notwithstanding compliance with the relevant federal requirements," Judge Linfield said in the ruling. "In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements."
Plaintiff April Christine Cabana claimed in her suit that Stryker pushed the off-label use of two products in her back surgery when the FDA had never approved the combined use. Excessive bone growth resulted and a second surgery with Medtronic’s bone graft device became necessary. Cabana claims that Infuse was only FDA-approved for a limited surgical procedure but that Medtronic promoted its off-label use and her surgeon used it in an off-label manner, according to her suit. The second surgery ended up worsening Cabana’s pain.
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