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.

If you or a loved one has been harmed by an unsafe medical device , contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal assistance, please call 800-581-6358.

Tags:

About Us

Sokolove Law, LLC is the nation’s largest marketer of legal services that help people obtain access to the civil justice system while ensuring they receive superior quality legal representation. With over 30 years of service, Sokolove Law has helped thousands of injured parties obtain the compensation they deserve from their legal claim such as mesothelioma, cerebral palsy, nursing home abuse, dangerous drugs, disability insurance denial, and medical malpractice cases.