Biologics

State Appeals Court Reverses Preempted Medtronic InFuse Case

A California appeals court overturns the preemption of a product liability lawsuit filed against Medtronic over its controversial InFuse bone-growth protein.

A California appeals court this week reanimated a product liability lawsuit filed over Medtronic‘s (NYSE:MDT) controversial InFuse bone-growth protein, reversing a lower court’s decision that federal regulations in this case preempt state rules.

The preemption doctrine is based on a U.S. Supreme Court ruling that state laws that differ from or add to federal regulations are trumped by the federal rules. The high court included a caveat, however: in some cases, claims citing state laws that exactly parallel the federal rules are allowed. The California Court of Appeal took that caveat into account in its January 27 decision, partially overturning a lower state court ruling that plaintiff John Coleman’s claims were preempted.

Coleman was implanted with the InFuse product in April 2009 in a posterior fusion operation, according to court documents. InFuse is approved only for anterior fusion procedures. Coleman allegedly suffered from numbness and pain after the surgery; CT scans revealed that the bone-morphogenetic material in the InFuse implant had spurred bone growth that “encased the nerves in Coleman’s spine,” according to the documents.

Read More: http://www.massdevice.com/news/state-appeals-court-reverses-preempted-medtronic-infuse-case

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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