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Stryker and Medtronic Preemption Bids Denied by Court in Bone Products Lawsuit

Sep 27, 2013

A California state court judge has denied motions by Stryker and Medtronic to dismiss a lawsuit filed over the companies’ bone proteins, ruling that federal law does not preempt the case from going forward.

April Cabana sued Stryker and Medtronic over alleged off-label promotion of the bone growth products, reports. The suit also included the hospital and surgeon who failed to inform her that they were using the experimental products.

During surgery for back pain, Cabana received Stryker's OP-1 Putty in combination with its Calstrux bone filler. OP-1 Putty had U.S. Food and Drug Administration (FDA) clearance under a humanitarian-use exemption and needed hospital board authorization. The combination of the putty and Calstrux bone-filler had never been examined or approved by the FDA, according to the complaint.

According to court documents, Cabana had a second procedure that involved surgeons removing excess bone and fusing the remainder with Medtronic's Infuse bone graft product, again in an off-label use. The FDA cleared Infuse for use in anterior procedures only, but Cabana’s surgeon chose a posterior approach, MassDevice reports. Cabana claims the combination of the two products caused excessive bone growth in her lower back, resulting in nerve compression and debilitating pain that required additional surgery.

Judge Terry Green of the California Superior Court for Los Angeles County denied the companies' motions to dismiss on preemption grounds, ruling that Cabana presented adequate evidence that Stryker had promoted the off-label combination of the OP-1 and Calstrux putties to allow a trial on her claims of liability failure to warn, negligence, negligence per se, breach of warranty, and fraud, according to court documents. Green also allowed similar claims against Medtronic to go forward. The trial is scheduled for Feb. 10, 2014.

In 2012, Stryker paid $15 million to settle charges that the company ran an off-label promotion scheme, including falsifying hospital records to authorize use of the OP-1 products, which were cleared only for humanitarian use, according to MassDevice. A few months later, the U.S. Justice Department closed an investigation of Medtronic, having found no evidence of wrongdoing.

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