Stryker, Medtronic Lose Preemption Bid in Lawsuit Involving Alleged Off-Label Bone Product Use

stryker_medtronic_court_loseA preemption bid made by device makers Medtronic and Stryker to dismiss a lawsuit filed over their bone protein products has been rejected.

A California state court ruled that federal law does not preempt the case from proceeding, according to The lawsuit involves the alleged off-label marketing of Stryker’s OP-1 Putty used with its Calstrux bone-filler and Medtronic’s Infuse bone graft.

In this case, a woman is suing the medical device makers, the hospital, and the surgeons for neglecting to advise her they were utilizing experimental products, according to The lawsuit alleges that the plaintiff received the OP-1 Putty in combination with Calstrux bone filler, both manufactured by Stryker, for her back pain. The Putty received clearance under a humanitarian-use exemption, which means that hospital board authorization is required prior to the product being used. The combination has not been reviewed or approved by the U.S. Food and Drug Administration (FDA), the complaint indicates, according to

In her second procedure, to correct the first procedure, the surgeons removed the excess bone, fusing the remainder with Infuse, which is an off-label use of that product, according to legal documents, wrote. At the time, Infuse was approved for an anterior procedure; however, the lawsuit claims the surgeon utilized a posterior procedure. The combination, according to the lawsuit’s claims, resulted in excessive lower backbone growth, which led to nerve compression, debilitating pain, and more surgery.

Judge Terry Green of the California Superior Court for Los Angeles County ruled that he plaintiff presented sufficient evidence that Stryker promoted the off-label OP-1 and Calstrux putties combination 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, reported. The judge also ruled in favor of the plaintiff’s claims of negligence, negligence per se, breach of warranty, and fraud concerning claims against Medtronic citing that evidence proved that Medtronic knew, but neglected to disclose, problems related to Infuse, according to Medtronic. The trial is scheduled for February 10, 2014.

In 2012, Stryker was charged with a misdemeanor $15 million over charges it was conducting off-label marketing and had falsified hospital records, according to

Meanwhile, in another case in which Medtronic sought reconsideration of a ruling, Medtronic asked Judge G. Murray Snow, U.S. District Court for Arizona, to dismiss the lawsuit on the grounds that Infuse is protected under federal preemption. Preemption is  legal concept that has protected a number of medical device makers in liability lawsuits brought over devices approved by the FDA, previously reported.

Judge Snow ruled that federal preemption does not apply in a case in which Medtronic is accused of marketing Infuse off-label; the plaintiff accused Medtronic of touting Infuse for procedures that were not FDA-approved, according to

The effect of preemption “vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not be reviewed by the FDA but has been promoted by the manufacturer,” Snow wrote. “Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device,” Judge Snow added, reported.

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