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Case over Stryker Bone Medical Devices can Proceed, Federal Judge Rules

Dec 30, 2014

For the most part, a lawsuit alleging that Stryker Corp. promoted the off-label combining of two medical devices can move forward, a Louisiana federal judge ruled. According to Law360, the plaintiff alleged that Stryker promoted the off-label combination despite being aware of the high risk of side effects, claiming design defect, breach of warranty, failure to warn and redhibition. U.S. District Judge Brian A. Jackson deneid Stryker's motion to dismiss the claims; and found that the allegations were sufficient to survive the motion under the Louisiana Products Liability Act. The plaintiff's fraud claim was dismissed.

The lawsuit, which was filed in June, alleges that the plaintiff suffered “debilitating injuries” after his surgeon used a combination of Calstrux and OP-1, a protein that stimulates bone growth, during his spinal surgery in Nov. 2006. The combining of the two products, which has not been approved by the U.S. Food and Drug Administration (FDA), allegedly caused bone formation in unintended areas of the body. The plaintiff successfully showed that the combination of the two products was “unreasonably dangerous in design” because there was another option that would not have had the same side effects, the judge said. Judge Jackson also pointed out that the company could have chosen not to promote the unapproved off-label combination.

In addressing Stryker's motion to dismiss the inadequate warning claim, the judge said that the plaintiff showed that the product caused harm and that the company continued to illegally promote the combination despite knowing about these risks. The plaintiff also alleged that Stryker only removed Calstrux from the market after the FDA reprimanded the company for its illegal off-label promotion and failure to report adverse events associated with the combination of the products; this strengthens his claim.

The judge also did not dismiss the plaintiff's claim of express warranty, citing his allegations that Stryker hid information about the combination of the two products and even marketed Calstrux as the “preferred” and “perfect carrier for OP-1”. The plaintiff's redhibition claim for future proceedings as well as his negligence claim were also upheld; it is clear that the plaintiff's petition alleges that Stryker Corp, parent company of Stryker Biotech, “informed, instructed, and recommended” actions to be taken by Stryker Biotech with regards to the marketing of the two products.

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