Last week, a Louisiana federal judge on Monday kept alive most of a suit claiming that Stryker Corp. promoted the off-label combined use of two medical devices despite knowing the high risk of side effects.
U.S. District Judge Brian A. Jackson found that the plaintiff’s claims under the Louisiana Products Liability Act were plausible, Law360 reports. The judge denied Stryker’s motion to dismiss the design defect, breach of warranty, failure to warn, and claims under Louisiana’s redhibition law, a consumer protection law. Judge Jackson ruled that allegations that Stryker Biotech LLC, a subsidiary of Stryker Corp., promoted the off-label combining of two prescription medical devices without approval from the Food and Drug Administration (FDA) were sufficient to survive Stryker’s motion.
The legal complaint alleges that after the man’s surgeon used the combination of devices, the bone void filler Calstrux, and OP-1, a protein that promotes bone growth, during 2006 spinal surgery, the man suffered “debilitating injuries” because the devices caused bone formation in unintended areas of his body. The judge found that the plaintiff had shown that the combination of the two products was “unreasonably dangerous in design” because there was a viable alternative – a combination that would not result in the same side effects as the combination used, Law360 reports. In addition, the judge said, the company could have chosen not to promote the unapproved off-label combination.
The judge said the plaintiff had shown that the product caused damage and the company knew about the risks, but continued to illegally promote the combination of the two products. Moreover, the claim was further supported by the allegation that Stryker removed Calstrux from the market only after the FDA had performed an inspection and formal reprimanded Stryker over its illegal off-label promotion and its failure to report serious adverse effects associated with the OP-1/Calstrux mixture, according to Law360.