In June 2009, Synthes, its Norial Corp. unit and four executives were indicted in federal court in Philadelphia. Synthes, based in West Chester, PA, is the world’s largest maker of bone-related medical devices. The government alleges that the company and its executives were involved in a conspiracy to hold unauthorized clinical trials of Norial XR and Norian SRS bone cement. According to the indictment, despite knowing the risks of these bone cement products, the company and its executives bypassed the FDA approval process for clinical trials. During the unauthorized trials, three patients died from a rapid drop in blood pressure during surgery. Recently, two of the indicted Synthes executives pleaded guilty to a misdemeanor charge of shipping misbranded Norial XR across state lines. The potential penalties include up to one year in prison and a $100,000 fine.
If you or a family member had Norian bone cement used during a procedure, contact Sheller, P.C. to discuss whether you have a legal claim. Sheller, P.C. represents individuals and classes of individuals who have suffered a range of injuries. Sheller lawyers have successfully represented people who have been injured by prescription drugs and medical devices. Contact us to discuss your potential claim.