The United States Attorney in Philadelphia has indicted Synthes Inc. and four of its executives on federal charges. Synthes is a medical device maker, and according to the indictment, they improperly marketed it’s bone filler, Norial XR for unapproved uses. The company is charged with conducting an unauthorized clinical trial, using the bone filler in two types of back surgery, called vertebroplasty and kyphoplasty. Three people died in the surgeries, though there is no proof that the deaths were caused by the bone filler. In vertebroplasty and kyphoplasty, a cementlike material is injected into a spinal fracture to repair it. However, the bone filler can escape and create a blood clot in the patient’s system. In 2002, the FDA issued a warning of these risks after receiving reports of injuries and deaths. Though the FDA approved the bone filler for general bone repair, Synthes was not to promote it for spinal procedures.
According to prosecutors, Synthes allowed its salesforce to promote the bone filler for unapproved uses and misled FDA inspectors. The four indicted Synthes executives are charged with shipping unapproved medical devices. Those criminal misdemeanor charges carry a potential one year prison term. Usually the federal government files civil lawsuits for this activity, and it is rare for criminal charges to be filed against company executives.
If you have received a Synthes bone filler product, contact the lawyers at Sheller, P.C., 215-790-7300, to discuss whether you have a potential claim. Sheller attorneys work aggressively to represent people injured by defective medical devices. We have successfully obtained compensation for injured people from medical device manufacturers and pharmaceutical companies.