Greed strikes again! According to federal prosecutors, Synthes Inc. executives illegally performed human testing and promoted their Norian XR bone filler for purposes not approved by the FDA simply to increase their profit margins. Synthes Inc.and Norian Corporation are American subsidiaries of the Swiss multinational medical device company.
Synthes ran over 200 unauthorized human trials of their bone filler involving patients who underwent one of two spinal procedures, vertebroplasty or kyphoplasty. In these procedures, the cement-like bone filler is injected into spinal fractures. Three patients died during the procedures. The four Synthes executives are now facing criminal charges and possible prison sentences.
Prosecutors allege Synthes knowingly approached doctors to perform the procedures despite a 2002 FDA warning of the risk of generating large blood clots. Even after learning of the deaths, Synthes continued to hold seminars teaching doctors how to perform the procedures and callously chose not to report the deaths to the FDA.
The federal prosecutors should be applauded for taking the unusual step of criminal indictments against these greedy corporate executives who put profit over concern for patient safety. Usually executives only face civil fines and go their merry way with their ill-gotten gains. Perhaps after a few executives are sent to prison there will be a clear message that the safety of medical devices being sold to the public must remain the paramount concern of medical device manufacturers.
Michael,
Very interesting article. I am working on an article about the FDA and came across this blog post. Would you happen to know who the patients were and if the doctors will also face charges?
Lucinda