Norian to Pay $23 Million for Illegal Bone Cement Tests

Philadelphia, PANorian Corp, accused of training surgeons to conduct unapproved clinical tests of its bone cement , "Norian SRS", has agreed to pay the maximum $23 million fine. Further, US prosecutors state that the company will admit criminality.

In a report by the Associated Press (AP), Norian and its parent company Synthes Inc, are described as having conducted tests of the bone cement between 2002 and 2004 on about 200 patients, three of whom died. The tests were stopped after the third death.

Not only do Norian and Synthes stand accused of subverting US Food and Drug Administration (FDA) safeguards, prosecutors said, but Norian and Synthes also failed to report the patient deaths to the FDA and lied to agency investigators.

The bone cement was developed to fill bone defects and is currently used in the arm. However it is not approved for use in the load-bearing spine. Notably, the surgeries cited by authorities frequently involved older patients with compression fractures.

AP reports that according to the June 2009 indictment, pilot studies of the bone cement showed that it produces blot clots in humans, while animal data suggest that the clots could migrate to the lungs. The patients who died were found to have suffered severe low blood pressure after receiving injections of the bone cement. None of the surgeons could rule out the bone cement as a factor in the deaths, an FDA investigator has said.