Synthes Inc., the American division of the Swiss medical device maker, will plead guilty to federal criminal charges that its North American subsidiary Norian Corp. made an illegal end run around the Food & Drug Administration for clinical trials in which three patients died.
The plea deal calls for the West Chester, Pa.-based company to pay $22.5 million in fines and be forced to sell Norian to help pay for the fines. Synthes pleaded guilty to one felony count of conspiracy to impair and impede the lawful functions of the FDA and 110 misdemeanor counts of shipping adulterated and misbranded bone cement called Norian XR across state lines.
Four executives who OKed the shipments are still awaiting sentencing, according to news reports.
Because Norian would be barred from receiving Medicare reimbursement, the U.S. Dept. of Health & Human Services and Synthes negotiated an agreement stipulating that Synthes will sell Norian by May to a third party. Synthes will also pay $670,000 in fines as part of the plea deal with federal prosecutors.
They alleged that Norian conspired to conduct unapproved clinical trials of the bone cement from 2002 until 2004 in vertebral compression fracture surgeries — contravening the FDA’s mandated label warning against using the cement in those procedures. The trials allegedly went on until a third patient died on the operating table. But even then the companies didn’t recall Norian XR and allegedly lied to FDA investigators during an inspection in an alleged attempt to conceal the trials.