Synthes is accused of running unauthorized trials of its bone filler, Norian XR, in two spinal procedures in which the product’s use had not been approved by the FDA — vertebroplasty and kyphoplasty.
Prosecutors reported that 200 patients underwent these procedures and that three people died as a result, although the deaths could not be linked specifically to the use of the product. The FDA previously issued a warning about the risks of the use of bone-filling material, which may create blood clots.
According to the report, Synthes considered seeking FDA approval for a clinical trial of the product in spinal operations but instead approached physicians to perform the operations, agreeing to assist the physicians’ in publishing the results of the study.
The executives face up to a year in prison for their participation.
Synthes denied any illegal promotion of the product.
Read the New York Times’ report on the Synthes unauthorized trials.
