RELATED DOCUMENT: Read the indictment against Synthes
Synthes is a medical device manufacturer and a multi-billion dollar international corporation. A subsidiary, called Norian, is also named in the indictment.
Investigators say the company decided to bypass the costly FDA approval process for a bone cement product.
It was approved for use on some bones, but not the spine, a potentially lucrative application.
The government says it was used on about 200 patients without their knowledge.
"Patients undergoing the procedure were not told they were research subjects, or provided an explanation of the risks they were being subjected to," said Kim Rice from the Food and Drug Administration.
The indictment says Synthes was trying to determine if the bone cement was safe to use on the spine, despite evidence that it caused blood clots that could travel to the lungs.
Synthes halted the use after three patients died on the operating table.
The government says they then tried to coverup their illegal activities.
"After the death of the third patient in January, 2004, Norian and Synthes did not recall the product from the market," said U.S. Attorney Michael Levy.
The four executives charged could get up to a year in jail.
Synthes, and its subsidiary, could be fined as much as $36 million dollars.
So far, Synthes has no comment.
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