PHILADELPHIA (CBS/AP) A Pennsylvania medical devices company will pay the maximum $23 million fine for illegally testing bone cement on about 200 spinal patients, three of whom died during surgery.
Federal prosecutors say West Chester-based Norian Corp. and its parent, Synthes, also will plead guilty to related criminal charges.
They say Norian trained surgeons to conduct unapproved clinical tests of its bone cement from 2002 to 2004, subverting Food and Drug Administration safeguards. They say the trials were stopped after the third patient death.
The cement was used to fill in defects in bones. The surgeries often involved older patients with compression fractures.
Company lawyers haven't returned messages left Monday.
Four Synthes executives who allowed the cement to be shipped across state lines are awaiting sentencing.
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