Area Medical Company Admits Illegal Testing On Patients
A suburban Philadelphia medical-device company will pay the maximum $23 million fine for illegally testing its 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, will also plead guilty to related criminal charges.
Officials say Norian trained surgeons to conduct unapproved clinical tests of its bone cement from 2002 to 2004, subverting Food and Drug Administration (FDA) safeguards. They say the trials were stopped after the third patient death.
Company lawyers did not immediately return messages Monday afternoon.
Four Synthes executives from Pennsylvania are awaiting sentence after pleading guilty in the case. They admit they allowed the bone cement to be shipped interstate.
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