Drug Company Fined $23 Million For “off label” Use of Bone Cement

From Legal Blog – San Francisco Personal Injury Attorney Brett A. Burlison.

As reported by the AP, the medical device company Synthes Inc. and its subsidiary, Norian Corp. have admitted to conducting unauthorized tests of its bone cement on about 200 spinal surgery patients. These of these patients died during surgery.

The company now faces $23 million in fines.

In 2009, a federal indictment accused the company of putting profits in front of patient safety.  This allegation was based on the way the company bypassed the Food and Drug Administration approval approval process for the clinical trial.

According to media reports, Norian has pleaded guilty to a single felony – conspiring to impede FDA functions.  Synthes has pleaded guilty to a related lessor misdemeanor.

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