Pa. company admits crimes in unapproved test of bone cement on patients, faces $23M fine   Leave a comment

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By Render Freeman

A medical device company near Philadelphia pleaded guilty to dozens of crimes Tuesday for conducting unauthorized tests of its bone cement on about 200 spinal surgery patients, three of whom died on the operating table.  Synthes Inc. and its subsidiary, Norian Corp., performed the tests from 2002 to 2004. Norian pleaded guilty Tuesday to a single felony, conspiring to impede FDA functions, along with 110 misdemeanor counts of shipping a mislabeled product. Synthes pleaded guilty to the shipping misdemeanor.The West Chester-based companies will also pay the maximum $23 million in fines.   Read the full story.


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