Philadelphia Bone Cement Device Company and its Executives Plead Guilty to Off Label trials
Philadelphia based Norian Corp, its corporate parent, Synthes, Inc., and four Norian executives have pleaded guilty in connection with conducting unauthorized tests of its bone cement product in the spine of more than 200 patients, an “off-label” use for which it had trained many surgeons. The trial were made on over 200 spinal surgery patients, three of whom died during the operation. The government is seeking prison time for the company executives who pled guilty, Norian and Synthes will pay the maximum $23 million in fines for their conduct. Synthes also agreed to sell Norian and to enter into a corporate integrity agreement.
For more information see: http://www.sacbee.com/2010/11/30/v-print/3221598/pa-firm-admits-crime-in-human.html