Processing Magazine

Pennsylvania Company Admits Crimes in Human Bone Cement Trial

December 1, 2010

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, according to the Associated Press. Synthes Inc., and its subsidiary, Norian Corp., performed the tests from 2002 to 2004. The product was approved for use in the arm, but not in the weight-bearing spine. Synthes, though, had trained surgeons to use it off-label so the company could gather data to support its expanded use. Doctors are allowed to use drugs and medical products for off-label uses, but companies cannot promote them that way. 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 companies will also pay the maximum $23 million in fines.