Between 2002 and 2004, Norian tested cement on patients without FDA approval, resulting in three patient deaths while on the operating table. Norian pleaded guilty to conspiracy to impede federal safety standards and 110 other misdemeanors. Synthes pleaded guilty to a misdemeanor of shipping a mislabeled product.
Synthes has agreed to sell Norian by May 24 and enter a corporate integrity agreement. Four executives from Pennsylvania are awaiting sentencing after pleading guilty.
Read the Philadelphia Inquirer report on the charges against Synthes and Norian.
Read more coverage on the FDA:
– Study: FDA 510(k) Clearances Costs $24M on Average
– FDA Warns Against Bisphosphonates for Osteoporosis Medication
– FDA to Revoke OK of Menaflex Knee Implant, Citing Meddling by Congressman, Former FDA Commissioner
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