On June 16, 2009, Synthes, Inc., and four of its executives were indicted on federal charges that they improperly promoted a bone filler for purposes not approved by the FDA. The indictment sends a strong message to similar companies. Usually Federal Prosecuters seek fines through civil lawsuits rather than bringing criminal charges.
Synthes and Norian Corporation are accused of encouraging the use of its bone filler, Norian XR, in unauthorized human trials. Norian XR was used in spinal procedures including verteplasty and kyphoplasty. Verteplasty and Kyphoplasty are procedures wherein a cementlike material is injected into a spinal fracture. Three people died during these human trials, though a direct link to Norian XR in these deaths had not been made yet.
Norian XR was approved by the FDA in 2002 for general bone repair. However, the company was warned against promoting the bone filler for spinal surgeries. The warning was based on information linking use of the bone filler in spinal procedures to the development of large bloodclots.
Norian faces potential fines of $28 million and Synthes faces fines of $8million. If convicted, the the executives could serve up to one year in prsion. The individuals charged in the indictment are Michael B. Huggins, president of Synthes Spinal Division; Thomas E. Higgins, Senior Vice President for Global Strategy; Richard E. Bohner, Vice President for Operations; and John J. Walsh, a Regulatory Affairs Executive.