Norian Corp. and Synthes, Inc. — Indicted for Illegal Testing of Bone Cement without FDA Approval Resulting in Patient Deaths

The U.S. Attorneys Office in Philadelphia has filed charges against various executives of Synthes, Inc., a subsidiary of Norian Corp., for “illegally tested bone cement during spinal surgery on about 200 patients, three of whom died on the operating table.”

According to the official indictment, these companies, “conducted their own tests of the product, called Norian XR, thus subverting Food and Drug Administration safeguards.” The indictment sets forth in pertinent part that pilot studies for Norian XR., “showed the bone cement reacted chemically with human blood in a test tube to cause blood clots.”

The companies allegedly, from May 2002 until fall 2004, conspired together, “to conduct unauthorized clinical trials of two versions of Norian in surgeries to treat vertebral compression fractures of the spine. These surgeries were allegedly performed “despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine.”

The FDA had previously approved Norian XR for use in certain bone voids or defects “but not for use in surgeries to treat vertebral compression fractures of the spine, a painful condition commonly suffered by older people.”

If you or someone you know has been treated with Norian XR for a spinal condition or injury and has suffered an adverse side effect, please contact our law firm immediately for a free consultation.