In a rare move, the US Food and Drug Administration (FDA) has filed criminal charges against a manufacturer of medical devices and four of its top executives for improper promotion of a cement-like bone filler, including encouraging surgeons to use the substance in ‘unauthorized’ human trials.  This type of activity usually generates civil, not criminal, charges.

Charges filed in federal court in Philadelphia name both the local and international headquarters for Synthes, Inc.; its subsidiary company, the Norian Corporation; and the parent company’s president of spinal division, senior vice president for global strategy, vice president of operations, and an executive of regulatory affairs as co-defendants.  The corporations are charged with conducting unauthorized human trials and the individuals are charged with misdemeanor counts of shipping unapproved medical devices.  Parent company, Synthes, faces fines totaling $8 million while Norian can be fined as much as $28 million.  The misdemeanor charges could bring a one-year prison sentence for each of the individual executives.

Synthes’ US operations are based in West Chester, Pennsylvania, and its global headquarters are in Solothurn, Switzerland.  The company has issued a statement declaring all actions it’s taken involving the bone filler, marketed under the name Norian XR, are legal.

Norian XR won FDA approval for general bone repair in 2002 but repairs to the spine were not included in that approval.  The product is designed to be injected into a bone fracture to promote healing but its use comes with the risk of blood clot creation.

The federal charges allege company officials discussed applying for FDA permission to conduct a trial using the bone filler in spinal surgeries but abandoned the idea.  What it did instead was approach specially selected surgeons to use the product in spinal procedures with the understanding Synthes would help the individual doctors get clinical results published.

In 2002, a University of Washington research scientist notified Synthes that his work on lab animals showed Norian XR was responsible for large blood clots that formed when the product escaped the bone.

Also in 2002, the FDA began receiving reports of injury and death associated with blood clots formed after Norian XR was used.  The agency issued a warning about these risks.

Federal charges claim Synthes’ executives discussed alerting its sales force of these potential risks and directing them to stop promoting the product for unauthorized uses but chose to work directly with doctors instead.  The company hosted educational sessions with these doctors, with instructions on how to use the bone filler more effectively.

By this time, as many as 200 patients of spinal surgery had been treated improperly with Norian XR and the company was poised for more aggressive promotion of the product when it received word of a third death caused by blood clots related to its use.  It was at this time the company stopped promoting the bone filler for spinal surgeries but it did not report any of the deaths to the FDA.

Charges also include misleading an FDA inspector.