The former President of Stryker Biotech in the USA and three of its current Sales Managers have been charged in a federal court with fraudulent marketing of surgical devices.

The indictment claims that the company and its senior executives promoted a use of the devices that was not approved by the FDA, was not subject to clinical trial, and was unsafe.

If they are convicted, not only could the company pay major fines, but the senior executives charged could face long prison sentences.

Stryker Biotech, LLC, based in Hopkinton, Massachusetts, its former President, Mark Philip, and its current Sales Managers, William Heppner, David Ard and Jeff Whitaker, are charged with participating in a fraudulent marketing scheme of devices used for spinal and long bone surgery.

Stryker Biotech, Philip, Heppner, Ard and Whitaker are charged with wire fraud and conspiracy. Stryker Biotech, Ard and Whitaker are charged with misbranding. Stryker Biotech and Philip are charged with making false statements to the FDA.

The indictment charges that the defendants participated in an illegal marketing scheme to promote the products OP-1 Implant and OP-1 Putty, used to stimulate bone growth in long bones and the spine. It charges that they promoted the combination of these devices with a bone void filler, and provided 'recipes' to medical professionals for mixing the devices with the filler.

The indictment claims that the defendants knew such a combination had never been subject to clinical trial and was not approved by the FDA. It also alleges that the combination led to serious medical problems in a number of patients. Stryker Biotech, Llc and Philip are also charged with making false statements to the FDA about the number of patients that Stryker Biotech was treating with OP-1 Putty.

If convicted of wire fraud, conspiracy, misbranding or false statement, Stryker Biotech faces fines of at least $500,000 on each count. If convicted of wire fraud, Philip, Heppner, Ard and Whitaker each face up to 20 years' imprisonment and fines. If convicted of conspiracy, they each face up to 5 years' imprisonment and fines. If convicted of misbranding, Ard and Whitaker each face up to 3 years' imprisonment and fines. If convicted of false statement, Philip faces up to 5 years' imprisonment and a fine.

The case has been investigated by the FDA, the Office of Criminal Investigations and the FBI.