Stryker BioTech LLC Accused of Illegal Marketing Scheme
Stryker Biotech LLC, a leading manufacturer in medical devices, has been accused of illegally conducting marketing schemes for bone-growth products. Accusations against the company claim that Mark Philip (former president of Stryker Biotech) and three managers of the company took part in a scheme that involved medical devices that had been used throughout invasive spinal surgery as well as bone surgery. The indictment also stated that Philip and Stryker LLC gave the Food and Drug Administration many false statements regarding the medical devices. “Stryker has been the target of a federal grand jury probe, which began in 2008, related to its bone growth products”. According to the Justice Department, the company promoted devices such as an OP-1 Implant and OP-1 Putty for many uses that the FDA had not approved. However, the company did have government permission to advertise only a small amount of their bone-growth products for reasons relating to “humanitarianism” in order to treat rare conditions. Instead of complying with guidelines set forth, Stryker “promoted a combination of the devices with a bone void filler” known as Calstrux. Allegations also claim that the company provided a “how to” in mixing the OP-1 products with Calstrux, which had never been approved by the FDA. If Stryker is fully convicted, the company may have to pay fines up to $500,000. The individuals who took part in the scheme may face jail time if they are convicted of such charges as wire fraud, conspiracy, and misbranding charges.