Stryker Biotech, a medical device company based in Hopkinton MA whose parent company is Stryker Corporation, has been indicted by a federal grand jury for marketing two medical devices which had not received FDA approval. The devices were designed for spinal and long bone surgeries. The indictment also accuses the company of trying to conceal their illegal marketing of the unapproved medical devices.
Prosecutors argue that company representatives aggressively marketed these products to doctors which resulted in several medical complications. According to the Boston Globe, “Former company president Mark Philip, who lives in Massachusetts, is also facing charges of wire fraud, conspiracy, and making false statements to the FDA. Three current sales managers were also charged in the case. Four other Stryker employees have already pleaded guilty to charges related to the case, according to the US Department of Justice.”
A spokesperson for the parent company, Stryker Corp. expressed disappointment in the indictment. Stryker Corp. is facing civil lawsuits from faulty artificial hips known as Trident PSL and Trident Hemispherical Acetabular Cups.