A federal grand jury in Boston indicted Stryker Biotech, former President Mark Philip and three former sales managers on charges of carrying out a fraudulent marketing scheme to sell products for use in spine and long-bone surgeries.
Grand jury indicts Stryker Biotech, ex-president
The company, a Hopkinton, Mass.-based subsidiary of Stryker Corp., and Philip were also charged with making false statements to the Food and Drug Administration. Philip, who is British, surrendered to authorities Oct. 28 and turned over his passport as a condition of his release. He is scheduled to be arraigned Oct. 30, a spokeswoman for the U.S. attorney's office in Boston said. The sales managers facing prosecution are David Ard of California, William Heppner of Illinois and Jeff Whitaker of North Carolina. They will be summoned at a later date.
Stryker Corp., Kalamazoo, Mich., issued a written statement saying the company is “disappointed with this action” and that Stryker Biotech could be excluded from participating in federal and state health programs if convicted.
The two products at issue, OP-1 Implant and OP-1 Putty, were approved by the FDA under a restrictive “humanitarian device exemption” to treat a rare condition. According to the indictment, the company allegedly encouraged surgeons and surgical staff to combine them with Calstrux, a Stryker product separately approved as a bone-void filler, into “cigars,” “Vienna sausages” and other shapes according to various recipes supplied by sales representatives.
The company later received reports of adverse events in some patients, and some surgeons reported that when they reopened the surgical site they found that the mixture had become the consistency of “oatmeal” or “grits.”
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