Medical device maker Stryker Biotech LLC and some of its top management have been indicted on federal charges they conducted a fraudulent marketing scheme for bone-growth products. As you know, Stryker Biotech, based in Hopkinton, Mass., is a division of Stryker Corp. of Kalamazoo, Michigan, a maker of orthopedic devices and other hospital products.
The indictment charged Stryker Biotech, its former president, Mark Philip, and three current sales managers with a scheme that involved devices used during invasive spinal and long bone surgeries. Both Philip and the company also were charged with making false statements to the U.S. Food and Drug Administration. Stryker has been the target of a federal grand jury probe, which began in 2008, related to its bone growth products. Stryker and its executives promoted devices known as OP-1 Implant and OP-1 Putty for use in a manner that was different from the use approved by the FDA, according to the Justice Department.
The company had a federal exemption that authorized it to sell only limited quantities of the bone-growth products for “humanitarian” reasons to treat a rare condition. Instead, the government says Stryker promoted a combination of the devices with a bone void filler, called Calstrux, and provided “recipes” of how to mix the OP-1 products with Calstrux in ways never presented to or approved by the FDA. If convicted on all charges, Stryker Biotech faces fines of $500,000 or twice the gross gain or loss from the offense, on each count. The indicted individuals face lengthy jail terms if convicted of wire fraud, conspiracy and misbranding charges.
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