HOPKINTON, Mass., Oct. 29 (UPI) -- A Massachusetts biotech firm and its former president were charged with fraud Thursday for allegedly marketing bone-growth devices for unapproved uses.
Hopkinton firm Stryker Biotech and former president Mark Philip were charged with participating in a fraudulent marketing scheme of medical devices used in spinal and long-bone surgeries, the U.S. Justice Department said in a release.
The indictment charged the firm promoted the devices, OP-1 Implant and OP-1 Putty, for uses that had neither been studied in clinical trials nor approved by the FDA.
The FDA approved the devices only to stimulate bone growth in treatment of a condition that affects fewer than 4,000 people in the United States and stipulated the devices could not be sold for a profit. The indictment charges the defendants promoted use of the devices, in combination with a bone-void filler, to be used in untested "recipes" molded into shapes similar to cigars.
Use of the combination caused "serious medical problems" in some patients, the indictment said.
Stryker Biotech and Philip also were accused of making false statements to the FDA about the number of patients Stryker was treating yearly with OP-1 Putty.
Current Stryker sales managers William Heppner of Illinois, David Ard of California and Jeff Whitaker of North Carolina also were charged in the indictment.
