Stryker’s OP-1 Implant and OP-1 Putty, designed to stimulate bone growth, are FDA-approved for limited use, but prosecutors said the company encouraged doctors to use them more frequently in combination with Calstrux, a bone void filler from Stryker.
The FDA recalled Calstrux in 2006, warning that adverse reactions had been reported when it was mixed with other bone growth products, and in July 2008, the agency warned that the two OP-1 products had been linked to potentially fatal complications when used in off-label procedures involving the cervical spine.
The indictment names Mark Philip, who was president of Stryker Biotech from 2004 to 2008, and three current sales managers, William Heppner in Illinois, David Ard in California and Jeff Whitaker in North Carolina.
The defendants allegedly instructed surgeons on ways to combine OP-1 and Calstrux products into “recipes,” molding the product into shapes called “cigars,” “tootsie rolls” and “vienna sausages,” while knowing that the combination had never been studied in a clinical trial and had never been FDA-approved.
The indictment also alleges that the combination caused “serious medical problems” in a number of patients, and the Boston Herald reported that some of these patients had to have further surgery to remove “unwanted bone growth.”
In February, two former Stryker Biotech sales reps agreed to cooperate with a federal investigators looking into the marketing of the OP-1 products, which have FDA “humanitarian” device exemption restricting its use to a condition affecting fewer than 4,000 patients a year.
Stryker, which is facing charges of wire fraud, conspiracy, misbranding and false statements to the FDA, could face fines of $4 million, double the damages or double the company’s gross profits stemming from the charges, whichever is greatest.
The company issued a statement about the indictments, saying it is “disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter.”
The U.S Attorney’s release on the Stryker Biotech indictments.
