Stryker Biotech LLC has been indicted on federal charges of illegally marketing bone growth products called the OP-1 Implant and OP-1 Putty. According to a press release issued by the Acting U.S. Attorney in Boston, Mass., the company’s former president, Mark Philip, and its current sales managers, William Heppner, David Ard, and Jeff Whitaker were also indicted.
According to the press release, OP-1 Implant and OP-1 Putty, which were used to stimulate bone growth in long bones and the spine, were approved by the Food & Drug Administration (FDA) under a highly restrictive Humanitarian Device Exemption. One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit.
The federal indictment alleges the defendants encouraged doctors to use the OP-1 Implant and OP-1 Putty more broadly in combination with a bone void filler, called Calstrux. It further alleges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA.
According to prosecutors, the defendants promoted the OP-1 products in a mixture with Calstrux because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.
Stryker is facing charges of wire fraud, conspiracy, misbranding, and making false statements to the FDA. If convicted on all eight counts, the company could face fines of $4 million, double the damages caused by the misconduct, or double the company’s gross profits stemming from the misconduct – whichever is greatest.
Mark Philip, William Heppner, David Ard and Jeff Whitaker were charged in with five counts of wire fraud and one count of conspiracy. Ard and Whitaker were also charged with misbranding. Philip was also charged with making false statements to the FDA.
As we’ve reported previously, four other Stryker employees have already pleaded guilty to charges related to the case.
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