Federal prosecutors dropped all charges against 1 of the former Stryker Biotech sales managers charged with illegally promoting the off-label use of two bone growth products and of lying to the FDA.
Former Stryker Biotech president Mark Philip was named alongside sales managers David Ard, Jeff Whitaker and William Heppner, in a grand jury indictment on charges of wire fraud and conspiracy in 2009. Stryker Corp.’s (NYSE:SYK) biotech arm and Philip were also charged with making false statements to the FDA.
Now the feds’ motion to dismiss the charges against Ard “in the interest of justice” has been granted by Judge George O’Toole Jr. of the U.S. District Court for Massachusetts, according to court documents.
The indictment alleged that the defendants were part of a scheme to promote the combined use of a pair of separate bone-healing products, each granted a narrow, provisional “humanitarian device exemption” by the FDA.
Combining the treatments and devices — the OP-1 Implant, OP-1 Putty and the bone void filler Calstrux — caused adverse effects in patients ranging from minor irritations to infections requiring follow-up surgeries. The indictment also charges that Stryker and Philip lied to the FDA about the number of patients treated each year with OP-1 Putty.
The case went before a jury last week. Heppner and Whitaker have asked O’Toole to declare a mistrial with prejudice, according to the documents. The judge has not yet ruled on those motions, but granted Philip’s move to sever the charges against him. That means Philip will be able to use communications he had with Stryker Biotech lawyers, which would otherwise fall under attorney-client privilege, in his defense.