Stryker Pays $15M Fine in a DOJ Settlement After Unapproved OP-1 Clinical Study
OP-1 Prosecutions Down To One (Walter Eisner @ OTW)
The Boston Globe reported on January 20 that prosecutors dropped felony conspiracy and fraud charges against two remaining Stryker Biotech OP-1 sales reps on trial in Boston.
Judge George O’Toole, Jr. of the U.S. District Court for Massachusetts agreed to dismiss all criminal charges against Jeff Whitaker and William Heppner. Charges against a third rep, David Ard, had been dropped earlier during the trial when the company agreed to plead guilty to a minor misdemeanor crime of misbranding a product and paid a $15 million fine.
The company had faced 13 felony charges.
Brandy Donini-Melanson, a spokeswoman for the U.S. attorney’s office, said in a statement that prosecutors agreed to drop the charges “in the best interests of justice.”
“These were fraud charges that never should have been brought,” said Robert Ullmann of Boston, who represented Heppner.
The Globe reported that defense lawyers and legal observers said they could not offer a single reason why the government ultimately decided to drop the case, only that it was clear that the government could not prove that an intentional fraud occurred.
The dismissal of the charges against the sales reps and the guilty plea by the company only leaves Stryker Biotech’s former president, Mark Phillips, still under prosecution. His case was separated from the main case earlier, based on technical legal issues and is set to go to trial next month.
The outcome of this trial is in stark contrast to the recent jail sentences issued in Philadelphia to former Synthes executives charged with conducting a clinical trial without FDA approval. In the OP-1 case, the company did have FDA approval for testing under a Humanitarian Device Exemption. Prosecutors had accused Stryker and the reps of marketing OP-1 in a mixture with Calstrux, a bone void filler, without FDA approval.