Litigation Attorneys Win Quick Dismissal of Criminal Charges in Off-label Promotion Case

Litigation Attorneys Win Quick Dismissal of Criminal Charges in Off-label Promotion Case


Shortly after the beginning of trial in the US District Court for the District of Massachusetts, WilmerHale attorneys secured a full dismissal of all criminal charges against client David Ard. Ard, a regional sales manager for Stryker Biotech, had been charged with conspiracy to defraud the FDA and commit wire fraud, as well as wire fraud, in connection with the alleged off-label promotion of medical devices distributed by Ard’s former employer, Stryker Biotech LLC.

Ard was indicted in October 2009, along with Stryker Biotech, the company’s ex-president and other regional sales managers. The government alleged that the defendants entered into a conspiracy and scheme to trick and mislead surgeons into using an unapproved combination of OP-1 and Calstrux, two medical devices sold by Stryker Biotech used in spine and other surgeries.

WilmerHale’s opening statement argued that, not only was there no evidence that Ard intended to mislead or defraud anyone, but that out of more than 10,000 surgeries where a combination of OP-1 and Calstrux were used, the rate of adverse events was less than 1%.

"We made it clear that we intended to call a number of doctors who would testify that they were never defrauded,” said Brent Gurney, lead partner in the matter. “And we planned to call [Stryker] witnesses who would testify that it made no sense that they would lie to doctors because their business model relied on strong and trusting relationships with these doctors," Gurney commented in The American Lawyer.

On January 17, 2012, after only one partial day of testimony, the government moved to dismiss all charges against Ard with prejudice, stating that it was “in the interest of justice” to do so. The government also stated on record that it did not consider Ard a co-conspirator.

"It was a very difficult case for the government,” Gurney said in BNA: Health Care Fraud Report. “This was a disappointing result for [the state's attorney's office] and they have said as much, but we give them a lot of credit for dropping these charges,” Gurney stated in FDA News.

In addition to Gurney, Ard was represented by Counsel Miranda Hooker, and Associates Phillipa Gage and Michael Wolin. Partner Bob Keefe also provided invaluable assistance throughout the duration of the matter.

*The dismissal was one of five cases featured in "Winning," the National Law Journal’s annual report on significant trial victories. (National Law Journal/, "Winning," March 12, 2012.)