The stakes could not have been higher. David Ard, former regional sales manager for Stryker Corp.’s biotechnology unit, faced charges of conspiracy and wire fraud related to the marketing of a bone growth product that hadn’t received U.S. Food and Drug Administration approval. He turned to Brent Gurney and Miranda Hooker of Wilmer Cutler Pickering Hale and Dorr.
Gurney, a partner, and Hooker, a counsel, assessed the case against their client as particularly weak, so they adopted a simple strategy: They refused to communicate with federal prosecutors. “The best defense often means staying silent,” Gurney said. “The U.S. attorney’s office never had any idea what we were going to argue. We kept it that way until the trial began.”
The Wilmer team was going up against the health care fraud unit of the U.S. attorney’s office in Boston, a marquee unit with a national reputation for winning convictions. “We were very strategic about what we were going to say to the government,” Hooker said. “Our defense was going to highlight good faith. I think that was new information for them.”
Gurney and Hooker prepared for more than two years. When the time came for their opening arguments in January 2011, Gurney told the story of Ard’s life: about Ard’s wife and three kids and how he worked out of his home near San Francisco as a sales manager; about his father, a disabled sheriff’s deputy; about his excitement at joining Stryker.
The reason for the excitement, he continued, was because of Stryker’s OP-1, a protein that grows bone and helps the human body to heal itself. The government charged the company, its former president and three sales managers, including Ard, with promoting off-label use of OP-1 implants and putty in combination with a bone-void filler called Calstrux, and covering up reports that it was harming patients.
“That to us was utterly inconsistent with who Dave was and how he lived his life,” Gurney said.
“This case arose out of the complicated off-label regulations by the FDA; Dave had done his very best to comply with those regulations,” Gurney said. Furthermore, to cover up adverse effects — essentially defrauding doctors — would be career suicide for anyone in the biotech field.
NO INTENT, NO CRIME
“The theme for the opening statement was if there was no intent, there was no crime,” Hooker said. “It was implausible to think that he would defraud these people.”
The government’s first witness spent about 90 minutes on the stand on a Friday. “It’s fair to say that the witness was not as strong or compelling as the government had hoped,” Gurney said. “We believed that the government knew the case was going very, very poorly.”
The following Monday, Gurney and Hooker met with prosecutors. They pointed out that some of the government’s own witnesses would testify that Ard never did anything wrong, and demanded that all charges be dropped. The prosecutors said they needed to mull it over.
Later that day, Gurney and Hooker were summoned to a follow-up meeting. They assumed prosecutors were going to offer a plea agreement. “When they told us they were going to drop the case, I was momentarily stunned,” Gurney said.
When they delivered the news to their client, he was overcome with emotion. “You carry a lot of weight and all the emotions rushed into my head all at once,” Ard said. “It was a fantastic moment for me and my family.”
The company didn’t fare as well. Stryker pleaded guilty to misbranding a medical device and paid a $15 million fine. Subsequently, the government dropped its case against former President Mark Philip and sales managers William Heppner and Jeffrey Whitaker.
Asked to comment on the defense team, Assistant U.S. Attorney Susan Winkler wrote via e-mail, “Mr. Gurney and Ms. Hooker were courteous and professional throughout the proceedings.” Gurney and Hooker were assisted by associate Michael Wolin. Partner Robert Keefe “did not appear in the courtroom, but he provided invaluable assistance,” Gurney said.
Throughout the trial, Gurney and Hooker said, they never doubted Ard’s innocence. He, in turn, never doubted their judgment. “They went right after the government, saying there wasn’t a stitch of evidence,” Ard said. “That was a brave and calculating thing to do.”
Now Ard is working to get his life back on track; he is unemployed and looking for work. He said he will never forget the work Gurney and Hooker put into the case. “Their life was committed to me getting my life back,” Ard said.
Matthew Huisman can be reached at email@example.com.