A member of the defense team in the recent failed prosecution of GlaxoSmithKline general counsel Lauren Stevens cited several lessons learned on Thursday.
“Have outside counsel sign your letters” when communicating with the U.S. government, Colleen Conry, co-leader of Ropes & Gray LLP’s government enforcement group, advised compliance officers at a conference in Washington, D.C. The government expects outside counsel to be “a little more aggressive” in replying to inquiries, which can possibly prevent misunderstandings down the line, she said.
In May U.S. District Judge Roger Titus in Maryland threw out the case against Stevens, saying it would be a “miscarriage of justice” to let it proceed to a jury. Stevens had been criminally charged with obstructing justice and lying to the government in an investigation of GSK’s marketing of the depression drug Wellbutrin.
The other lessons: “Don’t assume that the matter is closed” if the government stops responding to a company’s communications, and be transparent, Conry said.
Stevens, a former police officer in her 60s, responded on GSK’s behalf to the Food and Drug Administration when it made a request in October 2002 for voluntary disclosure of information about the marketing of Wellbutrin. The government suspected the drug company was promoting the drug for weight loss, which would have been illegal because the FDA had not approved the depression drug for weight loss, known as an “off-label” use.
The company chose Stevens for the job because she had a reputation for scrupulousness, Conry said. ”She was in every way the answer, not the problem” in compliance, Conry said. Stevens worked with outside counsel at King & Spalding LLP, a top-tier health-care industry law firm.
Stevens and King & Spalding conducted an internal investigation, interviewing some 20 witnesses. A focus was a promotional program of the kind that drug companies today have dramatically scaled back, in which GSK enlisted physicians to give talks about Wellbutrin.
The internal probe found that some doctors had created slide decks with potentially legally problematic language, Conry said. The team of lawyers decided not to turn over the slide decks without meeting with the FDA. “Remember, this was a voluntary request” from the government for information, she said.
But the FDA never responded to the meeting requests. What the GSK team didn’t know was that by the spring of 2003, a whistleblower had come forward in the matter. The FDA lawyers “go slient, and the team thinks they have lost interest,” Conry said. By late 2003, GSK had received a subpeona compelling the information, which was an indication that a more serious government investigation had begun.
Stevens was indicted twice and charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency and four counts of making false statements to the Food and Drug Administration. In her defense, Stevens argued she had relied on the advice of nationally recognized outside counsel.
The defense filed a Rule 29 motion moving to dismiss the case on the basis of lack of evidence. Titus, after saying in court that he had never granted such a motion, ruled in May that he would do so then. “[O]nly with a jaundiced eye and an inference of guilt that’s inconsistent with the presumption of innocence could a reasonable jury ever convict this defendant,” Titus said from the bench.
Regarding transparency, Conry said that if the GSK legal team had been “explicit with the FDA that in this voluntary request [they] would not hand over the [slide] decks without a meeting,” it would might have helped clarify the matter.
Conry is a former senior litigation counsel in the Criminal Fraud Section of the Department of Justice. She gave her remarks at the Pharmaceutical and Regulatory Compliance Congress, an annual event organized by the Pharmaceutical Compliance Forum, a group of senior compliance officers of some 50 pharmaceutical companies.