On May 10, 2011, Lauren Stevens, former associate general counsel for GlaxoSmithKline, was acquitted of six criminal charges surrounding allegations of obstruction and providing false answers to an FDA inquiry in violation of 18 U.S.C. 1519.
In November 2010, Stevens was indicted on four counts of making false statements, one count of obstruction of justice, and one count of falsifying and concealing documents related to GlaxoSmithKline’s off-label marketing of the anti-depressant, Wellbutrin. Last month, U.S. District Court Judge Roger Titus dismissed the charges after finding that prosecutors had given inaccurate and incomplete information to the grand jury about Stevens’ key defense--that she depended on the advice of counsel. However, the DOJ re-indicted Stevens after dismissal and the subsequent hearing ensued.
Steven’s case is noteworthy for several reasons. First, it raises concerns with in-house counsel that deal with federal government agencies, including those handling FCPA investigations or answering compliance-related questions from the DOJ, SEC, and FDA. Second, it involved an attorney safe harbor provision housed in federal statutes, which protects attorneys who rely on the advice of outside counsel. Finally, Ms. Stevens was not accused of taking part in the actual underlying wrongdoing, but was still charged in connection with the wrongdoing. This is unusual because “in most off-label drug cases, the government charges senior business executives, not attorneys” according to John Wood, former U.S. Attorney in Missouri.
Judge Titus’ ruling was equally unusual—in his tenure as a federal judge, he had never granted a directed verdict of acquittal before the defense presented its case—until now. In his opinion, Titus wrote, “I believe that it would be a miscarriage of justice to permit this case to go to the jury. There is an enormous potential for abuse in allowing prosecution of an attorney for the giving of legal advice. I conclude that the defendant in this case should never have been prosecuted and she should be permitted to resume her career.”
In coming to his decision, he stated, “it is clear that [Ms. Stevens’ statements made to the FDA] were made in good faith which would negate the requisite element [of specific intent to commit a crime] required for all six of the crimes charged in this case.” Moreover, “GlaxoSmithKline did not come to Ms. Stevens and say, assist us in committing a crime or fraud. It came to her for assistance in responding to a letter from the FDA.”
Titus said Congress designed the safe-harbor provision to protect an attorney who is zealously representing her client and “that vigorously and zealously representing a client is no a basis for charging an offense [of] obstruction of justice.” Titus concluded that Steven’s responses to the FDA “were in the course of her bona fide legal representation of a client and in good faith reliance of both external and internal lawyers for GlaxoSmithKline...[and] every decision that she made and every letter she wrote was done by a consensus.”
Accordingly, "I conclude on the basis of the record before me," Judge Titus said, "that only with a jaundiced eye and with an inference of guilt that's inconsistent with the presumption of innocence could a reasonable jury ever convict this defendant."