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E-Alert Case Updates

Indictment of Pharma Exec Dismissed Where Prosecutors Give Erroneous Instruction to Grand Jury

USA v. Stevens
No. RWT 10cr0694 (D. Md. 2011)

by Colleen K. O’Brien, Law Clerk
Semmes, Bowen & Semmes (

Ms. Stevens, a former Vice-President and Associate General Counsel of GlaxoSmithKline (GSK), was indicted by a federal grand jury for criminal charges arising from her responses to an FDA inquiry regarding the alleged off-label promotion of the anti-depressant drug Wellbutrin. The government alleged that Ms. Stevens obstructed the FDA’s investigation by withholding, concealing, and falsifying documents, and that she made materially false statements in her communications with the FDA. Ms. Stevens’ defense to the charges was that she relied, in good faith, on the advice of counsel in responding to the FDA’s inquiry. Her reliance on counsel’s advice negated any intent to obstruct the FDA’s investigation or to make false statements.

The Court explored the “advice of counsel defense,” which it deemed a misnomer. This is because, good faith reliance on the advice of counsel, when proven, negates the element of wrongful intent. Therefore, it defeats an essential element of a crime, rather than serving as an affirmative defense.

During the indictment, a grand juror asked the prosecutors whether it mattered if Ms. Stevens was getting direction from somebody else about how to handle the FDA investigation. The prosecutors told the juror that the advice of defense counsel was not relevant at the charging stage. To the Court, the prosecutors had misstated the law, and good faith reliance on the advice of counsel was “highly relevant to the decision to indict.” The prosecutors’ instructions were erroneous, serious misstatements of the law, which cast grave doubt as to the entire indictment. The indictment was tainted by substantial influence of the erroneous legal instruction. The Court dismissed the indictment without prejudice, so that the government could pursue the case before a different grand jury that was appropriately instructed as to the law on the advice of counsel.