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Indictment of Pharma Exec Dismissed Where Prosecutors Give Erroneous Instruction to Grand Jury
(March 2011) By Colleen K. O’Brien
For more information, contact Paul Farquharson.
USA v. Stevens,
No. RWT 10cr0694 (U.S. District Court for the District of Maryland, Mar. 23, 2011) |
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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.
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