As previously reported, media and legal analysts speculated that the November 8, 2010 indictment of former GlaxoSmithKline vice-president and associate general counsel Lauren Stevens would have a chilling effect on the lawyers and executives in the pharmaceutical industry. Stevens had asserted an advice-of-counsel defense after being indicted for obstruction and making false statements during a 2002 investigation by the U.S. Food and Drug Administration (FDA). The investigation centered on off-label promotion of the GSK drug Wellbutrin. Some legal experts hypothesized that the indictment could cause pharmaceutical counsel to become more conservative in their advocacy, whereas others speculated that the government could not prove the required intent for the charges.

On March 23, 2011, Judge Roger W. Titus of the U.S. District Court for the District of Maryland dismissed the criminal indictment based on the "erroneous and prejudicial" instructions given to the grand jury. The dismissal is without prejudice, allowing the government "to seek another indictment from a different grand jury that is properly advised" on the law.

Background on the Indictment

The November 2010 indictment charged Stevens with one count of obstruction, one count of falsification and concealment of documents, and four counts of making false statements to FDA in the FDA's 2002 investigation into off-label promotion of the GSK drug Wellbutrin. The focus was on Stevens' role in allegedly withholding from FDA some responsive documents while simultaneously representing that she had provided all available documents. Stevens also was charged with misrepresenting facts about GSK's advisory boards and whether GSK gave gifts to attendees of its speaker programs. In her defense, Stevens asserted that she relied in good faith on the advice of counsel in responding to the FDA's 2002 inquiry.

The Erroneous Instruction to the Grand Jury

Stevens and the court subsequently learned that the prosecutors, when instructing the grand jury on the charges for the indictment, had told a juror that "the advice of counsel defense . . . is a defense that a defendant can raise, once the defendant has been charged." In his March 23 order, Judge Titus concluded that "advice-of-counsel" defense is not really an affirmative defense but instead actually negates the intent to commit a crime, a required element for the charges of obstructing the FDA's investigation and making false statements. The jurors therefore were "instructed erroneously that the advice of counsel was irrelevant to a determination of whether there was probable cause to indict Stevens," and the jury should have considered whether intent was negated before deciding to indict Stevens in the first place. However, because the court found no evidence of willful prosecutorial misconduct, the court dismissed the indictment without prejudice. This will allow the government to seek a new indictment from a different grand jury.

Import for the Industry

The media and lawyers continue to follow the case closely, with the Stevens' indictment and trial serving as a sort of bellwether for the government's announced plans to make industry executives and counsel more responsible for alleged corporate misconduct.