On May 10, 2011, US District Court Judge Roger W. Titus dismissed the criminal case against GlaxoSmithKline’s in-house counsel, Laura Stevens for obstruction of justice and false statements made to the Food and Drug Administration (“FDA”). From the bench, he read a searing statement against the government’s prosecution stating that the case "should never have been prosecuted" and that Ms. Stevens "should be permitted to resume her career."
Congress has expressed increasing concern about the over-criminalization of government interactions, and this case is a poster child for reform. How did this happen? Who reviewed and approved the indictment? The Justice Department needs to ask these questions and demand answers. Once DOJ finds out what happened, they need to make sure that such a case never happens again.
The government’s indictment of Stevens focused on her role in responding to an FDA inquiry into GSK's promotional programs for Wellbutrin®, including her response to FDA requests for promotional materials for the drug (including those developed and used by parties outside of GSK) and information about compensation provided to attendees at Wellbutrin®-related promotional events.
According to the government, Stevens discovered—but failed to produce—promotional materials containing information about off-label uses for the drug. The government also alleged that Stevens concealed evidence by failing to produce information relating to gifts and entertainment provided in connection with Wellbutrin® promotions and that Stevens made false statements to the FDA by stating in various letters that GSK did not promote Wellbutrin® for off-label purposes
Judge Titus found that a prior court decision granting the government access to otherwise privileged information under the crime-fraud exception was incorrect. These documents, Judge Titus stated, reflected a careful review and thoughtful analysis of the FDA’s request.
Judge Titus concluded that while the responses that Stevens provided to the FDA "may not have been perfect," they were sent in the course of Stevens' bona fide legal representation of her client and in good faith reliance on internal and external counsel for the company. Judge Titus further held that the evidence presented at trial supported a conclusion that Stevens sought and obtained the advice of numerous other lawyers (including outside counsel) in connection with her responses to the FDA and that "every decision that she made and every letter she wrote was done by a consensus."
A deep sigh of relief was heard by all in-house counsel after Judge Titus’ decision to dismiss the criminal case. However, the mere fact that the case was brought indicates the Justice Department’s continuing focus on gatekeepers – attorneys, accountants, compliance officers – who are being targeted for criminal prosecution. In this environment it is important for in-house counsel to remain zealous advocates on behalf of their clients but they must remember to do so with prudence—and a good record of lawyerly conduct.