Sunday, May 22, 2011

Federal Judge Rebukes Prosecutors for Criminal Case Against In-House Counsel

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.


  1. I would like to add to my earlier comments that Titus was a partner at Venable, LLP, one of the largest lobbying and law firms in the nation's capital. Among the clients of Venable are numerous pharmaceutical and pharmaceutical related companies. These pharma companyies are making TENS OF BILLION yearly off the sale of off-lable drugs. The health and welfare of millions of innocent victioms is being affected by the dispensing of drugs unapproved for the illnesses they are prescribed. This is a big money scam, so big that it may exceed in value one trillion dollars over a ten year period. Because of Titus's ruling the FDA is powerless to stop this scam which aside from the health risks is costing Medicare and the insurance company incredible amounts of money. "Follow the money, stupid." If the government does have the guts to go after Titus and I doubt they do, they will find the trail right to his door. In my own esperience, I have discovered that Titus shared an office building for yearrs with our opposing attorney. They were buddies and he ruled every time in their favor. Titus is a world class crook, an embarassment to the legal profession and needs to be exposed, impeached and sent to the jail cell Ms. Stevens escaped.

  2. Once the government targets attorneys (whether in-house or outside counsel) for obstruction-related charges, where the attorney has no involvement or interest in the alleged underlying misconduct, we need to ask serious questions. Client representation is, by its nature, rife with nuances and attorney client privileged communication. It is ill-advised for a government regulatory agency (in this case the FDA), to examine, after the fact, attorney client privileged communications in an effort to build a federal obstruction case against an attorney who did not benefit from the alleged underlying misconduct. That would make the attorney’s job impossible, as a good faith judgment decision made by the attorney during the course of the representation, which ultimately is found to be less than optimal from the government’s point of view (or, with hindsight, even proves to be incorrect) could result in criminal liability for the attorney. Attorneys are retained to represent their clients. They are not pseudo government investigators, and they cannot be expected to be prescient, or to possess divine intuition.
    Ms. Stevens rightfully won this case, but I’m sure the judge’s statement that “this case should never have been brought” will provide her little solace at this point. She has been dragged through many years of painful federal criminal prosecution, having her reputation and career irreperably harmed in the process. Her personal life has likely been permanently affected. Taking on the DOJ is not a decision to be taken lightly – 95% of federal convictions result from pleas. Federal obstruction statutes carry maximum penalties of 20 years in prison, and the government has unlimited resources. To say that “this case should never have been brought” seems to belittle the courage that Ms. Stevens displayed in fighting for what’s right. I think we need to take a closer look at “prosecutorial discretion.” There apparently was reluctance by several US attorneys to sign off on this indictment. I wonder who ultimately signed it, and what he’s doing now? This type of prosection, particularly in an environment of trillion dollar deficits and devastating budget gridlock, is simply disgraceful.