Most international traders and service providers are right to think that government officials should be more pleasant in dealing with them. Those same individuals recognize that often lawyers are dealt with differently by the agency representatives simply because lawyers know well the procedures that should apply and will not agree to deviations based on the whim of a government individual. This is sometimes known as the "I get paid to be the bad guy" approach by members of the bar.
Now comes word that in-house attorney Lauren Stevens, who worked for Glaxo Smith Kline, has been indicted in the context of representing her client. The underlying facts involve an investigation by the FDA of GSK's marketing of Wellbutrin SR, which was approved by the FDA for the treatment of depression. The FDA claims to have learned that doctors were marketing the drug for weight-loss purposes and allegedly doing so with GSK's encouragement and even authorization. GSK was asked to provide documentation on this topic to the FDA, and, according to the FDA, certain materials supposedly incriminating to GSK's case were purportedly withheld by Ms. Stevens.
The indictment can be found at WestLawNews It details the allegations, including that GSK paid doctors to lecture about the drug, during which lectures off-brand uses were widely touted. The former GSK attorney is alleged to have agreed to provide a wide range of documentation from those lectures and other events. It is further alleged that Ms. Stevens sanitized the documentation before presenting those edited and incomplete materials to the FDA. According to the FDA, she thereby withheld materials she and the company had agreed to turn over. The indictment, handed down in Maryland, where the FDA is headquartered, references repeated instances of her withholding information and misrepresenting the facts.
As such, the lawyer was charged with obstruction of justice, falsification/concealment of documentation, aiding and abetting, and false statements. However, we are already hearing claims that what Ms. Stevens did was done on advice of counsel, and counsel has been described as an outside law firm well-versed in FDA law. So, is this case smoke or is it fire? Is this ChemNutra all over again? Is a government agency trying to make more out of a set of facts than is warranted in an attempt to make a point? We are following this case and will let you know.