Latest developments in the Pharma lawyer obstruction of justice case

Dec 30, 2010   

We had earlier blogged on the indictment of Lauren Stevens, the former Vice-President and Associate General Counsel for GlaxoSmithKline for allegedly making false statements and obstruction of justice in regard to a FDA investigation. That earlier blog is here. Now, in a recent development, it turns out that the government is seeking to prevent Stevens from relying on an “advice of counsel” defense at trial.

In a press account, it was suggested by her counsel that Stevens may raise an “advice of counsel” defense as it stated that Stevens did everything “consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer”. Soon afterward, the government filed a motion with the court to forbid Stevens from raising an “advice of counsel” defense at trial.

In that motion, which can be found here, the government states that “advice of counsel” cannot be a defense to the obstruction of justice charge against Stevens pursuant to 18 U.S.C. Sec. 1519 because it is not a “specific intent” crime. A “specific intent” crime is one in which the government must prove the defendant acted willfully, i.e., knew that the conduct charged violated the law. The government maintains in its motion that Sec. 1519 is a “general” intent crime, in that ignorance of the law is not an excuse; all that is required is proof that the defendant acted knowingly, i.e., not by mistake, when she allegedly covered up off label uses of a drug, with the intent to impede, obstruct or influence the FDAs investigation. According to the government, since Sec. 1519 does not require willful conduct, i.e., conduct committed with knowledge that it violated the law, advice of counsel that the conduct is lawful is irrelevant.

However, Stevens was also charged with other certain “specific intent” crimes that do require proof of willful conduct. 18 U.S.C. Sec. 1512, another obstruction of justice statute, requires proof that a defendant acted “corruptly”. 18 U.S.C. Sec. 1001, making false statements to the government, requires proof that the defendant knew he/she was acting unlawfully. In regard to these charges, the government argues in its motion that the “advice of counsel” defense should not be available until Stevens can satisfy that she fully disclosed all facts to the companys attorneys before seeking advice, and that she relied on the advice in a good faith belief that the conduct was legal. In another twist, the government takes the position that even if advice was given by lawyers to Stevens that her conduct was legal, those lawyers represented GlaxoSmithKline, not Stevens personally. Since she was not the lawyers client, according to the government, the defense should not be available.

What can so far be gleaned from the events in the Stevens case is how important it is to adequately document, in writing, the information provided to regulatory counsel and the advice received from regulatory counsel. In addition, in house counsel and compliance personnel must exercise heightened diligence to ensure that information provided to the FDA is accurate and complete. Given the governments hard nosed enforcement efforts, adequate documentation of this diligence and information and advice shared may make all the difference.

As of the date of this blog, Stevens had not yet responded to the governments motion. A hearing will most likely be held prior to a decision.