Health Law Alert: Five Lessons Learned (the Hard Way?) for In House Counsel

You may have wondered what became of the indicted in house counsel from GlaxoSmithKline (GSK) in United States v. Stevens, No. 10-CR 0694 (D. Md. Mar. 23, 2011). The case was enough to make most in house counsel sit up and take notice. The good news — Laura Stevens, Vice President and Associate General Counsel of GSK, was cleared of all charges. The bad news — this may not be the last case, if the government has its way. With attorney-client privilege on the minds of in house counsel, Stevens also demonstrates the importance of the advice of counsel defense. Below is a summary of the facts that may seem all too familiar to those in house counsel involved in government investigations, as well as five lessons we can all learn from Stevens.

The Facts

In Stevens, the United States Food and Drug Administration (FDA) opened an investigation to determine whether GSK had promoted its Wellbutrin drug for weight loss, a use not approved by the FDA. As part of its run of-the-mill investigative inquiry, the FDA asked GSK to submit documents and other materials related to GSK’s promotional programs of Wellbutrin. Laura Stevens, GSK’s then Vice President and Associate General Counsel, served as lead throughout the investigation. Stevens also retained the law firm King & Spalding to assist with the investigation. GSK submitted responsive documents and six formal letters in reply to the government’s inquiries. Stevens signed the documents on behalf of GSK. She was later indicted for this very act.

The Attorney General’s office indicted Stevens and charged her with obstruction of justice, falsification and concealment of documents, and making a false statement. The federal government alleged that Stevens withheld relevant documents from the FDA, the most important of which were documents showing that GSK promoted off-label uses of Wellbutrin. Additionally, the government alleged that Stevens, assignatory of the letters, made materially false statements by not including what the government saw as all the relevant documents.

Stevens’ primary defense to the charges was that she relied in good faith on the advice of counsel in responding to the FDA’s investigation, and that such reliance negated the requisite intent to obstruct the FDA’s investigation. Good faith reliance on the advice of counsel, when proven by the defendant, negates the element of wrongful intent that is required for a conviction. Relying on the advice of counsel defense, Stevens moved for judgment of acquittal at the conclusion of the prosecution’s case and the judge agreed. Below find five lessons to take from Stevens when faced with a government investigation in the hopes of avoiding similar prosecution.