United States v. Lauren Stevens: How FDA's Questions about Off-Label Promotion Led to the Criminal Prosecution of a Company Lawyer

Healthcare & Life Sciences Partner Michael Gaba and White Collar Defense Partner William Gould authored an article for FDLI Update Magazine titled "United States v. Lauren Stevens: How FDA's Questions about Off-Label Promotion Led to the Criminal Prosecution of a Company Lawyer."

In the article, Mr. Gould and Mr. Gaba discuss the recent case of United States v. Lauren Stevens and its application to life science companies and their in-house counsel. The Department was vigorous in its prosecution of Ms. Stevens, a retired vice president and former in-house attorney for GlaxoSmithKline (GSK), and the Maryland federal indictment charged her with two counts of obstruction and four counts of making material false statements during an FDA investigation into whether GSK improperly introduced a misbranded drug into interstate commerce. In his order dismissing the government's indictment for the second time, Judge Roger Titus discusses the appropriate parameters of attorney-client privilege and the importance of advice of counsel extensively.