By now you are probably familiar with the story of Lauren Stevens, a former vice president and associate general counsel of pharmaceutical company GlaxoSmithKline, who was prosecuted by the U.S. Department of Justice for allegedly misleading the Food and Drug Administration (FDA) about her company’s promotion of the anti-depression drug Wellbutrin.
It’s not often that we in-house lawyers get a scare like United States v. Lauren Stevens. Since the trial ended on May 10 when the judge granted a motion for acquittal, and the jury reportedly stood up and applauded, law firm advisories, blogs and seminars on how in-house lawyers can avoid going to jail for making statements to the government have been pouring forth.
Stevens’ repeatedly stated in her letters to the FDA that Glaxo had not established a program to promote Wellbutrin for weight loss, for which the drug was not approved. The statements were apparently based on a distinction between off-label promotion and Glaxo pursuing a “corporate strategy” of off-label promotion. Was it Stevens’ objective to respond to the FDA by providing promotional materials? Or did Stevens attempt to use the opportunity to discourage the FDA from further investigation?
It’s not clear what Stevens’ objectives were. The hard truth is that Stevens followed her agreement to produce anything and everything with a scaled-down effort to produce documents, followed by her discovery that, indeed, Glaxo-hired doctors were illegally promoting Wellbutrin. Faced with a dilemma of her own making, Stevens and the outside law firm engaged in a “black eye/feather in your cap”-type analysis of whether or not to follow through on Stevens’ initial commitment, which did nothing to help the situation.