Five years ago, the U.S. Department of Justice announced that it had charged GlaxoSmithKline vice president and associate general counsel Lauren Stevens with two counts of obstruction of justice and four counts of making false statements to the Food and Drug Administration (FDA). At issue were allegations that Stevens had sent a series of letters to the FDA denying that the company had promoted its drug Wellbutrin for off-label uses and that she failed to turn over evidence to the contrary, including various slides used by physicians paid by the company to promote the drug’s off-label use.
News of Stevens’ indictment rocketed through the ranks of corporate counsel nationwide, not simply because the Justice Department opted to pursue criminal rather than civil sanctions for the manner in which GlaxoSmithKline conducted itself during the FDA’s investigation, but also because it chose to prosecute not the company but Stevens individually. Indeed, the stakes for Stevens could not have been higher—if convicted she faced a maximum of 60 years in prison.
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