Two recent appellate decisions address issues that may significantly impact the content of training given by pharmaceutical and medical-device companies to their sales professionals. In Christopher v. SmithKline Beecham Corp., 132 S. Ct. 2156 (2012), the U.S. Supreme Court found that two pharmaceutical sales representatives were exempt from the Fair Labor Standards Act (FLSA) requirement that employees receive overtime compensation when they work in excess of 40 hours per week. In United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the Second Circuit reversed on free-speech grounds the criminal conviction of a sales representative for promoting a pharmaceutical product for unapproved uses. Christopher effectively establishes an FLSA safe harbor for employers based on how life-sciences sales employees are trained, instructed, and evaluated about their primary job function. Caronia raises serious questions about the authority of the federal government to regulate truthful statements about the unapproved use of regulated products. Life-sciences companies and their counsel would do well to consider both of these decisions in designing and updating their sales-training programs.
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