Whistleblowers: Treat Them With Kid Gloves

In the May/June 2010 edition of FDLI Update, HPM Director John R. Fleder published his latest article on enforcement matters. This article is entitled “Whistleblowers: Treat Them With Kid Gloves”. [link to article]. The article addresses various issues that companies face when they are confronted with employees who raise complaints within a company about its compliance with regulatory requirements. The article discusses how one company benefitted from having generated contemporaneous documents that refuted allegations that a company employee (and potential whistleblower) had made about the company’s alleged failure to comply with FDA-related requirements. The article also discusses the current government enforcement environment in which a large percentage of cases brought these days are based on whistleblower complaints. Finally, the article provides a number of practical suggestions for companies with regard to their treatment of potential and actual whistleblowers.