[author: Stephanie D. Willis]

For insights into how Foreign Corrupt Practices Act (FCPA) enforcement is creeping into the pharmaceutical and medical device manufacturer arena, see this article, which I co-authored with Paul Pelletier, former principal deputy chief of the Criminal Division’s Fraud Section at the Department of Justice (DOJ).  It discusses how DOJ is now using “letters of inquiry” and other informal practices to get pharmaceutical companies to report their knowledge of their competitors’ fraudulent activities to the government as a condition of resolving an investigation. 

On March 26th, a few days before the article published, another device manufacturer, Biomet, Inc., announced that it entered into a new Deferred Prosecution Agreement (DPA) and accompanying settlements with DOJ and the Securities and Exchange Commission.  Coupled with the DPAs DOJ entered into with Johnson & Johnson in April 2011 and Smith & Nephew in February 2012, this announcement signals the fact that DOJ apparenlty is looking beyond United States’ boundaries for health care fraud enforcement opportunities.