In recent years, the volume and scope of government investigations and qui tam relatorcomplaints concerning alleged ″off-label″ marketing by pharmaceutical, biological, and medical device manufacturers has skyrocketed. Typically pursued under the federal False Claims Act (FCA), such investigations can give rise to substantial liability for manufacturers in the form of treble damages and civil penalties. For example, between 2004 and 2010, the U.S. government collected approximately $7.9 billion from 21 settlements related to off-label drug marketing, with more than one-half of these settlements surpassing $100 million. Moreover, the government’s focus on investigating off-label drug marketing shows no sign of slowing, as there were more than $2 billion in settlements and judgments related to pharmaceutical FCA matters in 2011, many involving allegations of off-label marketing.
Eric M. Gaier, Benjamin Scher, and Arun Sharma