• The government settled 21 cases involving allegations of off-label marketing of drugs between 2004 and 2010.
  • 95% of the government’s investigations in these 21 instances were initiated by a qui tam complaint filed pursuant to the False Claims Act.
  • The government recovered $7.9 billion in criminal fines and civil settlements in these 21 cases.
  • 52% of the settlements were in excess of $100 million each.
  • The U.S. Attorney’s offices for the District of Massachusetts and the Eastern District of Pennsylvania were responsible for 13 of the 21 settlements, for which $7 billion (or 89% of the total proceeds) was recovered.
  • Drug companies were required to enter into Corporate Integrity Agreements in 81% of the cases.
  • Criminal pleas were made in 72% of the cases.
    • felony pleas were made in 29% of the cases
    • misdemeanor pleas were made in 43% of the cases
  • 80% of the criminal pleas were made in cases handled by the U.S. Attorney's offices for the District of Massachusetts and the Eastern District of Pennsylvania.

On March 31st, I will be speaking about the types of conduct that are likely to trigger an off-label marketing investigation by the government at ACI’s 11th National Forum on Fraud and Abuse in the Sale and Marketing of Drugs, taking place at the Millennium UN Plaza. If you are interested in attending this conference, please click here. For more FCA statistics, click here and here.