FCA Alert : Lawyers & Attorneys for Whistleblower, False Claims Act & Qui Tam Defense : Kelley Drye & Warren LLP

Here is a copy of the off-label marketing presentation that I prepared for ACI's conference on Fraud and Abuse in the Sale and Marketing of Drugs held last week in New York.  The presentation slides include:

• A summary chart of off-label marketing settlements with drug companies between 2004 and 2010. (Slide Nos. 1-4)
   
• A summary chart showing which U.S. Attorney's Offices have been most active in pursuing off-label marketing investigations against drug companies, and the success rates of each office (as measured by felony pleas, misdemeanor pleas, and settlement amounts).  (Slide Nos. 5-6)
   
• Recent government interventions and subpoenas in off-label marketing investigations. (Slide Nos. 7-11)
   
• The pipeline for future off-label marketing cases based on information about sealed qui tam cases recently disclosed by the DOJ. (Slide No. 12)
   
• 18 different types of conduct that are likely to trigger an off-label marketing investigation by the government.  (Slide Nos. 13-38) 

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• 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.
 

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