Detrol Settlement of $14.5 Million Adds to List of Off-Label Cases Under False Claims Act

Today, Greene LLP announced a $14.5 million settlement with Pfizer, Inc., involving allegations of off-label marketing of Detrol.  The case becomes the 23rd to successfully use the off-label theory first successfully employed by Greene LLP attorneys in Franklin v. Parke-Davis, a case which also involved Pfizer and centered on off-label promotion of an epilepsy drug, Neurontin.

Pharmaceutical Fraud

The False Claims Act allows whistleblowers to sue on the government’s behalf if they have knowledge of fraud on the government.  Submitting false claims for payment to government can result in treble damages under the False Claims Act, in addition to penalties of up to $11,000 per false claim.  In cases like those involving Detrol and Neurontin, whistleblowers allege that since off-label prescriptions for drugs are not covered by Medicare or Medicaid in most circumstances, a drug company causes the submission of false claims to the government when it markets drugs for off-label indications illegally.

Franklin v. Parke-Davis was filed in 1996 and settled in May 2004 by Greene LLP attorneys for $430 million in criminal penalties and civil fines.  Since that time, the 23 total cases settled under an off-label theory of liability under the False Claims Act have recovered $8,683,710,000 billion for the government, although four of those cases have also involved other theories of liability.  The civil portions of the 23 recoveries total $5,236,910,517, with approximately $4.5 billion directly attributable to off-label claims against pharmaceutical companies.

The Detrol settlement is the second from the list of 23 to be resolved without government intervention.  Both declined cases were successfully resolved by Greene LLP attorneys.  Click here for the complete list of 23 cases.

Update: Since the original publication of this post, there have been several new off-label promotion False Claims Act settlements, including $158 million with Johnson & Johnson for Risperdal (Texas only, with other marketing allegations yet to be resolved), $950 million with Merck for Vioxx, $1.5 billion with Abbott Laboratories for Depakote, and $3 billion with GlaxoSmithKline for several drugs.  Recoveries from cases employing Greene’s once-novel theory now surpass $14 billion.