False Claim Act
The September 3, 2009, settlement is the third in which Pfizer signed a corporate integrity agreement (CIA). The other agreements were signed in 2002 over Lipitor and in 2004 over epilepsy drug Neurontin. The action was related to a “qui-tam” or “relator action”. Under the False Claims Act the relators’ receive a portion of the recovery, in this case — the six whistle-blowers will receive payments of approximately $102 million from the federal recovery. The relator action was filed in 2003, by a former Pfizer sales representative, and Golf War veteran.
* Largest combined federal and state health care fraud settlement in the history of the Department of Justice
* Resolution includes $1.3 billion in criminal fines and forfeiture and a combined federal and state civil False Claims Act settlement of $1 billion
Allocation of combined civil settlement amount by drug:
- Bextra: $502,524,316
- Geodon: $301,462,065
- Zyvox: $97,945,019
- Lyrica: $48,223,886
- Kickback Drugs: $49,844,714
- Bextra was marketed for acute pain and surgical pain, but approved only for arthritis and menstrual cramp;
- Geodon (ziprasidone) was marketed for depression, mood disorder, and dementia, but approved only for schizophrenia;
- Zyvox (linezolid) was marketed for infections caused by methicilllin-resistant Staphylococcus aureus but only approved for pneumonia.
- Lyrica (pregabalin) was promoted for chronic pain, but was only approved for fibromyalgia.
Pfizer Inc. ignored a 2005 FDA Warning Letter to stop promoting its antibiotic Zyvox(R) as clinically superior to the significantly less expensive, generic vancomycin when its own FDA-approved label indicated otherwise The drug giant also defrauded federal and state taxpayers by marketing Zyvox off-label, according to a qui-tam whistleblower complaint filed by Philadelphia law firm Sheller, P.C. and other documents unsealed with today’s $2.3 billion Pfizer settlement. The $2.3 billion settlement included off-label marketing allegations for the withdrawn arthritis drug Bextra(R), which was included in the Sheller complaint. Zyvox (linezolid) is an antibacterial agent that is approved by the FDA to treat certain types of infections, including nosocomial pneumonia and complicated skin and skin structure infections (“CSSSIs”) due to Methicillin Resistant Staphylococcus Aureus (“MRSA”). Worldwide sales of Zyvox totaled $1.115 billion in 2008.
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