The Cochran Firm Legal Blog

The pharmaceutical company Pfizer is the manufacturer of Bextra, a drug for treating arthritis and menstrual pain. The FDA approved Bextra in 2001 for these purposes but rejected a request from Pfizer to also approve it for some other uses. However, Pfizer went ahead and marketed Bextra for those "off-label" uses and encouraged doctors to prescribe it.

(Note: Off-label use of a drug or device is not illegal. Any doctor can make a judgment call in a particular case and use a drug in a way that is not specifically FDA-approved. Usually this is quite safe and beneficial for the patient. The FDA is already overloaded and there is no way they can test every drug for every conceivable use, so they are selective about it. However, drug companies are barred from marketing their drugs for off-label use.)

In April 2005, the FDA asked Pfizer to withdraw Bextra from the market because of reports that off-label Bextra use was connected to heart attack, stroke, and pulmonary embolism, which is a blood clot that travels through the bloodstream and lodges in the lungs. High Bextra dosages were thought to be causing these pharmaceutical injuries.

In 2003, one of Pfizer's sales representatives filed a qui tam (whistleblower) lawsuit against Pfizer which started federal and state investigations into Pfizer's marketing practices of Bextra and other drugs.

The Whistleblower
John Kopchinski was hired in 1992 by Pfizer's then chairman and chief executive officer. Kopchinski is a West Point graduate and was serving in the Gulf war as an army officer at that time. He worked for Pfizer for eleven years, during which time he was asked to promote drugs despite undisclosed evidence that they could be risky for patients.

Kopchinski stated, "In the Army, I was expected to protect people at all costs. At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that."

Components of Pfizer's Fine
Of the $2.3 billion total amount, $1.8 billion is based on Pfizer's Bextra marketing. It includes both civil and criminal fines for off-label marketing. Under the False Claims act, Kopchinski will receive $51.5 million for his role as whistleblower and will pay his lawyers from that amount. Kopchinski will also be awarded an unknown amount under state false claims law.

If you have been harmed by a drug's dangerous side effects and are wondering whether you have a legal claim, please call or email our defective drug attorneys today for a free consultation.

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