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Bextra Whistleblower Case Started Investigation of Pfizer
Date:9/2/2009

WASHINGTON, Sept. 2 /PRNewswire/ -- The decision by a Pfizer sales representative in Florida to file a whistleblower ("qui tam") lawsuit in 2003 kicked off the federal and state investigations that led to Pfizer's record-breaking $2.3 billion settlement today.

"In the Army, I was expected to protect people at all costs," said the whistleblower, John Kopchinski, a West Point graduate and Gulf War veteran. "At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that."

The largest piece of the settlement -- $1.8 billion -- is solely due to Pfizer's improper "off-labeling" marketing of Bextra that Kopchinski exposed through his qui tam lawsuit. Pfizer is paying $502 million to settle civil charges and an historic $1.3 billion criminal fine both relating to Bextra marketing.

The FDA approved Bextra to treat arthritis as well as menstrual pain in very limited doses. Kopchinski alleged in his qui tam lawsuit -- which the government joined -- that Pfizer promoted Bextra for uses and in doses that far exceeded what the FDA had approved. This put patients at risk for serious health problems such as heart attack, stroke and pulmonary embolism (blood clot in the lung). The lawsuit also said that Bextra paid doctors kickbacks in various ways to influence them to prescribe and endorse Bextra for these "off-label" uses. Bextra was withdrawn from the market in 2005.

"Even though the FDA rejected Pfizer's application to sell Bextra for certain uses because of serious health risks, Pfizer had the gall to push those uses anyway using misleading information," said Erika A. Kelton, a Washington, D.C. lawyer whose firm, Phillips & Cohen LLP, represents the whistleblower. "Ignoring serious health risks to increase sales is outrageous."

(For details about the allegations involving Bextra, see Kopchinski's
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SOURCE Phillips & Cohen LLP
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