$1.8 billion of historic settlement covers civil and criminal fines for dangerous "off-label" marketing of Bextra
Sept. 2, 2009, WASHINGTON, DC. -- 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 Bextra was withdrawn from the market in 2005.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."
As provided by the False Claims Act, the federal government will award Kopchinski $51.5 million as a reward for the work he and his attorneys did on the case. He also will receive an undetermined reward under state false claims laws.
Ironically, Kopchinski was personally hired as a sales representative in 1992 by Edward Pratt, the chairman and chief executive officer of Pfizer at that time, after Kopchinski began corresponding with Pratt while serving as an Army officer in the Gulf War. Kopchinski worked for Pfizer for 11 years.
"It was wrong what Pfizer told its sales representatives to do," Kopchinski said. "Fortunately, once the government found out what was going on, it acted quickly to protect patients."
Attorney Kelton praised the work of the U.S. Department of Justice -- particularly Assistant U.S. Attorney Sara Bloom and Trial Attorney Sanjay Bhambhani -- and the National Medicaid Fraud Control Units team, headed by Massachusetts Assistant Attorney General Robert Patten.
Kopchinski expressed gratitude to the government and to his wife for her support throughout the six years he pursued the case. "The past six years have been very stressful," he said. "I'm glad it's finally over."
See "Pfizer settlement and Bextra whistleblower case" for the qui tam complaint, related exhibits and news stories about the case.
For more information about Phillips & Cohen's record, see P&C's Successful Whistleblower Cases.