Healthy Skepticism Library item: 16393
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Bextra Whistleblower Case Started Investigation of Pfizer
Reuters 2009 09 02
http://www.reuters.com/article/pressRelease/idUS158792+02-Sep-2009+PRN20090902
Full text:
$1.8 billion of historic settlement covers civil and criminal fines for
dangerous “off-label” marketing of Bextra
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 Bextra was withdrawn from the market in 2005.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 qui tam
complaint on the Phillips & Cohen website at www.phillipsandcohen.com.)
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.”
