Pfizer fined $2.3 billion for illegal marketing in off-label drug case

— -- In the largest health care fraud settlement in history, pharmaceutical giant Pfizer must pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra, the U.S. Department of Justice announced Wednesday.

Besides Bextra, the drugs were Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. Once the Food and Drug Administration approves drugs, doctors can prescribe them off-label for any use, but makers can't market them for anything other than approved uses.

Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a felony violation for promoting off-label uses of Bextra, such as for pain relief after knee replacement surgery. At the FDA's request, Pfizer pulled Bextra off the market in April 2005 because its risks, including a rare, sometimes fatal, skin reaction, outweighed its benefits. It had been approved only for treating rheumatoid arthritis, osteoarthritis and menstrual pain.

Pfizer also has agreed to pay $1 billion in civil damages and penalties to compensate federal health-care programs for false claims submitted as a result of its marketing Bextra and the other four drugs for off-label use or at unapproved dosages.

In an interview Wednesday with USA TODAY, former Pfizer sales representative John Kopchinski said he was told to distribute 20-milligram samples to rheumatologists and orthopedists, even though the FDA had approved only 10-milligram doses for arthritis. The 20-milligram doses were approved only for menstrual pain, yet Kopchinski says he never called on gynecologists or other doctors who would treat that complaint.

In 2003, Kopchinski, 45, a West Point graduate, filed the first whistle-blower lawsuit, leading to the Justice Department investigation. Kopchinski says he was inspired by David Franklin, who filed a whistle-blower lawsuit against Pfizer for promoting Neurontin — at the time approved only to control seizures — for unapproved uses such as treating bipolar disorder.