Pfizer paid $2.3 billion in 2009 to resolve illegal-marketing allegations.
The settlement involved allegations that Pfizer and its subsidiary Pharmacia had promoted several medicines for uses not approved by the U.S. Food and Drug Administration. The case particularly involved the painkiller Bextra, which Pfizer withdrew from the U.S. market in 2005 after safety concerns and regulatory pressure.
The 2009 agreement combined criminal and civil components. Pfizer agreed to pay $2.3 billion, including a criminal fine and payments connected with the civil False Claims Act. At the time, the Justice Department described it as the largest healthcare-fraud settlement and the largest criminal fine of its kind.
The case is frequently cited in discussions of pharmaceutical marketing and off-label promotion. Off-label prescribing itself can be lawful when done by a physician, but companies face restrictions on promoting medicines for unapproved uses. The settlement did not mean every prescription of the medicines was illegal.