World's Largest Drug Company Hit With Record Criminal Fine

Pharmaceutical company Pfizer, currently the largest drug company in the world, has been fined $1.3 billion for mispromoting Bextra, a once-popular painkiller that was taken off the market in 2004. Pfizer has agreed to pay an additional $1 billion in civil settlements to Medicare and Medicaid as reimbursement for improper prescriptions.

The federal investigation was sparked by the filing of a whistleblower lawsuit by a Pfizer sales representative who accused the drug company of marketing Bextra for unapproved, or “off-label” uses. Bextra (Veldecoxib) is a painkiller approved for relief of arthritis and menstrual pain. According to the whistleblowing employee - who will personally receive over $50 million in the settlement pursuant to whistleblower provisions in the federal False Claims Act - Pfizer promoted Bextra for uses and in doses that far exceeded the scope of the FDA approval.

A related settlement was also reached regarding kickbacks made by Pfizer to doctors for prescribing Bextra and several other drugs, often for off-label uses.

On the same day that Pfizer disclosed the cost of the settlement, it also announced the takeover of pharmaceutical giant Wyeth at a cost of $68 billion. The news of the merger overshadowed the news of the Bextra problem, which was understandably not highlighted by the drug company.

Doctors who prescribe drugs for a purpose or at a dosage not approved by the FDA may be committing malpractice and exposing themselves to liability. Although off-label use is quite common, it can be malpractice to prescribe drugs for off-label uses when there is no medical basis for doing so, or if safer, more established drugs are available that could accomplish the same purpose. Bextra, for instance, is an NSAID painkiller in the same class as aspirin, ibuprofen, and naproxen, all of which are widely available in differing forms and dosages, and are currently used to fight the type of pain for which Bextra was approved.

The use of defective or dangerous drugs, or the off-label use of otherwise safe drugs, can cause illness or injury, long-term damage, and even death. If you believe that you may have been injured by the prescription of a drug for an off-label purpose, contact our office for a consultation.