The Department of Justice has just announced that Pfizer, Inc. will pay a record $2.3 billion to settle allegations of off-label drug marketing. In January, 2009 the company announced its plans to set aside that amount in anticipation of the settlement. Allegations against Pfizer involved the illegal marketing of several drugs including its pain-killer and anti-inflammatory drug, Bextra, approved for arthritis use but promoted by Pfizer for other, unapproved applications. Under the Food, Drug, and Cosmetic Act and Food and Drug Administration regulations, a drug company may market its drugs only for those uses submitted to and approved by the FDA.

Pharmaceutical companies across the nation have faced massive federal and state lawsuits alleging deliberate, illicit marketing of drugs for unapproved uses, resulting in billions of dollars of false claims to Medicare and state Medicaid programs. In January drug giant Eli-Lilly paid a then-record $1.4 billion to resolve similar allegations involving its drug Zyprexa. As part of today’s settlement, Pfizer subsidiary Pharmacia and Upjohn Company agreed to plead guilty to one count of mis-branding Bextra with intent to deceive, and to pay a $1.195 billion criminal fine.

Three whistelblower lawsuits underlie the litigation against Pfizer. For their efforts and the efforts of their attorneys in securing the massive settlement, six whistleblowers will receive over $100 million.

To report Medicare or Medicaid fraud, contact Frohsin & Barger.