Attorney General Bill McCollum News Release
September 2, 2009
Media Contact: Jenn Meale
Phone: (850) 245-0150
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McCollum: Florida Recovers $58.2 Million from Pfizer Inc. in Billion Dollar Medicaid Settlement

~ Largest setttlement obtained by Florida Medicaid Fraud Control Unit ~


TALLAHASSEE, FL – Attorney General Bill McCollum today announced that Florida will receive a total of $58.2 million as part of a global settlement with Pfizer Inc. The agreement resolves civil and criminal allegations that Pfizer and its subsidiaries paid kickbacks and engaged in off-labeling marketing campaigns that improperly promoted numerous drugs that Pfizer manufactures. Pfizer will pay the states and the federal government a total of $1 billion in civil damages and penalties to compensate Medicaid, Medicare, and various federal health care programs for harm suffered as a result of its conduct. Florida’s civil case was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is a part of the Medicaid Fraud Control Unit.

“This settlement is a major victory for the taxpayers of Florida, and for those who count on the Florida Medicaid program to be able to provide assistance in their time of need,” said Attorney General Bill McCollum.

The settlement is the largest in history for the Florida Medicaid Control Unit and will ultimately send approximately $9.7 million to the State’s General Revenue Fund. Another $10.8 million will go to the state's Medicaid program for Pfizer's alleged improper actions.

The government entities alleged that Pfizer, the largest pharmaceutical manufacturer in the world, engaged in a pattern of unlawful marketing activity to promote multiple drugs for certain uses which the U.S. Food and Drug Administration (FDA) had not approved. While it is not illegal for a physician to prescribe a drug for an unapproved use, federal law prohibits a manufacturer from promoting a drug for uses not approved by the FDA.

The improper behavior included marketing Bextra for conditions and dosages other than those for which it was approved; promoting the use of antipsychotic drug Geodon for a variety of off-label conditions; selling pain medication Lyrica for unapproved conditions; and making false representations about the safety and efficacy of Zyvox, an antibiotic only approved to treat certain drug resistant infections.

Pfizer also allegedly paid illegal kickbacks to health care professionals to induce them to promote and prescribe Bextra, Geodon, Lyrica, Zyvox, Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec. These payments allegedly took many forms, including entertainment, cash, travel and meals. Federal law prohibits payment of anything of value in exchange for the prescribing of a product paid for by a federal health care program.

In addition to the civil fines, Pfizer subsidiary Pharmacia & Upjohn Company, Inc. will plead guilty to a felony violation of the federal Food, Drug, and Cosmetic Act (FDCA) and will pay a criminal fine and forfeiture of $1.3 billion. The criminal component of the resolution centers on the illegal marketing and promotion of Bextra, an anti-inflammatory drug that Pfizer pulled from the market in 2005.

The settlement is based on nine whistleblower cases that were filed in the United States District Court for the District of Massachusetts, the United States District Court for the Eastern District of Pennsylvania and the United States District Court for the Eastern District of Kentucky by private individuals who filed actions under state and federal false claims statutes. A National Association of Medicaid Fraud Control Units team participated in the investigation and conducted settlement negotiations with Pfizer.

As a condition of the settlement, Pfizer will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.

A separate $33 million civil settlement was also reached with 43 states, including Florida, over allegations that Pfizer engaged in unfair and deceptive practices when it marketed Geodon for off-label uses. Geodon is the brand name for the prescription drug ziprasidone. The drug has been approved by the FDA for treatment of schizophrenia in adults and for manic or mixed episodes of bipolar disorder in adults. However, Pfizer allegedly promoted Geodon for a number of off-label uses, including promoting Geodon for pediatric use and for use at higher than FDA-approved dosages. Pfizer has agreed to change how it markets Geodon.

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