On September 2, 2009, California Attorney General Edmund G. Brown Jr. announced that California will receive $34.8 million as part of a nationwide settlement with Pfizer, Inc., resolving civil and criminal charges that the company paid "illegal kickbacks" and conducted improper marketing campaigns for more than a dozen of its drugs.
Here is a link to a September 3, 2009 article in the New York Times about the settlement: http://www.nytimes.com/2009/09/03/business/03health.html
This settlement is based on nine whistleblower (qui tam) cases that were filed on behalf of California and other states in the U.S. District Court for the District of Massachusetts, the U.S. District Court for the Eastern District of Pennsylvania and the U.S. District Court for the Eastern District of Kentucky. Actions were filed by private individuals under state and federal false claims statutes, including California's False Claims Act.
Under the nationwide agreement, Pfizer will pay a total of $2.3 billion to the federal government and all 50 states. This is the largest health care fraud settlement in the history of the U.S. Department of Justice. Brown announced that California will receive an additional $2.7 million in a separate settlement with Pfizer over the illegal off-label marketing of Geodon, an anti-psychotic medication. Under this agreement, Pfizer will pay a total of $33 million to California and 42 other states.
The U.S. Department of Justice, California and other states contend that Pfizer engaged in a pattern of unlawful marketing activity to promote drugs for uses which the Food and Drug Administration (FDA) had not approved. It is not illegal for a physician to prescribe a drug for an unapproved use, but federal law prohibits a manufacturer from marketing a drug for off-label uses not approved by the FDA. This promotional activity included:
- Marketing Bextra for conditions and dosages other than those for which it was approved;
- Promoting the use of the anti-psychotic drug Geodon for a variety of off-label conditions such as attention deficit disorder, autism, dementia and depression for patients that included children and adolescents;
- Selling the pain medication Lyrica for unapproved conditions;
- Making false representations about the safety and efficacy of Zyvox, an antibiotic only approved to treat certain drug resistant infections.
The settlement also contends that Pfizer 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.
As a condition of the settlement, Pfizer will enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company's future marketing and sales practices.
California's pre-interest recovery of $34.8 million represents double damages, half of which will go to Medi-Cal. The remaining $17.4 million will be deposited, pursuant to state law, in the Attorney General's False Claims Fund, which is used to support ongoing investigations and prosecutions of false claims unlawfully filed at the expense of the state.
In a second settlement with Pfizer, it was alleged that Pfizer engaged in unfair and deceptive practices when it marketed Geodon for off-label uses between January 1, 2001 to December 31, 2007. 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. The complaint contends that Pfizer promoted Geodon for a number of off-label uses, including pediatric use and use at dosage levels higher than had been approved by the FDA. As part of the settlement, Pfizer has agreed to change how it markets Geodon and has agreed to stop promoting off-label uses. California will receive $2.7 million in civil penalties from Pfizer.
Any questions or comments should be directed to: tgreen@greenassoc.com. Tracy Green is a principal at Green and Associates. They focus their practice on the representation of professionals, particularly health care professionals. They have handled numerous investigations and cases relating to the federal and state Anti-Kickback and Stark laws. Their website is: http://www.greenassoc.com/
