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Pfizer Pays a Record Amount to Settle Federal and State Fraud Investigations Into Illegal Off-Label Marketing Practices
Date:9/2/2009

gnoring or materially understating Geodon's serious, and even life threatening, side effects."

According to Kenney, "among Geodon's most dangerous side effects is its potential to affect the heart's rhythm, a condition known as QT prolongation. If the QT interval is increased excessively, conditions are created whereby unstable heart rhythms can intercede and disrupt the normal, regular rhythm essential for heart function." According to Kenney, "such ventricular rhythm disturbances greatly increase the risk of sudden cardiac death."

Kenney and Deming also served as co-counsel to whistleblower Ronald Rainero, a former Pfizer sales manager who brought a qui tam lawsuit against Pfizer for unlawful marketing practices relating to the antibiotic Zyvox.

As part of the overall settlement, Pfizer agreed to pay $100 million to resolve allegations that it engaged in the marketing of Zyvox for a variety of off-label conditions beyond the methicillin-resistent Staphylococcus aureus ("MRSA") infections for which Zyvox was FDA-approved.

Rainero's complaint alleges that Pfizer made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zyvox in order to further the off label campaigns.

The federal investigation into Pfizer's Geodon marketing practices was conducted by the U.S. Attorney's Office for the Eastern District of Pennsylvania under the direction of U.S. Attorney Michael Levy, Assistant U.S. Attorney Marilyn May and Assistant U.S. Attorney Charlene Keller Fullmer. The federal investigation into Pfizer's Zyvox marketing practices was conducted by the U.S. Attorney's Office for the District of Massachusetts under the direction of Acting U.S. Attorney Michael K. Loucks and Assistant U.S. Attorney Sara Bloom.

Massachusetts Assistant Attorney General Bob Patten led the Geodon and Zyvox investigation o
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SOURCE Kenney, Egan, McCafferty & Young
Copyright©2009 PR Newswire.
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