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AstraZeneca Pays $520 Million to Settle Seroquel Whistleblower Claims
Date:4/28/2010

Kenney & McCafferty Represent Whistleblower Dr. Stefan Kruszewski

(PRWEB) April 28, 2010 -- AstraZeneca has agreed to pay $520 million in civil fines, penalties and damages to settle allegations that the company defrauded Medicare, Medicaid and other government-funded health care programs in connection with its marketing and promotional practices for the blockbuster atypical antipsychotic Seroquel (U.S. ex rel. STEFAN KRUSZEWSKI, MD v. ASTRAZENECA PHARMACEUTICALS, LP., Eastern District of Pennsylvania, C.A. No. 06-4004.). This is the largest settlement of off-label marketing claims brought under the False Claims Act to date that involved civil-only fines. The $520 million settlement resolves a qui tam lawsuit filed by whistleblower Dr. Stefan Kruszewski, one of two relators to file a case. Dr. Kruszewski was represented by Brian Kenney and Tavy Deming of the Kenney & McCafferty law firm, along with William Leonard of Obermayer, Rebmann, Maxwell & Hippel.

Seroquel, a potent atypical antipsychotic, was FDA-approved only for two narrow uses in adults, schizophrenia and manic episodes associated with bipolar I disorder, at the time that Dr. Kruszewski filed his complaint. Harvard-trained psychiatrist Dr. Kruszewski alleged, however, that AstraZeneca engaged in an egregious, long term off-label marketing scheme by specifically targeting children and the elderly when those uses were never properly tested or approved by the FDA and that AstraZeneca marketed the drug for a litany of off-label uses, including depression, anxiety, ADHD and insomnia.

Dr. Kruszewski's complaint further alleged that AstraZeneca arranged for clinical trials that embellished efficacy data and also downplayed the drug’s serious side effects. Dr. Kruszewski alleged that AstraZeneca used these studies to stifle physician concerns about the drug's serious treatment-emergent side effects, including
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