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Largest Civil Settlement in Pharmaceutical Case Announced by U.S. Department of Justice
Date:4/27/2010

s approved by the U.S. Food and Drug Administration ("FDA") only for schizophrenia and specific types of bipolar mania. AstraZeneca was charged with promoting Seroquel to physicians for use "off-label" in children and the elderly.  Doctors are allowed to prescribe drugs for unapproved uses but FDA rules state that drug manufacturers may only promote their products for approved conditions and age groups.

The settlement unsealed today by the U.S. Department of Justice and the U.S. Attorney's Office in Philadelphia indicates marketing practices for Seroquel included promotion of the drug by physicians participating in clinical studies and drug sales representatives encouraging doctors to prescribe for the unapproved uses.

Whistleblowers are protected by the federal False Claims Act, where employees aware of their company knowingly defrauding the government may sue without threat of being fired, harassed, demoted, or discriminated against for cooperating in an investigation of their employer.

"My client showed courage and determination in bringing forth the allegations against AstraZeneca," said Sheller. "As a company employee, he knew alerting the government to the marketing practices potentially put his professional life in jeopardy but he believed protecting public safety and bringing attention to fraud against the government outweighed his personal interests."

Sheller lauded the team in the U.S. Attorney's office for their investigation, including Chief of the Civil Division Virginia Gibson and Assistant U.S. Attorney Colin Cherico. "Once again, the U.S. Attorney's office in Philadelphia came through, supporting whistleblower efforts, recouping hundreds of millions for the government and its citizen taxpayers," said Sheller.


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SOURCE Sheller, P.C.
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