AstraZeneca to pay $520 million in largest pharmaceutical civil settlement

Sheller, P.C. is Primary Counsel for Record-Breaking $520 Million Civil Settlement; Firm Instrumental in Recovering More Than $4.2 Billion in Pharma Settlements in the Last 15 Months

AstraZeneca will pay the federal government $520 million in civil fines to settle charges of off-label marketing of the powerful antipsychotic drug Seroquel. The settlement is the largest pharmaceutical civil settlement and among the top five civil and criminal drug company settlements in U.S. history.

The first complaint in the matter was filed on behalf of a whistleblower by qui tam whistleblower, class action, and mass tort attorney Stephen A. Sheller, Esq. of Philadelphia's Sheller, P.C. in 2004.

Sheller and firm partner Brian J. McCormick, Jr., Esq. also represented whistleblowers in previous off-label, failure to warn, and consumer fraud drug investigations, including 2009's Eli Lilly and Pfizer record settlements for $1.4 and $2.3 billion respectively. The Sheller firm has been counsel for whistleblowers in cases that have brought more than $4.2 billion in settlements for the United States government in just the last 15 months.

Sheller is also known for pursuing Phillip Morris for fraud in the $10.1 billion "light" tobacco verdict and is currently mounting a nationwide consumer class action against Toyota.

Seroquel is 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.

Seroquel is among the top-selling drugs in the world with 2009 sales of $4.9 billion, 15% of AstraZeneca's $33.2 billion in revenue.

SOURCE Sheller, P.C.