AstraZeneca - $520 Million, 2010

In April of 2010, AstraZeneca LP and AstraZeneca Pharmaceuticals agreed to pay $520 million to resolve claims that the company marketed the drug Seroquel for off-label purposes and provided kick-backs to doctors who promoted its use. The settlement arose from two whistleblower cases filed in 2004 and 2006 that were later joined together.

The Practice: Illegal Marketing to Vulnerable Populations, and Kickbacks

In 2004, AstraZeneca drug representative, James Wetta, filed a qui tam lawsuit alleging that since 2001 the company had been illegally marketing Seroquel, an antipsychotic drug that is FDA approved only for the treatment of schizophrenia and bipolar disorder, for uses not approved by the FDA. The company targeted its illegal marketing to physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons. The suit further alleged that AstraZeneca provided illegal compensation to doctors to pose as authors of articles which were actually written by the company, promoting Seroquel for off-label uses, and to give promotional lectures to other health care professionals about unaccepted uses of Seroquel. The company also allegedly paid kickbacks to physicians to prescribe the drug to their patients for unapproved uses.

The qui tam suits alleged that, as a result of AstraZeneca’s actions, false claims were submitted to government health care programs, including Medicaid and Medicare, for uses that were not medically accepted and therefore not covered by the programs. In addition, AstraZeneca’s illegal compensation to doctors who promoted and prescribed Seroquel was a violation of the federal Anti-Kickback Statute.

In addition to the monetary component of the settlement, AstraZeneca agreed to enter into a five-year expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services to detect and prevent similar conduct in the future. The company is subject to monetary fines and/or exclusion from federal health care programs if it violates the terms of the agreement.

The Whistleblowers

James Wetta formerly worked as a drug representative at AstraZeneca. Mr. Wetta’s 2004 lawsuit against AstraZeneca triggered the U.S. government’s investigation into the company’s marketing practices for Seroquel that led to the $520 million settlement. Mr. Wetta received negative evaluations at work after he refused to market Seroquel for off-label purposes to child and adolescent psychiatrists, primary care physicians and elderly dementia patients. He was eventually fired from the company, allegedly as a result of his continued refusal to engage in these practices. Mr. Wetta also blew the whistle on Eli Lilly, while he was employed as a sales representative for that company, for its similar illegal marketing of antipsychotics.

Dr. Stefan Kruszewski is a psychiatrist who filed a case against AstraZeneca in 2006 claiming that the company misrepresented Seroquel’s risks and benefits. Dr. Kruzewski previously filed a case against Pfizer for its claims about the antipsychotic drug Geodon.

Mr. Wetta was awarded $45 million out of the federal government’s recovery from the AstraZeneca settlement, which will be shared with Dr. Kruszewski.

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