On April 27, 2010, the U.S. Department Of Justice announced that it has entered into an agreement with AstraZeneca LP and AstraZeneca Pharmaceuticals LP to settle a False Claims Act lawsuit alleging that the companies submitted claims for payment to U.S. government health agencies (such as Medicare, Medicaid, and TRICARE) in connection with a scheme to illegally market the anti-psychotic drug Seroquel for uses that were not approved as safe and effective by the Food and Drug Administration. According to the lawsuit, AstraZeneca promoted the unapproved uses of the drug by unduly influencing the content of company-sponsored continuing medical education programs and by engaging physicians to promote the unapproved uses through seminars and to conduct studies on the unapproved uses of Seroquel. Furthermore, AstraZeneca allegedly recruited doctors to serve as authors of articles that were “ghostwritten” by medical literature companies about studies that the doctors did not conduct. The lawsuit also alleged that AstraZeneca violate the federal Anti-Kickback Statute by offering and paying illegal remuneration to the doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the off-label uses of Seroquel.
The lawsuit was originally brought by a whistleblower on behalf of the Government under the qui tam provisions of the False Claims Act. As a reward for disclosing the unlawful conduct of AstraZeneca to the Government, the whistleblower will receive more than $45 million from the settlement.