Seroquel Lawsuit Settled for $520 million

AstraZeneca agreed to pay $520 million to resolve the civil suit brought about by federal and state entities. This monetary settlement was confirmed by the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT). They have decided that this settlement amount would be spilt between the federal government and the state Medicaid programs and District of Columbia. The government would be receiving only $302 million.

Seroquel is an oral drug containing quetiapine as main active ingredient. It is used for treatment of Schizophrenia in adults or children older tha
13 years. It is also used for treatment of bipolar disorder or manic depression in children above 10 years and adults. It is also used with other antidepressant drugs. Doctors prescribe it for other purposes as well. It was introduced for treatment of Schizophrenia in the market in 1997.

The use of Seroquel has been associated with hyperglycemia and diabetes in patients using this drug. Many studies also revealed the same fact. Reports about its association with these side effects started coming in since this drug came into circulation. FDA too issued safety alerts and warnings related to this drug.

The pharmaceutical company AstraZeneca was found guilty of promoting its drug for unapproved uses by paying kickbacks to doctors for off label promotion. It also suggested doctors to prescribe this drug for unapproved uses.

The pharmaceutical company was ordered to pay $520 million to department of justice for settlement of Department of Justice’s lawsuit against them. The lawsuit alleged that AstraZeneca improperly promoted its anti psychotic medicatio
Seroquel for off label uses. The Justice Department blamed AstraZeneca to market this drug for treatment of aggression, Alzheimer’s disease, anxiety, depression and post-traumatic stress disorder (PTSD). All these are off label uses of the drug.

Seroquel was approved for treatment of depressive and maniac episodes related to Bipolar Disorder and Schizophrenia. It was also found guilty of paying kickbacks to doctors for off label promotion of their drug Seroquel. This led to charges of Medicaid and Medicare fraud levied on them. It was so because doctors prescribed this drug to patients for uses not listed in medication guide of this drug, due to kickbacks paid to them.

Though doctors could prescribe drugs for other uses based on the clinical judgment, but companies could not promote their drugs for off label uses. AstraZeneca has been marred with numerous product liability lawsuits. It was associated with severe side effects such as hyperglycemia and diabetes.

The final agreement asked the firm to enter into a five-year corporate integrity agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement will take over an annual review of compliance program launched by AstraZeneca.

AstraZeneca came out of the trouble easily on such small amount. It was not a big blow for it as it had earned $4.9 Billion in 2009. The government started its investigation after a whistleblower lawsuit. This alleged AstraZeneca for promoting Seroquel to psychiatrists and other physicians for disorders not approved by FDA, betwee
2001 and 2006.
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