The largest multi-state consumer protection-based pharmaceutical marketing class action suit in history has settled. Pharmaceutical giant, AstraZeneca Pharmaceuticals LP, a London-based corporation, has agreed to pay New York, the District of Columbia, and 36 other states $68.5 million over marketing claims for its anti-psychotic medication, Seroquel.
AstraZeneca, which had about $32.8 billion in sales in 2009, had agreed in 2010 to pay $198 million to settle thousands of individual and group claims in the U.S.
The litigation claimed that AstraZeneca unlawfully marketed Seroquel to children and the elderly for depression, Alzheimer’s disease, dementia, anxiety, depression, sleep disorders, and post traumatic stress disorders. The Food and Drug Administration (FDA) did not approve use of the drug for these patients or for these particular conditions.
AstraZeneca was accused of not adequately disclosing Seroquel’s potential side effects and of failing to disclose information about the drug’s safety and efficacy. The company now warns that elderly patients with dementia who use Seroquel are at increased risk for death. For children and adults under age 24 who use the drug as an antidepressant, research indicates a heightened risk of sucide.
The drug is currently approved for schizophrenia, including pediatric schizophrenia, and bipolar disorder.