(Phoenix, Ariz. – October 7, 2008) Attorney General Terry Goddard today announced a record $62 million dollar settlement with Eli Lilly and Company (Eli Lilly), relating to the company’s alleged improper marketing of the antipsychotic drug Zyprexa®.
Today’s settlement is the largest ever multi-state consumer protection-based pharmaceutical settlement. This settlement follows a $58 million agreement with Merck in May 2008 regarding its product Vioxx. Arizona’s share of today’s settlement will be $ 2,205,705.
In a complaint filed in Maricopa County Superior Court, Goddard, along with 32 other state Attorneys General, alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa® for off-label uses - uses which are not approved by the U.S. Food and Drug Administration (FDA) - and for failing to adequately disclose the drug’s potential side effects to health care providers. While a physician is allowed to prescribe drugs for off-label uses, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
“Patients must be able to feel confident that drug makers are advertising truthfully and providing complete and accurate information to their doctors,” Goddard said. “Today’s record-setting settlement sends a clear message to the pharmaceutical industry that deception or incomplete disclosure in any form will not be tolerated. Arizona families will be safer as a result of today’s action.”
Zyprexa® is the brand name for the prescription drug olanzapine. The drug was first marketed for use in adults with schizophrenia in 1996. Since then, the FDA has approved Zyprexa® for the treatment of acute mixed or manic episodes of bipolar I disorder and for maintenance treatment of bipolar disorder.
While these drugs may reduce the risk of these symptoms associated with first-generation antipsychotics, they also produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia and other severe conditions. Zyprexa® has been associated with a high risk of weight gain, hyperglycemia and diabetes.
In late 2000, Eli Lilly began an aggressive marketing campaign called “Viva Zyprexa!” As part of that campaign, the company marketed Zyprexa® for a number of off-label uses. For example, it marketed Zyprexa® for pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions and in the elderly for the treatment and/or chemical restraint of patients suffering from dementia.