Lilly Settles Zyprexa Marketing Claims for $62 Million

Eli Lilly & Co. will pay $62 million to settle claims by 32 states and the District of Columbia that it improperly marketed the anti-psychotic drug Zyprexa for uses that were not federally approved.

The plaintiffs alleged that while the Food and Drug Administration has approved Zyprexa for use by adults with schizophrenia and bipolar disorder, Lilly violated their consumer protection and unfair-trade laws with an aggressive campaign to market the drug for pediatric uses and to fight dementia in the elderly.

California Attorney General Jerry Brown, whose state was among eight that led the negotiations, said in a statement that the accord is the "largest-ever multi-state consumer-protection-based pharmaceutical settlement."

Brown said Lilly's "Viva Zyprexa!" marketing push, launched in 2001, also included recommendations for doctors to prescribe the drug in unsanctioned high-dose treatments, exposing its users to serious side effects like diabetes, hyperglycemia and weight gain.

He said the uses Lilly promoted were not tested by the FDA and put those in the unapproved patient groups at risk for the adverse effects.

Under the agreement Lilly admitted no violation of the state laws cited but agreed to stop making any false or misleading statements about Zyprexa and to put its medical staff, not marketing personnel, in charge of all medical letters and references made publicly about the drug.

Lilly also will provide "accurate, objective and scientifically balanced responses" to unsolicited requests from health care providers for "off-label" information about Zyprexa.

It also must provide the settling states with a list of any medical professionals who have been paid more than $100 to promote or consult regarding its products.

The California settlement says Lilly must provide product samples of Zyprexa only to health care providers "whose clinical practice is consistent with the product's current labeling."

Judge Kevin A. Enright of the San Diego County Superior Court approved the state's settlement Oct. 8 .

An Eli Lilly executive said the settlement's requirements will not significantly change the company's operations.

"Lilly's policies and practices already mirror most of the provisions included in the proposed consent decrees," Robert A. Armitage, Lilly's senior vice president and general counsel, said in a statement.

"This resolution reflects our commitment to continually build on a foundation of compliance, accuracy and transparency," he added.

The participants in the settlement are Alabama, Arizona, California, Delaware, the District of Columbia, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin.

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