Attorney General Patrick C. Lynch today announced that he and 32 other attorneys general have reached a record $62 million settlement with Eli Lilly and Company arising from the alleged improper marketing of the antipsychotic drug Zyprexa. It is the largest multi-state consumer protection-related pharmaceutical settlement ever reached.

In a complaint filed today with the settlement agreement, Lynch alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for off-label uses and for failing to adequately disclose the drug’s potential side effects to health-care providers. Following an investigation lasting a year and a half, Eli Lilly agreed to change how it markets Zyprexa and to stop promoting its off-label uses, which are not approved by the U.S. Food and Drug Administration (FDA).

Rhode Island will receive $297,819 in settlement monies. The settlement orders that Eli Lilly pay the costs for the prosecution and investigation of the action. The remainder, about 80 percent, will go to the State’s General Treasury.

“Unfortunately, this is yet another case in which a pharmaceutical giant placed its priorities on profits, rather than on patients,” Attorney General Lynch said. “It’s right that Eli Lilly pay a high price for its deceptive and illegal marketing practices, which violated the Rhode Island Unfair Trade Practice and Consumer Protection Act. This case should be an example to all pharmaceutical companies that marketing aimed at pushing prescription drugs for off-label purposes will not go unnoticed, or go without punishment.”

Zyprexa, the brand name for the prescription drug olanzapine, was first marketed for use in adults with schizophrenia in 1996. Since then, the FDA approved Zyprexa — belonging to a class of drugs commonly referred to as atypical antipsychotics — for the treatment of various bipolar disorders. This class of drugs, while reducing symptoms, can also produce dangerous side effects. Zyprexa has been associated with a high risk of weight gain, hyperglycemia, and diabetes.

In 2001, 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, including marketing it for pediatric use, for use at high-dosage levels, for the treatment of symptoms rather than the diagnosed conditions, and in the elderly for the treatment and/or chemical restraint of patients suffering from dementia. Although a physician is allowed to prescribe drugs for off-label uses, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.

The settlement mandates that for a six-year period extending beyond the patent term for the drug, Eli Lilly can not make any false, misleading, or deceptive claims regarding Zyprexa and can not promote the drug using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses. Among the other terms of the settlement is that Eli Lilly must provide each participating attorney general with a list of health-care provider promotional speakers or consultants who were paid more than $100 by Eli Lilly. Eli Lilly can provide product samples of the drug only to a health-care provider whose clinical practice is consistent with the product’s current labeling.

Assistant Attorney General Maureen G. Glynn, who serves as the Department’s Health Care Advocate, handled the case.

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