Attorney General's News Release

October 8, 2008

Nixon announces multi-state settlement with pharmaceutical giant Eli Lilly; Missouri to receive $1.5 million

Jefferson City, Mo. - The state of Missouri will receive $1,547,959 as part of a $62 million nationwide settlement with Eli Lilly and Company arising from alleged improper marketing of the antipsychotic drug Zyprexa, Attorney General Jay Nixon announced today. Missouri is one of 33 states joining the multi-state consumer protection-based pharmaceutical settlement.

Nixon filed a settlement agreement today in Cole County Circuit Court. The settlement resolves allegations that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for off-label uses and also failed to adequately disclose the drug's potential side effects to health care providers. Following an 18-month investigation, Eli Lilly agreed to change how it markets Zyprexa and to cease promoting its "off-label" uses, which are not approved by the U.S. Food and Drug Administration (FDA).

"It's clear that this was a case of a major pharmaceutical company promoting a drug for uses for which it was not approved by the FDA," Nixon said. "In doing so, Eli Lilly misrepresented the drug's approved uses, its safety, and its effectiveness, to the detriment of Missouri consumers."

Eli Lilly began marketing Zyprexa to health care professionals for the treatment of 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 in bipolar disorder. The drug can cause potential side effects including weight gain, hyperglycemia, diabetes, cardiovascular complications, and an increased risk of mortality in elderly patients with dementia.

In October 2000, Eli Lilly began an aggressive campaign called "Viva Zyprexa!" As part of that campaign, the company marketed Zyprexa for a number of uses for which it was not approved by the FDA. For example, Eli Lilly marketed Zyprexa for pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and for the treatment and/or chemical restraint of patients suffering from dementia.

In addition to paying $1,518,128 to the state of Missouri as part of the settlement, Eli Lilly has also agreed to the following:

• Stop making false, misleading or deceptive claims regarding Zyprexa;
• Stop promoting Zyprexa using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
• Require its medical staff, rather than its marketing staff, to have ultimate responsibility for developing and approving the medical content for all medical letters and medical references regarding Zyprexa, including those that may describe off-label information;
• Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a health care provider regarding Zyprexa;
• Require its medical staff to be responsible for the identification, selection, approval and dissemination of article reprints containing more than an incidental reference to off-label information regarding Zyprexa, and that such information not be referred to or used in a promotional manner; and
• Only provide product samples of Zyprexa to a health care provider who clinical practice is consistent with the product's current labeling.

Inquiries from consumers should be directed to consumer@ago.mo.gov or 1-800-392-8222 (from within Missouri) or 573-751-3321 (outside Missouri).

All media inquiries should be directed to Press Secretary John Fougere.

E-mail      Phone: 573-751-8844         Fax: 573-751-5818