Other LanguagesOLYMPIA -- Attorney General McKenna today announced that he, along with 33 other attorneys general, reached a record $62 million settlement with Eli Lilly and Company concerning allegations that the company marketed its antipsychotic drug Zyprexa for unapproved uses. The settlement is the largest multistate consumer protection pharmaceutical settlement and follows closely on the heels of the states’ $58 million agreement with Merck in May 2008 regarding its product Vioxx.
“This settlement protects public health by requiring prescription drug manufacturers to market their drugs only for FDA approved uses and to not misrepresent the scientific research about their products,” McKenna said.
Washington’s share of the settlement is $1.6 million, to be used for consumer education, mental health-related programs and recovery of legal costs and fees. The settlement brings Eli Lilly into compliance with the state’s Consumer Protection Act and preserves legal options for potential additional claims, which the state of Washington reserves the right to address at a future date.
Washington filed its version of the settlement and complaint today in King County Superior Court. In the documents, McKenna alleged that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for uses not approved by the U.S. Food and Drug Administration and failed to adequately disclose the drug’s potential side effects to health care providers. Following an 18-month investigation by the states, Eli Lilly agreed to change how it markets Zyprexa and to cease promoting the drug for off-label uses.
Zyprexa is the brand name for olanzapine and belongs to a class of drugs traditionally used to treat schizophrenia and commonly referred to as “atypical antipsychotics.” First approved in 1996 as a treatment for adults with schizophrenia, Zyprexa was later approved for manic depression related to Bipolar I disorder.
Initially experts thought that atypical antipsychotics would be less likely to produce symptoms similar to those seen in patients with Parkinson’s disease and in those with motion disorders, and therefore could be used in long-term treatment of schizophrenia. While Zyprexa may reduce the risk of symptoms associated with first-generation antipsychotics, it can also produce dangerous side effects, including heart problems, hyperglycemia, weight gain and diabetes. It is also associated with an increased risk of death in dementia patients.
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. For example, it marketed Zyprexa for pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions, and for the treatment of dementia. While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
The settlement mandates that for a six year time period extending beyond the patent term for Zyprexa, Eli Lilly shall:
Promotional Activities
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Not make any false, misleading or deceptive claims regarding Zyprexa;
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Not promote Zyprexa by citing selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
Dissemination of Medical Information
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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. This information shall not be distributed unless certain criteria are met;
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Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information from a health care provider regarding Zyprexa;
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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;
Continuing Medical Education (CME) and Grants
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Disclose information about grants, including continued medical education on its Web site (www.lillygrantoffice.com ), for at least two years and maintain the information for five years;
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Not use grants to promote Zyprexa, or condition CME funding on Eli Lilly’s approval of speakers or program content;
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Contractually require continuing medical education providers to disclose Eli Lilly’s financial support of their programs and any financial relationship with faculty and speakers;
Payments to Consultants and Speakers
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Provide each signatory Attorney General a list of health care provider promotional speakers and consultants who were paid more than $100 for promotional speaking and/or consulting by Eli Lilly;
Product Samples
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Only provide product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product’s current labeling; and
Clinical Research
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Register clinical trials and submit results as required by federal law; register Zyprexa Eli-Lilly sponsored Phase II, III and IV clinical trials beginning after July 1, 2005; and post on a publicly accessible Web site all Eli-Lilly sponsored Phase II, III and IV clinical trials completed after July 1, 2004.
The Attorneys General from Illinois and Oregon led the investigation into Eli Lilly’s marketing and promotional practices. The participating states in the settlement are: Alabama, Arizona, California, Delaware, D.C., 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.
Assistant Attorney General Robert Lipson handled the case for AG McKenna’s Consumer Protection Division.
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Contacts:
Janelle Guthrie, AGO Communications Director, (360) 586-0725