RALEIGH, N.C. -- Eli Lilly and Company, a major pharmaceutical manufacturer, has agreed to pay a record $62 million to North Carolina and 31 other states to resolve allegations that the company improperly marketed the antipsychotic drug Zyprexa, officials said Tuesday.

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This settlement, the largest ever multi-state consumer protection settlement with a drug maker, comes a few months after Attorney General Roy Cooper and other attorneys general reached a $58 million agreement with Merck regarding pain drug Vioxx in May.

“Using misleading marketing to pitch prescription drugs is just wrong,” Cooper said. “Consumers and doctors deserve the most accurate information available about drugs and their potentially dangerous side effects.”

Cooper and the other attorneys general allege 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 (FDA) and failed to properly disclose the drug’s potential side effects to health care providers. Following an 18-month investigation, Eli Lilly agreed to make major changes to how it markets Zyprexa and to stop promoting it to treat conditions for which it has not been approved, known as off-label uses.

Eli Lilly will also pay $62 million to the states including $1.8 million to North Carolina.

Zyprexa is the brand name for the prescription drug olanzapine which was first marketed for use in adults with schizophrenia in 1996.  Since then, the FDA has also approved Zyprexa to treat bipolar disorder.

Zyprexa belongs to a class of drugs traditionally used to treat schizophrenia and commonly referred to as atypical antipsychotics.  When these drugs were first introduced in the 1990s, experts thought that they would produce fewer problematic symptoms than other antipsychotics and therefore could be used for long-term treatment.  However, atypical antipsychotics can 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!” to market the drug for a number of off-label uses. For example, it marketed Zyprexa for use by children, for use at high dosages, for the treatment of symptoms rather than diagnosed conditions, and for the treatment and restraint of elderly patients suffering from dementia. While physicians are allowed to prescribe drugs for off-label uses, drug companies are prohibited by law from marketing their products for off-label uses. 

Under today’s settlement, Eli Lilly is banned from making any false, misleading or deceptive claims about Zyprexa. 

In addition, for the next six years, Eli Lilly must, among other requirements:

• Not promote Zyprexa for uses which have not been approved by the FDA
• Not promote Zyprexa  by selecting symptoms instead of a diagnosis unless certain conditions are met 
• Provide accurate, objective and scientifically balanced responses to requests from physicians about off-label uses for Zyprexa 
• Provide product samples of Zyprexa only to doctors whose practices are consistent with the drug’s approved uses 
• Require its medical staff and not its marketing staff to be ultimately responsible for the medical content of all medical letters about Zyprexa 
• Not misuse grants or continuing medical education programs to promote Zyprexa 
• Register clinical trials and submit results as required by federal law and post on a public web site (www.lillygrantoffice.com) all Eli-Lilly sponsored Phase II, III and IV clinical trials completed after July 1, 2004.
  

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