$62 Million Settlement With Eli Lilly & Co. Resolves Unlawful Marketing Of Zyprexa

Texas Attorney General Greg Abbott and 33 other state attorneys general today reached a $62 million settlement with Eli Lilly & Co. The states’ investigation found that the pharmaceutical manufacturer unlawfully marketed its antipsychotic drug Zyprexa to health care providers.

The case stands as the largest multi-state consumer protection settlement brought against a pharmaceutical company. It follows on the heels of last May’s $58 million national settlement with Merck & Co. regarding its improper marketing of the former drug Vioxx.

Zyprexa is known as an “atypical antipsychotic” drug, which, since 1996, has been typically prescribed for treating adult schizophrenia. Since that time, the U.S. Food and Drug Administration (FDA) has also approved Zyprexa for the treatment of varying degrees of bipolar disorder and for maintenance treatment of this disorder. While medical experts believed the new generation of drugs like Zyprexa reduced motion disorder symptoms and those similar to Parkinson’s disease patients, the drug also produced unforeseen side effects such as weight gain, diabetes, hyperglycemia, cardiovascular complications and others.

Nonetheless, Lilly began an aggressive deceptive marketing campaign in 2001, downplayed the drug’s harmful side effects and routinely marketed Zyprexa to health care providers for what is known as “off-label” uses. While a physician may prescribe drugs for off-label uses, the law prohibits a drug manufacturer from marketing drugs to physicians for off-label uses. In this case, Lilly promoted Zyprexa for pediatric uses, for uses at higher dosage level than recognized by the FDA, for the treatment of symptoms rather than diagnosed conditions and to induce extreme sedation as a way to restrain elderly patients suffering from dementia.

Today’s settlement mandates that Lilly implement a number of important reforms for a six-year period, which will extend beyond the 2013 patent expiration term for Zyprexa. First, the settlement prohibits Lilly from making any false, misleading or deceptive claims regarding Zyprexa. The company’s medical staff, rather than its marketing staff, will be exclusively responsible for approving the medical content of letters and references regarding the drug’s properties. Lilly’s medical staff also must provide accurate and scientifically balanced responses to requests from medical providers about off-label use information.

The company will also only provide Zyprexa samples to providers whose practice is consistent with the product’s current labeling. The settlement also requires Lilly to disclose to the Office of the Attorney General the amount of speaker fees it pays to physicians who give presentations to other physicians on the company’s behalf about Zyprexa.