Attorney General Cuomo Announces Landmark Settlement With Eli Lilly To End Deceptive Advertising Practices And Off-label Promotion Of Antipsychotic Drug Zyprexa

New York, N.Y. (October 7, 2008) Attorney General Andrew M. Cuomo announced today that he, along with 32 other Attorneys General, reached a record $62 million settlement with Eli Lilly and Company arising from improper marketing and promotion of the antipsychotic drug Zyprexa. It is the largest ever multi-state consumer protection-based pharmaceutical settlement.  New York’s share of the settlement is over $3.1 million.

In a complaint filed today, Attorney General Cuomo alleged that Eli Lilly engaged in deceptive and misleading practices when it marketed Zyprexa for off-label uses and failed to adequately disclose the drug’s potential side effects to health care providers including diabetes, hyperglycemia and weight gain.  Following the Attorneys General’s investigation, Lilly agreed to change its marketing of Zyprexa and to cease promoting “off-label” uses of the drug, which are not approved by the U.S. Food and Drug Administration (FDA).

“The citizens of New York State should be able to rely on their doctor’s advice for prescriptions without having to worry about drug companies manipulating them or keeping them in the dark about the real risks associated with certain medications,” said Attorney General Cuomo. “Today’s settlement will deliver $3.1 million back to New York taxpayers and ensure that we bring a stop to the deceptive advertising practices and off-label promotions that have put our citizens and our dollars at risk for too long.”

Zyprexa is approved for the treatment of schizophrenia and certain instances of bipolar disorder. When it was first introduced to the market in the 1990s, experts thought that it would be less likely to produce Parkinson’s type symptoms and motion disorders, such as tardive dyskinesia, and therefore could be used in long-term treatment of schizophrenia. 

However, while Zyprexa may reduce the risk of these symptoms, it also produces dangerous side effects, including weight gain, hyperglycemia, and diabetes.  New York’s investigation demonstrated that Eli Lilly concealed and minimized the risks of these side effects.  Lilly also marketed Zyprexa for off-label and potentially dangerous uses including pediatric use, use at high dosage levels, use for the treatment of symptoms rather than diagnosed conditions, and use in the elderly for the treatment and/or chemical restraint of patients suffering from dementia.

The settlement contains powerful injunctive terms prohibiting the use of financial incentives to manipulate doctors, deterring off-label marketing and requiring that Lilly disclose scientific evidence of dangerous side effects.  The settlement bars Lilly from:

  • Making any false, misleading or deceptive claim regarding Zyprexa;
  • Using grants to promote Zyprexa;
  • Conditioning continuing medical education funding on Eli Lilly’s approval of speakers or program content; and
  • Giving product samples of Zyprexa to health care providers whose specialties are not consistent with Zyprexa’s label.

The settlement also requires that Lilly:

  • Disclose information about grants;
  • Provide a list of health care provider promotional speakers and consultants who were paid more than $100 for promotional speaking and/or consulting; and
  • Register and post on-line the results of clinical trials.

The case was handled by Assistant Attorney General Benjamin J. Lee under the supervision of Joy Feigenbaum, Bureau Chief of the Consumer Frauds and Protection Bureau.