Eli Lilly Settles Zyprexa Suit for $1.42 Billion

In a resolution that has been expected since October 2008, pharmaceutical company Eli Lilly pled guilty to a criminal charge and has agreed to pay $1.42 billion in a settlement for what federal prosecutors called the illegal promotion of the antipsychotic drug Zyprexa (olanzapine). The drug was found to increase the risk of severe adverse effects, including sudden cardiac death, heart failure, and life-threatening infections, in certain populations.

Lilly has pled guilty to a misdemeanor violation of the Federal Food, Drug, and Cosmetic Act regarding the off-label promotion of Zyprexa from 1999 to 2001. In a press release, the company disagreed with and did not admit to the civil allegations, but it agreed to settle the dispute over the allegations.

The drug was promoted in elderly populations as a treatment for dementia, including Alzheimer dementia, which was not federally approved. Currently, Zyprexa is approved for the treatment of mania and agitation associated with bipolar disorder and schizophrenia.

The drug company will also be subject to a period of increased regulation. It has entered a corporate integrity agreement with the Department of Health and Human Services that requires Lilly to maintain a compliance program and to follow integrity obligations for 5 years. If the company does not comply, it can be excluded from federal health programs. The settlement also stipulates that a third party must review company policies. Eli Lilly will pay about $438 million to the federal government and will make available approximately $362 million to states to settle civil suits.

Lilly CEO John C. Lechleiter, PhD, said, "We deeply regret the past actions covered by the misdemeanor plea. At Lilly we take seriously our responsibilities to abide by all laws. . . . we realize that we have a tremendous responsibility to the patients and health care professionals we serve."

[ Editor's note: a detailed account of this settlement will appear in the March issue of Psychiatric Times.]