Eli Lilly has agreed to pay $62 million to 33 states to settle allegations that the company marketed the antipsychotic Zyprexa for unapproved uses in violation of state consumer protection laws, the New York Times reports. The settlement, scheduled for announcement on Tuesday, will end an 18-month investigation led by the offices of the Illinois and Oregon attorneys general. According to the allegations, internal documents and e-mails indicate that Lilly marketed Zyprexa, which FDA has approved as a treatment for schizophrenia and mania associated with bipolar disorder in adults, as a treatment for dementia and milder forms of bipolar disorder (Berenson, New York Times, 10/7).

Lilly also marketed Zyprexa for use in children, according to the allegations (Swiatek, Indianapolis Star, 10/7). As part of the settlement, Lilly for six years will have to follow certain ethical marketing guidelines under which medical staff, rather than marketing staff, must write medical letters sent to physicians. Lilly will not admit wrongdoing under the settlement (Indianapolis Star, 10/7).

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Illinois Attorney General Lisa Madigan (D) in a statement said, "The company's deceptive marketing practices were illegal and highly dangerous." David Hart, senior assistant attorney general for Oregon, said, "We're trying to send a message to the pharmaceutical industry that consumer fraud is something we're going to investigate and prosecute." Lilly officials did not respond to requests for comment.

According to the Times, the settlement will mark the "largest settlement paid by a drug company in a state consumer protection case" and might "be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia," a case in which "Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa" (New York Times, 10/7).