Eli Lilly - Zyprexa

Company: Eli Lilly
Amount: $1.4 billion
Drug: Zyprexa
Year: 2009

When Eli Lilly ($LLY) announced its $1.415 billion settlement with the Justice Department, it was the largest amount ever paid by any one defendant. It would keep that record for only 8 months, till Pfizer's Bextra deal went public. But at the time, Justice officials bragged about the historic nature of the agreement: "the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind," the department's release crowed.

More than $1.4 billion may seem like a lot less today, with an impending settlement of up to $2.2 billion from Johnson & Johnson ($JNJ) and a forthcoming $3 billion agreement with GlaxoSmithKline ($GSK). But in January 2009, it outranked the previous top pharma settlement--TAP Pharmaceuticals, $875 million, 2001--by more than $500 million. 

Among the allegations: That Lilly pushed Zyprexa for children and for elderly dementia patients, both off-label uses. That it made particular efforts to push Zyprexa in long-term care facilities and nursing homes. And that Lilly aimed to make Zyprexa a primary care drug, despite the fact that it was only approved to treat two disorders--schizophrenia and bipolar disorder--typically not handled by primary-care doctors.

Lilly pleaded guilty to a misdemeanor misbranding charge for promoting Zyprexa off-label between 1999 and 2001, and for that charge it paid a fine of $515 million and forfeited $100 million. The civil wrap-up included $438 million for the feds and $362 million to states that agreed to settle.

In announcing the settlement, Lilly CEO John Lechleiter--fairly new on the job at the time--pledged personal commitment to "the highest standards of conduct" for everyone at Lilly and promised new programs to make sure everyone followed the rules. One visible result of the settlement: As required by the corporate integrity agreement, Lilly posts on its website information about payments or perks provided to doctors, in the original physician sunshine database.

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Eli Lilly - Zyprexa