On January 15, 2009, the Department of Justice announced that Eli Lilly and Company “agreed to plead guilty and pay $1.415 billion for promoting its drug Zyprexa for uses not approved by the Food and Drug Administration (FDA).”[i]

Zyprexa was originally approved by the FDA in 1996 for the treatment of various psychotic disorders. In 2000, the FDA expanded approval of Zyprexa for the short-term treatment of acute manic episodes associated with Bipolar I Disorder and the short-term treatment of schizophrenia.

The Department of Justice’s criminal information, filed in U.S. District Court, alleged that “Eli Lilly’s management created marketing materials promoting Zyprexa for off-label uses, trained its sales force to disregard the law and directed its sales personnel to promote Zyprexa for off-label uses.”

The criminal information said that “Eli Lilly expended significant resources to promote Zyprexa in nursing homes and assisted-living facilities.”[ii]

The criminal information further alleged that “building on its unlawful promotion and success in the long-term care market, Eli Lilly executives decided to market Zyprexa to primary-care physicians […]  even though the company knew that there was virtually no approved use for Zyprexa in the primary-care market.”[iii]

According to the Department of Justice, the $1.415 billion figure paid by Eli Lilly

“…includes a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind.”[iv]

[i] Press Release, “Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa: $515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 Million,” Department of Justice, January 15, 2009, https://www.justice.gov/archive/opa/pr/2009/January/09-civ-038.html.
[ii] Ibid.
[iii] Ibid.
[iv] Ibid.