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US v. Eli Lilly and Company (Zyprexa)


Food & Drug Administration Criminal

United States v. Eli Lilly and Company, Cr. No. 09-020 (E.D. Pa.)

Most Recent Update 3/26/09 (See end of document)

1/16/09 Update:

On January 15, 2009, the Assistant Attorney General for the Civil Division and Acting United States Attorney in Philadelphia announced a criminal information and a civil settlement involving pharmaceutical company Eli Lilly and Company. The case involves off-label marketing of Eli Lilly’s drug Zyprexa for uses other than what the Food and Drug Administration approved.  The company is charged with one count of distributing misbranded drugs with inadequate directions for use.  A plea agreement signed by Eli Lilly admits the company’s guilt to the criminal charge of misbranding. Specifically, Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia.  Eli Lilly has agreed to pay a $515 million criminal fine and to forfeit an additional $100 million in assets.  A civil settlement has been reached between Eli Lilly, the United States and relators, in which Eli Lilly will pay up to $800 million to the federal government and the states to resolve False Claims Act claims by Medicaid and other federal programs and agencies including TRICARE, the Federal Employees Health Benefits program, Department of Veterans Affairs, Bureau of Prisons and the Public Health Service Entities. The federal government will receive approximately $438 million from the civil settlement. The state Medicaid programs and the District of Columbia will share up to approximately $361 million of the civil settlement, depending on the number of states that participate in the settlement. The qui tam relators will receive $78 million from the federal share of the settlement amount. A Corporate Integrity Agreement (CIA) between Eli Lilly and the Office of Inspector General of the Department of Health and Human Services requires that a Board of Directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that Eli Lilly send doctors a letter notifying them about the global settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. Eli Lilly is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

The announcement was issued in a DOJ Press Release (1/15/09).

The following documents are attached:

Information

Plea Agreement

Government's Memorandum for Entry of Plea and Sentencing

Corporate Integrity Agreement

Civil Settlement

1/22/09 Update: 

The entry of plea and sentencing hearing in this matter will be held before the Honorable Robert F. Kelly on Friday, January 30, 2009, at 10:00 a.m. in Courtroom 11B, 11th floor of the United States District Court, United States Courthouse, 601 Market Street, Philadelphia, Pennsylvania. The case has been assigned the criminal docket number 09-020.

1/26/09 Update:

On January 23, 2009, the Government filed a Supplemental Motion in Anticipation of Sentencing in the United States District Court for the Eastern District of Pennsylvania.

2/3/09 Update:
 
On January 30, 2009, Eli Lilly and Company pleaded guilty to a violation of the Federal Food, Drug, and Cosmetic Act.  District Court Judge Robert F. Kelly accepted Eli Lilly's guilty plea, and sentenced the company to pay a $515 million criminal fine and to forfeit an additional $100 million in assets.  

The following documents are attached:
 

Judgment in a Criminal Case

Judgment and Order of Forfeiture

3/26/09 Update:

No change in status.