Eli Lilly and Co., Indianapolis, agreed to pay about $1.4 billion and plead guilty to promoting its anti-psychotic medication Zyprexa as treatment for dementia even though it was not approved for that use by the Food and Drug Administration, the Justice Department announced.
The penalties for the drugmaker include the largest fine imposed on an individual corporation in U.S. criminal prosecution, $515 million, the Justice Department said. The company also agreed to forfeit $100 million. Eli Lilly agreed to plead guilty to one misdemeanor criminal charge for the off-label promotion of Zyprexa as treatment of dementia between September 1999 and March 2001, the company said in a news release. “We deeply regret the past actions covered by the misdemeanor plea,” said John Lechleiter, company president, chief executive officer and chairman, in the release.
The company also agreed to a nearly $800 million civil settlement with the federal government and states to resolve False Claims Act claims and related claims. Eli Lilly said the company “disagrees with and does not admit to the civil allegations.”
Under the settlement agreement, the federal government will receive $438.2 million. The company agreed to pay $361.8 million to states’ Medicaid programs and the District of Columbia and entered into a corporate integrity agreement with the HHS’ inspector general’s office, which requires the company to maintain its existing compliance program and adopt additional measures for five years. The guilty plea and settlement must be approved by U.S. District Court. The government began its investigation of Eli Lilly in 2004 with the company’s cooperation, the drugmaker said.
