Eli Lilly settles Zyprexa lawsuit

Lilly said that it has been co-operating with the government in its investigation since it began in 2004. As part of the resolution, Lilly has agreed to plead guilty to one misdemeanor violation of the Food, Drug, and Cosmetic Act.

The company will also enter into a settlement agreement resolving the federal government’s civil investigation. Even though the company disagrees with and does not admit to the civil allegations, Lilly said that it has agreed to settle the dispute over these allegations. In addition, the company has agreed to settle civil investigations brought by the State Medicaid Fraud Control Units of the states that have coordinated with the Eastern District of Pennsylvania in its investigation.

Under terms for the resolution of the civil investigations, Lilly has agreed to make payments totaling nearly $800 million. Approximately $438 million will be paid to the federal government and approximately $362 million will be made available for payment to settling states.

Also, as part of the settlement, Lilly has entered into a corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services. This agreement will require Lilly to maintain its compliance program and to undertake a set of defined corporate integrity obligations for five years. The terms of the corporate integrity agreement are largely consistent with the company’s existing compliance program, said Lilly. They also provide for an independent third-party review organization to assess and report on the company’s systems, processes, policies, procedures and practices.

The settlement is subject to approval by the federal court in Philadelphia; the company anticipates a hearing on the settlement will occur within the next few weeks.