Eli Lilly Fraud Settlement.
Mar 30th, 2009 by Patrick Valtin
TALLAHASSEE, FL–Florida has entered into an agreement in principal for $35.6 million as part of a $738.4 million global settlement with Eli Lilly & Co., Inc. The settlement – which addresses four separate cases – resolves allegations the company illegally marketed untested and unapproved off-label uses of Zyprexa, including treatment of children and treatment of the elderly for dementia and depression.
The total monetary recovery, including a $615 million criminal fine assessed by the U.S. Attorney, totals $1.415 billion, the largest recovery in a health care fraud investigation.
In 2001, Eli Lilly began an aggressive marketing campaign called “Viva Zyprexa!” As part of that campaign, the company allegedly marketed Zyprexa for a number of off-label uses. While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for such uses. As an “atypical antipsychotic,” Zyprexa has been associated with an especially high risk of weight gain, hyperglycemia and diabetes. Off-label uses include any uses for which the drug has not received approval from the U.S. Food and Drug Administration.
The Attorneys General alleged that Eli Lilly caused off-label uses to be improperly billed to the states’ Medicaid programs for reimbursement claims. Additionally, the United States Attorney also charged Eli Lilly with a misdemeanor violation of the Food, Drug and Cosmetic Act for which Eli Lilly was criminally fined $615 million. Florida’s civil case was handled by the Attorney General’s Medicaid Fraud Control Unit.
In addition to the monetary recovery, Eli Lilly has entered into a corporate integrity agreement with the U.S. Department of Health and Human Services’ Inspector General. The agreement will include provisions to ensure Eli Lilly will market, sell and promote its products in accordance with all Federal health care program requirements.