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MADISON - Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states and the federal government and reached an agreement with Eli Lilly and Company to settle allegations it engaged in an off-label marketing campaign that improperly promoted the anti-psychotic drug Zyprexa.
As part of the agreement Eli Lilly has agreed to pay a total of $14,076,651.65 based on damages to the Wisconsin Medicaid program. Medicaid is a joint program funded by the federal and state governments to provide medical assistance to the state's neediest citizens. The settlement by Eli Lilly will consist of a payment to Wisconsin in the amount of $6,858,783.52 with the remaining $7,217,868.13 to the federal government.
Zyprexa is one of a newer generation of antipsychotic medications (called atypical antipsychotics) used to treat certain psychological disorders. Between September 1999 and December 31, 2005, Eli Lilly willfully promoted the sale and use of Zyprexa, primarily through a marketing campaign called "Viva Zyprexa," for certain uses which the Food and Drug Administration had not approved.
The promotional activities undertaken by Eli Lilly in the "Viva Zyprexa" campaign promoted Zyprexa not only to psychiatrists, but also to primary care physicians, for such unapproved uses as the treatment of depression, anxiety, irritability, disrupted sleep, nausea and gambling addiction. In implementing the campaign, Eli Lilly also provided remuneration and other things of value to physicians and other health care professionals. As a result of these promotional activities, Eli Lilly caused physicians to prescribe Zyprexa for children and adolescents, dementia patients in long term care facilities, and in unapproved dosage amounts, all of which are uses that were not medically accepted indications for which Medicaid programs would approve reimbursement.
A National Association of Medicaid Fraud Control Unit team participated in the investigation and conducted settlement negotiations with Eli Lilly on behalf of the settling states. Wisconsin's settlement is part of an agreement that calls for Eli Lilly to pay the states and federal government a total of $800 million in damages and penalties to compensate Medicaid and other federal healthcare programs for harm suffered. In addition, Eli Lilly has been charged with a misdemeanor violation of the Food, Drug and Cosmetic Act in the United States District Court for the Eastern District of Pennsylvania and has agreed to pay a $615 million criminal fine to resolve the charge.
As part of the settlement, Eli Lilly will enter a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General which will closely monitor the company's future marketing and sales practices.
"Pharmaceutical manufacturers who choose to participate in the Medicaid program have to follow the rules like anyone else," stated Van Hollen. "By encouraging the use of Zyprexa for unapproved uses, Eli Lilly was increasing profits by illegal means and may have been endangering the safety of program recipients. This settlement serves to protect both the program participants and the taxpayer."