DENVER – Colorado Attorney General John Suthers today announced that the State of Colorado will receive more than $2.6 million as part of a settlement with Eli Lilly and Company, over allegations that Lilly engaged in an off-label marketing campaign that improperly promoted the anti-psychotic drug, Zyprexa. The settlement represents Colorado’s state share of a global settlement announced today, in which the company will resolve four federal whistleblower lawsuits, as well as claims by numerous other states and the federal government.
Zyprexa is part of a newer generation of antipsychotic medications used to treat certain psychological disorders. The settlement, totaling over $1.4 billion, resolves allegations that Lilly willfully promoted the sale and use of Zyprexa for certain uses that the Food and Drug Administration (FDA) has not approved. While physicians are generally free to prescribe FDA-approved drugs for “off label” uses, with few exceptions drug manufacturers are not permitted to directly promote or market their drugs for such uses. Moreover, Colorado and other Medicaid programs usually do not pay for prescriptions for off-label purposes.
The claims alleged that Lilly promoted the off-label sale and use of Zyprexa primarily through a marketing campaign called “Viva Zyprexa,” which promoted the drug to psychiatrists and primary care physicians for unapproved uses such as treatment of depression, anxiety, irritability, disrupted sleep, nausea, and gambling addiction. To facilitate the marketing, the company allegedly provided remuneration and other things of value to medical professionals. Lilly allegedly persuaded physicians to prescribe Zyprexa for children and adolescents, dementia patients in long term care facilities, and in unapproved dosage amounts, with Medicaid programs footing much of the bill.
“These funds are a significant recovery for Colorado’s Medicaid program,” commented Attorney General Suthers. “This case should send a message that Colorado will not tolerate drug companies that fail to comply with the rules, increasing the burden on important state programs that benefit the sick and needy.”
The Colorado Attorney General’s Medicaid Fraud Control Unit facilitated Colorado’s portion of the settlement. In addition to the monetary recovery, Lilly will enter into a Corporate Integrity Agreement with the federal government, under which the U.S. Department of Health and Human Services will closely monitor the company’s future marketing and sales practices.