Utah Attorney General Mark Shurtleff announced today that the state has settled a 4-year-long battle with Eli Lilly over its marketing unapproved uses, so-called "off-label" uses, of its anti-psychotic drug Zyprexa. His news release indicates that the pharmaceutical giant will pay 24 million to resolve the matter:
Attorney General Mark Shurtleff recently reached a $24,000,000 civil settlement with pharmaceutical manufacturer Eli Lilly and Company for its "off-label" marketing of the anti-psychotic drug Zyprexa. The nearly 4-year investigation conducted by the Utah Attorney General’s office revealed that Lilly concealed its knowledge of Zyprexa’s association with significant weight gain and obesity, and that its sales force illegally promoted Zyprexa for uses not approved by the FDA.
"Drug companies are an important part of our health care system," says Shurtleff. "But when they engage in illegal marketing practices they are endangering the health and safety of patients."
It is a crime for pharmaceutical manufacturers to market their drugs for uses that are not approved by the FDA. Zyprexa was only approved for the treatment of schizophrenia and certain types of bipolar disorder in adults, but in 1999, Lilly’s long-term care sales force, its marketing branch that focuses on doctors who treat the elderly, began encouraging doctors to prescribe Zyprexa for dementia, Alzheimer’s, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. The Attorney General’s investigation showed that there were 1,769 Medicaid patients over the age of 65 who took Zyprexa but never had a diagnosis of either schizophrenia or bipolar disorder.
"Lives are endangered and costs are unnecessarily increased when pharmaceutical companies interfere with the FDA’s mission to insure that drugs are used safely," says Robert Steed, Assistant Attorney General and Director of the Utah Medicaid Fraud Control Unit. "Today’s announcement should send a clear message that those who would put corporate profits ahead of patient safety will be held accountable."
In October 2000, Lilly began instructing its general sales force to recommend Zyprexa to primary care physicians for the treatment of behavioral symptoms like agitation, aggression, hostility, sleep disturbances, depression and mood disorders even though schizophrenia and bipolar disorder are not conditions normally treated by these doctors. Lilly also trained its sales teams to avoid discussions with health care professionals about the weight gain side effect.
"I would like to commend the Department of Health and the Attorney General’s office for their work on this critical public health issue," says Representative David Clark, Speaker of the Utah House of Representatives. "The State Legislature will work to make sure this money is put to the best possible use to benefit all Utahns and particularly those that may have been affected by the off-label marketing of this drug."
"Today’s announcement should not be considered an indictment against the pharmaceutical industry in general," says UDOH Executive Director Dr. David Sundwall. "The pharmaceutical industry is a key partner in treating illness and preventing complications from diseases. Appropriate use of drugs can save a great deal of money by controlling unnecessary hospitalizations and surgeries. Further, we count on our nation’s pharmaceutical companies to fund research and development of the drugs we need to prevent, treat, and when possible, cure disease."
Assistant Attorney General Robert Morton, who assisted with this litigation stated, "This is by far the largest recovery ever in the State of Utah from our efforts to hold pharmaceutical companies accountable for their unlawful conduct. We are grateful to Director Sundwall and the excellent staff at the Utah Department of Health for the time, resources and expertise they provided during this litigation."
The Utah Attorney General’s Office oversees the Medicaid Fraud Control Unit to protect the integrity of Utah’s Medicaid program. The public can learn more about Medicaid fraud or report abuse at: http://www.attorneygeneral.utah.gov/145.html.
Utah’s House Speaker David Clark, R-Santa Clara, has indicated that the legislature will work to use the money to benefit those affected by off-label marketing. Let’s hope he follows through with this promise because this is a big victory for the people of Utah.
Bret Hanna of Wrona DuBois in Utah, focuses exclusively on litigating plaintiffs’ medical malpractice and catastrophic personal injury cases. He has represented clients in state and federal courts, in mediations, and in administrative proceedings in Michigan and Utah since 1991.