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Mississippi sues maker of prescription drug Zyprexa

Mississippi filed a lawsuit Monday against Eli Lilly and Co., alleging improper sales and marketing of the anti-psychotic prescription drug Zyprexa.

The lawsuit was filed in Lafayette County Circuit Court.

Tim Balducci of the Langston Law Firm in Booneville, named a special assistant attorney general to handle the case, said the lawsuit seeks to recover money the state spent to purchase Zyprexa to treat symptoms for which the drug has not been approved. It also seeks money spent in providing health care to certain Medicaid recipients who allegedly suffered injuries or illnesses, such a diabetes, after taking the drug.

The lawsuit also seeks injunctive relief.

Terra Fox, a spokeswoman for the Indianapolis-based company said: “Because we have not been served with the lawsuit, we cannot comment.”

Balducci said early estimates of the state’s purchasing claim suggest damages in the range of $30 million. He said estimates of the state’s claim for diabetes care of Zyprexa patients are much higher.

He said the lawsuit also seeks civil penalties as well as punitive damages and litigation costs.

“Damages could well be in the hundreds of millions of dollars,” Balducci said.

Sales of Lilly’s top-selling Zyprexa in the second quarter totaled $1.12 billion, a 2 percent increase year-over-year. U.S. Zyprexa sales fell 1 percent to $542.9 million on lower demand, but the decline was partially offset by higher prices. Conversely, international sales of Zyprexa increased 5 percent. The drug is sold in more than 45 countries.

Lafayette County is home to the North Mississippi Regional Center, an intermediate care facility for residents suffering from mental retardation and other developmental disabilities.

Balducci said the hospital is historically one of the state’s largest recipients of Medicaid funding, receiving on average between $25 and $30 million per year. Much of the state’s Medicaid spending is for prescription drugs, and Zyprexa consistently ranks near the top of the list, he said.

He said the lawsuit, which represents only one side of a legal argument, alleges that after receiving FDA approval of Zyprexa for treatment of patients with a diagnoses of schizophrenia or a bipolar disorder, Eli Lilly formed a scheme to increase the sales of the drug in Mississippi while avoiding the expense and delay of obtaining approval for other new, expanded or additional uses of the drug.

It claims the scheme consisted of the promotion of Zyprexa for non-medically accepted problems that are excluded from payment under the Mississippi Medicaid Prescription Drug Program.

Specifically, the lawsuit claims Eli Lilly trained and instructed its primary care sales force to attempt to expand the drug’s market by convincing primary care physicians to prescribe the drug for mood, thought and behavioral disturbances.

It also alleges the company established a consistent sales message to the primary care physicians “based on patients’ symptoms and behaviors, rather than on their confirmed diagnoses.”

The drug maker, through its primary care sales force, presented the physicians with hypothetical patient profiles which included “patients complaining of symptoms such as anxiousness, irritability, mood swings and disturbed sleep, and submitting to physicians that such hypothetical patients would be medically indicated for treatment with Zyprexa.”

Eli Lilly also knew its drug increased the risk to patients of contracting diabetes, yet failed to warn of the danger, the lawsuit claims.

It said that in April 2002, nearly a year and a half before Eli Lilly first warned of the risk of diabetes in this county, the company changed Zyprexa’s labeling in the United Kingdom and Japan to include warnings about the association between the use of Zyprexa and diabetes-related injuries.