Saturday, May 19, 2007

More Details - UTAH vs. Eli Lilly lawsuit

State of Utah sues Zyprexa maker
The Salt Lake Tribune and wire services

Some 1,500 Utah adults with insurance coverage through Medicaid have developed diabetes because they took the antipsychotic drug Zyprexa, Utah's Attorney General estimates.

    The state has filed a lawsuit against Zyprexa's manufacturer, Eli Lilly & Co., charging that the company improperly promoted the drug and failed to warn patients of adverse side effects that include diabetes, severe weight gain and pancreatitis. 
    About 100 Utah patients have already individually sued Eli Lilly, according to assistant Attorney General David Stallard. Others "may not have any idea that Zyprexa had anything to do with them developing diabetes," he said.

    Utah accuses Eli Lilly of pushing doctors to prescribe the drug to Utah Medicaid patients to treat "off-label" conditions like Tourette's syndrome, Alzheimer's and anorexia.

    The federal Food & Drug Administration has approved Zyprexa for treatment of schizophrenia and bipolar disorder. While doctors can prescribe drugs for a variety of illnesses, pharmaceutical companies are prohibited from marketing their drugs for non FDA-approved uses.

    Because the off-label prescriptions were subsidized by Medicaid, the state is seeking damages from Eli Lilly.

    Utah is the eighth state to file such a Medicaid lawsuit against the company, Stallard said.

    Eli Lilly spokesman Phil Belt said he was unfamiliar with the lawsuit and could not comment on it specifically. He said the company has training and compliance programs to ensure that all its products are marketed appropriately.

    Utah has paid $65 million for the 12,000 Medicaid patients prescribed Zyprexa since 1996, said Stallard, who works in the Attorney General's Medicaid fraud control unit.

    "By dollar volume, Utah Medicaid paid more for Zyprexa than any other drug since 2001," he said. "They've used it much more broadly than it was ever intended. Because of the risks, it shouldn't have been used that broadly."

    Of the 250,000 prescriptions written for the drug among Utah Medicaid patients, it's unknown how many of those were for off-label uses. The state is studying the Medicaid database to find out. Other states have reported off-label use at up to 70 percent.

    "Utah has paid millions of dollars for inappropriate and medically unnecessary doses of Zyprexa. As a result, Lilly has been illegally enriched at the expense of the state," the 3rd District Court lawsuit said.

    Utah is seeking civil damages and penalties, including $5,000-$10,000 for each prescription that was "not medically necessary."



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