Zyprexa at issue in 'off-label' suit against Lilly

Ann Knef Dec. 19, 2006, 3:30am

Eli Lilly and Co. is being sued in St. Clair County Circuit Court by a man who claims he developed pancreatitis from using the anti-psychotic drug Zyprexa.

Seeking a sum in excess of the jurisdictional requirements of the court, Demont Davis of Illinois claims Zyprexa is defectively designed, inadequately tested, dangerous to human health and lacked proper warnings as to the dangers associated with its use.

Davis is represented by D. Todd Mathews of Brown & Crouppen in St. Louis.

According to the suit filed Dec. 13, Davis claims he was diagnosed with diabetes while taking Zyprexa. He claims that Lilly illegally promoted Zyprexa with physicians in a scheme known as "off-label" use.

On Monday Eli Lilly defended itself against allegations raised in a recent New York Times story that said the drugmaker had inappropriately promoted its anti-psychotic medication Zyprexa to prescribing physicians, according to a Dec. 18 report in Market Watch.

A statement issued by Lilly indicated the drug manufacturer has not promoted Zyprexa for "off-label" use.

As reported by Market Watch, "At Lilly, we do not engage in off-label promotion - as alleged in The Times article," Dr. Steven Paul, Lilly's executive vice president for science and technology, said in a statement on Monday. "Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses."

Davis alleges he was prescribed Zyprexa for an unnecessary and off-label use.

"Defendant Lilly's drug, Zyprexa, negatively and detrimentally affected Plaintiff's blood sugar and endocrine system gradually over time and duration," the complaint states. "Not until Defendant's March 1, 2004, 'Dear Doctor Letter,' did the Plaintiff possess sufficient information to cause them to inquire about their diabetes-related injuries associated with Zyprexa in an effort to determine the legal wrongs of the Defendant alleged herein."

The suit claims there is "no valid scientific evidence to support the contention that Zyprexa is safe and effective for treatment of any off-label use."

Eli Lilly introduced the drug in 1996 for treatment of adults with schizophrenia. In 2001, Zyprexa updated its labeling to include a newly approved indication for the short-term treatment of acute manic episodes associated with Bipolar Disorder.

The suit claims Lilly became aware of large numbers of adverse event reports on file with the Food and Drug Administration's "medwatch" database involving diabetes-related illnesses associated with the use of Zyprexa. It also states that Lilly knew of the hazards associated with Zyprexa, yet "affirmatively and actively concealed information which clearly demonstrated the dangers of Zyprexa and affirmatively misled the public and prescribing physicians with regard to the material and clear risks of Zyprexa."

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