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An Illinois man is suing drug maker Eli Lilly, accusing the company’s blockbuster antipsychotic drug Zyprexa of causing him to develop diabetes.

Caleb Russell said he began taking Zyprexa in 2003 at age 13 to treat schizophrenia and acute manic episodes associated with bipolar disorder. Soon after he started using Zyprexa, Russell was diagnosed with diabetes, his lawsuit alleges, according to a report in the Madison St. Clair Record.

“Defendant Lilly’s drug, Zyprexa, negatively and detrimentally affected Plaintiff’s blood sugar and endocrine system gradually over time and duration,” the suit states.

Zyprexa is among a group of newer antipsychotic drugs and was approved in the United States in 1996. The drug has long been linked to high incidence of diabetes, hyperglycemia, pancreatitis and other blood sugar disorders. Many patients on Zyprexa gain weight and develop diabetes soon after beginning the medication.

Zyprexa is the third-best selling drug in the world, with annual sales at or above the $4.4 billion mark.

FDA Warnings Came Too Late?

The Food and Drug Administration warned in 2005 that using Zyprexa and similar antipsychotic drugs can cause premature death in elderly patients with dementia-related psychosis.

Lilly changed Zyprexa’s labeling in October 2007 to warn users and physicians prescribing the drug of the dangers of blood-sugar disorders. Russell’s lawsuit accuses the drug company of waiting too long to address the blood-sugar risks on Zyprexa’s labeling and said Eli Lilly was receiving hundreds of reports of adverse events in patients taking the drug in 1996 but failed to take action sooner.

Zyprexa’s labeling had been changed on the product sold in parts of Europe and Japan to warn about the increased risk of diabetes, but the label warnings were not changed in the United States for another year, Russell’s suit alleges.

In 2003, the FDA required Lilly and other drug companies to warn users about the link between taking antipsychotic drugs and an increased risk of diabetes. The company only issued that warning because makers of all such antipsychotic drugs were required to do so, according to the suit.

Off-Label Promotion Alleged

Russell’s suit also accuses Lilly of promoting off-label uses of the drug for treating conditions that have not been approved by the FDA. Russell was prescribed Zyprexa for an off-label treatment, he said.

“Lilly knew of the hazards associated with Zyprexa; 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; they did so with the intent that prescribing physicians would continue to prescribe Zyprexa; they then well know that prescribing physicians would not be in a position to know the true risks of Zyprexa; and they know that prescribing physicians would rely upon the misleading information that they promulgated,” the suit states.

Russell would not have taken Zyprexa if he known of the potentially life-threatening risks associated with doing so, his suit states.

Suit Seeks Damages

Russell’s lawsuit against Lilly includes 11 counts, including strict product liability, intentional infliction of emotional distress, negligent infliction of emotional distress, common law fraud, negligence, negligent misrepresentation, fraudulent misrepresentation, express warranty, implied warranty and statutory consumer fraud, according the Record.

He is seeking a court order declaring Lilly’s actions in marketing Zyprexa unfair and $50,000 in attorney’s fees plus costs and pre-judgment interest in addition to damages in excess of $350,000.

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This entry was posted on Tuesday, July 14th, 2009 at 11:22 am and is filed under For the consumer, Health & Medicine, Legal News, Legal Professional News. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.