Bipolar drug Zyprexa targeted in St. Clair County suit

A high volume television advertiser, St. Louis plaintiff's firm Brown & Crouppen, has a new medicine in its crosshairs--Zyprexa.

The drug, manufactured by Eli Lilly and Company and the third best selling pharmaceutical on the market, is used to treat schizophrenia and bipolar disorder.

Seven people filed suit in St. Clair County Circuit Court Dec. 30, alleging that Zyprexa caused the onset of diabetes or pancreatitis.

The plaintiffs include Carl Bavone, Constance Morrow, Jessica Perry and Roger Yon, of Illinois, Debbie Bernsley of Indiana, Robert Goatee of Kentucky and Terrance Hause of Minnesota.

In 2001, Zyprexa was approved for the short-term treatment of acute manic episodes associated with bipolar disorder.

The plaintiffs' claim that immediately after Zyprexa's release, 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.

They claim Lilly knew of Zyprexa's propensity to cause diabetes, but failed to adequately warn doctors and patients.

According to the complaint, on Sept. 11, 2003, the FDA informed all manufactures of atypical antipsychotic drugs, including Lilly, that due to an increasing prevalence of diabetes-related illnesses associated with this class of drugs, that all labeling must bear a warning.

The plaintiffs also claim that despite the FDA's mandate, Lilly waited until March 1, 2004, to send physicians a "Dear Doctor Letter" advising of the new warnings and claim the warning did not appear in the Physicians' Desk Reference until the 2005 edition.

The plaintiffs claim that if they had been adequately warned of the potential life-threatening side effects, they could have chosen other prescription medications and avoided Zyprexa.

"Lilly negligently, recklessly and wantonly failed to warn plaintiffs, and the general public, of the risks associated with taking Zyprexa. Lilly failed to do so even after various studies, including their own, showed that there were problems concerning the risks of diabetes and diabetes-related injuries associated with Zyprexa," the complaint states.

They claims Lilly endeavored to deceive them and the public by not disclosing the findings of various studies, including its own that revealed problems concerning the dangers of Zyprexa.

They also claim Zyprexa negatively and detrimentally affected their blood sugar and endocrine systems gradually over time and duration and not until the "dear doctor letter" did they have knowledge to cause them to inquire about their diabetes-related injuries.

The plaintiffs' claim Lilly failed to use reasonable care in testing and inspecting Zyprexa, failed to use reasonable care in the manner and method of warning them and failed to implement a reasonably safe design.

Represented by John Driscoll and Seth Sharrock Webb, the plaintiffs are each seeking damages in excess of $150,000 plus costs of the suit.

05 L 770 (20th Circuit)