Zyprexa Lawsuits Alleged Failure to Warn About Diabetes Side Effect Risk
In the first part of June 2005, Eli Lilly & Co. said it had reached an agreement with certain groups of plaintiffs' lawyers to settle most of of the legal claims against the pharmaceutical company over its antipsychotic drug Zyprexa.
Lilly will establish a fund not to exceed $690 million to pay compensation to those plaintiffs who agree to settle their legal claims against the drug company. The settlement offers by Lilly are expected to be accepted by approximately 8,000 patients who used Zyprexa. Lilly said that when finalized, the settlement would resolve the majority of pending claims in federal and state courts, as well as many cases that were not filed in accordance with a "tolling agreement" between Lilly and certain groups of plaintiffs' lawyers. Most of the patients' claims alleged that Zyprexa had given the patients diabetes or diabetes-related health problems.
Concerns that Zyprexa caused weight gain and, in turn, diabetes emerged about five years ago. As use of Zyprexa expanded, increasing number of reports surfaced that doctors saw pronounced weight gain and worsening cholesterol levels in certain patients. Many of the Zyprexa legal claims claimed that Lilly had not put increased warnings about Zyprexa's risks in the package insert when the company first learned about the weight gain - diabetes side effect problem, allegedly as early as 1996 -- well before the FDA requested that Lilly make such a label change in 2003.
As background, due in large part to lawsuit filings against Lilly, Zyprexa was at the center of a debate over the safety of the newer generation of antipsychotic drugs, known as atypical antipsychotics. The FDA ruled in 2003, however, that the whole class of atypical antipsychotics carried the weight gain - diabetes side effect risk. At the same time, the FDA ordered Lilly to add stronger warnings to the Zyprexa package insert, or warning label, and made other companies do the same for their atypical antipsychotic drug products.
Lilly Chairman, President and Chief Executive Sidney Taurel said in a statement, "While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors."
Finally, a Lilly spokesman emphasized that the drug company will "continue its vigorous defense of Zyprexa" in the remaining cases. "We continue to remain steadfast that there is no causal link between the atypicals and diabetes," said John Lechleiter, executive vice president of pharmaceutical operations at Lilly.
(Posted by: Tom Lamb)