These agreements follow a master settlement Lilly entered into in June 2005 that covered approximately 8,000 claimants in the US, as well as additional settlements of approximately 2,500 claims.
Lilly is not disclosing the terms of the settlement but said that the amount for the 18,000 claims is substantially less than the $700 million paid for over 8,000 claims in the June 2005 settlement. Lilly said it is reviewing the impact the settlements will have on its fourth-quarter earnings but believes it will not exceed $500 million.
“While we remain confident that these 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 physicians,” said Sidney Taurel, CEO of Eli Lilly and Company.
Approximately 1,200 claims that have been identified to Lilly are not included in this settlement. These will go to trial starting in April.
Most of the lawsuits claim that before September 2003, the information in the package insert, which listed the risk of hyperglycemia and diabetes as an infrequent adverse event since 1996, was not adequately displayed. In September 2003, the FDA required label changes for all atypical antipsychotics that added information about the relationship between these medicines and diabetes.
A New York Times article recently alleged that Lilly had purposefully disregarded safety issues concerning Zyprexa. Lilly said it will continue to vigorously defend Zyprexa in the remaining product liability cases, third-party payer and state cases.