CA Court Finds Drug Company Could Have Warned About Drug Risks

A California appellate court has ruled that the generic manufacturer of Prozac could have changed its own label to warn of the suicide risks of the drug without approval from the FDA.
The case involved a 26 year old man who committed suicide in 2004 after taking fluoxetine, a generic version of Prozac for a little over a month. The lawsuit alleged that Eli Lilly, the generic manufacturer of fluoxetine, had a duty to warn patients of the risks associated with the drug. Lawyers for Eli Lilly argued that the company could not have added a warning about suicide risks because the FDA had already approved the drug for market use.
However, U.S. District Judge A. Howard Matz of the Central District of California, ruled against Eli Lilly’s pre-emption argument, relying heavily on the Supreme Court’s Wyeth v. Levine ruling.
This is another important case in which the pre-emption argument, used to prevent injured consumers from seeking justice in state courts because of prior FDA approval, has been denied.