A federal judge late last week rejected an effort by Lilly and Sandoz to dismiss a lawsuit stemming from the August 2004 suicide of a 26-year-old California man who was taking a generic version of the Prozac antidepressant. The lawsuit was filed by Noe Carrasco's mother, who claims the drugmakers failed to warn of the suicide risks associated with the pill.
The drugmakers argued that preemption was a defense, and Sandoz also maintained that, as a generic maker, it wasn't legally allowed to voluntarily revise its label without prior FDA approval. But in a 30-page opinion, Judge Howard Matz wrote Sandoz’s argument "lacks merit" and the drugmakers offered "nothing but theoretical assumptions of what the FDA would have done, and that is not enough to warrant a finding of preemption." He also noted that "at no point prior to Carrasco's suicide did Lilly request to add suicidal language to the Prozac label and so the FDA never rejected such a request."
Preemption, you may recall, is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA unsuccessfully argued last year before the US Supreme Court that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.
However, Matz opined that "Lilly's argument fails, because Lilly ignores its burden here. To establish a preemption defense, a drug manufacturer must produce ‘clear evidence that the FDA would not have approved a change to (the drug’s) label.' ...A mere possibility that the FDA might not have allowed an enhanced suicidality warning for Prozac...is not enough to warrant preemption.”
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