PHILADELPHIA (CN) – The 3rd Circuit held that state-law claims accusing Pfizer, GlaxoSmithKline and other drugmakers of failing to put stronger suicide warning labels on their antidepressants are pre-empted by the Food and Drug Administration’s labeling rules.
“(A) state-law obligation to include a warning asserting the existence of an association between (antidepressants) and suicidality directly conflicts with the FDA’s oft-repeated conclusion that the evidence did not support such an association,” Judge Sloviter wrote.
In the underlying lawsuits, the families of two people who killed themselves while taking the antidepressants Zoloft and a generic version of Paxil filed complaints under state law, claiming the warning labels needed to mention that the drugs could increase the risk of suicide in adults.
Drugmakers argued that they could not be sued under state law because they had complied with the FDA’s labeling requirements.
The appeals court agreed that FDA rules pre-empt the state-law claims, but specifically limited its holding “to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires.”