State Court Judge Says Zoloft Warning Claims Preempted by FDCA

LEWISBURG, W.Va. - Requiring a drug manufacturer to include in its labeling a warning that was repeatedly rejected by the FDA as unsubstantiated and unwarranted would stand as an obstacle to the FDA's ability to execute the purpose of the Food Drug & Cosmetic Act (FDCA), a West Virginia state court judge has ruled. Price, et al. v. Cook, et al., No. 99-C-12-R (W.Va. Cir. Ct., Greenbrier Cty.).

Dismissing as preempted the plaintiffs' allegation that Pfizer failed to warn of suicide risks associated with the antidepressant Zoloft, Judge James J. Rowe of the Greenbrier County Circuit Court held that at …