FDA pre-emption halts generic Plaxil trial

A US federal court in Pennsylvania has ruled that the widower of a woman who committed suicide after taking the antidepressant drug paroxetine HCl may not claim product liability for the alleged failure to warn of suicide risks, because the Food and Drug Administration did not demand any such warning and the agency controls their wording.

The plaintiff had tried to claim damages against both generic manufacturer Apotex and UK-based world number two drugmaker GlaxoSmithKline, which owns the patent for Plaxil, the branded version of the antidepressant drug. GSK's involvement in the law suit was based on the argument that it was responsible for the wording of warnings used by Apotex.

US District Judge Michael Baylson's finding means that Pennsylvania's tort laws are pre-empted by the federal Food, Drug and Cosmetic Act, which assigns responsibility for labeling to the FDA. The case also sets the precedent that the Hatch-Waxman amendments to the FDCA, by forcing generic drugs to carry the same warnings as for branded products, provide FDA cover from litigation for generic drugmakers in labeling disputes.