Pre-emption fans took one on the chin last week when a federal judge changed his mind. U.S. District Court Judge David Hamilton reversed a previous opinion that dismissed a Paxil suicide case, saying that FDA approval would shield drugmakers from state-court claims. In his new opinion, Hamilton wrote that he had "failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rests squarely with the drug manufacturer."
That Paxil case--brought by a woman whose brother, a priest, shot himself 22 days after starting the drug--will be reopened. But like so many other state-court claims brought by patients, it could be rendered moot this fall when the Supreme Court hears a case widely considered to be an opportunity for the justices to confirm pre-emption.
- see the post at Pharmalot