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 [1] at Pharmalot
Related Articles:
Reps introduce anti-preemption bill [2]
Quaid: Preemption unfair to patients [3]
Preemption debate heats up [4]
Supremes vote 4-4 in pre-emption suit [5]
Links:
[1] http://www.pharmalot.com/2008/07/judge-reverses-preemption-ruling-in-paxil-case/
[2] http://www.fiercepharma.com/story/reps-introduce-anti-preemption-bill/2008-06-27
[3] http://www.fiercepharma.com/story/quaid-preemption-unfair-to-patients/2008-05-15
[4] http://www.fiercepharma.com/story/preemption-debate-heats-up/2008-05-13
[5] http://www.fiercepharma.com/story/supremes-vote-4-4-in-pre-emption-suit/2008-03-04