Pre-emption handed GlaxoSmithKline the victory in a lawsuit over a 13-year-old who committed suicide while taking the antidepressant Paxil. A California judge cited the pre-emption rule in dismissing the suit, saying that the case created a direct conflict between federal labeling requirements and state tort law. Glaxo couldn't have complied with both, the judge said, and federal law pre-empts state law--so out with the suit.
The thing is, this ruling could not only set a precedent, causing all sorts of damage suits against drug companies to get tossed, but might be a harbinger of an even bigger precedent-setter. The Supreme Court is set to consider a couple of cases that rest on this notion of pre-emption. As the reasoning goes (greatly simplified; I'm no lawyer) the federal government vested FDA with the power to regulate drugs and devices, so FDA approval should shield drugs and devices from state liability.
- check out the coverage [1] from Pharmalot
Related Articles:
UK patients sue for Paxil withdrawal. Report [2]
Study highlights link between Paxil and suicide. Report [3]
Glaxo to let Mylan make generic Paxil. Report [4]
Study: Antidepressant warnings work. Report [5]
Links:
[1] http://www.pharmalot.com/2008/02/glaxo-wins-paxil-suicide-suit-due-to-preemption/
[2] http://www.fiercepharma.com/story/uk-patients-sue-for-paxil-withdrawal/2008-01-09?utm_medium=nl&utm_source=link
[3] http://www.fiercebiotech.com/story/study-highlights-link-between-paxil-and-suicide/2006-05-12
[4] http://www.fiercepharma.com/story/glaxo-let-mylan-make-generic-paxil/2007-10-23
[5] http://www.fiercepharma.com/story/study-antidepressant-warnings-work/2008-01-08?utm_medium=nl&utm_source=link