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 from Pharmalot
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