Supreme Court to consider 'pre-emption' for drug companies

Diane Levine, who lost part of her right arm after a medical mistake, was awarded $6 million by a Vermont jury in her suit against Wyeth. In her case, she contended that the catastrophe that took part of her arm, the misuse of Wyatt drug Phenergan, might have been avoided if Wyeth had adequately warned her about the risks of using the drug.

Now, however, the Supreme Court could throw the Vermont judgment out. Levine has been caught up the battle over "pre-emption," the notion that plaintiffs shouldn't be allowed to bring cases in state court if a product meets federal standards. Advocates of pre-emption argue that since the label on the Phenergan administered to Levine had been approved by the the FDA, she shouldn't be allowed to sue. But Levine argues that Wyeth should be held responsible for not offering a warning on the risks associated with IV push, which caused the gangrene that destroyed her arm when it was incorrectly done on an artery.

Wyeth--and other drug and devicemakers who have taken on similar cases--argue that they couldn't change the label to comply with Vermont law, or they'd violate federal law. Levine and her lawyers, meanwhile, argue that the tougher warning is allowed and that federal law just sets a minimum. 

Now, the Supreme Court will examine, for this case at least, whether the federal standards were enough. The resulting decision, attorneys say, could turn out to be one of the most important of the current term.

To learn more about the case:
- read this piece from the New York Times

Related Articles:
Dems plan anti-preemption bill for devices
Pre-emption debate heats up
Reps introduce anti-preemption bill
Supremes to mull block on drug suits

Post a comment