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Promethazine has been on the market since 1956. FDA said reports and medical literature and reports the agency received about side effects from the drug showed it has been linked to an unspecified number of gangrene cases requiring amputation.
In a 6-3 decision in March, the Supreme Court rejected Wyeth's claim that federal approval of Phenergan and its warning label should have shielded the company from lawsuits like Levine's.
Prior to that, business groups had aggressively pushed for such limits on lawsuits through the doctrine of "pre-emption" -- the idea that federal regulation trumps rules that might differ from state to state.
The Supreme Court had largely agreed, ruling in the prior term that FDA approval shields medical devices from most lawsuits.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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