Federal Court Throws Out "Failure-to-warn" Suit On Celebrex
Failure to warn claims stricken, but false advertising claims allowed to proceed.
Published Aug 28, 2006
A US Federal District Court judge has ruled that several prospective class action lawsuits against Pfizer over an alleged suppression of data about Celebrex's cardiovascular risks are pre-empted because they conflict with the authority granted to the FDA to control drug warnings.
The Court found that the plaintiff's theory that Celebrex has cardiovascular risks greater than that of other NSAIDS, a warning that the FDA has considered and found to be scientifically unsubstantiated.
The Court allowed false advertising claims to stand because it determined that ..."the FDA does not intend to its review of promotional materials to preempt false advertising claims."
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