STORY FROM: Drugs & Medical Devices

Failure to Warn, ‘Failure to Suspend Sales’ Claims Not Preempted, Ga. Appeals Court Rules

ATLANTA — Claims of failure to warn and “failure to withdraw or suspend sales” asserted against the makers of generic Reglan are not federally preempted because they seek to impose state law requirements that parallel those imposed by federal law, the Georgia Court of Appeals has ruled.

However, in a Nov. 20 opinion, the court said a claim accusing generic drug makers of failing to communicate a 2004 label change to health care providers is preempted. The “duty of sameness” articulated in PLIVA v. Mensing prevents generic drug manufacturers from sending warning letters communicating a label change if name brand ...

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