
Which of the following is true regarding FDA approval of drug labels in relation to state law claims for failure to warn?
A) FDA approval of the label on a brand-name prescription drug does not preempt state failure-to-warn claims arising out of injuries caused by the drug nor does FDA approval of the label preempt state failure-to-warn claims related to approved generic drugs bearing the FDA-mandated label.
B) FDA approval of the label on a brand-name prescription drug preempts state failure-to-warn claims arising out of injuries caused by the drug, and federal law also preempts state failure-to-warn claims related to approved generic drugs as long as they bear the FDA-mandated label.
C) FDA approval of the label on a brand-name prescription drug preempts state failure-to-warn claims arising out of injuries caused by the drug, but federal law does not preempt state failure-to-warn claims related to approved generic drugs bearing the FDA-mandated label.
D) FDA approval of the label on a brand-name prescription drug does not preempt state failure-to-warn claims arising out of injuries caused by the drug, but federal law preempts state failure-to-warn claims related to approved generic drugs as long as they bear the FDA-mandated label.
Correct Answer:
Verified
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