Which of the Following Is True Regarding FDA Approval of Drug

question 11

Multiple Choice

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.

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Definitions:

Probable Cause

Any essential element and/or standard by which a lawful officer may make a valid arrest, conduct a personal or property search, or obtain a warrant.

Arrest Warrant

A document issued by a judge or magistrate that authorizes the arrest and detention of an individual.

Reasonable Suspicion

A standard used in criminal procedure that allows law enforcement to initiate an investigation or make an arrest, based on specific and articulable facts that suggest criminal activity is afoot.

Criminal Fraud

The act of deliberately deceiving another individual or entity with the intention of causing damage, often financial.