Whether a state-law, failure-to-warn claim that parallels a defendant's failure to follow FDA labeling regulations is impliedly preempted?

QUESTION PRESENTED Rita McDaniel sued because Defendant failed to ensure the distribution of an FDA-mandated warning to her husband. Tennessee recognizes a tort claim based on failure to warn. Parallel federal regulations, 21 C.F.R. §§ 208.24(a), (b), require Defendant to ensure that sufficient medication guides are made available pharmacies or distributers for distribution to patients. Defendant also misled Mr. McDaniel’s doctor. The question presented is: Whether a state-law, failure-to-warn claim that parallels a defendant’s failure to follow FDA labeling regulations is impliedly preempted?