09-993 Pliva, Inc., v. Mensing

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Torts
Preemption

Federal drug regulations applicable to generic drug manufacturers preempt state tort claims for failure to provide adequate warning labels.

The Court finds impossibility here. If the Manufacturers had independently changed their labels to satisfy their state-law duty to attach a safer label to their generic metoclopramide, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. Thus, it was impossible for them to comply with both state and federal law. And even if they had fulfilled their federal duty to ask for FDA help in strengthening the corresponding brand-name label, assuming such a duty exists, they would not have satisfied their state tort-law duty. State law demanded a safer label; it did not require communication with the FDA about the possibility of a safer label.
588 F.3d 603 and 593 F.3d 428, reversed and remanded.

09-993 Pliva, Inc., v. Mensing

Thomas, J.; Sotomayor, J., dissenting.

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