In Wyeth v. Levine the Supreme Court held that FDA approval of the warning label on a drug did not mean the drug maker could not be sued for having an inadequate warning label on the drug.

Question

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The Supreme Court ruling in Wyeth v. Levine affirmed that FDA approval of a drug's warning label does not shield the drug manufacturer from state law liability for inadequate labeling under certain circumstances. Therefore, the statement that FDA approval of the warning label means the drug maker cannot be sued for an inadequate warning label is false.

In Wyeth V