In Wyeth v. Levine the Supreme Court held that FDA approval of the warning label on a drug set the federal standard that was not subject to change without FDA approval.

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In Wyeth v. Levine, the Supreme Court held that FDA approval of a drug's label does not preempt state law claims alleging inadequate labeling or failure to warn, meaning that pharmaceutical companies can still be held liable under state law for harm caused by their drugs, even if the drug's labeling was approved by the FDA.

In Wyeth V