On March 4, 2009, the U.S. Supreme Court issued its eagerly awaited decision in Wyeth v. Levine, U.S. Supreme Court No. 06 1249, 555 U.S. ____ (2009). In a 6-3 decision delivered by Justice Stevens, the Court held that federal law does not preempt Levine’s state law failure-to-warn claim concerning the adequacy of a prescription drug label. The Court also stated that a company may unilaterally add a stronger warning to a product label pursuant to the FDA’s “changes being effected” (“CBE”) regulation, and emphasized that a company—and not the FDA bears primary responsibility for drug labeling.

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