In Mason v. Smithkline Beecham Corp., No. 08-2265, the Seventh Circuit faced a suit against the maker of the popular antidepressant Paxil brought by the parents of a 23-year-old who committed suicide two days after she started taking the drug.

In light of the Supreme Court’s decision in Wyeth v. Levine, 555 U.S. _, 129 S.Ct. 1187 (2009), the court stated: “Although the Court found that preemption did not exist in Levine, it held that there could be preemption if the manufacture met the stringent standard of proving that there was clear evidence the FDA would have rejected the proposed change in the drug’s label.”

Based on the extensive showing required by Levine, the court concluded that the defendant failed to meet its burden of demonstrating by clear and convincing evidence that the FDA would have rejected a label change warning about the risk of suicide in young adults.

Related Resources:

  • Full text of Mason v. Smithkline Beecham Corp.Decision in Wyeth v. Levine

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