U.S. Court of Appeals for the Tenth Circuit

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Tenth Circuit vacates and remands district court’s decision

June 02, 2010

The Tenth Circuit vacated and remanded the district court’s dismissal of this case in light of the Supreme Court’s ruling in Wyeth v. Levine. In Wyeth v. Levine, the Supreme Court held that federal law did not impliedly preempt a lawsuit alleging that an FDA-approved drug label failed to adequately warn of the drug’s risks.

U.S. Chamber files amicus brief addressing federal preemption of failure to warn lawsuit against drug manufacturer

July 27, 2009

NCLC urged the Tenth Circuit to hold that the FDA’s intentional efforts to avoid overwarning patients and doctors about unsubstantiated drug side effects should preempt the plaintiffs’ state-law failure-to-warn lawsuit. In this case, the plaintiffs sued Wyeth alleging that the drug manufacturer should have included a warning that the antidepressant could cause suicide, despite the FDA’s well-founded fear that such warnings would discourage people who needed the drugs from using them. This case is one of the first to consider the scope of the Supreme Court’s recent decision (Wyeth v. Levine) about implied preemption of state tort lawsuits over drug labeling. Contrary to the plaintiffs’ tortured interpretation of Levine, the Supreme Court’s decision did not spell the end of conflict preemption, NCLC argued in its brief. NCLC also showed that the last two presidential administrations recognized and supported the conflict preemption doctrine. Failure-to-warn lawsuits like this one undermine the FDA’s careful and scientific judgments that too many unsubstantiated warnings on a drug label will discourage patients from using possibly lifesaving drugs, NCLC cautioned.

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