A federal judge in California dismissed a case brought by the family of a 13-year-old girl who committed suicide while taking the antidepressant, citing a controversial rule that FDA approval of a drug preempts state lawsuits challenging safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA, a notion the US Supreme Court is expected to decide after agreeing to review a different case.
In the Paxil case, US District Court Judge Frank Damrell, Jr. dismissed the suit “on the grounds that, under state law, all of the claims required showing that Glaxo should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality.” And so he decided the lawsuit created "a direct conflict with the federal labeling requirements for Paxil established" by the FDA, "preempting the plaintif's claims, according to a statement issued by Glaxo's attorneys.
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In the Paxil case, US District Court Judge Frank Damrell, Jr. dismissed the suit “on the grounds that, under state law, all of the claims required showing that Glaxo should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality.” And so he decided the lawsuit created "a direct conflict with the federal labeling requirements for Paxil established" by the FDA, "preempting the plaintif's claims, according to a statement issued by Glaxo's attorneys.
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