The estate and heirs of Bethany Cartwright sued Pfizer, alleging that it’s anti-depressant drug Zoloft caused her to commit suicide. Denying the defendant’s motion to dismiss, the court noted that the FDA’s regulations “merely set minimum standards with which manufacturers must comply” and “expressly do not prohibit a manufacturer from ‘adding [to] or strengthening a contraindication, warning, precaution, or adverse reaction.'” 21 C.F.R. §314.70(c)(6)(iii)(A). This provision, the court noted, together with 21 C.F.R. §201.57(e), make it clear that “manufacturers, not the FDA, are tasked with the responsibility of taking proactive steps once a manufacturer learns of ‘reasonable evidence of an association of a serious hazard with a drug.'” With respect to Zoloft in particular, Judge Steger opined that: “Given the hearings by both Congress and the FDA regarding suicidality, the FDA’s PDAC’s recent decision to recommend black box warnings regarding suicidality in children and adolescents, and the numerous experts who have concluded that there is a link between SSRIs, like Zoloft, and suicidality, it would be inconceivable to this Court to argue that an additional warning regarding suicidality would be false or misleading.” Rejecting, further, the argument that Texas tort law would somehow “interfere” with the FDA’s objective of ensuring that all warnings are supported by scientific evidence, the court concluded that “Texas law compliments and is parallel to the FDA’s regulations,” as “the FDA’s objective, as expressed through its regulations, demonstrate that manufacturers should provide consumers with all the safety information about their drugs as soon as the information is known, which is exactly what Texas law requires.” Cartwright v. Pfizer, Inc., No. 6:04cv292, 2005 U.S.Dist.LEXIS 5599 (E.D.Tex. March 31, 2005).
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