The survivor of a man who committed suicide sued Pfizer alleging its drug Zoloft contributed to his death. Pfizer argued that the failure-to-warn claims were preempted. Rejecting the manufacturer’s claims of express preemption, Judge Rosenbaum observed that “FDA regulations explicitly permitted defendant to unilaterally strengthen its warning label at any time without regulatory pre-approval. 21 C.F.R. §§ 314.70(c)(6)(iii)(A). This particular regulation was promulgated precisely to allow drug-makers to quickly strengthen label warnings when evidence of new side effects are discovered. See 30 Fed. Reg. 993 (Jan. 30, 1965). Thus, as the FDA has noted, the regulation ‘permits the addition to the drug’s labeling or advertising of information about a hazard without advance approval’ by the FDA. 44 Fed. Reg. 37447 (June 26, 1979).” Then rejecting claims of express preemption, (i.e. a warning would have frustrated Congress’ goal of ensuring the scientific validity of drug label information; the viability of State Law failure-to-warn laws pressures drug manufacturers to paper their labels with unsubstantiated warnings in order to avoid lawsuits), the court found it “obvious” that state failure-to-warn claims “do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered – even before any FDA action.” Indeed, the regulation “underscores the crucial flaw in defendant’s argument: Congress certainly did not intend to bar drug companies from protecting the public when enacting the FDCA; its goal was to protect the public.” Witczak v. Pfizer, 377 F.Supp.2d 726 (D.Minn. 2005).
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