The Philadelphia Inquirer on Sunday examined the impact of a federal policy codified in the preamble of FDA's new drug-labeling code in which federally approved warning labels supersede state laws in product liability lawsuits. The policy was created in 2000 but not codified until the new drug labeling code was published on June 30. FDA in the preamble to the new code said that it "believes that state laws conflict with and stand as an obstacle to achievement of the full objectives and purpose of federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated." According to the Inquirer, drug companies are now "[b]randishing the preamble" in court cases "with motions to dismiss failure-to-warn claims." The Inquirer highlights the dismissal -- based on the preamble -- last month of a case by a man in Philadelphia whose wife committed suicide in 2003 while taking the antidepressant Paxil. The lawsuit claims GlaxoSmithKline and Apotex, makers of the drug, failed to warn patients in 2003 about Paxil's suicide risks. The case has been appealed to Third Circuit U.S. Court of Appeals in Philadelphia, "taking the lead in a jurisdictional dispute that attorneys predict will not end until it hits the U.S. Supreme Court," the Inquirer reports. Lawyers on both sides of the case say FDA pre-emption could block many "failure-to-warn" claims against drug companies, if the preamble is upheld, according to the Inquirer. However, most motions based on the preamble have failed, according to the Inquirer. "It's a naked power grab for the industry, and I think the courts are seeing through it," Leslie Brueckner, staff attorney at Trial Lawyers for Public Justice, said (Ginsberg, Philadelphia Inquirer, 7/9).

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