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With a stroke of the pen, the Third Circuit U.S. Court of Appeals could wipe out thousands of tort claims against pharmaceutical companies for allegedly failing to warn doctors that patients who use the antidepressant Paxil and other prescription drugs may be more likely to commit suicide. At issue is whether the Food and Drug Administration’s new drug labeling rules pre-empt state tort claims for failure to warn of potential side-effects as the agency argues, or if the trial judge was too deferential to the agency’s pre-emption claim. “Prescription drug liability cases are all about the adequacy of the warning label,” said Mary Davis, a law professor at the University of Kentucky who specializes in products liability. If the Third Circuit upholds the pre-emption ruling from a federal suit in Pennsylvania, it could wipe out nearly every prescription drug warning case involving Celebrex, Bextra, Vioxx and Zoloft, she said. Davis predicted that the U.S. Supreme Court would almost certainly resolve the pre-emption issue in the next couple of years, perhaps with this case. The appeal has already drawn amicus support for the plaintiff from a dozen scientists and doctors who evaluate pharmaceuticals. They contend that pre-emption “would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA.” Joseph Colacicco sued GlaxoSmithKline PLC and Apotex Inc., both makers of antidepressant Paxil, saying that his wife committed suicide in October 2003, 21 days after she began taking Paxil for mild depression. Colacicco claims wrongful death, negligence and a failure to warn her doctor of a link between the drug and increased risk of suicide. Colacicco v. Apotex, No. C05-05500MMB. The FDA filed an amicus brief with the trial court stating that in October 2003, when Paxil was prescribed to Lois Colacicco, “there was no reasonable evidence available at the time of an association between adult use of the drug and suicide.” To change the label would have been misleading, the FDA stated. But five months later, in March 2004, the FDA did order expanded warnings of the suicide potential, according to Colacicco’s attorney, Harris Pogust of Pogust & Braslow in Conshohucken, Pa. The agency declined to discuss the current appeal. The FDA pre-emption claim is relatively recent. It breaks a long-standing presumption by the FDA against pre-empting state common law tort claims. In 1996, the then-FDA chief counsel, Margaret Jane Porter, said that state tort liability operates independently, providing a “layer of consumer protection.” In 2000, its proposed drug labeling rule changes stated that there was no intention to pre-empt state claims. SECOND-GUESSING FDA? But by 2003 the agency had made an about-face. The FDA chief counsel, Daniel Troy, submitted briefs in five private tort suits arguing unsuccessfully that federal law pre-empts state common law claims. Then in January 2006, the FDA added in a preamble to the newly adopted labeling rules that the Food, Drug and Cosmetic Act “preempts conflicting or contrary state law.” The rules took effect on June 30, 2006. “This is backdooring legislation to pre-empt state action,” said Matthew Leckman, an attorney for Colacicco also with Pogust & Braslow. Glaxo attorney Andrew Bayman disagreed. “Nobody wants to eliminate the tort system, but if the FDA studies and reviews labeling, should a state suit be able to second-guess the FDA?” asked Bayman, a products liability defense lawyer with King & Spalding in Atlanta. Companies should not “slap on every conceivable warning under the sun; it could scare people away from using appropriate medicine,” he said. U.S. District Judge Michael Baylson is the first to defer to the FDA’s new assertion of implied pre-emption of state law in the new rules. He dismissed the suit, which is now before the Third Circuit. “It is abundantly clear that the FDA’s position is entitled to significant deference,” he wrote. Pogust disputes the deference given the FDA, particularly in the face of its recent change of heart. He said the ruling “could potentially do away with all failure-to-warn pharmaceutical cases. In Celebrex, in Vioxx, [pre-emption] is raised in every one of those cases,” he said. The FDA action “does not seem to be a public health concern as much as a political concern,” Pogust said. He argued that when an agency vacillates in its position, as the FDA did between 2000 and 2006, the Supreme Court has said it is less entitled to deference. Pamela A. MacLean is a reporter with The National Law Journal, a Recorder affiliate based in New York City.

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