Teen Paxil-related suicide case is not preempted, judge says.
The plaintiffs in the lawsuit, New Jersey residents Marion Knipe and Harold Garrison Jr., are the parents of 16-year-old Harold "Jake" Garrison. A dermatologist who was treating Jake for acne prescribed Paxil off-label for treatment of his body dysmorphic disorder, a psychiatric condition in which a person is excessively concerned about a real or imagined defect in his or her physical appearance.
Shortly after Jake refilled his second Paxil prescription, he committed suicide by gunshot. Jake's parents claim that his death was the result of his ingestion of Paxil and that GSK was liable for failing to warn them and Jake's physician about the risk of suicide that the drug posed to children and adolescents.
GSK filed a motion for summary judgment, citing the Third Circuit's April ruling in Colacicco v. Apotex, Inc. (521 F.3d 253 (3d Cir. 2008) ). In that case, which involved a suicide by an adult that was allegedly caused by Paxil, the appeals court determined that the plaintiffs' failure-to-warn claims were preempted because they conflicted directly with the federal Food, Drug, and Cosmetic Act and its implementing regulations. GSK argued that Colacicco was controlling in Knipe and contended that if GSK had included a pediatric suicidality warning on Paxil's label, as proposed by the plaintiffs, the FDA would have deemed the drug to be misbranded.
Senior District Court Judge Ronald Buckwalter denied the motion, writing that Colacicco was not dispositive because "the Third Circuit explicitly limited its holding 'to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires.'"
Buckwalter noted that in Colacicco, the "Third Circuit focused solely on whether a claim for failure [to] issue a warning regarding adult suicidality was preempted. At no point did the court mention any studies that were done with respect to pediatric use of Paxil." Indeed, he continued, "Paxil has never been approved for pediatric use and, therefore, the FDA never reviewed any safety and efficacy data regarding pediatric use prior to approval of the drug."
"The most important thing about the decision is that it limits the contours of Colacicco. [The Third Circuit in] Colacicco said that it was a very limited ruling, and this court confirmed that," said Bijan Esfandiari of Los Angeles, lead attorney for the Knipe plaintiffs.
Following the summary judgment standard, Buckwalter found that there was a genuine issue of material fact as to whether GSK had "reasonable evidence" of an association between Paxil and pediatric suicidality before September 2002--the date of Jake's refilled Paxil prescription and subsequent suicide. The court held that the plaintiffs had made a sufficient showing that if GSK had added a pediatric warning to Paxil's label before September 2002, the FDA would not have rejected the change or have deemed it to be a misbranding of the drug.
Moreover, the plaintiffs' proposed warning did not conflict with federal regulations because "at the time Paxil was prescribed for Jake Garrison the second time in September of 2002, the FDA had yet to publicly state its position regarding a link between the pediatric use of Paxil, or other [selective serotonin reuptake inhibitors], and an increased risk of suicidality," Buckwalter wrote.
The court declined to defer to the FDA's position on the preemption of state failure-to-warn lawsuits, as stated in the FDA's 2006 preamble of its drug labeling regulations and in amicus briefs filed by the government on behalf of the FDA in other litigation. In so doing, it relied on the Third Circuit's recent decision in Fellner v. Tri-Union Seafoods to support its finding that, where the FDA has expressed only an informal policy opinion after a plaintiff allegedly suffered an injury, that opinion is not sufficient to preempt a state tort lawsuit. (539 F.3d 237 (3d Cir. 2008).)
"The timing of the Fellner decision was fortuitous--it gave Judge Buckwalter an opportunity to rely upon a more recent Third Circuit precedent that confirmed not only the viability of the presumption against preemption, but also demonstrated that Colacicco is not the end all and be all" on preemption, Esfandiari said.
Esfandiari is handling a number of other Paxil pediatric suicide cases. However, "this is the first preemption ruling that involves a pediatric suicide that occurred in the time period after GSK completed its pediatric clinical trials and during a four-year window when GSK had knowledge of the risks but failed to issue a warning or seek a label change," he said.
And, as the court concluded in Knipe, "A state failure-to-warn action will not usurp or undermine the FDA's responsibilities to ensure an accurate label, but rather will close the void in the authority of the FDA, which can neither independently regulate off-label use nor require additional clinical trials."
In a separate ruling, Buckwalter denied GSK's motions for summary judgment on most of the plaintiffs' causes of action, allowing the case to proceed to trial. ( Knipe v. SmithKlineBeecham, 2008 WL 4442635 (E.D. Pa. Sept. 30, 2008).)
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|Date:||Nov 1, 2008|
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