A federal judge in Pennsylvania today denied SmithKline Beecham Corp., doing business as GlaxoSmithKline (GSK), a second chance at its argument that a couple’s claims that the Paxil maker failed to properly warn that pediatric patients using the antidepressant are at an increased risk of suicidal behavior are preempted, but agreed to grant the drug maker’s request for interlocutory appeal to the Third Circuit U.S Court of Appeals.

Judge Ronald L. Buckwalter of the Eastern District of Pennsylvania rejected GSK’s assertion that “newly discovered” evidence presented by the drug maker demonstrated that it submitted information about the use of Paxil in the pediatric and adolescent patients to the Food and Drug Administration prior to April 2002 and that the agency held that the manufacturer could not add a warning about the risk of suicide in those patient populations. In support of its argument, GSK claimed that it submitted data from Study 329, which investigated the use of the antidepressant in pediatric patients, to the FDA on several occasions as early as 1998. However, Judge Buckwalter pointed out that all of the data from Study 329 was not available until April 2002, and that even then, the listing of adverse events under the term “emotional lability” caused the FDA to seek clarification from the company.

“In short, the newly-submitted evidence from GSK shows that it repeatedly offered only snapshots of its studies to the FDA without providing full data until April 2002,” the judge wrote. “Moreover, GSK obscured the relevancy of the data — either knowingly or unknowingly — by coding suicidal behavior as ‘emotional lability’ and suggesting to the FDA that there was no increased rate of suicidality in pediatric users of Paxil.”

Judge Buckwalter also rejected the manufacturer’s argument that the FDA’s approval of three new indications for Paxil in 2003 indicated the agency’s refusal to require a warning regarding the use of Paxil in pediatric patients based on the U.S. Supreme Court’s ruling in Sprietsma v. Mercury Marine (537 U.S. 51, 123 S. Ct. 518 [2002]) as well as the company’s requests to have the court revisit other portions of its ruling denying GSK’s summary judgment motion.

In certifying the ruling for interlocutory appeal before the Third Circuit, Judge Buckwalter held that the preemption issue is a controlling issue of law about which there is substantial difference of opinion and that the appeals court’s decision would materially advance the litigation.

The case is Knipe v. SmithKline Beecham, No. 06-3024.