Judge in Pennsylvania Rules Paxil Labeling Suit Not Preempted
The JereBeasley Report - April 2008
Page 7
A Philadelphia judge ruled last month that federal law can't preempt a state product liability claim centering on the alleged failure of the makers of Paxil to warn about the increased risk of suicide. Judge Allen L. Tereshko, the coordinating judge of the Philadelphia Common Pleas Court's Complex Litigation Program, denied a defense motion for summary judgment, ruling that the doctrine of federal preemption does not preclude the plaintiffs from arguing that GlaxoSmithKline failed to fulfill its duty to warn users of Paxil of an alleged association between the use of the drug and suicidality. The defense argued that the plaintiffs should be precluded from making that argument in state court under implied conflict preemption, saying that allowing the state court action over the adequacy of the Paxil label would result in conflicts with the FDA's exclusive authority to determine the content of the label. Judge Tereshko wrote in his opinion:
Defendant asserts that such inquiry is precluded by federal law since the content of the drug's label is governed by federal law and the duty to supplement the label is somehow subsumed into the [federal Food and Drug Administration] regulatory scheme. Defendant's position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not pre-empt a state's ability to allow one of its citizens to inquire whether the manufacturer breached that duty.
The Philadelphia mass tort program has always been regarded as one of the finest in the country, and that makes the judge's ruling most significant. There are no other Pennsylvania common pleas court opinions dealing with the federal preemption issue in pharmaceutical cases since the FDA unveiled revisions to its prescription drug labeling requirements in January 2006 and unveiled the "preemption preamble," which said that FDA approval of drug labels preempts conflicting or contrary state law. A case against GSK involving Paxil will now proceed to trial. Sol H. Weiss will try the case for the plaintiffs. There are 60 cases pending in the Philadelphia Paxil program, according to Stanley Thompson, the director of the Complex Litigation Center. Tereshko's decision shows that claimants injured by defective drugs or relatives of people injured by defective drugs can maintain their lawsuits in state court.
Judge Tereshko correctly said that it was not Congress' intent for federal law to preempt state causes of action and that the Federal Food, Drug and Cosmetic Act is silent on that issue. He noted that Congressional hearings leading up to the passage of the Federal Food, Drug and Cosmetic Act included the decision to not include a provision for a federal cause of action because common law rights of action existed. Judge Tereshko dismissed the defense's argument that use of beneficial drugs could be discouraged if they were mislabeled with warning information not based upon scientific evidence of know risks. He concluded such an argument is putting language into the federal law that is not there. The U.S. Supreme Court is slated to take up a preemption case, Levine v. Wyeth, which obviously will have a say in the preemption battle, and likely will decide the issue.
|
