The U.S. District Court for the Southern District of Indiana recently issued a ruling that has important repercussions for pharmaceutical manufacturers. In a case captioned Tucker v. SmithKline Beecham Corp., No. 1:04-cv-01748, the Court ruled pharmaceutical manufacturers may be held liable under Indiana law for inadequate labeling of prescription drugs. In doing so, the Court held that the plaintiff's state law failure-to-warn claims against a pharmaceutical manufacturer were not preempted by federal law, and that the plaintiff could proceed with her case.
The case involves a man who committed suicide in September of 2002 after being prescribed Paxil in August of 2002. The plaintiff, the deceased's sister, brought a wrongful death suit under Indiana law against the drug's manufacturer claiming (1) that her brother committed suicide as a result of taking Paxil, and (2) that the manufacturer breached its duty to warn of an increased suicide risk in adults taking the drug.
The manufacturer argued that it could not be held liable for the alleged inadequacy of the drug's labeling because the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and FDA labeling requirements preempt the plaintiff's state law failure-to-warn claims. The Court initially agreed with the manufacturer, and in September of 2007 granted the manufacturer's motion for summary judgment because the plaintiff's “state law claims stand in direct conflict with the FDA’s labeling requirements for Paxil issued pursuant to federal law. . . .” Thus, the Court concluded that this was a case of conflict preemption, i.e., a situation where it is impossible to comply with both state and federal requirements.
The plaintiff then asked the Court to reconsider its decision, and in a rare change of heart, the Court reversed course and decided that the plaintiff's state law failure-to-warn claims regarding pharmaceutical labeling are not preempted. The Court observed that it previously had failed to appreciate that, in the Court’s view, FDA regulations allow a manufacturer to strengthen pharmaceutical labels unilaterally and immediately, without prior FDA approval, when the manufacturer has reasonable evidence of a serious hazard. Manufacturers may strengthen their labels in this manner under the "Changes Being Effected" provisions of the FDC Act. The Court reasoned that although the FDA might later disapprove of the unilateral labeling change, the FDA's disapproval would not constitute a violation of federal law, which would be necessary for the Court to find preemption. In the Court's words, "responsibility to strengthen a label still rest[s] squarely with the drug manufacturer." The Court declined to adopt FDA's policy that claims of this type should be preempted.
It is interesting to compare Tucker to a recent Third Circuit case — Colacicco v. Apotex, 521 F.3d 253 (3d Cir. 2008). Colacicco also involves Paxil and claims of inadequate warning and reaches a seemingly opposite conclusion — that plaintiffs' claims of inadequate warning of the risk of suicide from Paxil and similar drugs were preempted. The Colacicco Court also gave greater deference to FDA's current position on preemption than the Court in Tucker, and found that the "Changes Being Effected" provisions of the FDC Act did not give plaintiffs a way around preemption. The Court in Tucker essentially did not address this Third Circuit opinion. The differences between these cases should make for some interesting arguments if the almost inevitable appeal of Tucker occurs.
The final judicial word might well come from the Supreme Court late this year or early next year when the court decides Wyeth v. Levine, a pharmaceutical preemption case. (Note that earlier this year the Supreme Court found preemption in Reigel v. Medtronic, an express preemption case involving medical devices.) Congress has also been considering legislation in this area which could affect any preemption argument.
Tucker reinforces the importance of both product liability expertise and FDA regulatory expertise when defending drug and device cases. Tucker relies on the interpretation of complex FDA regulatory provisions and practice in the context of complex product liability law and facts. Likewise, unless and until the Supreme Court or Congress acts, we will see conflicting decisions from different courts. This may well lead to increased forum shopping by plaintiffs and the need for defendants to more aggressively seek to move cases to different jurisdictions. One must watch Congress and be prepared to get involved if the situation merits.