Some of the most important preemption issues of late have involved application of the doctrine of implied preemption in cases involving prescription pharmaceuticals and whether courts should defer to the FDA’s views on preemption promulgated in its Final Rule on drug labeling. In the preamble to the Final Rule, the FDA emphasized its view that its regulation of drug labels should have preemptive effect over product liability lawsuits involving prescription drugs, and took issue with the proposition that its label requirements are “minimum standards” that manufacturers may unilaterally strengthen. See 71 Fed. Reg. at 3934-35.
The Third Circuit is the current hot spot, as it has scheduled oral argument for December 10, 2007 in two companion cases reaching opposite conclusions on these questions. The first is Colacicco v. Apotex, Inc., 432
F. Supp. 2d 514 (E.D. Pa. 2006), rev. pending No. 06-3107 (3d. Cir. Dec. 29, 2006), a case in which the plaintiff sought to impose liability for the manufacturer’s failure to provide particular warnings the FDA had rejected as scientifically unsubstantiated. In upholding preemption, the Eastern District of Pennsylvania deferred to the FDA’s views as espoused in the Final Rule, and in an amicus brief the FDA filed in response to a request from the court. The second case set for argument December 10 is McNellis v. Pfizer, Inc., 2005 WL 3752269 (D.N.J. Dec. 29, 2005), rev. pending No. 06-5148 (3d. Cir. Dec. 15, 2006). In McNellis, the New Jersey District Court concluded that conflict preemption principles do not shield a manufacturer from common law liability, even where the FDA has rejected the very warnings the plaintiff seeks to impose through litigation. It also was unwilling to provide any deference to the FDA’s views on preemption. Because the District Court certified the issue for immediate appeal, the Third Circuit availed itself of the opportunity to decide an important issue based on the record in two separate cases.
Other courts also are deciding prescription drug preemption questions. In Tucker v. SmithKline Beecham Corp., No. 04-CV-1748, 2007 WL 2726259 (S.D. Ind. Sept. 19, 2007), the plaintiff contended that a manufacturer failed to warn of an increased suicide risk from an anti-depressant. Supported by a robust record reflecting extensive FDA attention to this issue, the manufacturer moved for summary judgment on the basis of federal preemption and the district court granted the motion. It noted that the FDA had opportunity to consider the plaintiff’s warning and had in fact, “affirmatively reject[ed]” the theory on which it was based—thus allowing the plaintiff’s claim that to move forward would pose a direct conflict with the FDA’s conclusion. Id. at *9–*10; see also Prohias v. Pfizer, Inc., 490 F. Supp. 2d 1228 (S.D. Fla. 2007) (claim basing liability on FDA-approved labeling is preempted, but claims basing liability on an unapproved label can go forward); Sykes v. GlaxoSmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007) (because the FDA approved the products’ label and had rejected the unsubstantiated risk information plaintiffs argued should have been included, failure-to-warn claims preempted); Price v. Cook, No. 99-C-12, 2007 WL 2154766 (W. Va. Cir. Ct. July 9, 2007) (where the FDA rejected the suicidality warning that plaintiffs advocated, failure-to-warn claims preempted).
Even when a court expresses deference to the FDA and its views of preemption, however, a manufacturer will not necessarily prevail if the plaintiff’s theory is different from those identified in the Final Rule as presenting a conflict between the federal and state requirements leading to preemption. In Sarli v. Mylan Bertek Pharm., No. 07-CV-43, 2007 WL 2111577 (M.D.N.C. July 19, 2007), for example, the court acknowledged that in the “current posture” of the case, it could not determine whether the FDA had reviewed and rejected the labeling proposed by the plaintiff, or whether the manufacturer had failed to include a statement that it had proposed to include. Id. at *3-*4. Given the ambiguous state of the regulatory record for the drug, the court concluded that it could not determine whether a conflict existed, and thus could not grant summary judgment on a preemption defense. See also Kelly v. Wyeth, 22 Mass. L.Rptr. 384, 2007 WL 1302589 at *5
The Third Circuit concluded that advertisements complying with FDA-approved labeling were not actionable under state consumer protection laws. Id. at *6. Of importance, the panel found that the “degree of discretion inherent in the regulations [governing the advertising of prescription drugs] demonstrates that the FDA envisioned itself occupying an ongoing and extensive role in the supervision of prescription drug advertising.” Id. at *8. Furthermore, the court found an “even stronger case for preemption” where it found that the consumer fraud laws could be used to “question the veracity of statements approved by the FDA,” especially since the FDA approved labeling of the drug formed the basis for the allegedly fraudulent advertising. Id. at *9. Hopefully, this decision foreshadows a favorable outcome for the Colaccico and McNellis cases that the Third Circuit soon will address.