Preemption Update: Colacicco v. Apotex, et al.

On March 9, 2009, the United States Supreme Court granted petitions for writs of certiorari in two cases that were pending from the Third Circuit Court of Appeals: Colacicco v. Apotex, et al., 08-437, and Pa. Employees Benefit Trust Fund v. Zeneca, 07-822. The High Court ordered further review in each case in light of its decision last week in Wyeth v. Levine.

In Levine, which we blogged about last week, Wyeth v. Levine Blog, the United States Supreme Court held that the plaintiff’s state-law-based, negligent-failure-to-warn claim was not impliedly preempted by federal prescription drug regulations, explaining in part: “[A]bsent clear evidence that the FDA would not have approved a change to [the prescription drug’s] label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.” Slip op. at 15 (emphasis added). By contrast, in Colacicco and Zeneca, the Third Circuit had rendered holdings in favor of implied preemption in the fields of prescription drug labeling and prescription drug marketing, respectively.

There is obvious tension between the Third Circuit’s preemption opinions and the High Court’s opinion in Levine. Indeed, the mere fact of remand in these two cases suggests the Supreme Court’s view that the cases are properly controlled by Levine. Certainly, the two remands signal the first of many tangible ripple effects from the Levine opinion. The battleground is now clearly set for determining the ambit of Levine, and more pragmatically, the ambit of the FDA’s regulatory conduct vis-à-vis consumer lawsuits.