Although the landscape of the Federal Food Drug and Cosmetic Act (FDCA) preemption of private Surgeon General class action claims continues to shift under our feet in California, first with POM and recently with this case, the Sixth Circuit has recently made clear that consumer protection claims that would not have existed “but for” the provisions of the FDCA will likely be impliedly preempted. Richard Loreto et al. v. The Procter and Gamble Company, (6th Cir. Ct. App. Case No. 10-4274, opinion filed Feb. 22, 2013).
This case is an interesting one. Like many labeling class actions, Messrs. Loreto and Buffa’s claim arose after the FDA issued a warning letter to Procter & Gamble, makers of NyQuil, claiming that the NyQuil + Vitamin C products violated the FDCA as they combined OTC drug ingredients with vitamin C, a blend the FDA claimed was not “proven safe and effective” and thus an unlawful new drug. See the letter here. Plaintiffs brought a series of state law claims, most based on the allegations in the FDA letter, alleging that they never would have bought the product had they known it was “illegal.” In its partial affirmance of the district court’s 12(b)(6) dismissal, the Sixth Circuit held that the claims that are based solely on the FDCA violations, including technical labeling deficiencies and P+G’s failure to file a new drug application, were impliedly preempted, as the state law claim derives entirely from the provisions of the federal law. Citing Buckman, the Court reaffirmed that:
“the FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the law’s substantive provisions.” Id. at 4 citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001).
But unfortunately for P+G, it did not stop there. The Sixth Circuit revived the other aspects of the plaintiffs’ claim – that P+G’s representations that the vitamin C would blunt the effects of a cold falsely induced them to purchase this product instead of a lower-cost version. Finding that this claim was not tethered to the FDCA, the Court let plaintiffs proceed. To add insult to actual injury, the Court reversed the District’s court’s findings that the plaintiffs lacked standing and that they had received the effective cold remedy they paid for. The Sixth Circuit concluded that plaintiffs suffered an “ascertainable loss” in that they lost the price difference between DayQuil and the cheaper version they claim they would have purchased.
What does this all mean? It offers some hope that the all-too-common class actions that follow warning letters from the FDA (and the CPSC and others) may face implied preemption if the plaintiff’s claims rely exclusively on technical noncompliance with the FDCA, its regulations, or the Food Labeling Guide. A less optimistic view, of course, is that implied preemption of follow-on class actions will be found only in narrow circumstances—namely those where the plaintiff cannot repackage the regulator’s claims into an ordinary false advertising case.