After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food, drug, and cosmetic labels—even those that complied with FDA law—on false advertising theories. Reed Smith recently defeated just this type of false advertising class action in the over-the-counter drug context, and the decision merits attention for the guidance it provides on preemption and primary jurisdiction arguments.
In Gisvold v. Merck & Co. Inc., No. 3:14-cv-01371, 2014WL6765718, at *1 (S.D. Cal. Nov. 25, 2014), the putative plaintiff class alleged that consumers have learned to associate higher SPF values with greater sun protection, but that high SPF labels were misleading because sunscreens with SPF values of greater than 50 allegedly do not provide any increased clinical benefit over sunscreens with an SPF equal to 50.
Relying on these allegations, plaintiff asserted that SPF 55, SPF 70+, SPF 80 and SPF 100+ labeling was false, misleading, and reasonably likely to deceive the public under California’s Unfair Competition Law, Cal. Bus. & Prof. Code § 17200 et seq. (“UCL”), the Consumer Legal Remedies Act, Cal. Civ. Code § 1750 et seq. (“CLRA”), and breach of express warranty theories. The putative class sought both damages and injunctive relief, including an order requiring a label disclaimer about the supposed lack of clinical benefit from high SPF sunscreens.
The U.S. District Court for the Southern District of California dismissed the proposed putative class action on primary jurisdiction and preemption grounds. The court found that the plaintiff’s claims were preempted by the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”), which governs over-the-counter drugs like sunscreen. The court cited Pom Wonderful, but in this instance found that the FDCA included an express preemption statute that was “unambiguous and broad in scope”:
[N]o State ... may establish or continue in effect any requirement [¶] that relates to regulation of [OTC drugs]; and [¶] that is different from or in addition to, or that is otherwise not identical with a requirement under [the FDCA].
21 U.S.C. § 379r (emphasis added).
Not only did this express preemption statute apply, but there were applicable federal requirements as well. Under the FDCA, over-the-counter sunscreens are governed by federal regulations that provide for SPF testing procedures and SPF labeling requirements. 76 Fed. Reg. 35620-21 (Jun. 17, 2011) (Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use). Significantly, these regulations mandate that over-the-counter sunscreen labels state the SPF value resulting from the detailed testing procedure described in the regulation. 21 C.F.R. § 201.327(a)(1) & (I) (describing testing procedure to arrive at appropriate SPF values and providing that labels “shall” state the SPF value).
Addressing the plaintiff’s proposal for a label disclaimer about the effectiveness of high SPF sunscreens, the court found that this would “plainly add[ ] to and is not identical with the FDA’s requirements, [and thus] is expressly pre-empted.”
The court also dismissed the action on primary jurisdiction grounds, because the issue of whether high SPF sunscreens provide additional clinical benefit of sunscreen is an issue currently pending before the FDA. See 76 Fed. Reg. 35672 (Jun. 17, 2011) (Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use) (“Proposed Rule”).
Because the FDA was engaged in rulemaking on the issue, the court found that requiring the manufacturer “to make a disclaimer and engage in corrective advertising . . . presents substantial risk of inconsistent rulings on issues presently pending before the FDA.” Furthermore, “the investigation of clinical benefits of drugs is particularly within the FDA’s initial decision-making domain, and is therefore not appropriate for adjudication before completion of the FDA’s own decision-making process.”
The take-away from Gisvold is that while Pom Wonderful highlighted areas in which federal false advertising causes of action can coexist with FDA authority—and because it captured the imagination of plaintiffs’ class action lawyers—that is not necessarily the end of the analysis. Even after Pom Wonderful, (1) false advertising causes of action based upon state law should remain preempted to the extent they simply add requirements concerning matters that are already addressed by FDA jurisdiction; and (2) the doctrine of primary jurisdiction will trump a state or federal advertising cause of action where the matter at issue is under consideration by the FDA, and is uniquely within that agency’s sphere of expertise.
Client Alert 2015-002