Gisvold v. Merck & Co., Inc – Case Brief Summary (Federal Court)

In Gisvold v. Merck & Co., Inc. (S.D.Cal. 2014) 62 F.Supp.3d 1198, the plaintiff in Gisvold alleged that sunscreen products with an SPF over 50 do not provide any increase in clinical benefit over SPF 50 products, and thus contended that labels stating SPF values over 50 are false and misleading under Business and Professions Code section 17200, Civil Code section 1750, and express warranty. Gisvold sought an order that defendants charge the same price for the SPF 50+ products as SPF 50 products "and/or that they include 'a disclaimer on the label or packaging that a SPF value above 50 does not provide proportional clinical benefits.'" (Gisvold, at p. 1201.) Just as Eckler requests here, Gisvold sought an order that the company "engage in a corrective advertising campaign." (Ibid.)

In Gisvold, the district court concluded that the plaintiff's claims were preempted. In contrast to the Corra decision, the Gisvold court reviewed the express preemption language in the federal statute: "The FDCA, which includes an express pre-emption statute, is unambiguous and broad in scope ..." and quoted 21 United States Code section 379r. (Gisvold, supra, 62 F.Supp.3d at p. 1202.)

The court also reviewed the FDA's final rule regarding labeling and effectiveness of sunscreen products, noting that they mandate the SPF value. The court found that the plaintiff's argument was broader than her pleading: "the essence of Plaintiff's claim is that 'Merck's SPF 55, 70+, 80 or 100+ representations ... on its Coppertone SPF 55-100+ collection are false, misleading, and reasonably likely to deceive the public.'" (Ibid.)

The court concluded that "in seeking to provide greater consumer protections, Plaintiff targets Merck's sunscreen label (which complies with current FDA regulations), and proposes a disclaimer regarding the level of sunscreen effectiveness beyond SPF 50. Because the proposed disclaimer plainly adds to and is not identical with the FDA's requirements, Plaintiff's action is expressly pre-empted under 21 U.S.C. § 379r." (Id. at pp. 1202-1203.)