We've addressed sunscreen class actions here from time to time. The FDA regulates sunscreen as an OTC drug, and so these class actions can generate decisions of interest in areas of preemption and primary jurisdiction. For instance, we told you about, Gisvold v. Merck & Co., 62 F. Supp. 3d 1198 (S.D. Cal. 2014), in which a court found preempted a putative class action plaintiff's claim that the Coppertone SPORT SPF 100+ she bought at Walmart should have disclaimed that it was no more effective than sunscreen with an SPF of 50. The court based its preemption determination on the plaintiff seeking labeling that was different from that required by the FDA. In addition, the court invoked primary jurisdiction, deferring to the FDA on how to address SPF values greater than 50, as the FDA was already in the process of evaluating that issue.
But, as in medical device cases, preemption in sunscreen litigation can seem muddled. Just recently in another sunscreen class action, Dayan v. Swiss-American Prods., Inc. (E.D.N.Y. Mar. 30, 207), a federal court in New York rejected a preemption-based motion to dismiss a claim that the labeling of a sunscreen product as SPF 45 was misleading because the product actually performed at a lower SPF level. As support for his claim, plaintiff pled data from tests conducted under the FDA's SPF testing protocols. The court adopted a magistrate's report and recommendation, which reasoned that the plaintiff's "state law claims [sat] next to federal regulations and are not premised on Defendant's alleged failure to comply with FDCA requirements." Id. at *4. Sort of a parallel violation claim for sunscreen.
As the court conceded, though, its distinction between what is preempted and what is not is, at best, "tricky." Id. at *10. There seems to be little to no air on which plaintiff's claim can survive between express and implied preemption. If, as his case develops, plaintiff is left to argue that the defendant followed FDA-mandated protocols in testing the sunscreen and disclosing the results, his claim that the label should nonetheless be different would seem to trigger preemption because it would require something different from what the FDA requires. On the other hand, if plaintiff's claim, as fleshed out through discovery, appears to be that the defendant failed to follow FDA protocols, it would start to read like an improper attempt to privately enforce FDA regulations.
In other words, sunscreen preemption seems every bit as messy as medical device preemption. Maybe, in this case, it can be cleared up at the summary judgment stage—that is, if this case gets passed class certification—where defendant may have another chance, based on a full record of what plaintiff is trying to do, to ask for judgment based on preemption.
This article is presented for informational purposes only and is not intended to constitute legal advice.
