When Jame Gumb urged his captive to put lotion on her skin, he was not concerned with improving its firmness. While Buffalo Bill from "Silence of the Lambs" may not be who most would think about when reading Franz v. Beiersdorf, Inc., No. 14cv2241-LAB (RBB), 2015 U.S. Dist. LEXIS 102784 (S.D. Cal. Aug. 5, 2015), the serial killer with an obsession for skin did come to our mind. Franz involves a purported class action over a lotion that allegedly violated consumer protection laws by how its labeling represented its ability to firm skin and allegedly violated California unfair competition law in being marketed without an approved NDA by FDA. The defendant’s motion to dismiss made a few arguments, but we are most interested in the argument that primary jurisdiction requires dismissal or stay of the unfair competition claim.
If you were to peruse our primary jurisdiction posts, you might notice the cases typically involve federal claims that are not subject to preemption (as state law claims may be). We have posted before on California courts evaluating preemption in the context of consumer protection and unfair competitions claims for sunscreens. Other than the timing of when sunscreen and skin lotion typically get applied—and the absence of an obvious serial killer reference for the former—at first blush, the products seem similar enough that we might have expected preemption to be the argument raised against the state law claims in Franz. It probably should not have been a surprise that FDA treats some skin lotions as cosmetics and others as drugs—whereas sunscreens are regulated as cosmetics—so the regulatory framework is different. Without digging too deeply, however, it still seems like an allegation that the defendant should be liable under state law for selling a product in violation of the FDCA—without FDA coming to that same conclusion—walks right into the sort of preemption articulated in Buckman.
Anyway, preemption was not at issue and primary jurisdiction was, so the court analyzed primary jurisdiction under a fairly well-developed body of Ninth Circuit law. This version of primary jurisdiction allows a case to be stayed or dismissed without prejudice until an administrative decision can be reached when "an otherwise cognizable claim implicates technical and policy questions that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch." Id. at *10 (citation omitted). The four factors for primary jurisdiction are:
(1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.
Id. at **10-11 (citation omitted). As you might expect for a claim based explicitly on the allegedly unlawful sale of an FDA-regulated product—especially one plaintiff contended should be considered a drug—these factors easily weigh in favor of primary jurisdiction. Issues of whether a substance is a drug and requires a NDA to be sold in the United States—here, based upon consideration of whether the lotion simply moisturizes skin or tries to up its production of collagen—is a technical question within FDA’s jurisdiction as assigned by Congress. Id. at **11-12. So, primary jurisdiction applies and the claim should not go forward until FDA weigh in.
But how would FDA weigh in? Why, through the mechanism of a citizen’s petition, which we usually see in drug and device litigation as something plaintiff lawyers or their proxies—Public Citizen comes to mind (and any parallels to Buffalo Bill are up to the reader)—as a way to stir up attention and litigation. If the plaintiff here chooses to file one, then FDA’s decision is due in 180 days—per the court and regulation, but not in practice—and a federal court can review the agency action "with the benefit of a developed administrative record." Id. at **12-13. A dismissal with prejudice based on pleading a preempted claim is the best. However, there would be more than some benefit to putting a claim on hold until FDA rules on a citizen’s petition and then framing the issue for the court as to whether the FDA’s action—and the vast majority of citizen petitions on drugs do not give the petitioner what is requested—was abuse of discretion. According to the analysis in Franz, this might be an option for a defendant in a drug and device case where the complaint makes a big deal of regulatory compliance but preemption is not a viable option for some reason.