Today’s opinion, In re SoClean, Inc., Mktg., Sales Pracs., & Prods. Liab. Litig., No. 22-MC-00152-JFC, 2025 WL 974258 (Sp. Mstr. W.D. Pa. Mar. 20, 2025), involves a lot of case-specific discussion with little applicability to the broader readership of the Blog. But it also contains some general observations regarding invading the province of the FDA that are “so fresh and so clean” (if this litigation name takes you back, as it does us, to circa 2000 Outkast).
SoClean manufactures and markets cleaning devices and accessories for CPAP and BiPAP machines (collectively, “PAP” machines), including some produced by Philips. As readers of the Blog will remember, there is a now largely settled MDL for products liability claims related to the recall of certain Philips PAP machines (the Philips Recalled CPAP MDL). The MDL that produced today’s decision, In re SoClean, Inc., Mktg., Sales Pracs., & Prods. Liab. Litig., relates to the facts of that MDL and is before the same court. And as in the Philips Recalled CPAP MDL, the MDL Judge has appointed the Special Master, a former judge, to prepare Reports & Recommendations on substantive motions, which is unique indeed.
Plaintiff SoClean brought claims under the Lanham Act and other unfair competition claims, claiming that the Philips defendants misled consumers in their recall notice stating that ozone and ozone cleaners were responsible for foam degradation in the PAP machines. The Philips defendants counterclaimed, alleging false statements using their trademarks and about their products. Before the Special Master was Philips’s motion for summary judgment on lack of standing. The Special Master recommended denial of the motion.
Much of the opinion relates to case-specific Lanham Act and standing issues, but it contains some choice words for parties thinking they can second-guess the FDA.
Philips’s position in its motion for summary judgment was that SoClean lacks standing because SoClean “illegally marketed its products”—thus, it had no legally protected interest in the conduct. In re SoClean, 2025 WL 974258, at *11. This purported illegal marketing related to the FDA’s 2020 Safety Communication stating that devices using ozone to clean PAP machines “are not legally marketed for this use by FDA in the U.S., and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown,” as well as FDA’s subsequent statements that the SoClean device had not been appropriately classified. Id. at *19.
The Special Master rejected the notion that the legality of marketing a product with a certain device classification was something a court should be deciding. The FDCA does not provide a private right of action, and the Special Master noted that the Third Circuit had observed that it is “not appropriate for a court in a Lanham Act case to determine preemptively how a federal administrative agency will interpret and enforce its own regulations.” Id. at *16 (quoting Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 231–32 (3d Cir. 1990.)). “[C]ourts have repeatedly declined to determine whether certain acts represent a violation of the FDCA.” Id. at *18.
The Special Master held that any determination of the lawfulness of SoClean’s conduct would require the Court to determine SoClean’s compliance vel non with the FDCA. However, the Special Master observed that there had been no clear determination by the FDA that SoClean’s sale and marketing of the device was unlawful (unlike with some other producers of ozone devices), nor did the FDA take any enforcement action, such as a warning letter. “If the Court were to conclude that SoClean’s actions were unlawful under the FDCA, this would be an overstep of the Court’s authority to question the FDA’s prosecutorial discretion under the FDCA.” Id. at *19.
Because the analysis and the interpretation of the FDCA lies within “the exclusive province of the FDA, a judicial determination that SoClean’s conduct was unlawful under the FDCA is precluded.” Id. Philips’s standing argument, therefore, could not be determined “without overreaching into the FDA’s jurisdiction.” Id.
Plaintiffs cannot use the Lanham Act as a vehicle to preemptively determine FDCA issues that are properly given to the FDA itself. This holding, if adopted by the MDL Court, is significant for any case, Lanham Act or otherwise, where a party is seeking to supplant the FDA’s judgment.