court finds unique tracking of units of fluoride products immaterial even if vaguely safety-related

Method Pharmaceuticals, LLC v. H2-Pharma, LLC, 2025 WL 2298395, No. 2:20-cv-753-ECM (M.D. Ala. Aug. 8, 2025)

Method asked the court to reconsider its ruling granting summary judgment on certain false advertising claims to H2, which sells a fluoride product as a supplement; the court declined, elaborating on its consideration of materiality. (Claims of false advertising as to FDA approval are still pending.)

At issue in this opinion is serialization (serial number tracking so each unit is unique). The court previously found that serialization was not material to the purchasing decisions of participants in the fluoride pharmaceutical market. The theory here was that market participants falsely believed that H2’s products were serialized, which contributed to their purchases.

Ignoring the procedural context, H2’s evidence indicated that customers don’t purchase based on serialization but primarily consider the price and available volume. The record evidence included contracts between wholesalers and manufactures not requiring serialization. Also, the FDA did not begin enforcing serialization until 2023—three years after H2 changed its label.

It was insufficient to argue that serialization was material because it was an “inherent characteristic.” “[T]he ‘inherent quality or characteristic’ formulation adopted by [the Eleventh Circuit] does not replace the consumer-oriented nature of the materiality inquiry with a scientific one.”

Method further argued that consumers expect fluoride products to be serialized, because consumers expect a product to comply with federal law. But that reasoning would require the court to make a finding that it couldn’t without intruding on the FDA’s jurisdiction: whether H2’s fluoride products are dietary supplements (as H2 promotes them, and which need not be serialized) or prescription drugs (which must be). Plus, there wasn’t evidence that consumers falsely believed H2’s products complied with federal law in a manner that affected their purchasing decisions; specifically, there wasn’t evidence that consumers think the products are FDA-approved prescription drugs.  

There was also a dispute over Walgreens, which allegedly agreed that Method’s and H2’s products were not substitutable, which Method argued indicated that serialization was material to Walgreens. But Walgreens continued to substitute H2’s fluoride products for Method’s even after Method sent Walgreens a copy of the original complaint in this case. “If serialization was as material to Walgreens’ decision as Method claims, Walgreens likely would have ceased … substituting H2’s products for Method’s, which Walgreens did not.” (There are also contractual failure-to-supply penalties involved; Method “never asked Walgreens the question about the reasons underlying its decision to find H2’s and Method’s products different.”)

Finally, Method argued that serialization relates to safety and is therefore material. “While the Court accepts the basic premise that safety concerns may be material, the Court is not persuaded in this instance because Method again does not show that customers make purchasing decisions based on a preference for serialized or non-serialized products because of a difference in safety.”