Implied falsity and infant formula

Evolve Biosystems, Inc. v. Abbott Labs., 2022 WL 846900, No. 19 C 5859 (N.D. Ill. Mar. 22, 2022)

Evolve (and the Regents of the UC) sued Abbott for patent infringement related to an infant formula product; Abbott counterclaimed for false advertising under the Lanham Act and unfair competition under Illinois and California state law. “Evolve countered with its own counterclaims under these same laws. Specifically, Evolve alleges that Abbott made false and misleading advertising statements about Abbott’s competing Similac Probiotic Tri-Blend product.” The court denied Abbott’s motion to dismiss.

Evolve sells a Bifidobacterium longum subsp. infantis (“B. infantis”) probiotic product for preterm infants called EVIVO. “Research indicates that EVIVO, in combination with human milk oligosaccharide prebiotics, promotes B. infantis colonization in the infant gut, improving patient outcomes. Evolve’s EVIVO product is used in newborn intensive care units (“NICUs”) across the country.”

“[R]umors began to emerge that Abbott was preparing to launch a B. infantis product that would compete with EVIVO,” allegedly causing Evolve to lose business. And Abbott allegedly did intend to launch directly competing a B. infantis product—called Similac Probiotic Tri-Blend. It prepared marketing materials for Tri-Blend and listed it for sale on Abbott’s website. Evolve allegedly continued to lose business from potential customers who paused discussions with Evolve to wait for Tri-Blend’s imminent release.

Evolve’s EVIVO product utilizes a particular strain of B. infantis, which is allegedly better than other species/strains and can “grow more robustly in an infant’s gut,” which then can improve patient outcomes. Evolve alleges that using its products “significantly reduced necrotizing enterocolitis ... compared to cohorts receiving no probiotics” and “significantly reduced late onset sepsis ... compared to those receiving the probiotics bacterium L. reuteri and those receiving no probiotics.” Tri-Blend allegedly uses a different B. infantis strain rendering it less effective such that it “may not survive well in the infant gut.”

Abbott advertised that Tri-Blend has “potency” and “stability” and is composed of “high-quality probiotic strains,” while allegedly being aware that B. infantis is more important than other probiotics and that the strain in Abbott’s product is not as effective as the strain in Evolve’s product. Abbott also states that Tri-Blend is a “unique blend,” and its marketing materials and advertisements proclaim that multi-strain probiotics “have functional advantages over single strain probiotics.” Abbott instructed its sales representatives to convey that message to customers in order to distinguish between Tri-Blend and competing products like Evolve’s EVIVO. Abbott allegedly intended to suggest to consumers that the BB-02 B. infantis strain comprises one-third of the colony-forming units in the Tri-Blend product, but it hasn’t verified that.

Rule 9(b): Evolve sufficiently pled the who, where, what, and how. “Abbott is correct that Evolve has not pleaded exact times and exact locations, that is when and where the challenged statements or labels were delivered to ‘hospitals and NICUs.’ Yet, Rule 9(b)’s particularity standard requires ‘flexibility when information lies outside of [the] plaintiff’s control.’ And as between the parties, it is Abbott that knows the exact times and dates of its sales pitches and product deliveries to its customers in this case. Therefore, Evolve’s pleading satisfies Rule 9(b).”

Puffery: Were “statements that Tri-Blend is a ‘unique blend’ with ‘high-quality probiotic strains,’ exhibits ‘potency & stability,’ and has ‘functional advantages over single strain probiotics’ ” actionable? First, statements are not puffery if they can be tested—if they make “objective claims” that describe “specific or absolute characteristics of a product capable of testing.” “Second, commercial statements are not puffery if reasonable consumers could rely on them in their purchasing decisions—if they are ‘specific’ enough to induce ‘consumer reliance.’” Evolve alleged that the physical characteristics of the strains causing them to differ were measurable, as were the strains’ clinical effects on preterm infants. It was reasonable to infer that probiotic viability in manufacture and transport was also measurable, and that potential consumers—here, hospitals and their NICUs—are aware that infant probiotic products can be tested for function and efficacy. Thus, it was reasonable to infer that customers of infant probiotic products rely on such commercial language as “poten[t],” “stabl[e],” and “high-quality” to denote the products’ function and efficacy. So too with statements that Tri-Blend is a “unique blend” with “functional advantages over single strain probiotics,” which “invokes a testable comparison between single-strain and multi-strain probiotics.” Abbott’s own exhibits specifically cited a scientific study to support the statements that Abbott’s Tri-Blend product is a “unique blend” and that multi-strain probiotics “may have functional advantages over single strains.” Another stated that Abbott’s product has been subjected to “controlled, rigorous testing,” that its “product potency & stability [is] ensured,” and that the product was “tested.”  Consumers could reasonably treat these as statements of fact.  Nor was the use of the word “may” in “may have functional advantages over single strain probiotics” protection against misleadingness, since Evolve was entitled to present evidence of actual consumer understanding.

What about the allegedly implied misrepresentation that infantis BB-02 accounted for 1/3 of the product? Abbott argued that its label wasn’t “commercial advertising or promotion.” But that phrase means nothing more than “promotional material disseminated to anonymous recipients.” The label was that. It was plausible that describing the product as a “blend” of three ingredients implicitly conveys to consumers the message that those three ingredients are present in equal parts.