Gerber's Good Start troubles continue

Hasemann v. Gerber Prods. Co., 2024 WL 1282368, No. 15-CV-2995(EK)(JAM), 16-CV-1153(EK)(JAM), 17-CV-0093(EK)(JAM) (E.D.N.Y. Mar. 25, 2024)

Gerber Good Start Gentle formula isn’t like most other infant formulas, which are made with “intact” cow’s milk protein. GSG uses cow’s milk protein that has been partially broken down (“100% Whey-Protein Partially Hydrolyzed”). The FDA allowed GSG to make “certain specified, modest claims” related to atopic dermatitis, aka eczema, which is the most common allergic disease in infants.

But the FDA was very limited in what it allowed: It would not object if Gerber claimed that “little scientific evidence suggests” that feeding certain infants a “100% Whey Protein Partially Hydrolyzed infant formula” for the first four months of life “may reduce the risk of developing atopic dermatitis throughout the 1st year of life.” The FDA also agreed not to challenge the assertion that “very little scientific evidence suggests” that the benefits may persist “up to 3 years of age.”

Gerber then revised GSG’s packaging to say, among other things, that GSG was the first and “only” formula “to reduce” an infant’s “risk of developing allergies.”

Previously, NY and Florida classes were certified, and there are also individual claims under New York, Florida, North Carolina, and Wisconsin law.

Here, the court denied Gerber’s motion for near-complete summary judgment (except Wisconsin individual claims) and denied plaintiffs’ motion for partial summary judgment, and also cabined the scope of Gerber’s expert’s testimony.

Plaintiffs alleged two misrepresentations (1) GSG “reduces the risk of infants developing allergies.” (2) Implied FDA endorsement, which allegedly occurred when Gerber “deemphasized” the qualified health claim’s “underwhelming specifics” in its ads.

First, a safety-seal sticker on certain GSG canisters stated: “1st & ONLY Routine Formula // TO REDUCE RISK OF DEVELOPING ALLERGIES // See label inside.” That label, which could be peeled back before purchase (if you would actually do that in a store) stated, in part:

Good to know. Our Comfort Proteins® Advantage ... If you choose to introduce formula and have a family history of allergy, feeding a formula exclusively made with 100% whey partially hydrolyzed, like GOOD START Gentle formula, during the first four months of life may reduce the risk of atopic dermatitis* throughout the 1st year, compared to formulas made with intact cow’s milk protein. The scientific evidence for this is limited and not all babies will benefit.

The asterisk following “dermatitis” referred to this statement: “*the most common allergy in infancy. GOOD START Gentle formula should not be fed to infants who are allergic to milk or infants with existing milk allergy symptoms. Not for allergy treatment.”

Second, a full-page print magazine ad that featured an image of a baby’s face with the sentence: “The Gerber Generation says ‘I love Mommy’s eyes, not her allergies.’ ” Smaller text below this line, next to an image of a GSG canister, stated:

If you have allergies in your family, breastfeeding your baby can help reduce their risk. And, if you decide to introduce formula, research shows the formula you first provide your baby may make a difference. In the case of Gerber Good Start Gentle Formula, it’s the Comfort Proteins Advantage that is easy to digest and may also deliver protective benefits. That’s why Gerber Good Start Gentle Formula is nutrition inspired by breastmilk.

Third, there was a similar TV ad with “may also” language. (The FTC did not like these ads either.)

Plaintiffs alleged that these ads were false and misleading because there was no scientific evidence supporting the claim that GSG reduced the risk of developing certain allergies or atopic dermatitis.

As for the implied FDA endorsement: (1) A coupon affixed to certain GSG containers described it as “the first and only formula brand made from 100% whey protein partially hydrolyzed, and that meets the criteria for a FDA Qualified Health Claim for atopic dermatitis.” It also bore a gold roundel, featuring the phrase “1st AND ONLY” surrounded by the phrase “MEETS FDA QUALIFIED HEALTH CLAIM.” (2) A print magazine advertisement described GSG as the “1st Formula with FDA qualified health claim.” (3) Another print ad said GSG was “the first and only infant formula that meets the criteria for a FDA Qualified Health Claim.”

In fact, the FDA authorizes health claims only when there is “significant scientific agreement.” It allows qualified health claims when they are “supported by some scientific evidence” and accompanied by a disclaimer; the FDA doesn’t approve these claims, but instead exercises enforcement discretion not to go after them. Crucially, “[t]he qualified health claim about GSG that the FDA ultimately permitted is not the claim Gerber originally sought permission to make.” Although Gerber referred to the qualified health claim determination in its ads, it didn’t use any of the approved versions.

Gerber’s proposed expert witness, a pediatric gastroenterologist who worked at Gerber for nearly two decades, first as the Medical and Scientific Director, then as the Global Chief Medical Officer, would opine that “Gerber had, and has, a scientifically sound basis” to represent that “feeding [GSG] instead of intact cow milk protein formula (CMF) to infants with a family history of allergy in the first month of life can reduce the risk that said infants will develop allergies, particularly and specifically atopic dermatitis.” He would further opine that “there is a significant and substantial body of scientific evidence to support the representations in the Challenged Advertisements.” “These opinions are, of course, more forceful than the claims the FDA permitted Gerber to make on the same subject.”

Plaintiffs’ arguments about bias, lack of data, and prejudice/confusing the jury did not justify his exclusion, but did justify limiting his testimony. He could be impeached with his relationship with Gerber. As for inadequate data, his report was “at base a literature review” considering 20 peer-reviewed publications of infant trials; he identified four studies as high quality. Three of those reported that the subjects receiving GSG or its equivalent saw statistically significant reductions in atopic dermatitis or other allergic diseases for at least a short time. Other studies showed no reduction compared to ordinary cow’s milk formula, or at least no statistically significant reduction. A review of medical literature is generally reliable methodology.

However, it could not appropriately include “findings that had not been published before Gerber disseminated the challenged advertisements. … Here, the operative question is whether Gerber’s challenged ads were misleading when made, not whether they would be misleading if made today.” Thus, the expert would be limited, when opining on the science underlying claims in a given ad, “to the body of research that existed when that advertisement debuted.” But most of the “high quality” studies would qualify under that restriction. Plaintiffs disagreed that the studies were “high quality,” but that was an issue for the factfinder.

As to summary judgment: there was a genuine issue of material fact about whether reasonable consumers would perceive the ads to claim that GSG could reduce allergy risk. (Is that not obviously what the ads say, especially the sticker touting: “1st & ONLY Routine Formula // TO REDUCE RISK OF DEVELOPING ALLERGIES // See label inside.”?) “Even accepting, arguendo, that the more cabined language on the ‘label inside’ clarified that GSG does not reduce the risk of developing allergies, a jury could still find that a reasonable consumer would be left with that impression.” As to the other ads, the implication was obvious, and a jury could find it so. (I’m not clear how a reasonable jury could find otherwise.)

Further, internal communications showed that Gerber actively endeavored to make an allergy claim with these ads: Gerber asked its advertisers in a “communications brief” to “[c]reate a strong link between GSG ... [and] an allergy risk reduction benefit.” Gerber’s marketing team described “being challenged to find ways to push the envelope with bringing the allergy message forward.” Gerber told its ad firm that it “would now like to pursue” an ad “that actually uses the word ‘allergy’ in the headline (where previously we were not able to).”

There was also a genuine dispute of material fact as to whether the “first and only” group of challenged ads claimed FDA endorsement of GSG. “[A]dvertisements that reframe critiques of a product as praise can constitute false advertising.”

Gerber argued that none of the ads explicitly claimed to reduce allergies (uhhh… I do not think that word means what you think it means) or made FDA-endorsement claims, and there was no extrinsic evidence about what claims consumers would take away.

But “the requirement of extrinsic evidence to prove that implied assertions in ads are false is chiefly a requirement of Lanham Act false advertising claims — claims not present here.” (And by the way, it has no foundation in the Lanham Act, either. Courts just made it up as a case-management tool, while imposing a different rule in TM cases.) “GBL and FDUTPA claims challenging deceptive advertisements have no extrinsic evidence requirement. Those statutes ‘are not mere Lanham Act analogues.’”

“The plaintiffs need not adduce extrinsic evidence of consumer perception to create a jury question on the deceptiveness element.” (Side note: the individual plaintiffs’ own testimony should be “extrinsic evidence,” too.) (Extra side note: I know we’re all textualists now, but maybe this debate would be aided by talking about why requiring extrinsic evidence, or survey/consumer perception evidence testimony in particular, would be important.)

However, the plaintiffs didn’t show as a matter of law that GSG couldn’t reduce allergy risk. Likewise, whether the FDA statements were false was a triable issue, though it was a close call: “Gerber has adduced little evidence to rebut the plain implications of its advertising, when compared to the qualified health claims that the FDA actually authorized. … Here, though there is no genuine dispute about whether the FDA ‘endorsed’ GSG, there is … a lingering dispute about whether Gerber implied such an endorsement.”

Nor was summary judgment appropriate for either side on a price premium theory. Plaintiffs’ experts, who used conjoint analysis and similar standard techniques, were not unquestioned. Under the relevant state laws, “damages need not be calculated by mathematical precision” but “may include estimates based on assumptions, so long as the assumptions rest on adequate data.” One of the experts calculated price premiums in ways that didn’t rely on conjoint analysis, but used internal Gerber metrics, including its own estimate of the price elasticity of demand, for the value Gerber would realize from promoting the qualified health claim, including its projection of 6-10% growth in the United States for the first six months after introduction of an “allergy claim” to the U.S. market;  Gerber sales forecasts that quantified various factors, including the “allergy claim,” as “impactors” on future sales; and the price increases for GSG that Gerber implemented from 2011 to 2014, spanning the period of these claims.

Gerber’s core argument was that GSG was priced equal to or below other formulas in the Gerber Good Start line during the class period, even though these other formulas undisputedly did not make the challenged claims. But there was also evidence that Gerber expected to be able to raise prices across “the entire Good Start portfolio” thanks to the challenged advertising. This was a jury question.