Gerber's Good Start troubles continue

Hasemann v. GerberProds. 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 StartGentle 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 beenpartially broken down (“100% Whey-Protein Partially Hydrolyzed”). The FDAallowed GSG to make “certain specified, modest claims” related to atopicdermatitis, aka eczema, which is the most common allergic disease in infants.

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

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

Previously, NYand Florida classes were certified, and there are also individual claimsunder New York, Florida, North Carolina, and Wisconsin law.

Here, the courtdenied Gerber’s motion for near-complete summary judgment (except Wisconsinindividual claims) and denied plaintiffs’ motion for partial summary judgment, andalso cabined the scope of Gerber’s expert’s testimony.

Plaintiffs allegedtwo misrepresentations (1) GSG “reduces the risk of infants developingallergies.” (2) Implied FDA endorsement, which allegedly occurred when Gerber“deemphasized” the qualified health claim’s “underwhelming specifics” in itsads.

First, a safety-sealsticker on certain GSG canisters stated: “1st & ONLY Routine Formula // TOREDUCE RISK OF DEVELOPING ALLERGIES // See label inside.” That label, whichcould 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 tointroduce formula and have a family history of allergy, feeding a formulaexclusively made with 100% whey partially hydrolyzed, like GOOD START Gentleformula, during the first four months of life may reduce the risk of atopicdermatitis* throughout the 1st year, compared to formulas made with intactcow’s milk protein. The scientific evidence for this is limited and not allbabies will benefit.

The asteriskfollowing “dermatitis” referred to this statement: “*the most common allergy ininfancy. GOOD START Gentle formula should not be fed to infants who areallergic to milk or infants with existing milk allergy symptoms. Not forallergy treatment.”

Second, a full-pageprint 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.’ ” Smallertext below this line, next to an image of a GSG canister, stated:

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

Third, there was asimilar TV ad with “may also” language. (TheFTC did not like these ads either.)

Plaintiffs allegedthat these ads were false and misleading because there was no scientific evidencesupporting the claim that GSG reduced the risk of developing certain allergiesor atopic dermatitis.

As for the impliedFDA endorsement: (1) A coupon affixed to certain GSG containers described it as“the first and only formula brand made from 100% whey protein partiallyhydrolyzed, and that meets the criteria for a FDA Qualified Health Claim foratopic dermatitis.” It also bore a gold roundel, featuring the phrase “1st ANDONLY” surrounded by the phrase “MEETS FDA QUALIFIED HEALTH CLAIM.” (2) A printmagazine advertisement described GSG as the “1st Formula with FDA qualifiedhealth claim.” (3) Another print ad said GSG was “the first and only infantformula that meets the criteria for a FDA Qualified Health Claim.”

In fact, the FDA authorizeshealth claims only when there is “significant scientific agreement.” It allowsqualified health claims when they are “supported by some scientific evidence” andaccompanied by a disclaimer; the FDA doesn’t approve these claims, but insteadexercises enforcement discretion not to go after them. Crucially, “[t]hequalified health claim about GSG that the FDA ultimately permitted is not theclaim Gerber originally sought permission to make.” Although Gerber referred tothe qualified health claim determination in its ads, it didn’t use any of the approvedversions.

Gerber’s proposed expertwitness, a pediatric gastroenterologist who worked at Gerber for nearly twodecades, first as the Medical and Scientific Director, then as the Global ChiefMedical Officer, would opine that “Gerber had, and has, a scientifically soundbasis” to represent that “feeding [GSG] instead of intact cow milk proteinformula (CMF) to infants with a family history of allergy in the first month oflife can reduce the risk that said infants will develop allergies, particularlyand specifically atopic dermatitis.” He would further opine that “there is asignificant and substantial body of scientific evidence to support therepresentations in the Challenged Advertisements.” “These opinions are, ofcourse, more forceful than the claims the FDA permitted Gerber to make on thesame subject.”

Plaintiffs’arguments about bias, lack of data, and prejudice/confusing the jury did notjustify his exclusion, but did justify limiting his testimony. He could beimpeached with his relationship with Gerber. As for inadequate data, his reportwas “at base a literature review” considering 20 peer-reviewed publications of infanttrials; he identified four studies as high quality. Three of those reportedthat the subjects receiving GSG or its equivalent saw statistically significantreductions in atopic dermatitis or other allergic diseases for at least a shorttime. Other studies showed no reduction compared to ordinary cow’s milk formula,or at least no statistically significant reduction. A review of medical literatureis generally reliable methodology.

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

As to summaryjudgment: there was a genuine issue of material fact about whether reasonableconsumers 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 // Seelabel inside.”?) “Even accepting, arguendo, that the more cabined language onthe ‘label inside’ clarified that GSG does not reduce the risk of developingallergies, a jury could still find that a reasonable consumer would be leftwith that impression.” As to the other ads, the implication was obvious, and ajury could find it so. (I’m not clear how a reasonable jury could findotherwise.)

Further, internalcommunications showed that Gerber actively endeavored to make an allergy claimwith these ads: Gerber asked its advertisers in a “communications brief” to“[c]reate a strong link between GSG ... [and] an allergy risk reductionbenefit.” Gerber’s marketing team described “being challenged to find ways topush the envelope with bringing the allergy message forward.” Gerber told itsad 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 genuinedispute of material fact as to whether the “first and only” group of challengedads claimed FDA endorsement of GSG. “[A]dvertisements that reframe critiques ofa product as praise can constitute false advertising.”

Gerber argued thatnone of the ads explicitly claimed to reduce allergies (uhhh… I do not thinkthat word means what you think it means) or made FDA-endorsement claims, andthere was no extrinsic evidence about what claims consumers would take away.

But “the requirementof extrinsic evidence to prove that implied assertions in ads are false ischiefly a requirement of Lanham Act false advertising claims — claims notpresent 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 differentrule in TM cases.) “GBL and FDUTPA claims challenging deceptive advertisementshave no extrinsic evidence requirement. Those statutes ‘are not mere Lanham Actanalogues.’”

“The plaintiffs neednot adduce extrinsic evidence of consumer perception to create a jury questionon the deceptiveness element.” (Side note: the individual plaintiffs’ owntestimony should be “extrinsic evidence,” too.) (Extra side note: I know we’reall textualists now, but maybe this debate would be aided by talking about whyrequiring extrinsic evidence, or survey/consumer perception evidencetestimony in particular, would be important.)

However, theplaintiffs didn’t show as a matter of law that GSG couldn’treduce allergy risk. Likewise, whether the FDA statements were false was a triableissue, though it was a close call: “Gerberhas 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 anendorsement.”

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

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