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.”
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.”
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.