Stanley v. Bayer Healthcare LLC, 2012 WL 1132920 (S.D. Cal.)
Stanley brought a putative class action under the CLRA and
UCL as well as for breach of express warranty, based on Bayer’s sales of
probiotic supplements. Her doctor
recommended probiotics for diarrhea, and she bought Bayer’s caps on her
pharmacist’s recommendation. She also
read the outside of the box, which said, “Helps Defend against Occasional
DIARRHEA.” She used the product for 6-7
days but stopped when she got no relief.
Her claims covered the caps along with variants sold as a supplement and
as fiber. All the products prominently
claim benefits to digestive and immune health.
Stanley argued that Bayer’s claims lacked scientific or
clinical substantiation. Bayer moved for
summary judgment on the ground that lack of substantiation is not a basis for
relief under the UCL or CLRA. The court
agreed that it was the plaintiff’s burden to show falsity or misleadingness,
and that there was no private cause of action for substantiation. Only public authorities can seek
substantiation under California law to prevent undue harassment of advertisers
and provide the least burdensome method of obtaining substantiation.
The court noted that material omissions could found a
private claim if the defendant had a duty to disclose. Stanley’s basic argument was that the health
claims themselves inherently, and here misleadingly, implied scientific
substantiation. In particular, she
argued that the claims were misleading because there was insufficient evidence
to support the general claim that the product
promoted overall digestive health and helped defend against
occasional diarrhea and other gastrointestinal problems, and because Bayer
didn’t conduct strain specific studies of the 3 strains of probiotics in
combination, as touted on its packaging and in ads. (The claims included “Contains the most
common and most studied bacteria for digestive health (Lactobacillus and
Bifidobacterium which closely resemble your body's natural good bacteria),” and
“There's scientific evidence that Lactobacillus and Bifidobacterium help
relieve gas, diarrhea, constipation and other GI discomforts.”)
Stanley contended that the weight of the evidence from
peer-reviewed, double-blind, placebo-controlled studies suggested that
probiotics have little effect on digestive or immune health. However, none of her experts opined that the
claims “Helps Defend Against Occasional constipation, diarrhea, gas and
bloating” or “promotes overall digestive health” were actually false or
misleading.
Scientists are likely to sigh at this, but the court
concluded that “At his deposition, [one of plaintiff’s experts] testified that
probiotics may provide benefits to some people,” based on his testimony that
the results of studies varied dramatically.
Asked, “So in essence are you saying here, then, that probiotics provide
health benefits to some people and … don't provide health benefits to others?”
he said, “You can't say, because of the variation. There's no—you can't
scientifically conclude anything.” Asked
“So you can't rule out that probiotics do work for some people?” he said “It's
inconclusive.” xkcd covers this better than I ever could, on the
related issue of significance. (This is
not to say that there weren’t weaknesses in the expert opinions; the court
suggested that there was some gobbledegook involved, and the experts apparently
didn’t review the articles on which Bayer relied for its claims.) Another plaintiff’s expert more clearly said
that probiotics can benefit some people and harm others, or help the same
person at some times and harm at others—though the court thought that was
detrimental to Stanley’s case, it seems to me that a reasonable person might
consider there to be a significant difference between “this product helps
support digestive health” and “this product might help support digestive health
or might harm it, and we don’t know how to predict who experiences which
result.”
Because the court thought this case was essentially about
lack of substantiation, it just said that there’s no private cause of action
for lack thereof, rather than addressing the idea—which competitors have
occasionally had some success with in Lanham Act cases—that a health claim
inherently contains implied representations about substantiation, which can
then be misleading.
Stanley also couldn’t show a genuine issue of material fact
about whether Bayer complied with federal standards for substantiation,
assuming that this would be “unlawful” under the UCL. Because it’s a dietary supplement, Bayer
isn’t required to do much. It submitted
the structure/function claims to the FDA as required and the FDA didn’t
object. Plaintiff’s expert lacked the
regulatory expertise of Bayer’s expert and couldn’t explain why Bayer should
have been required to do more.
Stanley’s reading of the statement “helps defend against
occasional diarrhea” as promising that she would get relief from her diarrhea
wasn’t evidence of likely deception. The
side panel said “[t]his product is not intended to diagnose, treat, cure, or
prevent any disease,” and her doctor, though recommending probiotics, didn’t
recommend Bayer’s product in particular.
Nothing on the package etc. represents that it would relieve diarrhea; a reasonable consumer
wouldn’t be misled into believing that it was a diarrhea medication, especially
since there are a host of products on the market to treat ongoing
diarrhea. Thus, there was no evidence
that the product didn’t work as advertised, “to promote overall digestive
health and to defend against occasional diarrhea and other gastrointestinal
issues.” Nor did Stanley identify
exactly what Bayer should have disclosed other than that, to be effective, the
product would need to be taken continuously for an unknown period; the
packaging itself says it’s a “daily” or “everyday” supplement.
The court then turned to Stanley’s arguments that the
packages affirmatively represented that Bayer conducted clinical studies of the
combined effectiveness of the 3 probiotics.
The back of the 45-count caps says “[c]ontains a proprietary blend of 3
clinically tested strains of good bacteria.”
But the back of the 30-count caps, which Stanley bought, didn’t have
that language, and she didn’t recall reading or relying on any claims other
than the diarrhea one on the front of the box.
Bayer made a similar claim to pharmacists, but not to the public, and
there was no evidence that Stanley’s pharmacist saw the letter.
Stanley’s express warranty claim also failed because nothing
on the product warranted that use for 6-7 days would relieve her diarrhea.
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