Corbett v.
PharmaCare U.S., Inc., 2024 WL 1356220, No. 21cv137-JES (AHG) (S.D. Cal. Mar.
29, 2024)
The court partially
grants class certification and rejects motions to exclude experts. Plaintiffs
allege consumer protection and breach of warranty claims based on PharmaCare’s
Sambucol product, a dietary supplement that is advertised to “support immunity”
and contain a proprietary extract of black elderberry. Sambucol comes in
various forms, including syrup, tablets, capsules, and gummies. The challenged
labels include some combination of the following statements: “Supports
Immunity”; “Scientifically Tested” (xkcd is,
as always, excellent on this); “Supports the immune
system”; “Virologist Developed”; “provides strong immune system support to help
you and your family stay healthy throughout the year. … conveniently arms you
with some of the best protection nature has to offer”; “only Sambucol® can
guarantee consistent, immune supporting properties in every serving”; “Developed
by a world renowned virologist, Sambucol®’s unique manufacturing process
preserves and maximizes the naturally occurring health benefits of the Black
Elderberry”; “used in published scientific studies. No other elderberry brand
can make the same claim”; “Developed by a world renowned virologist, Sambucol®
has been trusted by millions worldwide. Sambucol can be taken every day for
continuous immune support.”
Plaintiffs had two
theories: first, the products contain a new unreported dietary ingredient and
therefore, were illegal to sell as dietary supplements. Second, the products
were labeled and marketed in a way that claims that they mitigate or prevent
disease.
The court allowed
the parties’ experts and their dueling consumer perception surveys, plaintiffs’
materiality survey, and dueling conjoint analysis/damages opinions.
One of the
plaintiffs was a fine representative; he testified that he wouldn’t have bought
the products if he’d known of the illegality, which didn’t make him atypical.
The other testified that he only bought products that didn’t make the alleged
misrepresentations at the core of the disease claim, so wasn’t a typical
representative for the disease claims. On the other hand, it didn’t matter that
he didn’t recall seeing the “dietary supplement” label because the crux of the
argument was that plaintiffs wouldn’t have bought the products if they’d known
they were illegal, which didn’t depend on reading the phrase “dietary
supplement.”
Because of state-law
differences, a nationwide class couldn’t be certified, but a California one
could be. The court declined to find the drug theory preempted at this time,
noting that California’s Sherman Law adopts the FDCA’s provisions; this isn’t
obviously an attempt to directly enforce the FDCA.
Predominance for the
drug claims was satisfied based on the theory that an illegal unapproved
ingredient would render the products illegal for sale, and that a jury could
find that illegality would be material to a reasonable consumer. “Plaintiffs’
unfair or deceptive business practice NDI claim may rest upon a theory that
even putting the products for sale on the marketplace is an implicit
representation that they are being legally sold and comply with the FDA.”
Further, this finding could be supported at the certification stage “based on
evidence such as the perception of the named representatives and does not
require survey evidence.”
Predominance for the
disease claims: PharmaCare argued that the labels varied between products, and
while the majority of packaging contains the statements “support immunity” and
“scientifically tested” on the front of the package, the statement “virologist
developed” varies in its location, including on other sides of the package and
in varying font sizes. Courts don’t require uniformity, only “sufficiently
similar representations.” The question was whether differences were “materially
different.”
There was no dispute
that the phrases “scientifically tested” and “supports immunity” appeared on
the front of the packaging of all products and in largely the same format and
prominence. As for “virologist developed,” it appeared variously on the back,
side, and top panels, which the court didn’t find materially different from one
another (as front placement might have been). The text also differed, in that mostly
“virologist developed” appeared as part of a bulleted list, but for several of
the products, it appeared in a paragraph on the package. Still, the text wasn’t in a smaller or
finer print; “this difference in how this one phrase appears on packaging is
not ‘materially’ different to preclude class certification, particularly in
light of the other statements that do appear consistently amongst all the
packaging for the products.”
|
variants of "virologist developed" |
PharmaCare argued
that disclaimers on the packaging precluded a disease claim: “[t]his product is
not intended to diagnose, treat, cure or prevent any disease” on the back or
the side, but not on the front. Whether disclaimers avoid deception is
typically a question of fact.
Plaintiffs’ consumer
perception survey showed people products with and without the challenged
representations, modified to be “brand neutral”—that is, removing mentions of
Pharmacare and Sambucol, botanical imagery, and modified the background color
so that participants could not use that to determine the brand.
The results showed
that test group respondents shown the challenged representations were 2.2 times
more likely to perceive the surveyed health benefits (51.9% versus 24.2%, or 27.7%
net deception). Defendants’ expert
criticized the survey universe as overbroad—nearly half hadn’t purchased any of
the products at issue in the past. He also argued that the survey didn’t test
the theory of liability, and that the survey should have tested individual
representations individually; used open-ended rather than closed-ended
questions; and used actual packaging instead of modified packaging.
Defendants’ expert’s
survey used respondents that shopped at supermarkets and drugstores who’d made
a recent purchase in the product category of nutritional supplements/vitamins.
After being shown one
of defendants’ products, respondents were asked open-ended questions, including
1) “please list all the reasons that you would or would not purchase this
product;” and 2) “if you were to purchase [the product], would you have any
expectations about specific benefits it would provide” and if answered yes,
asked to explain their beliefs. Respondents were also asked a close-ended
question on how likely it was that the product would deliver these specific
benefits, being able to choose between “very likely,” “somewhat likely,”
“neither likely nor unlikely,” “somewhat unlikely,” “very unlikely,” and “don’t
know/no opinion.”
Then respondents
were shown actual labels and asked to select any of 24 options of statements on
the packaging that appealed to them, which included the challenged representations.
If they did, they got a follow-up:
In this survey, only
39.8% of respondents identified health-related reasons for why they would purchase
the product, and only 21.2% identified immunity support. Only 71.2% of
respondents answered that they would expect the product to provide benefits; 49.2%
reported some health-related benefit, with 33.9% identifying immune
support/boost immune system. Id. Dr. Keegan’s survey further tested attributes
that consumers found appealing, including the following:
Further questions found that consumers varied in their certainty:
Defendants’ surveyor
concluded that consumers provide a wide range of reasons for purchasing the
products, without a unified or predominant reason driving their decision, that
they had wide expectations of the benefits the product would provide, that
there was wide variation in what consumers found appealing based on the
statements on the packaging, and that consumers did not uniformly understand
the statements to mean what plaintiffs assert they mean.
Plaintiffs’ expert
had his own criticisms, mostly about use of open-ended questions for most of
the survey, and a close-ended question with a ton of options. He contended that
using such questions in a self-administered online survey tends to
underestimate phenomena, and that survey experts believe that close-ended
questions are “more appropriate for scientifically rigorous, quantitative
survey research.” In his view, the survey encouraged respondents to answer “I
don’t know” to his open ended questions, while providing 24 options for the
close-ended question encouraged “under selection” of options.
Moreover, to plaintiffs’
expert, the responses actually supported the claim: “5 of the 7 most
“appealing” claims were related to the Plaintiffs’ challenged claims: ‘Supports
your immune system’ (62.7 % of respondents); ‘Supports immunity’ (59.0%);
‘Strong immune system support to help you and your family stay healthy
throughout the year’ (48.9%); ‘Immune supporting properties’ (48.9%); and
‘Scientifically tested’ (41.0%).”
The dispute didn’t
defeat predominance, because it could be resolved classwide.
So too with the
dispute over plaintiffs’ materiality survey (and defendants’ expert’s modified
version thereof). The materiality survey was a referendum: it tested consumers’
preference for buying the products with or without the challenged representations.
Consumers were 11 times more likely to choose the product with the
representations (8.1% versus 91.9%).
Defendants’ expert argued that this was
dumb, because the format drew attention to the only difference between the
products, and the product packaging in the control left open space that, in the
real world, would be filled with other product benefit claims. He conducted a survey
showing only Sambucol with the claims to one group and Sambucol without to the
other, and found “no statistically significant difference between respondents’
likelihood of purchasing products with and without the Considered
Representations.”
Again, this “amounts to a disagreement on survey methodology,
rather than suggestions that a survey could not be designed to test materiality
in the first place.”
Damages: Plaintiffs
first argued that a full refund model could be used to measure damages where a
plaintiff’s theory of liability is that the product is valueless (which an
illegal or useless product would be). The court disagreed on uselessness,
because plaintiffs didn’t show that the products had no other benefits at all. Plaintiffs
also argued that a product might actually be worthless if it was illegal to be
sold as it was, but the cited cases involved a greater degree of illegality (illegal
nicotine sales to youth, or poison sold as food, or a Schedule III controlled
substance).
But a price premium
model could work, and it was enough at this stage to propose, in detail, how
that would be done.