The court engaged in an extremely detailed discussion of the
scientific evidence here in resolving some of the parties’ Daubert challenges to the other side’s experts. Plaintiffs alleged that Bayer made false and
deceptive claims about prostate health benefits for One-a-Day Men's Health
Formula and One-a-Day Men's 50+ Advantage. They argued that, despite mounting
scientific evidence that the ingredients didn’t support prostate health and didn’t
reduce the risk of prostate cancer, Bayer deceptively marketed the products as
having such benefits, gaining an unfair advantage over other vitamin makers. The key two claims were representations that
the products supported overall prostate health and that “emerging research
suggests selenium may reduce the risk of prostate cancer” (only made for the
Men’s Health product). The selenium
claim was on the back of the product package, highlighted, bolded, and
italicized. Bayer ran many TV ads with
the same or similar messages, e.g., “Did you know one in three men will face
prostate issues? One in three, really? That's why One–A–Day Men's is a complete
multivitamin ... with Lycopene, which ... Harvard studies suggest may help
prostate health.”
Plaintiffs alleged that they read and relied on the claims
on the product packaging, and saw and relied on TV ads making the prostate
claims.
The parties each identified three experts and sought to
exclude the other’s. Because the court
found that plaintiffs’ claims were wrongly based on lack of substantiation
rather than proof of falsity or deception, summary judgment was warranted
without any inquiry into the validity of plaintiffs’ damages calculations.
Plaintiffs’ experts essentially opined that the prostate
claims were unsubstantiated—not backed by credible scientific evidence—when
Bayer made them, and that scientific evidence showed that selenium
supplementation didn’t affect the incidence of prostate cancer. Bayer’s experts
opined that scientific evidence existed to substantiate the claims during the
class period.
I won’t go through the arguments in detail, but among the
tidbits: Bayer argued that some of the expert opinions were preempted by FDA
guidance allowing Bayer to make these claims.
In 2003, the FDA approved a “qualified health claim” regarding selenium:
“Selenium may reduce the risk of certain cancers. Some scientific evidence
suggests that consumption of selenium may reduce the risk of certain forms of
cancers. However, the FDA has determined that this evidence is limited and not
conclusive.” The court disagreed. While
any allegations based on language exactly replicating this statement would be
preempted, the FDA didn’t allow any claim specifically linking selenium to a
reduced risk of prostate cancer.
Moreover, though Bayer was not required to substantiate its
claims, objecting to an expert’s conclusion that the claims were
unsubstantiated wasn’t a proper means to exclude testimony.
The FDA doesn’t recognize food intake studies as
substantiation for cancer risk reduction claims; plaintiffs argued that Bayer’s
experts therefore couldn’t rely on food intake studies, while Bayer argued that
the World Cancer Research Fund and at least one study disagreed, and that it
was only making structure/function claims, not cancer risk reduction claims.
The court determined that plaintiffs’ objection went to weight rather than
admissibility.
Testimony from plaintiffs’ marketing expert was also
excluded, despite his extensive qualifications and the arguable reliability of
his conclusions. His report was
ultimately just a chronology of Bayer’s marketing efforts focusing on prostate
health as the “reason to believe” in the products, quoting third party market
research and Bayer’s own internal documents.
The underlying evidence, if admissible, could come in at trial without
an expert’s help.
The court then turned to Bayer’s motion for summary
judgment. Under California law, private
parties may not bring lack of substantiation claims. (This discussion finesses the question of
establishment claims—statements that expressly or by implication indicate that
scientific evidence supports the marketer’s specific claim. Claims for supplements or other
health-related products are almost inherently going to be establishment
claims. Lanham Act doctrine is that
establishment claims can be proved false by showing that the evidence
underlying the establishment claim doesn’t actually support it. Why can’t you also show a violation of
consumer protection laws when (1) reasonable consumers would receive a “tests
prove” message, (2) tests don’t prove the statement at issue, and (3)
reasonable consumers would attach weight to/rely on the presence of scientific
proof?)
The reason for limiting substantiation claims to public
authorities is to “prevent undue harassment of advertisers” and provide “the
least burdensome method of obtaining substantiation for advertising claims.”
Initially, Bayer argued that the UCL and CLRA claims were
preempted by the Nutrition Labeling and Education Act (NLEA), because the FDA
drafted and approved the statement “selenium may reduce the risk of certain
forms of cancer.” Bayer argued that,
logically, prostate cancer was just a specific form of cancer, and “some
scientific evidence” was essentially synonymous with “emerging research,” so
Bayer’s statement “emerging research suggests selenium may reduce the risk of
prostate cancer” was squarely within the ambit of the FDA-approved language. (Later, the FDA approved the following
qualified health claim: “Two weak studies suggest that selenium intake may reduce
the risk of prostate cancer. However, four stronger studies and three weak
studies showed no reduction in risk. Based on these studies, FDA concludes that
it is highly unlikely that selenium supplements reduce the risk of prostate
cancer.”)
The court found no preemption. “[T]he representations at issue clearly
included additional language never approved or even considered by the FDA.” Even
the older FDA-approved claim was “Selenium may reduce the risk of certain
cancers. Some scientific evidence suggests that consumption of selenium may
reduce the risk of certain forms of cancers. However, the FDA has determined
that this evidence is limited and not conclusive.” This never specifically
linked selenium to prostate cancer, whereas Bayer did, stating on the package,
“Did you know that prostate cancer is the most frequently diagnosed cancer in
men and that emerging research suggests Selenium may reduce the risk of
prostate cancer? One–A–Day Men's Health Formula is a complete multivitamin plus
key nutrients including Selenium to support a healthy prostate” and only then
adding the FDA-approved statement. “[I]t
is clear that Bayer exceeded the bounds of the language authorized by the FDA.”
Under the UCL and CLRA, it’s the overall
representations that matter.
However, Bayer did better with its substantiation
argument. Plaintiffs argued that they
were really contending that the prostate statements were provably false/likely
to deceive consumers. Here, they
contended, substantial evidence existed that the ingredients Bayer pointed to don’t support prostate health or reduce
the risk of prostate cancer. So this
wasn’t a case where there was no evidence one way or the other, but rather a
case where Bayer’s claims had been disproved.
At least with respect to zinc and vitamin E, Bayer had
evidence allowing a structure/function claim for prostate health and plaintiffs
didn’t present evidence that zinc and vitamin E don’t support prostate health, instead just trying to cast doubt on
Bayer’s evidence. As to lycopene and
selenium, the court also found that there was evidence to support Bayer’s
contentions and that plaintiffs were ultimately relying on a lack of
substantiation theory.
The court broke the timeline down based on the appearance of
a major selenium study changing the landscape of scientific understanding over
time. (Interestingly, plaintiffs argued
that Bayer internally disagreed with its lawyers’ attempts to discredit a major
study, citing internal documents saying things like “[after this study,] Selenium
... looks like it not only has no effect on prostate health but as a
supplement, it may do more harm in prostate cancer patients.” ) The court found that plaintiffs raised
genuine concerns about substantiation after the study, but still couldn’t bring
the claim. Moreover, the court found
that there was still a possibility that selenium supplements could reduce the
risk of prostate cancer. Thus, this
wasn’t a case of per se falsity through complete lack of substantiation. “[I]n the absence of affirmative evidence
that scientific research did not support the Prostate Cancer Claim … , the
strength of Bayer's evidence is irrelevant and Plaintiffs' claims are based on
“lack of substantiation” rather than proof of falsity.” The difference between a claim with no
evidentiary support and a claim that has been disproved was dispositive. Any substantiation determination would have
to be made by the FDA.
Plaintiffs argued that they could still show
deceptiveness. The court disagreed. “[C]ase law is less than clear as to what a
private plaintiff needs to prove to successfully litigate a cause of action
alleging misleading or deceptive practices,” and plaintiffs’ deceptiveness
arguments were confusing. The court
understood them to be that Bayer’s representations were deceptive because they
were unsubstantiated, but because Bayer’s representations weren’t provably
false, private plaintiffs couldn’t bring that kind of claim. (Again, note the finessing: which representations weren’t provably
false? The explicit health/cancer
claims, or the implicit “scientific evidence supports our health/cancer
claims”?) The court contrasted this to a
case in which plaintiffs explained how the representations at issue were
deceptive and had proof of actual deception.
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