Tuesday, April 23, 2013

lack of substantiation not actionable by consumers

Johns v. Bayer Corp., 2013 WL 1498965 (S.D. Cal.)

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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