Tuesday, April 24, 2012

No "lack of substantiation" claim under Cal. law

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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