As an openly defense-oriented blog, most of our posts deal with cases in which plaintiffs could not make out their claims. They didn’t have sufficient evidence of a design defect. They couldn’t prove proximate causation. That type of thing. But, what if plaintiff’s claim is that the defendant can’t prove its claim about its product? Well, in California, you can’t do that.
That was the issue addressed by the court in Stanley v. Bayer Healthcare LLC, 2012 U.S. Dist. LEXIS 47895 (S.D. Cal. Apr. 3, 2012). Plaintiff’s doctor recommended she take probiotics to help relieve the diarrhea she had been experiencing as a result of her diverticulitis. Based on her pharmacist’s recommendation, plaintiff purchased Phillips’ Colon Health Probiotic Caps (“PCH”), which contained the following statement: “Helps Defend against Occasional DIARRHEA.” She used the product for about a week without any relief. She filed a consumer fraud class action complaint one week later. Id. at *2-4. Seems to be curious timing, but we’ll refrain from further comment on that. Because, despite the quick filing of the suit, plaintiff had almost a year to develop her allegations and theories – without success.
Attempting to state a claim under California’s Consumer Legal Remedies Act (“CLRA”) and Unfair Competition Law (“UCL”), plaintiff alleged that defendant’s statements about the digestive and health benefits of PCH were false and misleading because defendant had “a complete lack of scientific or clinical data to support its claims,” and defendant “fail[ed] to provide the consumer with a single bit of information that would support its claims about the benefits of the [PCH],” and defendant’s claims “are not substantiated by the vast majority of generally accepted scientific literature.” Id. at *5. Putting aside whether plaintiff could prove any of those allegations, she had a bigger problem – California doesn’t recognize a private cause of action for failure to substantiate an advertising claim:
Private individuals may not bring an action demanding substantiation for advertising claims. Instead, pursuant to Cal. Bus. & Prof. Code § 17508, only prosecuting authorities may require an advertiser to substantiate its advertising claims.
Id. at *9 (citations omitted). See National Council Against Health Fraud, Inc. v. King Bio Pharmaceuticals, Inc., 107 Cal. App. 4th 1336, 1344 (2003) (“[p]rosecuting authorities, but not private plaintiffs, have the administrative power to request advertisers to substantiate advertising claims before bringing actions for false advertisement ....”).
Faced with this clear statement of the law, plaintiff acknowledged that a claim based on lack of substantiation wasn’t actionable, but then responded to defendant’s motion for summary judgment on this ground by arguing that defendant failed to substantiate its claims. Stanley, 2012 U.S. Dist. LEXIS 47895, at *12. Huh? If you are shaking your head in confusion, so are we and apparently so was the court:
Plaintiff argues at length both in her motion for class certification and in opposition to the summary judgment motion that Defendant's claims regarding the general digestive and immune system health benefits of PCH are actually false because they lack proper scientific substantiation. However, the alleged lack of substantiation does not render claims false and misleading under the UCL or CLRA.
Id. at *12. Plaintiff’s expert evidence suffered from the same fatal flaw – none of plaintiff’s experts opined that defendant’s statements about the product’s benefits were “actually false, or explain[ed] how those statements might mislead a reasonable consumer.” Id. at *15-16. Rather, they focused on an alleged lack of substantiation – for which there is no private cause of action.
Apparently waking up to the reality of having targeted a non-actionable claim, at the time of the class certification and summary judgment hearing, plaintiff argued for the first time that she could maintain her action under the “unlawful conduct” arm of the UCL. The alleged unlawful conduct was defendant’s failure “to properly substantiate its claims pursuant to standards set by the FDCA.” Id. at *19. The court had several reasons for discounting plaintiff’s “unlawful conduct” argument, including that it raised issues regarding preemption that would have required briefing and that it was still essentially a lack of substantiation claim. Id. But the court examined the underlying evidence anyway, which didn’t further plaintiff’s cause.
Under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), manufacturers of dietary supplements, which PCH is, are allowed to make certain “structure/function claims” without pre-approval by the FDA. Id. at *21. Structure/function claims are statements that
describe[] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize[] the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.
Id. (quotation marks omitted). A dietary supplement manufacturer must provide notice to the FDA within 30 days of first use of a structure/function claim, and must include a disclaimer on the label stating that “the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease.” Id. (citations and quotation marks omitted).
Plaintiff’s experts, therefore, attempted to opine that the statements on the PCH labeling were health claims – which require more rigorous substantiation -- not structure/function claims. However, plaintiff’s experts had to admit that they didn’t know how the FDA defines a health claim. To which the court had this to say:
Plaintiff cannot create a genuine issue of material fact regarding whether Defendant met the level of substantiation required under federal law by presenting opinions from experts who are not aware of the relevant regulatory standards.
Id. at *23. We certainly like the sound of that.
Plaintiff tried a few other avenues to attempt to save her claim, but they proved to be as full of potholes as the lack of substantiation claim:
- The product didn’t work for me – OK, but “nothing on the PCH box, internal packaging, or advertisement represents to consumers that the product is intended to relieve diarrhea. The fact PCH did not relieve Plaintiff's diarrhea does not mean a reasonable consumer would be mislead into believing it would work as Plaintiff suggests. The Plaintiff has failed to produce any evidence that the product does not work for the purposes for which it is advertised - to promote overall digestive health and to defend against occasional diarrhea and other gastrointestinal issues.” Id. at *24.
- They didn’t tell me I had to take it continuously – But the packaging said: “Daily Probiotic Supplement” and the label directs that PCH is “to be taken Daily or Everyday to support digestive health.” So, “what additional material fact [did] Defendant [have] an affirmative duty to disclose?” The court agreed that plaintiff left that question unanswered. Id. at *27-28.
- A different size bottle of PCH that I didn’t buy contained a statement that I didn’t rely on about scientific studies that I allege is misleading – The court’s conclusion is self-explanatory: “There is no evidence Plaintiff . . .ever saw the [statement]. Thus, the statement cannot form the basis of Plaintiff's false advertising claim.” Id. at *30.
So, no private cause of action for lack of substantiation plus no evidence to prove any statement was false or misleading equals no class action. Toss in the good expert sound bites and this case certainly sits well in our stomachs.