United States: Out Of Align-Ment: Sixth Circuit Affirms Class Certification In Probiotics Case

A recent Sixth Circuit decision that affirmed certification of a multi-state consumer class action asserting false advertising claims concerning Align – a Proctor & Gamble probiotic product promising digestive health benefits – has left us with an uneasy feeling in the pit of our stomachs. In Rikos v. P&G, the judge writing the opinion of the Court in a split decision (with one concurrence and one dissent) found that the class plaintiffs had shown commonality and typicality, despite the fact that unrebutted evidence tended to show that the product actually worked as advertised for a subset of the class.

As the dissenting judge persuasively pointed out, certification should have been denied under recent Supreme Court precedent. As it is, this case has the potential for allowing doomed class actions to linger in court much longer than they should and creating logistical problems for trial courts applying this precedent.

The product in question is an over the counter probiotic marketed to the general public as a supplement that "naturally helps build and support a healthy digestive system, maintains digestive balance, and fortif[ies] your digestive system with healthy bacteria." The consolidated class plaintiffs, suing under California, Illinois, Florida, New Hampshire and North Carolina law, argue that the digestive benefit marketing claims were false because Align is a placebo at best and snake oil at worst.

Probiotics are considered to be a promising field of medicine with potential as an effective treatment, but research is in its infancy. That said, Procter & Gamble provided evidence at the "rigorous analysis" stage of class certification that indicated Align is an effective treatment for sufferers of irritable bowel syndrome. The class plaintiffs did not rebut this evidence, but promised to prove definitively that Align does not work through a yet to be designed clinical trial after certification.

The majority decision reasoned that the commonality requirements were fulfilled because the common question presented by the class was "whether Align is 'snake oil' and thus does not yield benefits to anyone" and certification was appropriate if the plaintiffs "can prove" that all class members suffered the same injury. In other words, the fact that the class plaintiffs proposed a clinical trial that could theoretically prove that Align does not work at all for irritable bowel syndrome sufferers and otherwise healthy consumers alike was sufficient to justify class certification. This reasoning incorrectly disregards evidence in the record at the certification stage, however, and sets the certification bar far too low.

Under recent Supreme Court precedent, Walmart Stores, Inc. v. Duke in particular, evidence showing that the product works as advertised is not beyond the scope of the court's "rigorous analysis" for class certification. In this case, the unrebutted evidence that Align worked for irritable bowel syndrome sufferers – who were not excluded from the putative class of consumers – should have torpedoed certification under Rule 23 for failure to prove commonality and that common questions will predominate.

As the dissent cogently explained, "[b]ecause the evidence tends to show that these two groups [i.e. irritable bowel syndrome sufferers and otherwise healthy consumers] respond differently to Align, Plaintiffs have failed to meet their burden of showing that their theory of liability leads itself to common investigation and resolution." In practice, as the dissent recognized, the decision to allow plaintiffs to "define the question at an impossibly high level of abstraction" will create confusion and redundancy. If the product does work for some consumers (as the evidence indicated it does), the trial court will either have to whittle down the class it certified so broadly to eliminate sub-classes for whom the product actually works or dismiss the claim entirely, as it could have done previously. The correct approach – as the Supreme Court recognized – is to take care of this issue at the class certification stage.

The concurrence, which suggests that its author felt a degree of queasiness with the majority decision, proposes a Solomonic solution: bifurcate the case to decide first whether Align provides any gastric health benefits at all. "If, as Plaintiffs claim, there is no scientific evidence that Align promotes digestive health for anyone, the case can proceed in the regular course. If on the other hand, Plaintiffs' proofs fail to establish that Align has no digestive health benefits, the case should be dismissed." It is still unclear, however, why this issue was not or could not be resolved in Proctor & Gamble's favor at the class certification stage: the defendant actually came forward with evidence the product works for class members suffering from irritable bowel syndrome, which the plaintiffs did not rebut. Allowing the plaintiffs another bite at the apple defeats the point of "rigorous analysis" at the certification stage.

This decision is still very fresh, but we will keep our readers informed as courts, consumers and advertisers digest its implications.

Out Of Align-Ment: Sixth Circuit Affirms Class Certification In Probiotics Case

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