Class Finds P&G’s Claims Hard to Stomach

SAN DIEGO (CN) - Procter & Gamble pushes its over-the-counter drug Align with false claims about what its "probiotic bacteria" can do, consumers say in a Superior Court class action.

Procter & Gamble pushes the drug for "digestive care." It began selling it in two sizes, for $30 and $40, in early 2009.

Lead plaintiff Dino Rikos says Procter & Gamble can't substantiate the claims it makes for the drug.

"Procter & Gamble claims in its advertising, including the packaging for Align, that these health benefits result because 'Only Align Contains Bifantis®, a Unique, Patented Probiotic,' that will 'restore your natural balance and bring peace to your digestive system.' Procter & Gamble has no support for these claims, even though it states that it does, going so far as to claim it has clinical proof. Procter & Gamble's representations are false, misleading and reasonably likely to deceive the public," the complaint states.

"Prominently placed on its product packaging and in its other advertisements, Procter & Gamble stated and continues to state that Align contains the unique and patented probiotic bacteria 'Bifantis®.' Procter & Gamble advertises and continues to advertise that 'Align is different because only Align contained Bifantis, a patented probiotic strain,' that 'brings peace to your digestive system.' For marketing its Align product, Procter & Gamble uses its trademarked phrase, 'Great Digestion Through Science.'

"In truth, the ingredient matrix found in Align has never been substantiated, clinically or otherwise, and Procter & Gamble has no legitimate basis to make these claims. In fact, the only purported clinical trial that Procter & Gamble discusses on its website concerns the effects of Bifantis in treating symptoms of inflammatory bowel disease ('IBS'), rather than the general population, to whom the advertisements are targeted. Even then, the study concludes that '[n]o statistically significant differences between [placebo and Bifantis] groups were observed at any time-point' relating to daily IBS symptom assessments. Results from this Procter & Gamble funded study are not published in a peer-reviewed scientific journal.

"Two of the other primary studies relied upon by Procter & Gamble as scientific proof - O'Mabony et al. 2005 and Whorwell et al. 2006 - fall far short of substantiating the Align marketing claims. Both are heavily flawed." (Brackets and parentheses in complaint.)

Proctor & Gamble claims, and advertises, that probiotics are "good bacteria," but "scientists have not yet mapped the tens of thousands of bacteria strains in the human body's intestinal flora, and do not know whether increasing one type of bacteria provides health benefits," the complaint states.

"There is almost no scientific support for the notion that healthy people, such as those targeted by Procter & Gamble, benefit from bacterial supplements, such as the bacteria at issue. If probiotic bacteria do have any health benefits, they must survive the digestive tract in sufficient quantities to achieve the possible benefit. However, there is no consensus on the quantities of probiotics people might need to ingest or for how long, in order to achieve a probiotic effect, if probiotics have any such effect in healthy people."

Proctor & Gamble's misrepresentations "appear prominently and conspicuously on every Align container" and its ads make the false claim that "Align, with its probiotic bacteria cultures, provides clinically proven digestive health benefits to the general public," according to the complaint.

"Procter & Gamble's advertising and marketing campaign is designed to cause consumers to buy Align as a result of this deceptive message, and Procter & Gamble has succeeded. Despite being nothing more than a sugared capsule filled with naturally occurring bacteria, a 28-count package of Align retails for approximately $30, while a 42-count package retails for approximately $40."

Rikos and seeks damages and an injunction for violations of the Consumers Legal Remedies Act and Unlawful Business Acts and Practices.

He is represented by Thomas O'Reardon II with Blood, Hurst & O'Reardon.

Earlier this year, a federal judge denied Procter and Gamble's motion to dismiss but also refused to issue injunction, saying Rikos lacked standing "because he individually does not and cannot allege a threat of future injury," according to the complaint. The judge did say, however, said Rikos could pursue his injunctive-relief claims in state court.

Though Procter and Gamble allegedly claims that "federal courts lack the authority to stop" its conduct, attorney Tim Blood told Courthouse News "that this position seems flawed and ultimately will be corrected."

Blood Hurst will "pursue all available remedies to address a defendant's conduct, including pursing monetary relief in federal court and injunctive relief in state court," the lawyer said. "Our choice would be to have one court address all relief, but Procter & Gamble prefers a more inefficient and wasteful course of action."

Procter & Gamble spokeswoman Christine Wever declined to comment on ongoing litigation.

"Probiotic" refers to naturally occurring organisms that are supposed to be beneficial to their hosts. The term is of dubious "scientific" value.

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