lack of substantiation versus falsity

In re Bayer Phillips Colon Health Probiotic Sales Practices Litig., No. 11–3017, 2014 WL 5776153 (D.N.J. Nov. 6, 2014)

This is another case where Bayer argued that the plaintiff’s claims were merely based on “lack of substantiation” for Bayer’s scientific claims that the combination of 3 bacterial strains in its Phillips Colon Health Probiotic products “helps defend against” “constipation, diarrhea, [and] gas and bloating.”  Plaintiff argued that a wide range of advertising “consistently conveyed one message: Phillips’ Colon Health, with its probiotic bacteria cultures, is scientifically proven to provide all consumers with digestive and immune system health benefits.”  The court agreed that lack of substantiation couldn’t ground a private action under Illinois or California consumer protection law, but found that plaintiffs had stated a claim for falsity.  The court did not specifically note that plaintiff was trying to falsify the “scientifically proven” part of that, but the allegations on which it relied are instructive.

The complaint alleged that the European Food Safety Authority (EFSA) reviewed the scientific proof in relation to the strains of bacteria and concluded that the data didn’t demonstrate a cause and effect relationship between consumption and “improvement of intestinal transit within the normal range,” “decreasing potentially pathogenic intestinal microorganisms in infants and children aged between 0 and 36 months,” “immune system improvement,” or “maintenance of defenses against pathogenic bacteria.” The court found that these scientific studies allowed the court to draw the reasonable inference that Bayer’s claims were false or “at a minimum” misleading.  The misleadingness, I think, has to come from the implicit or explicit claim that the benefits of the product are scientifically proven.  As I often say, this isn’t a lack of substantiation theory; not all claims need to be scientifically proven.  But when health and similar claims are proven to be not founded in science, the inherent representation that they are so founded has been falsified.