Last month, the United States District Court for the District of New Jersey granted summary judgment in favor or Bayer HealthCare LLC in a consumer class action over its probiotic dietary supplement.
In short, the dispute involved allegations that Bayer knowingly made false digestive health-related efficacy claims in violation of California and Illinois consumer protection laws.
Plaintiffs’ expert apparently conflated the standard necessary to substantiate drugs with dietary supplements. Moreover, allegations that Bayer’s representations were untrue because the company had no supportive studies was a lack of substantiation theory, not one proving actual falsity.
Dietary supplements are not regulated as drugs. According to the U.S. Food and Drug Administration guidelines, a drug’s effect must be supported by randomized, placebo-controlled, double-blind clinical trials. Dietary supplements, on the other hand, may be substantiated by “competent and reliable scientific evidence.”
As confirmed by the court, “[i]n essence, Plaintiffs’ expert opines that absent an RCT showing PCH’s efficacy, Bayer’s claims that PCH promotes digestive health are false. This lack-of-substantiation theory is not the legal standard. Without understanding the proper legal requirements to demonstrate whether Bayer’s statements about PCH are false and misleading, [Plaintiffs’ expert] cannot offer an informed opinion as to whether that standard has been met.”
“Plaintiffs failed to present competent evidence to create a genuine issue of material fact that Bayer’s claims that PCH promotes overall digestive health … are actually false or misleading,” stated Judge Vasquez.
The full scope of this ruling’s precedential value is presently unclear. The Federal Trade Commission continues to require at least two double-blind placebo controlled human clinical studies, consistent with the overall body of scientific evidence, to substantiate health-related efficacy claims.
Nevertheless, many are hopeful that requiring plaintiffs to put forth evidence of falsity will serve to curtail the proliferation of state consumer fraud class action “unsubstantiated claim” lawsuits aimed at the dietary supplement industry.
See In re Bayer Phillips’ Colon Health Probiotics Sales Practices Litigation, 11-03017 (D NJ).
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