Plaintiffs in a proposed class action lawsuit filed against Bayer HealthCare LLC over a popular probiotic are appealing a summary judgment order in favor of the company.
Bayer was accused of making false and misleading claims regarding its dietary supplement, Phillips’ Colon Health (PCH), the same product subject to FTC litigation in a case that was closely followed by the industry.
In April, U.S. District Judge John Michael Vazquez ruled in favor of Bayer on all counts in the class action lawsuit.
“In sum, plaintiffs failed to present competent evidence to create a genuine issue of material fact that Bayer’s claims that PCH promotes overall digestive health and helps defend against occasional constipation, diarrhea, gas, and bloating are actually false or misleading," the judge concluded in his 30-page order.
In the FTC lawsuit, the issue was whether Bayer’s representations above were substantiated with “competent and reliable scientific evidence." The government argued the answer was no, causing Bayer to be in violation of an earlier consent decree, but a federal judge in New Jersey sided with Bayer in a 2015 decision.
Bayer, the court pointed out, produced nearly 100 studies to support its PCH claims.
“As two other courts have held, competent and reliable scientific evidence does not require drug-level clinical trials, and the government cannot try to reinvent this standard through expert testimony," Judge Jose Linares wrote in his 2015 opinion.
Lawyers with Sidley Austin LLP, who defended Bayer in both cases, viewed the 2017 summary judgment order as an “important decision" that “should help to rein in the onslaught of lawsuits that improperly target dietary supplements.
“First, the court's decision reinforces that dietary supplements are not regulated as drugs and structure/function claims need not be supported by randomized controlled clinical trials," the attorneys wrote in an article for Lexology.com.
Bayer, however, can’t move on yet from the class action lawsuit. On May 17, plaintiffs filed a notice of appeal to the U.S. Court of Appeals for the Third Circuit. James Cecchi, an attorney in Roseland, New Jersey who signed the notice of appeal on behalf of the plaintiffs, didn’t immediately respond to an emailed request for comment.
"We believe the District Court’s ruling dismissing this case based on the failure of plaintiffs to meet their burden of proof was correct and should be affirmed on appeal," Bayer said in an emailed statement. "The benefits of Phillips’ Colon Health have been fully substantiated as demonstrated by numerous clinical, animal and genetic studies. The District Court’s ruling was the third time that a federal court has found that plaintiffs have failed to prove their claims regarding the benefits of Phillips’ Colon Health probiotics.”
As in the FTC case, a crucial aspect of the class action lawsuit turned on the testimony of experts.
In concluding PCH’s claims are false, plaintiffs’ expert—Stefano Guandalini, M.D., a pediatrics professor at The University of Chicago Medicine—relied on double-blind, placebo-controlled, randomized trials (RCTs). For PCH’s statements to be true, Guandalini opined, they must be supported with RCTs, and he maintained the testing required to determine a product’s efficacy would be the same for a dietary supplement or drug, according to Vazquez’s summary judgment order.
But the judge rejected the expert’s opinion that an RCT is required to support PCH’s statements, and he said Guandalini was unaware of or misunderstood the “legal standard required to prove that a statement about a dietary supplement is ‘true and not misleading.’
“In essence, plaintiffs’ expert opines that absent an RCT showing PCH’s efficacy, Bayer’s claims that PCH promotes digestive health are false," Vazquez wrote. “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, Dr. Guandalini cannot offer an informed opinion as to whether that standard has been met."
Later in his order, Vazquez further distinguished the substantiation standard from the plaintiffs’ burden of proof.
The “question," he said, “is not whether there is sufficient evidence to support PCH’s claims, but rather whether plaintiffs have presented proof that PCH’s claims are in fact false or misleading."
Guandalini’s interpretation of three RCTs did not establish the falsity of PCH’s statements because “[t]he studies were not designed to test whether PCH ‘promote[s] overall digestive health’ and ‘helps defend against occasional constipation, diarrhea, gas, and bloating,’" the judge observed. Rather, the purpose of two of the studies was to ascertain the effect of PCH on individuals with irritable bowel syndrome (IBS) and severe IBS, he noted.
“These ‘chronic’ and ‘reoccurring’ symptoms are far more severe than the occasional constipation, diarrhea, gas and bloating that PCH claims to defend against," the judge wrote.
In his deposition, Guandalini admitted he didn’t know whether PCH was incapable of helping to promote overall digestive health.
Wrote Vazquez: “In short, Dr. Guandalini did not offer a definitive opinion as to whether PCH’s claims that it promotes overall digestive health and helps defend against occasional constipation, diarrhea, gas, and bloating were actually false."