In the case, lawyers for a class headed by two male plaintiffs claimed that the product did not alleviate their clients' intestinal discomfort. The complaint went on to delve into the backing for the claims on Phillips Colon Health, or PCH, maintaining that the claims were not adequately substantiated.
“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,” wrote Judge John Michael Vasquez in his summary judgement dismissing the suit.
The plaintiffs brought forth an expert witness, Dr. Stefano Guandalini, MD a professor at the University of Chicago. In his deposition, Dr. Guandalini denigrated PCH because it was “clinically proven to be ineffective”for people suffering from Irritable Bowel Syndrome (IBS). But under cross examination, Dr. Guandalini admitted that it is possible that PCH could have benefits for users who don’t fall within the IBS group.
One size doesn’t fit all
Bayer’s expert witness, Dr. Daniel I. Merenstein, MD, a tenured associate professor at Georgetown University, where he has led research into the effects of probiotics, said that PCH is generally effective against occasional constipation, diarrhea, gas, bloating, and the occasional failure of the product to provide these benefits is not evidence that the claims are overblown. After all, Dr. Merenstein pointed out, drugs that have specific, proven benefits also come with admonitions that some patients will not respond to treatment.
“There is nothing out there that does it for everyone. People can exercise and have a heart attack. People can get a flu vaccine and get the flu. And people can take Phillips Colon Health and have diarrhea,” he said.
Attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig, said the tack taken in this suit is one that is cropping up more often lately. Rather than try to prove that the defendants have made false and misleading claims in their advertising, class actions lawyers seek to cast doubt on the underlying science.
“They are essentially trying to shift the burden from having to prove false and misleading advertising to alleging the defendants’ claims are not substantiated,” Prochnow told NutraIngredients-USA.
In this vein, Dr. Guandalini, the expert witness for the plaintiffs, said in his deposition that he believed the standard of evidence to prove a claim on a drug and the claim on a dietary supplement ought to be the same. When asked if he understood how FDA regulates drugs and dietary supplements differently, he stated he “did not have enough authority” to make a judgement. Vasquez wrote that Dr. Guandalini’s ignorance of the regulations regarding supplements, as well as his ignorance of the legal standard for what constitutes a “false and misleading” claim, means his opinions in the matter carried little weight.
“In 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, Dr. Guandalini cannot offer an informed opinion as to whether that standard has been met,” Vasquez wrote.
Precedential value could be minimal
Prochnow said that plaintiff’s lawyers often file case under the guise of stepping in to do FDA’s work (or that of another regulatory agency) when the agency is either unwilling or unable to enforce the law. But this latest legal tactic seems to lay bare what many observers open suspect, that these cases are about the bottom line and not about protecting consumers.
“There is no private right of enforcement on for lack of substantiation,”he said.
As to what the victory means for future class action suits, Prochnow said the picture is less clear.
“You could say this was one for the good guys,”he said. “In the future, class action lawyers can’t just look at a warning letter and pick something out as the basis for a suit. They actually have to do some work to have some substantiation of their own that claims are false and misleading. But our clients get demand letters all the time. They are essentially fishing expeditions, and not everyone has the time or the money of a Bayer to defend them.”