Bayer Awaits Court Ruling in Clash with DOJ Over Probiotic Dietary Supplement

Government lawyers last week made a final push to persuade a New Jersey court that Bayer Corp. has failed to adequately back up its claims that a dietary supplement known as Phillips’ Colon Health promotes a healthy gut.

U.S. District Judge Jose Linares held a seven-day hearing in June to weigh expert testimony and other evidence in a case that the dietary supplement industry has cited as a worrisome pattern by the FTC to subject natural products to an expensive and cumbersome drug standard.

An expert retained by the U.S. Justice Department has insisted Bayer failed to comply with a 2007 court order or so-called consent decree because the company didn’t conduct human clinical trials to substantiate its claims that Phillips’ Colon Health helps protect against constipation and diarrhea, as well as gas and bloating. Bayer entered the consent decree to resolve the government’s allegations that the company had made unsubstantiated claims concerning its One-A-Day WeightSmart vitamin.

The Justice Department has moved to hold Bayer in civil contempt for violating the consent decree. Government lawyers have asked a judge to assess $25,000 in damages for each day Bayer continues to be in contempt, and impose compensatory damages that are tied to Bayer’s sales of its popular supplement, which was introduced in 2008.

Bayer has maintained it had ample evidence to back up its product claims with “competent and reliable scientific evidence," the requirement in the consent decree that was the main subject of the court testimony. The consent decree defined “competent and reliable scientific evidence" as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."

Bayer and dietary supplement trade organizations have argued the government is seeking to hold the company to a standard that is applicable to the drug industry: requiring randomized, placebo-controlled, double-blind clinical trials in order to substantiate claims about a product.  

Bayer said last year that its probiotic claims were backed by several clinical trials on the species of bacteria in the product, in vitro and animal studies on the bacteria strains, and genomic tests that confirm the strains help protect against constipation, gas, bloating and diarrhea.

Under proposed findings of fact and conclusions of law submitted on July 30 by the Justice Department, Linares would hold that what is considered “competent and reliable scientific evidence" is based on expert evaluations. He also would find under the government’s proposed findings that the consent decree didn’t need to specify the requirement for human clinical trials in connection with Bayer’s probiotic statements.

“If, as Bayer asserts, the specific way in which the competent and reliable standard applies to each claim must be explicitly written into the ‘four corners’ of the 2007 Order, the underlying ‘competent and reliable scientific evidence’ standard could never be sufficiently clear without delineating the specific scientific substantiation necessary for every conceivable covered claim," the government’s proposed findings declare. “In addition, the drafting of injunctions would become an exercise in prognostication as this Court could protect against future misconduct only if it successfully predicted every single type of claim that creative wrongdoers might use."

Proposed findings of fact and conclusions of law submitted by Bayer sought to persuade the judge that its experts are more credible than the government’s expert, Loren Laine, M.D., a professor of digestive diseases from the Yale School of Medicine.

Bayer sought to undermine Laine’s credibility, citing his lack of knowledge of the law and regulations governing the dietary supplement industry. Unlike Laine, Bayer’s experts understood that supplements and drugs are regulated differently and relied on FTC guidance in forming their opinions, according to Bayer’s proposed findings.

Bayer’s experts, including M. Brian Fennerty, M.D.—a professor of medicine at the Oregon Health & Science University and a clinical researcher in the field of gastroenterology—testified that the company satisfied the “competent and reliable scientific evidence" standard.

“I know there was competent and reliable scientific information available in 2008," Fennerty reportedly testified, “and in order to make sure my recollection was correct, I repeated a search … up to 2008, and there were hundreds of publications substantiating the claims that were available in the scientific literature and the public domain in 2008."