Bayer Case Highlights the Importance of Involving an Expert in Substantiation

By Jennifer M. Thomas –

For the past few days, industry has reacted with anxiety to the government’s decision to pursue an order to show cause why Bayer, Corp. should not be held in contempt of that company’s 2007 consent decree with FTC due to its marketing of the Phillips Colon Health probiotic dietary supplement.  See Motion for Order to Show Cause Why Defendant Should Not Be Held in Contempt, No. 07-cv-00001, Docket No. 4 (D.N.J. Sept. 12, 2014).  Specifically, many commentators fear that the FTC is attempting to impose a drug-level substantiation requirement on claims for probiotic dietary supplement products.  See, e.g., here and here.

The FTC’s standard for substantiation in the Bayer case, while not consistent with the more flexible standard articulated in FTC guidance, is not particularly novel in the context of FTC litigation.  We agree that is not appropriate for dietary supplements generally (although certainly not unprecedented).  But we would add that FTC’s asserted substantiation standard is just that – asserted.  And it has a key limitation that is inherent in the definition of “competent reliable scientific evidence”:  It is dependent on the opinion of FTC’s expert. 

FTC’s motion for an order to show cause expressly relies on the opinion of Dr. Loren Laine, a gastroenterologist and professor at Yale University, both (1) for the substantiation requirements that should apply to Phillip’s Colon Health, and (2) to apply those substantiation requirements to the data and information provided by Bayer in support of its claims.  This reliance on an expert is seemingly unavoidable for FTC, where the order in question – as well as the body of FTC case law beyond this order – defines “competent and reliable scientific evidence” specifically based on the “expertise of professionals in the relevant area.”  (The Bayer 2007 order defines “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.”)  But it provides an opportunity for companies to insure themselves against an FTC motion like the one faced by Bayer, as was made abundantly clear by FTC’s loss in the Garden of Life case, where the district court determined – and the 11th Circuit agreed – that a “battle of the experts” did not constitute  contempt.

Accepting the lessons of Garden of Life and Bayer, the appropriate insurance for companies is a process for substantiation of claims that relies on the opinions of a qualified expert, at least for claims that are novel or otherwise high priority for FTC action.  Specifically, if a company engages a qualified expert to evaluate the scientific evidence for the company’s proposed advertising claims, then uses its claims in reliance on the expert’s opinion, that company can hardly be said to have acted in contempt of a court order.  And even when there is no existing consent decree, documented reliance on the opinions of a qualified expert puts the company in a much better position vis-à-vis FTC with regard to the “competent and reliable scientific evidence” standard as presently defined.

Finally, we note that in addition to the opportunity for an ounce of prevention presented by FTC’s necessary reliance on experts for its substantiation standard, any opinion set forth by such an expert on a broadly-applicable standard (i.e. all studies on probiotics must be strain-specific because it is impossible to extrapolate between one strain and another) is vulnerable to challenge by another qualified expert, depending on the specifics of the case.  For example, the company’s expert may agree that, in general, it is difficult to extrapolate from the demonstrated efficacy of a one strain in humans to the efficacy of another strain, but for certain types of probiotics or with certain additional data, extrapolation is appropriate.  And a court may find the company’s expert’s views as convincing as those of the FTC’s expert(s).

No doubt Bayer has engaged its own expert to rebut Dr. Laine’s opinion. We look forward to reading the company’s response to FTC’s motion, which is due October 3.