U.S. Court to FTC: Two Studies Are Too Much

by Edward F. Glynn Jr. on Feb 3, 2015 3:00:00 AM Advocacy

POM_Wonderful_Logo-921744-editedOn Friday, January 30, the U.S. Court of Appeals for the District of Columbia Circuit handed down its long-waited opinion in POM Wonderful LLC vs. FTC. This appeal, from a Final Order of the FTC, had been argued on May 2, 2014, and the outlines of decision issued by the court had been made pretty clear at the time of the argument.

The case arose out of advertising claims made by POM Wonderful that drinking pomegranate juice had been scientifically proven to provide various health benefits, including treating, preventing or reducing the risk of such conditions as heart disease, prostate cancer and erectile dysfunction. Many of those ads contained references to scientific evidence, including trials with various patient populations. Importantly, the Commission had found in its administrative trial, and affirmed on appeal, facts that showed that while earlier studies cited by POM Wonderful provided some support for some of the claims by the company, later studies with larger patient populations conducted under more rigorously controlled circumstances showed no effect on the conditions from the consumption of pomegranate juice, thus failing to confirm the earlier studies.

The Commission found, and the court affirmed, that making health claims based on the earlier, smaller and less well controlled studies, while ignoring the later, larger, and more rigorously controlled study results, resulted in claims that were deceptive and unsubstantiated. That part of the court’s opinion follows well-trodden footsteps.

The more interesting part of the opinion relates to the discussion of the importance of randomized controlled trials in supporting the making of disease claims and Constitutional limits, based on the First Amendment, on the ability of the Commission to insist on two, rather than one, randomized controlled trial (“RCT”) as a condition of making such claims.

The court cited approvingly to the expert testimony discussed in the Commission’s opinion that describe the benefits of well-designed RCT’s. The use of a control group, for example, would allow investigators to distinguish between real effects from the intervention, and other changes, including those “due to the mere act of being treated (“placebo effect”) [and] the passage of time.”  Similarly, random assignment of a study’s subjects to treatment and control groups and “double blinding” (i.e., when neither the study participants or the investigators know which patients are in the treatment group and which patients are the control group) make it less likely that participants or investigators will consciously or unconsciously take actions potentially biasing the result. The court found that the requirement of a RCT to substantiate disease claims was fully defensible in that context.

However, the Commission in its Order had required not one, but two RCT’s to substantiate any disease-related claims and the court concluded that requirement trenched on the First Amendment. The court hypothesized a circumstance under which a very well conducted RCT, with adequate blinding and related requirements permitted conclusion regarding results to a very high certainty. The court concluded that withholding that information from the public pending completion of a second RCT was improper because “consumers may be denied reasonable, truthful information about products with a demonstrated capacity to treat or prevent serious disease” with the result “that would subvert rather than promote the objectives of the commercial speech doctrine.” The court further dismissed earlier FTC consent orders that included the two RCT requirement as not persuasive and stated that POM Wonderful’s history of selected references to studies ignoring later unfavorable ones, could not justify the two RCT requirement.

There has recently been vigorous, if not heated, debate between and among the Commissioners about the desirability of insisting on two RCT study requirements in consent orders, with the majority (including the Chairwoman) insisting on the requirement. The decision by the Court of Appeals, with its Constitutional basis, will do much to shape further thinking on the subject.

Edward F. Glynn Jr. is a partner at Locke Lord Edwards, LLP.

Edward F. Glynn Jr.'s blog
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