United States: Punch To The Gut: Government Denied Contempt Ruling In Bayer Probiotic Case

Bayer recently avoided a contempt finding concerning its Phillips' Colon Health ("PCH") probiotics advertising. Bayer advertised PCH as "Promot[ing] Overall Digestive Health" and "Help[ing] Defend Against Occasional Constipation, Diarrhea, Gas and Bloating." The Government contended Bayer violated a 2007 consent decree requiring Bayer to possess "competent and reliable scientific evidence" substantiating such claims.

To support its PCH claims, Bayer had produced to the FTC nearly 100 public domain studies—not conducted by Bayer—showing that the three species of bacteria found in PCH provided digestive health benefits. The Government argued these studies were insufficient, and that the PCH claims needed to be supported by a clinical trial that was (1) randomized, (2) placebo-controlled, (3) double-blinded, (4) performed on humans, (5) done in the target population, (6) performed on the specific product at issue, (7) analyzed using appropriate statistical methods, and (8) designed with the desired outcome as the primary endpoint. In other words, the Government contended Bayer needed to substantiate its PCH claims with drug-level clinical trials. Although Bayer's cited studies included, for example, a double-blinded, placebo-controlled study showing that one of the species in PCH "significantly alleviates irritable bowel syndrome and improves quality of life," and a double-blinded and randomized study showing that two species in PCH reduced the duration and severity of diarrhea, the studies did not meet all of the Government's criteria. Thus, according to the Government, Bayer was in contempt.

In a decision that must have been gut-wrenching for the Government, the court found the Government failed to give Bayer notice that "competent and reliable scientific evidence" meant drug-level clinical trials. The consent decree did not mention randomized controlled clinical trials, and following the consent decree the Government had not told Bayer or anyone else in the industry that such trials were required for probiotic claims. Further, the FTC had issued guidance defining "competent and reliable scientific evidence" as being flexible and not requiring any specific study format.

Drug-level clinical studies were required only if Bayer claimed that PCH could treat, cure or prevent a disease. Applying the FDA's rule regarding structure-function claims, the court found Bayer's PCH advertising claims were dietary supplement claims, not disease claims. Indeed, every package of PCH and every advertisement contained a disclaimer stating that PCH "is not intended to diagnose, treat, cure or prevent any disease." Numerous other probiotic makers made similar claims as Bayer, and the Government had never contended such claims were disease claims. The court recognized that, were such claims classified as disease claims, many of the most popular probiotics sold would violate the law and be subject to seizure by the FDA. Accordingly, the court found that Bayer had not made any express disease claims for PCH.

Nor had Bayer made any implied disease claims. The Government did not come forward with any consumer survey data or testimony or other evidence that Bayer's advertising impliedly communicated a message that PCH was intended to prevent, treat or cure any disease. Notably, Bayer's advertisements featured healthy people playing golf, riding a tour bus, on safari, and getting on an airplane. As a Government witness conceded, "[n]one of [PCH's] advertisements show sick people." Bayer advertised that PCH prevents, treats or cures constipation, diarrhea, gas and bloating, but these are "variations of the normal state of health," not diseases, the court found.

Punch to the Gut: Government Denied Contempt Ruling in Bayer Probiotic Case

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