We were alerted to a case by attorney Richard Newman, which was between Bayer Corp and the federal government was just recently unsealed and the 38-page opinion from US District Judge Jose Linares has been made available. In the opinion it is quite clear that not only did Bayer Corp win the case, but the Judge felt that the federal government had made virtually no case at all.
Linares was asked to decide whether or not the statements that Bayer made regarding Phillips’ Colon Health (a dietary probiotic supplement) violated the consent decree put forth by the FTC in years past. The judge clearly stated that Bayer’s statements did not violate this decree at all and that the government’s attempt to show that they did fell far short of any sort of proof.
During the hearing itself, Bayer provided the court with almost 100 different studies, each of which supported the claims that were made regarding their product.
In response to these studies and other information involved with the case, Judge Linares wrote, “As two other courts have held, competent and reliable scientific evidence does not require drug-level clinical trials, and the Government cannot try to reinvent this standard through expert testimony.”
The FTC was demanding, through their ‘star witness’ (Loren Laine, MD) that the claims made by Bayer needed to be backed up by nothing short of human or ‘randomized clinical trials’ and nothing else would suffice.
One of Bayer’s attorneys commented in an interview saying, “The court agreed the government’s standard was new, we had no notice, that it was baseless and that Bayer had science.” To put it simply, the FTC was attempting to change the standards that have been in place regarding dietary supplements of this type, and the judge simply wasn’t buying it.
In the final opinion, the Judge wrote, “The Government’s position that Laine-Level RCTs are required is found nowhere within the four corners of the consent decree, but only within the expert report that was filed with the Government’s motion for contempt. The consent Decree that Bayer agreed to in January of 2007 speaks only of ‘competent and reliable scientific evidence.’ The Consent Decree does not mention randomized controlled clinical trials of any kind, let alone say they are required. In the seven years after entering the Consent Decree, the government never told Bayer or anyone else in the industry that drug-level trials or Laine-Level RTCs were required.”
While this is not likely the last time that the FTC will attempt to increase their influence in this area, this court case clearly shows that they will not have an easy road ahead of them. This is not the first time that the FTC has lost in this type of case and won’t likely be the last. The government is continuously attempting to gain influence into the supplement industry and won’t be giving up anytime soon.
