Two Microbiology Experts’ Opinions Allowed in Drug Case

Plaintiff’s and defendant’s microbiology experts were challenged on numerous grounds involving a new probiotic supplement. Both motions were denied
Facts: This case (United States of America v. Bayer Corporation – United States District Court – District of New Jersey – April 30th, 2015) involves claims made by Bayer regarding its product Philips’ Colon Health (PCH) related to constipation, diarrhea, gas, and bloating.

In January 2007, a consent decree was entered by the court involving claims by another Bayer product (One-A-Day WeightSmart vitamins). The government claimed that Bayer was making claims regarding the efficacy, benefits, and performance of the product without having any scientific evidence to back-up these claims. One part of the settlement stated that Bayer was not allowed to make any future claims about its products without having any reliable scientific evidence to substantiate them.

In 2011, The Federal Trade Commission (FTC) began investigating the claims made by Bayer regarding PCH and whether the claims were in violation to the consent decree from 2007. From 2011 to 2012, Bayer provided evidence to the advertised claims related to constipation, diarrhea, gas, and bloating. The FTC then transferred the case to the Department of Justice (DOJ) for purposes of enforcement. In September 2014, the DOJ filed a Motion for an Order to Show Cause why Bayer should not be held in contempt for violation of the 2007 decree.

Both parties called microbiologist expert witnesses to help plead their cases. The defendant called Dr. Andrew Benson, a geneticist and microbiologist, who provided two opinions: 1) Geneticists and microbiologists do not need specific types of clinical trials which are randomized, controlled, double blind, or product-specific; 2) the bacteria in PCH have a genetic core that assists in digestion. The plaintiff’s motion includes arguments that Dr. Benson’s opinions weren’t based on sufficient facts, his testimony was unreliable, and that his testimony moves too far from his area of expertise.

The plaintiff called Dr. Frederic Bushman, a professor of microbiology at The University of Pennsylvania. After reading the material that Bayer provided to the FTC, and after reading extensively on the issue, Dr. Bushman concluded that the defendant did not have reliable or scientific evidence to support their specific claims at issue. The U.S. state that this evidence should be excluded for three reasons: 1) Dr. Bushman lacks experience and expertise on the present issue; 2) The legal standard in the consent decree was not applied correctly; and 3) His testimony was not credible.

Discussion: Regarding Dr. Benson, the court opined that the plaintiff did not provide any evidence that would lead them to exclude any of the testimony proffered. It noted that the Dr. Benson not only has the experience and expertise to testify, but he used peer-reviewed articles and his own research, which was relevant to the case. In addition, plaintiff attacked the experts conclusions and weaknesses of his research, which is not relevant to a Daubert motion.

Regarding Dr. Bushman, the defendant, likewise, did not provide any convincing proof that any of their arguments would hold muster in regard to Daubert. Bayer’s statement that the legal standard was incorrectly applied is not relevant either because that is not a requirement of an expert witness.

Held: Both microbiologists’ expert testimony were allowed and both motions to exclude said testimony were denied.

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