Antitrust Law Daily Wrap Up, CONSUMER PROTECTION—N.D. Cal.: Expert report excluded in FTC suit against supplement marketer, (Oct 7, 2013)

By Tobias J. Gillett, J.D., LL.M.

In an FTC action against a marketer of nutritional supplements over its claims regarding the effects of its supplements on diabetes, the federal district court in San Francisco has excluded an expert report offered by the marketer because it did not satisfy the relevance and reliability requirements of Federal Rule of Civil Procedure 702 and the Supreme Court’s decision in Daubert (FTC v. Wellness Suport Network, Inc., October 4, 2013, Spero, J.).

The FTC filed suit against Wellness Support Network, Inc. (WSN), alleging that it engaged in false or unsubstantiated advertising of its Diabetic Pack and Insulin Resistance Pack dietary supplements, in violation of Sections 5(a) and 12 of the FTC Act. The FTC challenged nine specific claims made by WSN about its supplements. WSN introduced expert testimony from Dr. M. Arthur Charles, a Clinical Professor of Medicine with extensive experience in the study and treatment of diabetes. Charles’ report concluded that “it appears that the Diabetic Pack and the Insulin Resistance Pack both can be used to improve prediabetes and diabetes,” that “Wellness Support Network’s two Packs are justified, and perhaps even needed, as a medical food supplement to be used with the full knowledge of patients’ physicians for use in prediabetes and diabetes,” and that “the claims made by Wellness Support Network are truthful and substantiated.” The FTC moved to exclude Charles’ expert report.

Relevance. The court concluded that the report did not satisfy the relevance requirement of Federal Rule of Civil Procedure 702 and the Supreme Court’s approach to it in Daubert v. Merrell Dow Pharmas., Inc., 509 U.S. 579 (1993). Although the report opined that WSN’s supplements could “be used to improve diabetes,” and that WSN’s claims were “truthful and substantiated,” the court observed that issue before the court was whether the particular claims that the FTC challenged were false or unsubstantiated. Charles’ report and deposition testimony did not identify the specific claims to which he referred in his report, and therefore the report did not “speak clearly and directly” to the issue before the court, and was not “likely to be helpful to the trier of fact.”

Reliability. Even if the court had found Charles’ opinions to be relevant, it would have excluded them because he had not shown that he had used a scientific method that complied with Daubert. Charles had “arbitrarily” created a hierarchy of the degree of clinical effectiveness of the ingredients in WSN’s products, including “strongly supporting usefulness” ingredients, those in which there were “human randomized and/or controlled clinical trial published in peer-reviewed journals”; “supporting usefulness” ingredients, those in which there were “uncontrolled, open label studies in normal, pre-diabetic or diabetic humans”; and “possibly supporting usefulness” ingredients, those in which there were “preliminary human anecdotal or animal studies.” Charles did not cite any objective sources supporting the use of those classifications “by (at least) a recognized minority of scientists in his field.”

Moreover, Charles also provided no support for his use of only “positive clinical studies,” other than his unsupported assertion that “the properly conducted, positive studies take precedence.” He again cited no objective source showing that this was “an accepted scientific method,” and the court noted that “Daubert requires that Charles address alternative explanations for the purportedly positive studies.”

Finally, the court observed that Charles had appeared to rely on Food and Drug Administration regulations governing medical foods in creating his system of classification, which the court viewed as “further highlight[ing] the fact that his methodology is not grounded in scientific principles.” Even if the FDA would consider WSN’s supplements to be “medical foods” for purposes of FDA regulation, the court noted that “the degree of regulation they would be subjected to by the FDA simply is not relevant to the issues of this case.” Charles’ use of the FDA’s regulatory scheme to support his analysis, rather than scientific principles, did not “satisfy Daubert’s requirement that an expert must offer ‘scientific knowledge,’” according to the court.

The case is No. 10-cv-04879-JCS.

Attorneys: Austin A.B. Ownbey for FTC. Leslie Holmes (Holmes & Usoz LLP) for Wellness Support Network, Inc.

Companies: Wellness Support Network, Inc.

Cases: ConsumerProtection FederalTradeCommissionNews CaliforniaNews