NPA files amicus brief in Schwabe and Nature’s Way lawsuit to prevent “dangerous precedent” in claims substantiation standards

January 25, 2019

NPA filed amicus brief in support of a petition by Schwabe and Nature’s Way for the 9th Circuit Court of Appeals to rehear, en banc, arguments in an appeal filed by Kathleen Sonner. A panel of the 9th Circuit Court reversed the decision of the District Court that granted summary judgment against her in a lawsuit she filed, alleging that the manufacturers were making false health claims about Ginkgo biloba product.

The Natural Products Association (NPA; Washington, DC) filed an amicus brief in the legal case Sonner vs. Schwabe North America, Inc. and Nature’s Way Product LLC being heard by the U.S. Court of Appeals for the 9th Circuit in California. Kathleen Sonner is a private litigant suing the manufacturers for making alleged false advertising claims on products containing Ginkgo biloba. Sonner’s complaint dating back to 2015 alleges that there is no scientific evidence that supports claims that Ginkgo biloba products benefit mental sharpness, memory, and concentration.

In district court, the defendants, Schwabe and Nature’s Way, moved for summary judgment, supported by expert testimony and clinical evidence the companies provided demonstrating cognitive benefits from Ginkgo biloba. A summary judgment is a motion by one of the parties against the other contending that all factual issues are settled and can be decided upon without a full trial. The plaintiff opposed the motion and introduced expert testimony of her own, and evidence to the contrary; however, the court granted the summary judgment motion because the plaintiff’s testimony did not critique or disprove the defendants’ evidence and only provided a different opinion. The manufacturers won.

As a result, Sonner filed an appeal with the U.S. Court of Appeals for the 9th Circuit in California, and a panel of judges reversed the district court’s decision and remanded for further proceedings, meaning that the case will go back to trial. In response to the 9th Circuit’s panel decision, the defendants filed a petition to rehear the appeal en banc, meaning they want to rehear the appeal in front of all the judges of the 9th Circuit court. NPA’s amicus brief is filed in support of the manufacturers, arguing that the petition to rehear en banc be granted.

NPA argues that the district court’s decision should stand because a party is only entitled to a summary judgment if “there is no genuine dispute as to any material fact,” and Sonner did not argue that the defendant’s testimony was unqualified or unreliable. By contrast, the 9th Circuit’s panel’s opinion is that the plaintiff does not have to “fatally undermine” the defendant’s evidence to proceed to trial, and that “If the plaintiff’s evidence suggests that the products do not work as advertised and the defendant’s evidence suggests the opposite, there is a genuine dispute of material fact for the fact-finder to decide.”

NPA says it believes that this panel’s decision is not in line with previous decisions by the court that found “an advertising claim is not false-and the plaintiff thus cannot meet its burden of proof-where the defendant has scientific evidence supporting the claim, even if the evidence is ‘equivocal.’”  Different interpretations and scientific results may exist, but the fact that there are differences does not necessarily prove that an advertising claim is false. NPA also argues that the panel decision ignores the regulatory framework for dietary supplement claims-specifically, structure function claims, which are allowed by the Dietary Supplement Health & Education Act of 1994 (DSHEA). These structure function claims need to be substantiated by reliable scientific evidence, but dietary supplement manufacturers are not required to conduct their own clinical trials to test the efficacy of their products. FTC also has reliable scientific standards but has no fixed formula for the number and types of studies required to measure the adequacy of claims.

In its brief, NPA points out that there should not exist different substantiation standards in the supplement regulatory world and in the courts-that is, if a claim is considered substantiated by regulatory standards, a private plaintiff like Sonner should not then be able to sue on different substantiation grounds. “If supplement companies have competent and reliable evidence sufficient to substantiate product claims under federal statute, regulations, and case, that should be considered sufficient evident to defeat a private false-advertising case such that summary judgment in their favor is proper,” states NPA in its brief.

Finally, NPA also contends that the panel’s decision threatens First Amendment rights protecting commercial speech. “The lack of ‘significant scientific agreement’ about claims made by dietary supplement sellers does not allow the government to ban that speech as false or misleading,” writes NPA.