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District Court for the Northern District of California rules on claims that supplements affect protein metabolism in the brain (Racies v. Quincy Bioscience, LLC) Download PDF

  • Government
  • Judicial
  • Neuroscience

Determines that plaintiffs cannot sue under California law merely for lack of substantiation, nor would they have standing to seek injunctive relief in similar cases, but they may sue for defendant’s misrepresentations of “body chemistry”.

Updated last December 22, 2016
for the 05/19/2015 decision.
What it does 

Racies v. Qunicy Bioscience, LLC is a district court case ruling that plaintiff’s allegations of fraud in violation of the California Unfair Competition Law (UCL) can be sufficient to state a claim when they can plead with specificity. 

In this case, the Court ruled that a plaintiff may bring a claim under the “fraudulent” prong of the UCL so long as the claim is well pleaded with specificity. However, the plaintiff cannot:

  • Bring a case under the UCL for falsity based on lack of substantiation alone;
  • Bring a case under the UCL for unlawfulness based on lack of substantiation alone;
  • Bring a case under the California Consumer Legal Remedies Act (CLRA) for fraudulence based on lack of substantiation alone; or
  • Seek injunctive relief when the plaintiff cannot “demonstrate a real and immediate threat of repeated injury in the future.”
The facts 

Plaintiff, Phillip Racies, purchased and consumed Prevagen, a product of the defendant, Quincy Bioscience, LLC. Prevagen was “a purported brain health supplement made with the protein Apoaequorin.” Racies paid $27.99 for the product and suffered “injury-in fact” because the product “did not and could not improve memory or support healthy brain function as represented.”

Decision Points 

The Court denied defendant’s motion to dismiss plaintiff’s claims that defendant’s advertising gave rise to a viable claim for fraud under the UCL.

Here, the Court found that the plaintiff’s allegations, listed below, were sufficient to state a claim under Rule 12(b)(6) and pleaded with sufficient specificity under Rule 9(b):

  1. Prevagen does not improve memory or brain function because its active ingredient Apoaequorin (AQ) is destroyed by the digestive system;
  2. The daily protein consumption from an average diet (75 grams) would dilute the AQ enough that there would be no measurable effect on the brain; and
  3. Taking Prevagen would have no effect on brain function or memory.

In doing so, the Court held that the plaintiff can affirmatively prove falsity of defendant’s product claims if:

  • Plaintiff can prove that Apoaequorin is destroyed in digestion; or
  • If plaintiff can prove that the dosage is in such a trivial amount that it cannot biologically affect memory or brain function.

Furthermore, the Court held that plaintiff’s lack of evidence to support his claim of fraudulence in defendant’s advertising does not defeat plaintiff’s case at this stage. 

Relevant Science 

The relevant science pertaining to this case concern brain supplements in general and AQ in particular. Brain supplements are drugs that are purported to enhance memory, brain health, and general cognitive ability. However, the science behind brain supplements is still incomplete, and a causal relationship between supplements and brain enhancement is still being explored. Major research universities, including the University of California, Berkeley, Harvard University, and Stanford University, point out that brain health is complex; while supplements might have some effects, there are too many factors that also affect brain health, like genetics and dietary habits, so that the science of supplements is far from definitive.

Apoaequorin is a calcium binding protein originally derived from jellyfish. Apoaequorin is the key component of defendant’s drug, Prevagen, which is marketed to improve memory and cognitive ability. The American Pharmacists Association (APA) notes that AQ is unlikely to be absorbed to a significant degree because it divides into amino acids during the digestive process. The APA also notes that “human data on Apoaequorin are limited to small, company-sponsored trials that do not meet expected scientific standards.”

Where & When 
Background 

Pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure, defendants may file a motion to dismiss, which will be granted if the plaintiff fails to state a claim upon which relief can be granted. Furthermore, as required by Rule 9(b), where the plaintiff is alleging fraud, they must plead that claim with particularity

According to National Council Against Health Fraud Inc. v. King Bio Pharms. Inc., private litigants cannot bring UCL claims based on an alleged lack of substantiation. Lack of substantiation is a claim that the defendant has not produced evidence to support their statements. Based on the King Bio precedent, only the permitted prosecuting authorities have been permitted by the California legislature to require substantiation of advertising claims. In terms of policy, this is a means to protect advertisers from “undue harassment” by private citizens. 

Status 

On September 30, 2016, the United States District Court, Northern District of California set a case management conference for October 11, 2016 to discuss trial scheduling. If the case goes to trial, instead of ending at a settlement agreement, the losing party can seek an appeal with the United States Court of Appeals for the Ninth Circuit. 

Primary Author 
Jonathan Ng, JD Candidate
Editor(s) 
Emilia Chiscop-Head, PhD
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