Prevagen is advertised as a “clinically tested” brain health supplement. But the complaint for this class action alleges that it has not been clinically tested and does not in fact do anything for brain health. The complaint brings suit against three Quincy Bioscience companies as well as Prevagen, Inc.
The Nationwide Class for this action is all US citizens who, within the relevant statute of limitations, bought the products at issue. There is also a New Jersey Subclass, for citizens of New Jersey.
Prevagen is made with the protein apoaequorin and is sold in various forms (regular strength, extra strength, chewables, or extra strength chewables). It is advertised as being “clinically tested” to “improve memory” and as supporting “healthy brain function, sharper mind, and clearer thinking”; it is claimed to “improve memory within 90 days.”
However, the complaint claims that Prevagen has not been subject to the randomized clinical trials that consumers would assume, that it does not do what it claims to, and that what testing it has undergone does not support the claims.
A substance that changes the structure or functioning of the body is a drug and must be approved by the Food and Drug Administration (FDA). However, under the Dietary Supplement Health and Education Act (DSHEA), a supplement manufacturer may make similar claims if certain requirements are met. One of those requirements is that the maker must be able to substantiate the claims.
The complaint says that the standard for scientific evidence for health benefits is “demonstrating its value over placebo through high quality and well-conducted randomized controlled clinical trails (‘RCTs’).” It quotes the FDA’s Guidance for Industry as saying that reliable scientific evidence is “tests, analysis, research, studies, or other evidence based on the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
However, the complaint claims that the only test on Prevagen that may have been randomized, the Madison Memory Study, is “unreliable and flawed.” The complaint claims that the study “shows that Prevagen does not improve memory.”
It goes on to say, “After failing to find a treatment effect for the sample as a whole, the researchers conducted more than 30 post hoc analyses of the results, examining data broken down by several variations of smaller subgroups” in a way that “greatly increased the probability that some statistically significant differences would occur by chance alone. Even so, the vast majority of these post hoc comparisons failed to show statistical significance between the treatment and placebo groups…”
The complaint thus alleges that the claims on the Prevagen labels and in the Jellyfish Protein TV advertisement are false.
It brings suit under the New Jersey Consumer Fraud Act and the New Jersey Truth-in-Consumer Contract, Warranty and Notice Act, and claims unjust enrichment.