Back in 2017, the FTC and New York AG charged Quincy Bioscience and its founders with making false and unsubstantiated claims to market its dietary supplement Prevagen. Widely advertised and promoted, and sold both to the public and healthcare practitioners, the supplement – containing a jellyfish protein – was promised to improve memory and provide other cognitive benefits. As alleged in the complaint, the defendants principally relied on one double-blind, placebo-controlled human clinical study using objective outcome measures of cognitive function to support their claims. The study involved over 200 subjects taking either Prevagen or a placebo. The subjects were assessed on nine computerized cognitive tasks, designed to assess a variety of cognitive skills, including memory and learning, at various intervals over a period of ninety days. However, the results failed to show a statistically significant improvement in the treatment group over the placebo group on any of the cognitive tasks. Further, the post hoc analyses of the results, looking at data broken down by several variations of smaller subgroups for each of the cognitive tasks, also mostly failed to show statistical significance between the treatment and placebo groups.

Notwithstanding the fact that the study showed no statistically significant improvement in subjects taking Prevagen compared to subjects taking a placebo, the defendants touted the study in the advertising, claiming that the double-blinded, placebo-controlled study showed dramatic improvement.  Further, notwithstanding the fact that the claims were premised on the inclusion of jellyfish protein in the supplement, the defendants did not have any studies showing that the orally-administered protein could cross the human blood brain barrier. In other words, according to the complaint, defendants made false and unsubstantiated health claims, in violation of the FTC Act and New York General Business Law. The regulators sought an injunction to prevent further dissemination of eight specific claims, as well as restitution, refunds and disgorgement. 

A jury trial in the Southern District of New York followed. The jury found that the eight claims were not supported by competent and reliable scientific evidence, and that two of them --  about reduction of memory problems due to aging -- were materially misleading under New York law. Each claim was found to have a “tendency to deceive.”  Accordingly, the Court ordered the defendants to immediately remove all eight statements (and any others similar to them) from use in connection with any and all forms of promotion of Prevagen, and to cease their use in the promotion of Prevagen in any way. 

The court, when subsequently requested by the New York AG to amend the judgment to include statutory penalties and costs, as well as disgorgement, refused. However, the court affirmed the nationwide injunction: the defendants were ordered to cease the use of the eight claims in Prevagen' s marketing “in a reasonable and practical amount of time and without delay.” In affirming the injunction but denying the request for disgorgement, the court held that “[the defendant’s] loss of the use of all eight Challenged Statements in its marketing and public relations, at a single blow, is not a trivial event. It involves years of accumulated goodwill, whose loss must be replaced with costs and effort. That relief aligns with the purpose of both the FTC Act and the New York Statutes, and it should be administered in proportion to the damage caused by each statement's tendency to deceive, as found by the jury, whose verdict was discriminating and perceptive. The jury' s careful denials that six of the Challenged Statements were materially misleading counsels forbearance rather than rigor in the calculation of a just judgment, stopping short of the pursuit of monetary penalties, particularly in light of the evidence that the defendants intended no harm.”  In other words, apparently the injunction will hurt defendants enough and the fact that consumers spent as much as $69 per bottle for the supplement was either insufficiently addressed at trial, or is itself inadequate to support a demand for disgorgement.

If the court is right that requiring defendants to drop all their memory boosting claims and change their marketing for the supplement “is not a trivial event,” even in the absence of a monetary penalty, then this case should serve as (yet another) important reminder that health claims – and especially brain and memory claims targeting an aging population – must be based on reliable scientific evidence. While it’s obviously very disappointing for an expensive clinical trial not to produce the desired results, touting the study anyway, or slicing and dicing the data to finagle a way to make the claims, is a risky move.  Even in the new administration, it seems likely that false and misleading health claims will continue to be a top priority for regulators.