In 6-year-old litigation, the Federal Trade Commission (FTC) last week pushed back against arguments made by Quincy Bioscience that its advertising claims for Prevagen—a brain health supplement—are supported by “competent and reliable scientific evidence.”
An FTC lawyer, Andrew Wone, argued in a Jan. 14 letter to U.S. District Judge Louis L. Stanton that it wouldn’t be appropriate for him to grant summary judgment to the defendants because disputes remain over the facts.
Quincy Bioscience has been fighting New York state and federal regulators over whether the company violated deceptive advertising laws.
A previous letter from Quincy Bioscience to Stanton summarized why the lawsuit should be dismissed. Geoffrey W. Castello, an attorney representing Quincy Bioscience, argued in a Dec. 21 letter “there is no material disputed fact that Quincy has met the legal standard required to substantiate its claims.”
And since the challenged advertising claims comply with FTC guidance and the Dietary Supplement Health and Education Act of 1994 (DSHEA), New York’s claims against Quincy Bioscience under state law fail as well, Castello argued.
Pending before Stanton is defendants’ motion for a pre-trial conference regarding a motion for summary judgment.
Wone disagreed that summary judgment in favor of the defendants would be appropriate.
“Plaintiffs have proffered experts in the relevant fields, including memory, cognition, clinical trials and biostatistics, who have opined that defendants’ scientific evidence does not meet the standards of their respective fields to substantiate the claims challenged in the complaint,” the FTC lawyer wrote to Stanton. “Defendants’ assertions that their scientific evidence is undisputed ignores this contradicting evidence.”
Wone also asserted the government can seek an injunction because the defendants violated the FTC Act at the time the lawsuit was filed and continue to engage in such prohibited behavior. Castello had argued the plaintiffs cannot seek injunctive relief because the challenged claims are no longer being made.
“Because there are many disputed issues of material fact, and injunctive relief is still available, the FTC respectfully requests that the court deny defendants’ request for a pre-motion conference or leave to file a motion regarding summary judgment,” Wone concluded in his letter to Stanton.
The defendants are expected to file a reply to Wone’s letter, after which Stanton will issue a ruling.
The judge has not yet granted permission to file any motions for summary judgment. According to Wone’s letter, Stanton previously said that in order to request such relief, “you have to make the statement that there is no genuine issue as to any material fact with a straight face.”
If the dispute between the defendants and government agencies is not fully decided on summary judgment motions or otherwise settled, it will go to trial—with the testimony of competing experts likely playing a big role in a final decision whether the advertising claims are determined to be false and unsubstantiated.
History of litigation
In January 2017, the marketers of Prevagen were charged in a lawsuit with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits and is “clinically shown” to work.
The case is distinguishable from many other lawsuits filed against companies in the dietary supplement industry by FTC.
Regulators were not concerned with the adequacy of the overall study upon which Quincy Bioscience relied to tout its advertising statements. In fact, to assess the impact of Prevagen on older adults, Quincy Bioscience conducted a randomized, double-blind, placebo-controlled study, what the company’s lawyers described in court documents as the “gold standard" to corroborate the advertising statements.
Instead, the controversy largely boiled down to an interpretation of the “Madison Memory Study"—what the study’s results showed. Although the study failed to show any statistically significant results for the study population as a whole, statistically significant results were identified among certain subgroups.
In one subgroup, for example, participants showed statistically significant improvements over individuals who received the placebo in three of nine tasks: measuring memory, psychomotor function and visual learning.
In their complaint, state and federal regulators noted “researchers conducted more than 30 post hoc analyses of the results looking at data broken down by several variations of smaller subgroups for each of the nine computerized cognitive tasks." Such analysis, the complaint asserted, “greatly increases the probability that the statistically significant improvements shown are by chance alone."
In his recent letter to Stanton, Wone cited several disputed facts, “including many aspects of defendants’ primary human clinical study, the Madison Memory Study.”
“For example, the parties’ experts offer competing opinions on whether it was properly designed, conducted and analyzed using reliable statistical methods, whether it yielded statistically significant results, and how to interpret such results,” Wone wrote.
In 2017, in granting the defendants’ motion to dismiss the federal claims, Stanton found the lawsuit neglected “to do more than point to possible sources of error but cannot allege that any actual errors occurred."
However, a U.S. appeals court in 2019 vacated his judgment, finding regulators “made plausible allegations that Quincy’s marketing campaign for Prevagen contained deceptive representations.”
More recently, though, Quincy Bioscience caught a break in court after Stanton dismissed a claim for monetary relief following a ruling by the U.S. Supreme Court.
At the time the 2017 complaint was filed, regulators noted Prevagen sales had exceeded $165 million.