Quincy Bioscience, the marketer of a brain health supplement known as Prevagen, signaled its intent to formally request dismissal of a lawsuit filed by the Federal Trade Commission and New York State Office of the Attorney General.
In a Dec. 21 letter to U.S. District Judge Louis L. Stanton, an attorney representing Quincy Bioscience, Geoffrey W. Castello, requested a pre-motion conference regarding a motion for summary judgment.
The letter summarized why the complaint against Quincy Bioscience should be dismissed, likely foreshadowing a more thorough summary judgment motion at some point.
Quincy Bioscience has been fighting New York State and federal regulators over whether the company violated deceptive advertising laws.
“After over six years of investigation and litigation, the record shows that there is no material disputed fact that Quincy has met the legal standard required to substantiate its claims,” Castello wrote in the four-page letter to Stanton, who presides in the Southern District of New York. “Summary judgment is therefore appropriate.”
A lawyer representing Quincy Bioscience co-founder Mark Underwood also wrote a pre-motion letter in December to Stanton. Michael B. de Leeuw requested permission to file a motion for summary judgment, based on the theory that the court does not have “personal jurisdiction” over Underwood for the claims asserted by the state AG’s office.
Counsel for the defendants consented to a request by the government agencies to have until Jan. 14 to respond to the letters.
Stanton has yet to set a briefing schedule for any summary judgment motions, which if filed and eventually granted by the judge, would partially or fully decide the case ahead of a trial.
In his recent letter to the judge, Castello disputed the plaintiffs’ allegations that the advertising claims for Prevagen are false and misleading.
“Put simply, there can be no dispute that the challenged claims are supported by “competent and reliable scientific evidence” as defined in the [FTC] guidance,” he stated. “Other courts have rejected similar attempts by the FTC to require more substantiation than is required.”
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.
Stanton in 2017 dismissed a lawsuit against Quincy Bioscience, but 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.
In the lawsuit against Quincy Bioscience, regulators were not concerned with the adequacy of the overall study upon which the company 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 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.
Castello, in his letter to Stanton, argued the plaintiffs cannot seek injunctive relief because the challenged claims are no longer being made.
“In 2020, defendants entered into a nationwide class action settlement in Collins v. Quincy Bioscience, LLC, No. 1:19-cv-22864 (S.D. Fla.), in which they agreed to add language that Prevagen’s marketing claims are ‘based on a clinical study of subgroups of cognitively normal or mildly impaired individuals’ i.e., healthy, older adults,” he wrote. “All of Quincy’s advertisements now contain this or a similar language, and therefore, even accepting plaintiffs’ allegations as true, there can be no dispute that Quincy is no longer ‘violating’ or ‘about to violate’ the FTC Act.”
Counsel for the defendants had no immediate comments for this story about their recent letters to Stanton in response to emails from Natural Products Insider. An FTC spokesman said the agency does not comment on pending litigation, and the New York AG's office did not immediately respond to an email.