TINA files appellate brief in a case it claims it inspired

Preva-Primer

Back in January 2017, the Federal Trade Commission (FTC) took aim at Quincy Bioscience. Quincy had aggressively marketed its supplement Prevagen, touting the results of “a landmark double-blind and placebo controlled” study that supported Quincy’s claims that Prevagen improved memory. The commission, teaming with the New York attorney general, filed a complaint against the company, challenging those claims in the Southern District of New York.

The complaint deconstructed Quincy’s study. The FTC first noted that the main study conducted by Quincy failed to show that Prevagen improved memory (an observation the court would later agree with). But Quincy, the commission claimed, was relying on the results of “more than 30 post hoc analyses” of the main study data – analyses that it claimed involved dubious math. By dividing the main study data into smaller chunks, the FTC claimed, Quincy could claim the results that it wanted to without true mathematical rigor – the smaller studies were in reality, the FTC contended, swamped in statistical noise and inherently unreliable.

Second Act

The court granted Quincy’s motion to dismiss in full, arguing that although the FTC had noted that the substudies were possibly faulty, it hadn’t presented definitive evidence that they were in actuality – not enough to establish the claims as false or unsubstantiated.

This decision was challenged by the plaintiffs in the 2nd Circuit Court of Appeals, which brought the case full circle. In March 2018, Truth in Advertising Inc. (TINA, along with the AARP, Advertising Law Academics and the National Consumers League) filed an amici brief in support of reversing the decision; TINA claims that the FTC and New York state action against Quincy was inspired by its own 2015 investigation against the Prevagen marketing.

The Takeaway

INA’s brief argues that the original case should have stopped short when the district court acknowledged that the main study failed to show that Prevagen lived up to its claims. According to the brief, post hoc analyses “are not part of prospective, double-blind, clinical trials; they are separate retrospective analyses of trial data performed after the study has concluded to try to find patterns that were not primary objectives of the study.”

The brief then took the district court to task, claiming it had mistakenly elevated the post hoc analyses to the same level of credibility as the main study. “Though plaintiffs’ complaint includes allegations that pertain to inadequate post hoc analyses, the critical allegations are those that demonstrate that the best evidence available – the overall study results – contradict Quincy’s marketing claims.”

The 2nd Circuit’s eventual decision may establish precedent for evaluating the competing claims of double-blind studies and analyses based on smaller samples of the same data. This is a case we will be continuing to watch. Stay tuned for the 2nd Circuit’s ruling.