WASHINGTON—The Natural Products Association (NPA) said it will file an amicus curiae brief in the U.S. Supreme Court in an effort to defending the dietary supplement industry from a damaging the Ninth Circuit Court of Appeals decision that could require supplement makers to release all adverse event reports (AERs), even if they are not statistically significant.
The “overreaching and potentially dangerous” decision, according to NPA, stems from the Matrixx Initiatives, Inc. v. Siracusano case, which focused on whether mere nondisclosure of AERs renders a company liable under federal securities laws, no matter how significant the event reported. NPA reported the Ninth Circuit issued an unprecedented decision, affirming the liability link and permitting a class action lawsuit based on this premise to proceed.
“While the case involves an over-the-counter (OTC) product, there are clear implications for the supplement industry, especially as the reporting requirements for OTCs and supplements were enacted in the same piece of legislation” said John Gay, executive director and CEO of NPA. “In this brief, we were able to focus on our industry’s perspective, and bring to bear NPA’s experience with the legislative history of the law that created the AER system.”
Scott Bass, of NPA’s counsel Sidley Austin LLP, argued the Ninth Circuit decision is wrong because evaluation of safety signals is a scientific judgment ultimately made by the FDA. “Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” he noted. “The statute explicitly states that AERs are not proof of causation.”
Jonathan Cohn, who authored the brief for Sidley Austin, added, “The practical consequence of the Ninth Circuit’s decision, if it is not reversed, is that manufacturers of dietary supplements very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless – but expensive – strike suits against the supplement industry.”
“The Ninth Circuit’s action is not good for manufacturers, not good for consumers, and just is not good law. We hope the Supreme Court will agree,” said Gay.
