Industry groups believe that a verdict in a current court case could be problematic for companies that file adverse event reports. Matrixx Initiatives, Inc. v. Siracusano involves securities fraud in which the courts agreed that the defendants had intentionally left out important information by not disclosing a possible link between the firm’s cold medication and some users’ loss of smell. This ruling enabled a class action lawsuit to move forward.
The Natural Products Association (NPA) filed an amicus curiae brief because the aforementioned case sets the precedent that nondisclosure of adverse event reports (AERs) “can give rise to liability under federal securities laws—even when those reports are not statistically significant.” The NPA believes this ruling has the potential to affect the supplement industry in the future in that they would be forced to publicly disclose all AERs—even those that are insignificant. This may dissuade consumers from taking potentially beneficial remedies and would cost supplement makers extra time and money.
The Council for Responsible Nutrition and the Consumer Healthcare Products Association also issued a brief. They argued that an AER “does not necessarily indicate a causal relationship between a product and an adverse event” and “determining the incidence of an adverse event based on adverse event reports is not a straightforward process.” Typically, the U.S. Food and Drug Administration analyzes and acts on AERs, if need be. Putting this job in the hands of manufacturers may make it more difficult for them to identify meaningful information about AERs.
Published in WholeFoods Magazine, October 2010