A recent story in Concussion Litigation Reporter took an extensive look at how mouth guard maker Brain-Pad, Inc. found itself at the center of a case involving the Federal Trade Commission, consumer complaints, and a tough punishment for making false claims about the safety benefits of its mouth guards.
Brain-Pad was claiming that the mouth guard “creates new brain safety space” and “reduces risk of concussions from lower jaw impacts.” It also advertised the product as “tested and proven to reduce risk of internal head injuries and concussions from lower jaw impacts” and “biochemically tested & proven.”
These claims caught the attention of David Vladeck, Director of the FTC’s Bureau of Consumer Protection. “Mouth guards can help to shield a person’s teeth from being injured, and some can reduce impact to the lower jaw,” he said. “But it’s a big leap to say these devices can also reduce the risk of concussions. The scientific evidence to make that claim just isn’t adequate.”
The article went on to quote a half-dozen legal experts about the significance of the development and what it means for the countless other concussion product manufacturers going forward. As bonus coverage, we wanted to share some bonus coverage on the blog.
“The FTC order was not harsh with respect to penalties sought, but does place an onerous burden for Brain-Pad to make future claims,” said Cal Burnton, a partner at Edwards Wildman Palmer in Chicago.
“It was not harsh with respect to the penalty. The FTC has authority of impose civil penalties, consumer redress, and other monetary remedies. These penalties can run from thousands to millions of dollars. Here, the FTC has challenged the claims of Brain-Pad that its product reduces the risk of concussions, and asserted that there is no reasonable basis to make these assertions, and that in fact, the scientific studies do not establish that the mouth guards reduce the risk of concussions. Rather than seek any type of fine or forfeiture, however, the FTC resolved the matter by simply enjoining Brain-Pad from making future claims without scientific studies to back up the claims.
“It was harsh in that the FTC now requires Brain Pad for the next 20 years in order to make product safety claims to have competent and reliable scientific evidence that has been conducted in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results. Brain Pad needs to have a sound, accepted and supportable scientific basis to make any claim involving reduction of the risk of concussions and its products. Failure to have what is recognized as generally accepted science to support its claims will be deemed a violation of the consent decree. Controversial evidence will not be sufficient. The particular health claim must be one that is accepted generally and supported by the weight of scientific evidence.”