By Cadie Carroll, Staff Writer, Sports Litigation Alert
With football season under way and concussions remaining a hot topic for safety reasons, many athletes, coaches, schools, teams, and leagues have already started looking to manufacturers for a way to minimize the danger of concussions.
That demand has led to a plethora of new products—of which one of the more interesting product categories has been the mouth guard.
One mouth guard being developed by New England Patriots’ team dentist Gerald Maher is designed to position the player’s jawbone further forward and downward to reduce the initial impact of a blow to the jaw.
It is speculated that the extra space created by moving the jaw forward could decrease the severity of a concussion by providing a “buffer” space that absorbs some of the shock of the hit.
“A lot of times with concussions, it’s not so much the initial impact as much as it’s your brain actually bouncing off the wall of the inside of your skull,” said Patrick Spieldenner, head football trainer at Indiana University. “But you can lower the impact by absorbing the shock. And if you lower it, and cushion it, hopefully the impact to the side of the skull decreases.”
Claims Around Mouth Guards Draw Scrutiny
However, no matter how innovative this idea may be, the operative word is “hopefully.”
No one has yet to prove that the buffer space created by moving the jaw forward can in fact cushion blows to the head, and there is still no systematic evidence suggesting mouth guards accomplish such a task.
“Mouth guards can help to shield a person’s teeth from being injured, and some can reduce impact to the lower jaw,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection. “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.”
One manufacturer that may regret taking that leap is Brain-Pad, Inc. who, last month, 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.”
Lack of Scientific Data Dooms Brain Pad
That’s a far stretch for anyone to make, especially being that the company had no scientific research, tests or documentation to lend validity to their claims.
Gary Wolensky, a partner at Hewitt Wolensky LLP, told Sports Litigation Alert that “whatever representations are made regarding the core purpose of the product need to be backed up with valid scientific data and studies” and that there were currently “no valid scientific studies that show a mouth guard, in and of itself, can reduce the risk of concussions.”
That bottom line was ultimately the deciding factor in the FTC’s case against Brain-Pad, as outlined by Maura Marcheski and Leonard Gordon, partners at Venable LLP:
“The FTC announced the proposed settlement with Brain-Pad, Inc. and its President Joseph Manzo that bars the defendants from misrepresenting the health benefits of mouth guards or other athletic equipment designed to protect the brain from injury. Following the settlement, Brain-Pad cannot make unsupported claims that its mouth guards reduce the risk of concussion from lower jaw impacts, reduce the risk of concussions generally, or have been clinically proven to do either.”
What’s important to note about the FTC’s decision is what that means for other companies that find themselves walking the line that Brain-Pad overstepped.
Attorney: FTC Sends a Warning
Charles Gfeller, a partner at Seiger Gfeller Laurie LLP, told Sports Litigation Alert that this case shows the FTC’s “willingness and intent” to investigate claims, particularly in regards to concussion prevention, and that manufacturers should be careful when choosing their words.
“To the extent that a manufacturer of a product claims that the product can reduce the risk of, or even eliminate, concussions, it had better have substantiation for this claim,” said Gfeller. “Other manufacturers should be aware of this and take great care to avoid making unsubstantiated claims about the efficacy of their products.”
Tommy Dean, a certified athletic trainer for Louisiana Athletic Care, agreed, saying that “other product manufactures will hopefully think twice about marketing a known useless product as ‘concussion proof’ or otherwise now that the FTC has spoken.”
Dean’s advice to consumers: “Do not be fooled into buying a product that claims to be anything ‘proof.’ I own rain gear that is marketed as rain ‘proof’ but still managed to get soaked in the rain.”
With that in mind, and after examining the strength behind the FTC’s warning, it seems that manufacturers may need more than just “evidence” behind their claims.
Cal Burnton, a partner at Chicago based Edwards Wildman Palmer, specified just how much, saying that “the level of proof required may be daunting to many product sellers” in that it must have “competent and scientific evidence… demonstrated to a degree of probability bordering on certainty.”
Burnton went on to explain how sellers will no longer be able to rely solely on “in house” researchers and that they will now need “independent outside medical experts” to prove their claims, lending an independent view separate from the company’s best interest.
“Controversial evidence will not be sufficient,” he said. “The particular health claim must be one that is generally supported by the weight of scientific evidence.”
Helmet Maker Welcomes Scrutiny
Glenn Beckmann, Director of Marketing Communications at helmet manufacturer Schutt Sports, said that “for such an important national safety concern, we believe it is imperative that consumers are able to discern good information from bad,” a paramount goal of the FTC as seen in this case.
Many attorneys across the nation are quick to agree, as did Eugene Egdorf, a partner at Lanier Law Firm.
“The FTC has the legal authority to regulate advertising,” Egdorf said. “Its purpose in so doing is to protect consumers from false or misleading ads that misrepresent the characteristics or quality of goods.”
Beckmann and Egdorf are both correct, and this case speaks volumes to fact that manufacturers must provide consumers with true, complete information on a product if they are expected to remain morally sound and in good standing with the FTC.
“Concussions are of course the biggest issue in football today — the last thing we need is for athletes to believe that something like a mouth guard is a silver bullet that makes them safe and have that impact how an athlete acts on the field,” Egdorf said.
With today’s advances in technology, medical research and manufacturing it is not completely farfetched to believe that one day scientific data will back up claims that a mouth guard could help decrease the impact of a hit to the head.
Could. Decrease. Impact. Hit. These are important words to note, being that nothing out there will ever be able to claim it actually ‘prevents a concussion.’
Therefore, regardless of where one finds themselves in the debate on whether or not a mouth guard can reduce concussion-related injury, doctors, dentists and coaches can all agree on one thing: players need to use mouth guards for their original, intended purpose- to protect their teeth, not their brain.
