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Last week, the Federal Trade Commission filed a lawsuit in California federal court against Gravity Defyer Medical Technology Corporation, alleging the company made unsubstantiated claims that its shoes reduced pain in the knee, back, ankle and foot and helped with conditions such as plantar fasciitis, arthritis, joint pain and heel spurs.
But the FTC case is less about the shoes and more about the imaginative ways the agency continues to find ways to seek monetary relief in the wake of AMG Capital Management LLC v FTC. There are a few things here worth discussing.
First, the FTC is asking for civil penalties. How, you ask me? The complaint alleges that Gravity Defyer owner Alexander Elnekaveh violated a 2001 FTC consent order involving his former company, Gadget Universe, which sold an automotive aftermarket magnetic fuel line device. Under the order, Elnekaveh and Gadget Universe agreed “not to misrepresent, in any way, expressly or by implication, the existence, content, validity, results, conclusions or interpretations of any test, study or research”.
Fast forward 20 years. In the lawsuit filed last week, the FTC alleged that advertisements for Gravity Defyer shoes made inappropriate claims (“clinically proven to relieve pain, including 85% less knee pain, 91% less less back, 92% less ankle pain and 75% less foot pain”) which violate the 2001 consent order because the study defendants relied on is neither reliable nor sufficient to support pain relief claims.
This brings us to our second point. The ads cite a study, conducted by Gravity Defyer, that the FTC found flawed. The agency argues the study:
- Was of insufficient size and duration
- Did not provide adequate double-blinding or adequate control for other treatments participants might have received
- Relies solely on participants’ self-reported levels instead of including range of motion or other functional tests
- Did not consider data from approximately twice as many participants who wore the shoes with and without the special sole
- Included results from participants who stopped wearing shoes
It remains to be seen whether any court takes a similar view on the study of defendants.
This case serves as an important reminder for people who signed consent orders and then opened new businesses. The provisions of the consent order may apply to your new businesses, even if they are completely different for the products or services. After the AMG decision, the FTC is likely to focus more on “repeat offenders” because of the possibility of obtaining civil penalties – which can cost more than $40,000 bybreach.
Finally, to avoid stubbing your toe when making health claims, including pain relief claims, you need double-blind, button-down studies to support the claims you want to make.
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The author would like to thank summer associate Ashley M. Qamar for her assistance in writing this article.
The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.
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