Last week, the Federal Trade Commission filed a lawsuit in federal court in California against Gravity Defyer Medical Technology Corporation alleging the company made unsubstantiated claims that its footwear reduces knee, back, ankle, and foot pain and helps with conditions such as plantar fasciitis, arthritis, joint pain, and heel spurs.
But the FTC’s case is less about footwear than it is about the imaginative ways the agency continues to find ways to pursue monetary relief in the wake of AMG Capital Management LLC v. FTC. There are a few things here worth discussing.
First, the FTC is seeking civil penalties. How, you might ask? The complaint alleges that Gravity Defyer’s owner, Alexander Elnekaveh, violated a 2001 FTC consent order involving his former business, Gadget Universe, which sold an automotive aftermarket fuel-line magnet device. Under the order, Elnekaveh and Gadget Universe agreed to “not mispresent, in any manner, expressly or by implication, the existence, contents, 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 ads for Gravity Defyer’s footwear make improper claims (“clinically proven to relieve pain, including 85% less knee pain, 91% less back pain, 92% less ankle pain, and 75% less foot pain”) that violate the 2001 consent order because the study the defendants relied on is neither reliable nor sufficient to back up the pain relief claims.
That brings us to our second point. The ads cited a study, conducted by Gravity Defyer, that the FTC found to be flawed. The agency argues the study:
- Was of insufficient size and duration
- Failed to ensure adequate double-blinding or adequately control for other treatments that participants might have received
- Relied solely on participants’ self-reported levels instead of including range of motion or other function tests
- Failed to take into account 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
Whether a court takes a similar view of the defendants’ study remains to be seen.
This case serves as an important reminder for individuals who have signed consent orders and then open new businesses. The provisions of the consent order may apply to your new businesses, even if they are completely different for products or services. After the AMG decision, the FTC is likely to focus more on “repeat offenders” because of the potential to obtain civil penalties—which can cost more than $40,000 per violation.
Finally, to avoid stubbing your toe when making health claims—including pain relief claims—you need buttoned-up, double-blind studies supporting 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 drafting this article.