Last week, the Federal Trade Commission (“FTC”) announced a settlement with Neurometrix, the makers of the Quell electrical nerve stimulation device. In the complaint, the FTC alleged that the company made false claims about Quell’s ability to treat chronic and severe pain throughout the body, even though the device is only placed below the knee, and allegedly false claims that the device is clinically proven and cleared by the Food and Drug Administration (“FDA”) to treat full body pain. The case provides a good reminder that the FTC remains focused on health claims and the standards that the FTC requires for marketing products making health claims.
The FTC’s complaint also challenged advertising claims about Quell users’ results from using the device, including that 81% of people achieve significant pain relief with Quell, and that Quell relieves chronic or severe pain throughout the body caused by a wide range of conditions, including osteoarthritis, nerve damage, sciatica, shingles, and fibromyalgia.
The FTC rejected the company’s proffered substantiation for its claims. Although randomized, controlled clinical trials had been conducted on the Quell device, those studies had substantial flaws. For example, the FTC alleged that the science submitted was insufficient to substantiate the claims because the studies were not blinded, used too small a sample size, were not of sufficient duration, and failed to control for other treatments that subjects received such as pain medications. Another study failed to observe statistically significant differences in the group using the device. The FTC alleged that none of the clinical trials conducted on Quell (or on any substantially similar device with comparable dosing and placement), nor the entire body of relevant scientific evidence, demonstrated that Quell is effective in relieving chronic and severe pain beyond the site of application. These criticisms serve as a useful checklist in considering substantiation and the claims advertisers can make from studies.
Interestingly, Commissioner Christine Wilson issued a statement in response to the Commission’s authorization to file a complaint and settlement against Neurometrix, in which she concurred in part and dissented in part with the FTC’s decision. She agreed that Neurometrix made unsubstantiated claims regarding Quell’s ability to treat non-localized pain.
However, she cautioned the Commission not to impose an “unduly high standard of substantiation that risks denying consumers useful information.” According to Commissioner Wilson, some of the claims made about the device were based on accepted scientific literature and precedent, and the scientific community has determined that TENS devices, like Quell, can provide some non-localized pain relief, so the claim that Quell could cure some non-localized pain is not unfounded.
Commissioner Wilson urged the FTC to “focus [its] scarce resources on marketers that make serious health and disease claims with little to no support. And I encourage the Commission in future cases to give careful weight and consideration to all evidence submitted in support of claims, including emerging science, trends, and real world consumer data. Finally, I note that when deciding whether to take enforcement action, we must balance the risks of chilling research, innovation, and the dissemination of useful information against the potential benefits of enforcement.” Whether her warnings will have any impact on case selection and remedies at the FTC remains to be seen.