Pain Relief Device Marketers to Pay $4M

Advertising Law

The marketers of a pain relief device reached a deal with the Federal Trade Commission (FTC), agreeing to pay at least $4 million and stop making the claims challenged by the agency as false and deceptive.

According to the FTC’s complaint, NeuroMetrix and CEO Shai Gozani promoted the Quell transcutaneous electrical nerve stimulation device as “clinically proven” and “FDA cleared” for chronic pain relief throughout the body. Ads claimed that by applying Quell to a location below the knee, “Neural pulses travel to the brain, triggering a natural response that blocks pain signals in the body for relief from chronic pain.”

According to the FTC, the company claimed its device would cause the release of “natural pain blockers” in the back, legs, feet or anywhere else and that 81 percent of users achieved “significant” pain relief and 67 percent significantly reduced their pain medication. According to the FTC complaint, company claims extended to conditions such as osteoarthritis, nerve damage, sciatica, shingles and fibromyalgia.

The Massachusetts-based company advertised Quell via television and online ads, on social media, and at major trade events. The company charged consumers between $250 and $300 for the product, plus the cost of electrodes (another $30 approximately every two weeks when they needed to be replaced).

However, the FTC concluded that NeuroMetrix lacked sufficient support for the claims and the claims were not within the scope of the company’s Food and Drug Administration (FDA) clearance. Although Quell was the subject of two randomized, controlled clinical studies, the FDA took issue with the limited indications studied (i.e., pain associated with cancer and low back pain), lack of control for placebo effect (in the case of the low back pain study) and study size.

To settle the charges, the proposed stipulated order reiterates and reinforces existing legal requirements that prohibit the defendants from making pain-relief claims unless they are true, not misleading, and supported by competent and reliable scientific evidence (consisting of human clinical testing based on standards generally accepted by relevant experts—that is, randomized, double blind and well controlled and conducted by qualified researchers).

The defendants are also barred from making misrepresentations about clinical proof or the scope of FDA clearance for any device.

In addition, the defendants must pay a $4 million judgment and turn over up to another $4.5 million in future foreign licensing payments.

“With the opioid crisis, consumers are searching for drug-free pain relief,” FTC Bureau of Consumer Protection Deputy Director Daniel Kaufman said in a statement about the case. “Devices claiming pain relief without scientific support harm consumers and undermine the market for non-drug products. The FTC will act on empty promises of pain relief.”

Although the FTC unanimously voted to approve the complaint and proposed consent order, Commissioner Christine S. Wilson issued a statement concurring in part and dissenting in part, “to the extent that the complaint challenges all claims that the device can deliver non-localized pain relief and with respect to the allegation that the defendants falsely claimed that the devices were ‘FDA cleared’ for widespread pain relief.”

Wilson cautioned the agency to “be careful not to impose an unduly high standard of substantiation that risks denying consumers useful information, diminishing incentives to conduct research and chilling manufacturer incentives to introduce new products to the market.”

To read the complaint and stipulated order in FTC v. NeuroMetrix, Inc., click here.

Why it matters: The settlement illustrates two lessons for companies making health-related claims. First, ensure that the testing methodology is sufficient. “It’s not enough for advertisers to ‘have a study,’” the agency wrote in a blog post. “The FTC will look at the clinical testing in question to determine if the methodology and results are sufficient to support the claims in the ad.” Second, be careful when referencing the FDA. “The FTC takes misrepresentations about purported FDA clearance or approval very seriously. Don’t convey broad, unqualified FDA clearance claims that you can’t substantiate.” The settlement also aligns with FDA requirements for companies (i.e., that claims made be consistent with prior clearance or approval).

Additionally, it is important to note that the product was the subject of clinical studies evaluating its effect on pain. That the studies did not meet the FTC’s standards for substantiation of claims serves as a warning sign for companies that develop clinical evidence for claims after initial FDA clearance.

The settlement is a cautionary tale for companies that the FTC and FDA continue to engage in oversight of medical claims, particularly in sensitive areas such as pain relief.

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