The Federal Trade Commission (FTC) and the marketers of Willow Curve, a low-level light therapy device, have agreed to a Stipulated Order for Permanent Injunction and Monetary Judgment forbidding false claims that the device treats chronic, severe pain and associated inflammation. The Order also imposes a $22 million judgment, suspended pending the payment of $200,000 each by individual defendants Ronald Shapiro, MD (a kidney specialist) and David Sutton, co-owners of the defendant companies marketing the device, based on their ability to pay. The Order resolves a six-count Complaint filed by the FTC against the defendants for violation of federal laws against deceptive advertising.
The FTC, which had been investigating the defendants since 2017, apparently agreed with SBM’s own Dr. Harriet Hall, who wrote about the Willow Curve in 2015:
Willow Curve makes a lot of claims, but there is no credible evidence to back them up. There are a lot of unanswered questions and red flags. Even if the effect is significant, it appears to be small in magnitude. . . . I’m not persuaded that the Willow Curve has any unique advantages over other, much less expensive products. . . . My inclination would be to stick to less expensive, more evidence-based treatments until Willow Curve has been properly tested.
You heard it here first, folks.
What’s a Willow Curve?
According to the FTC’s Complaint:
Willow Curve is a curved plastic device that applies low-level light and mild heat to the site of pain, via light-emitting diodes (“LEDs”) and heat resistors. To start a 24-minute “treatment” session, consumers select from among five different settings, which differ with respect to the parameters of the light emitted, such as angle, frequency, and sweep pattern. Willow Curve also includes sensors on its curved underside that purportedly measure skin-surface temperature.
“Low level light therapy” is a confusing and, per some experts, inaccurate term, as it can refer to devices with differing light sources and with varying mechanisms of action and therapeutic intent. The devices go by many names in addition to low-level light therapy, including low-level laser therapy, cold laser therapy, low-power laser therapy, low-intensity laser, low-energy laser therapy, monochromatic infrared light energy therapy, and, when applied to acupuncture points, laser acupuncture. According to a 2018 review by Quackwatch, these devices
may bring about temporary relief of some types of pain, but there’s no reason to believe that they will influence the course of any ailment or are more effective than standard forms of heat delivery.
But if you read or heard Willow Curve’s marketing materials, you’d think it was something out of a Silicon Valley start-up, a veritable Theranos. Advertisements used words like “therapeutic laser technology” and “digital anti-inflammatory technology” with “diagnostic sensors [to] gather information that’s used to adjust the kinetic energy that stimulates your body’s own natural pain-relieving pathways”, equipped with a “smart onboard computer [that] adjusts the protocol to your needs”. The device’s “joint scanning technology collects information from at and below your skin surface. . . [and] calculates and digitally delivers multiple energy beams that change thousands of times/second” and “produces dynamic multi-band alternating pulse therapy” to boot.
Promoted as an alternative to opioids, steroid injections, and surgery, the Willow Curve was “proven to relieve pain and stiffness in minutes”, sometimes in “as little as 12 minutes”, or just “24 minutes”, or at least “the next morning”, or in “two or three days”, depending on the particular testimonial. And no side effects! In sum, “nothing short of a miracle”.
Of course, if you’re selling miracles, you can charge a lot, and Willow Curve did just that. Since around 2014, Willow Curve typically cost $599, the price rising to $799 in 2018.
Big claims can get you in big trouble. The FTC requires “competent and reliable scientific evidence” to support health claims and testimonials like those used extensively by Willow Curve only serve to convey “the implied claim that the advertiser has proof to support the underlying efficacy representation”. Willow Curve had none of this, and is now, per the Stipulated Order, permanently enjoined from claiming that any device they sell is clinically proven to:
- Treat or relieve severe or chronic pain, including that due to rheumatoid arthritis, diabetic neuropathy, nerve damage, fibromyalgia, shingle, lupus, torn tendons, broken bones, or other specific health conditions;
- Treat or reduce inflammation;
- Provide pain relief comparable to drugs or surgery;
- Restore mobility and joint function to consumers with restricted movement;
- Reduce pain by a specific amount on pain scales or relieve pain for a certain percentage of users; or
- Evaluate or diagnose the cause of individual consumer pain.
Which just goes to show you how expansive Willow Curve’s claims were. For example, advertising represented that the device “reduces pain by three to ten points” on a numerical pain scale and that an incredible 99% of consumers “achieve significant pain relief”.
The Order leaves open the possibility that, at some point, the defendants might actually create a device that does any or all of these things and more. If they do, they’ll have to support any advertising claim with competent and reliable scientific evidence, defined in the Order as:
tests, analyses, research, or studies (1) that have been conducted and evaluated in an objective manner by experts in the disease, condition, or function to which the representation relates; (2) that are generally accepted by such experts to yield accurate and reliable results; and (3) that are randomized, double-blind, and placebo-controlled human clinical testing of the Device, when such experts would generally require such human clinical testing to substantiate that the representation is true.
Not FDA anything
Misrepresenting the Willow Curve’s effectiveness was not the defendants’ only sin. Various promotional materials represented that the device was “FDA Registered”, certified, or approved. But, as the FTC explains in the Complaint, the FDA classifies medical devices into one of three categories based on the risk they pose to the public. Higher-risk products (think X-ray machines) cannot be sold without pre-market approval, which requires a rigorous review of safety and efficacy data. Lower-risk devices undergo the less stringent “510(k)” review, which requires showing the new device is “substantially equivalent” to an existing device already legally marketed in the U.S. Finally, the FDA has exempted some lower-risk devices from even this less stringent level of review, “such as heating pads and topical heating devices that emit infrared light, such as Willow Curve”, requiring no FDA review before being marketed. In other words, the Willow Curve, with its alleged “digital anti-inflammatory technology” and “diagnostic sensors” and so forth is actually the regulatory equivalent of a $13.98 Walmart heating pad.
The FDA also requires that manufacturers and distributors of medical devices register annually and submit a device list so the agency knows where devices are made. The defendants never did this either. Thus, the Willow Curve was never registered, certified, or approved by the FDA, as claimed.
(Consumers may not be aware that, as the FDA explains, “Registration and Listing does not denote approval or clearance of a firm or their devices”, meaning that when you see “FDA registered” or “FDA listed” in advertising it not indicative of the efficacy or safety of the product, no matter how much the marketer would like you to believe otherwise.)
After paying hundreds of dollars for this gizmo and finding out it didn’t work as claimed, some purchasers tried to exercise their advertised right to a “risk-free trial” or a refund. Even that turned out to be a sham. Per the Complaint, consumers were required to pay shipping, handling, and other fees to return their devices. In many cases, refund requests were not honored or took a year or more to process. The FTC also charged the defendants with using deceptive “native” ads, which were commercial content disguised as independent journalistic content. Defendants are permanently enjoined from all of these deceptive and misleading practices as well.
If the individual defendants don’t pay the $200,000 each, the full $22 million judgment can come crashing down on their heads, as it will if they violate any of the other terms of the Order. And, as if in warning to similar device marketers, the FTC’s press release announced that that the suit is “the FTC’s first to challenge health claims made for a low-level light therapy device”, with the implication that others may follow.
But what about the poor consumers, stuck with their curved plastic casings embellished with LED lights? The Order does not specifically mention any relief for them, although the Order does say that the monies from the defendants “may” be deposited into a fund administered by the FTC and be used for “consumer redress”. The defendants are required by the Order to send all of their customers a letter telling them about the suit, and that the FTC says they don’t have evidence to support their health claims and can’t make any claims unless they have evidence to back it up. It does not say anything about customers recovering any money for their troubles.
The Willow Curve (now $699) is still on the market, albeit with far more subdued health claims. The consumer must also purchase a battery “specifically intended” for it ($39.99) or a charger ($29.99) to run the thing.
The website says that Willow Curve is “currently focused entirely on temporary relief for joint pain” and that a there is a “great deal of published research which is ongoing”. Two journal articles are referenced, one of which doesn’t have anything to do with joint pain. The other is more or less an opinion piece saying that “low-level laser (light) therapy [LLLT]” is “beneficial for pain relief and can accelerate the body’s ability to heal itself”. It cites some supporting evidence, but is not a critical review of the evidence, and acknowledges limitations on the therapy’s acceptance. The website also claims “the Willow Curve device is the only LLLT device recognized by the American Medical Association and was granted a unique insurance CPT Procedure code 0552T”, but I was not able to verify that information.
Willow Curve has also rescinded its “risk-free trial” and refund policies. If you pay $699 and don’t like it, too bad. Caveat emptor!