TRIA Beauty Files Lawsuits Against Maker of no!no! Hair Removal Device
TRIA Beauty, Inc., the leader in light-based at-home beauty solutions, today announced that it has filed lawsuits against Radiancy Inc. (”Radiancy”) and Oregon Aesthetic Technologies, Inc. (”OAT”) in the United States District Court for the Northern District of California.� The lawsuits seek relief from Radiancy’s and OAT’s ongoing campaigns of false and misleading advertising and other unfair competitive practices related to their respective no!no! hair removal and ANSR:BEAM devices.� The suits seek injunctions and damages in connection with their claims.
“TRIA has invested heavily to develop technologies that make it simple for our customers to achieve smooth, clear, healthy-looking skin while in the comfort of their own homes,” said Kevin Appelbaum, President and Chief Executive Officer.� “Thanks to our years of clinical trials and FDA clearances, consumers know they can trust the effectiveness and safety of our products.”
“This industry has become saturated with competitors that intentionally make false and misleading advertising claims and market their products as medical devices having by-passed the clinical and regulatory work and expense required to validate the devices and demonstrate their safety and effectiveness.� Litigation is not something we enter into lightly; however, we believe we are obligated to take legal action, when appropriate, in order to protect our competitive position and clear up the confusion these false and misleading claims have created for consumers worldwide.”
TRIA designs, manufactures, markets, and sells clinically-proven and United States Food and Drug Administration (”FDA”) cleared light-based skincare treatments for safe, home use by its customers in the United States.� The FDA has granted Section 510(k) clearance for the TRIA Laser Hair Removal System as an over-the-counter (”OTC”) device for permanent hair reduction.� To TRIA’s knowledge, the TRIA Laser Hair Removal System remains the only OTC device to have such FDA clearance that is available for use at home.� To obtain this FDA clearance, TRIA conducted extensive testing to establish that consumers could use the TRIA Laser Hair Removal System safely and effectively in their own homes.� In addition, the FDA has granted Section 510(k) clearance for the TRIA Clarifying Blue Light as an OTC device for the treatment of acne, based on clinical testing demonstrating the safety and effectiveness of that product for use in the home environment.
In its complaint against Radiancy, TRIA charges that Radiancy has conducted a massive campaign of national television and Internet advertising to the general public to promote sales of its no!no! hair removal device and that this advertising includes numerous bogus claims.� Among other things, TRIA alleges:
- In its labeling and advertising, Radiancy repeatedly claims that the no!no! hair removal device will permanently reduce hair density and hair re-growth by up to 94%.� Although Radiancy alleges that it has “clinical studies” that support this claim, those studies do not establish any permanent hair reduction, much less one of up to 94%.� In fact, TRIA believes, based on its understanding of how the no!no! hair removal device works, that Radiancy’s unsupported permanent hair-reduction claims are false and misleading.
- TRIA’s FDA-cleared Laser Hair Removal System, unlike the Radiancy product, does produce a permanent reduction in hair regrowth and is an advanced light-based technology adapted from the same technology used in dermatologists’ offices.� The light waves penetrate the skin surface and are absorbed by the hair follicle, which is then disabled.� The Radiancy device, by contrast, consists merely of a heated wire that melts or chars the surface hairs with which it comes into contact.� Although the no!no! hair removal device does not use or incorporate lasers, Radiancy falsely advertises the no!no! hair removal device as being “like laser” for hair removal and its technology as “laser-like.”
- In a further effort to trade off TRIA’s reputation for quality, Radiancy has purchased and uses phrases incorporating the TRIA name as “keywords” on leading Internet search engines, including Google, Yahoo!, and Bing to generate sponsored links to Radiancy’s websites when Internet users conduct a search using one of these terms.� This use is likely to cause confusion, to cause mistake, or to deceive consumers and infringes TRIA’s trademark rights.
The case against OAT involves similar issues.� According to the complaint, OAT makes a number of false and misleading claims that its ANSR:BEAM device has been “clinically tested and proven” to be safe and effective in treating acne.� OAT cites and summarizes a number of peer-reviewed clinical studies in support of these claims.� None of these studies, however, involved the ANSR:BEAM, and TRIA believes that the ANSR:BEAM has not been the subject of any clinical trials, at least none that has established its safety or effectiveness in treating acne.� Therefore, these claims are all false and misleading.
OAT also claims that the ANSR:BEAM has replicated the specific light wavelength of clinically-proven treatments and developed a low-powered, safe, handheld, phototherapy unit, safe for daily use.� The studies cited by OAT, however, involved blue-light phototherapy devices operating at a materially different wavelength from the wavelength at which OAT indicates the ANSR:BEAM operates.
With respect to the FDA’s requirement that all companies — including Radiancy and OAT — obtain either premarket approval or Section 510(k) clearance before marketing a medical device, Mr. Appelbaum explains that, “TRIA’s policy is to alert FDA of violations of this requirement and to request that FDA take appropriate action.� Whatever action FDA may or may not take, however, TRIA is entitled to seek damages and injunctive relief in court because of Radiancy’s and OAT’s false advertising, and that is what we are doing.”
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