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LEGAL NEWSLINE

Tuesday, March 19, 2024

Ultherapy procedure has not received premarket FDA approval, consumers claim

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SACRAMENTO, Calif. (Legal Newsline) – Consumers have filed a class action lawsuit against the manufacturers and sellers of a nonsurgical cosmetic procedure over allegations that it is deceptively advertised as being Food and Drug Administration approved.

Georgia Tryan and Marilyn Echols, as individuals and on behalf of other members of the general public similarly situated, filed a complaint on Sept. 29 in the U.S. District Court for the Eastern District of California against Ulthera Inc. and Merz North America alleging violation of California's Consumers Legal Remedies Act, False Advertising Law and Unfair Competition Law.

According to the complaint, the plaintiffs allege that they had purchased defendants' Ultherapy for a premium price as a non-surgical cosmetic procedure that utilizes several medical device components. The plaintiffs allege the defendants lead customers to believe the process has undergone a rigorous FDA-approval process with all the safety and efficacy. The plaintiffs allege that Ultherapy has not received premarket FDA approval but rather merely a 510(k) premarket notification clearance. The plaintiffs allege the defendants misrepresented this fact to allegedly increase revenue and gain an advantage over competitors.

The plaintiffs hold Ulthera Inc. and Merz North America Inc. responsible because the defendants allegedly failed to disclose and actively misrepresented the true nature of the FDA's clearance of Ultherapy and intentionally concealed material facts about the product and breached their duty not to do so.

The plaintiffs request a trial by jury and seek an order to cease using "FDA cleared" on their website and in advertisements; award of compensatory, exemplary and statutory damages; attorneys' fees; costs; pre- and post-judgment interest; and such other relief as may be appropriate under the circumstances. They are represented by Bevin Allen Pike, Robert K. Friedl and Trisha K. Monesi of Capstone Law APC in Los Angeles.

U.S. District Court for the Eastern District of California Case number 2:17-cv-02036-MCE-CMK

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