On Wednesday, Women’s Health Specialists PLLC (WHS) filed suit against the manufacturer of an energy-based laser device that it was allegedly told had U.S. Food and Drug Administration (FDA) approval to treat the symptoms of vulvovaginal atrophy, a condition related to menopause. The complaint argues that defendant Cynosure Inc., a division of Hologic Inc., deceived it into purchasing a six-figure piece of medical equipment known as the MonaLisa Touch after lying about its approved uses.
The Western District of Tennessee complaint explains that WHS first learned of Cynosure’s MonaLisa Touch in 2015 through the manufacturer’s direct marketing efforts. A Cynosure representative explained that “several million dollars would be spent on multimedia advertising for the MonaLisa Touch to ensure an ‘excellent and high profile branding’ ” and that Cynosure would provide WHS with web and marketing support. The representative also specifically promoted the device as intended to treat symptoms of vulvovaginal atrophy.
Based on the representative’s assurances, WHS purchased a MonaLisa Touch in March 2015 for about $157,000. The device was delivered shortly thereafter.
On Jul. 30, 2018, the FDA issued a warning to patients considering and health care providers offering procedures intended to treat vaginal conditions related to menopause using energy-based laser devices. The warning stated that undergoing such treatment could result in adverse side effects, and such treatments’ efficacy was neither established nor had the treatments received agency approval. An FDA official stated that the agency released the notice because it had become aware that companies were deceptively marketing the treatments as safe and effective.
The complaint avers that Cynosure was one of the companies the FDA was referring to in its admonition. The agency reportedly sent the defendant a letter dated Jul. 24, 2018, regarding its marketing of the MonaLisa Touch to treat the vaginal symptoms of menopause, for which the company did not have regulatory approval.
WHS became aware of the FDA’s warning in November 2019. It reportedly ceased marketing the device and given the FDA cautioning, has since “only rarely used the device.” The filing contends that had the plaintiff been aware that the MonaLisa Touch was not FDA approved for the treatment of vulvovaginal atrophy, WHS would never have made the purchase.
The complaint states three counts of fraud and one of unjust enrichment. The plaintiff seeks compensatory, equitable, and/or restitutionary damages.