On August 22, 2018, on behalf of a obstetrician/gynecologist, KL sued Cynosure, a manufacturer of medical laser systems. The complaint asserts that its products which were intended to treat serious illnesses deceptively marketed its MonaLisa Touch devices as safe for “vaginal rejuvenation,” according to a new federal class action lawsuit. The lawsuit followed a warning from the Food and Drug Administration that using laser-based devices for off-label vaginal rejuvenation carry “serious risks,” and that companies like MonaLisa Touch maker Cynosure Inc. have engaged in flagrant “deceptive marketing” to sell these devices.
The lawsuit alleges that Cynosure deceived healthcare providers across the country about the benefits and safety of its MonaLisa Touch. Cynosure touted its MonaLisa Touch as a “treatment that renews intimacy and changes lives” with “virtually no side effects.” But Cynosure failed to mention that while the FDA had cleared this type of device to treat such conditions as abnormal or pre-cancerous cervical or vaginal tissue, the agency never approved the MonaLisa Touch laser for vaginal rejuvenation. The company also did not disclose that laser-based vaginal rejuvenation can cause serious harm. The FDA’s recent warning recognized that laser-based vaginal rejuvenation “may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.” FDA Commissioner Scott Gottlieb, M.D. cautioned that the “deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
KL’s client is a company headed by Dr. Robert A. Salk, who leased one for his practice in Warwick, RI at a cost of over $200,000. Dr. Salk, a former military physician who is also a clinical assistant professor at Women and Infants Hospital of Rhode Island, the primary teaching hospital in obstetrics and gynecology for Brown University’s medical school, is bringing the lawsuit on behalf of all purchasers or lessors of the device nationwide.
In response to the FDA’s warnings, Dr. Salk and his practice immediately ceased using the MonaLisa Touch device; however, they remain financially liable for the full terms of their lease. In the lawsuit, Dr. Salk and his attorneys detail how Cynosure extensively marketed the probe as safe and meant to be used for vaginal rejuvenation procedures, including through testimonials from women who claimed the MonaLisa Touch solved the issues they had had with physical intimacy. Nowhere in its marketing materials did Cynosure disclose the serious risks associated with using a laser on vaginal tissue.
The lawsuit is Three R LLC v. Cynosure, Inc, case number 3:18-cv-30133, filed in the U.S. District Court for Massachusetts. A copy of the complaint can be found here.