Case 2:21-cv-02012-MSN-atc Document 1 Filed 01/06/21 Page 1 of 11 PageID 1
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`UNITED STATES DISTRICT COURT
`FOR THE WESTERN DISTRICT OF TENNESSEE
`WESTERN DIVISION
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`WOMEN’S HEALTH SPECIALISTS, PLLC.,
`Plaintiff,
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`Case No. ______________
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`v.
`CYNOSURE, LLC,
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`Defendant.
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`COMPLAINT
`JURY TRIAL DEMANDED
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`Plaintiff, WOMEN’S HEALTH SPECIALISTS, PLLC (“Plaintiff” or “Plaintiff Women’s
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`Health Specialists”) by its attorneys, for its Complaint against the Defendant, CYNOSURE, LLC,
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`(“Cynosure” or “Defendant”), respectfully alleges upon information and belief as follows:
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`PARTIES
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`1.
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`Plaintiff Women’s Health Specialists, PLLC is a citizen of the State of Tennessee,
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`it is incorporated in the State of Tennessee, and its offices are located in Germantown, Shelby
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`County, Tennessee.
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`2.
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`Defendant, Cynosure, LLC, (formerly Cynosure, Inc.) is a Delaware corporation
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`with its headquarters in Westford, Massachusetts, and is a division of Hologic, Inc., which is a
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`Delaware corporation that has headquarters in Marlborough, Massachusetts.
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`JURISDICTION AND VENUE
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`3.
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`This Court has diversity jurisdiction over this case under 28 U.S.C. § 1332
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`because Plaintiff is a citizen of a State other than that of the citizenship of the Defendant. The
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`amount in controversy is alleged to be over the minimum requirement of $75,000.
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`4.
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`5.
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`Venue is proper in this Court because Plaintiff resides in this District.
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`This Court has personal jurisdiction over Defendant as Defendant conducts
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`business in Tennessee and committed the acts herein in Tennessee, as described further in this
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`Complaint.
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`FACTUAL BACKGROUND
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`6.
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`This action concerns Plaintiff’s financing and purchase of a medical device sold
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`by Defendant called the MonaLisa Touch.
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`7.
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`Plaintiff learned of the MonaLisa Touch on or about March of 2015 through direct
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`marketing efforts by Cynosure, including emails sent by Cynosure directly to Dr. Val Vogt, a
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`member of Women’s Health Specialists practice at that time.
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`8.
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`Cynosure representative, Christopher Binion (“Binion”) was a representative of
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`Defendant, and at all times discussed herein acted as Defendant’s agent.
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`9.
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`Binion stated that several million dollars would be spent on multimedia advertising
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`for the MonaLisa Touch to ensure an “excellent and high profile ‘branding’” for the device, and
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`that Women’s Health Specialists would be provided web and marketing support.
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`10.
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`Binion also specifically promoted the MonaLisa Touch as a device to treat the
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`symptoms of vulvovaginal atrophy. [See Christopher Binion email of March 17, 2015 attached
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`hereto as Exhibit A and incorporated herein by reference.]
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`11.
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`As a result of this promotion and representations, Plaintiff justifiably believed that
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`the MonaLisa Touch had been approved by the United States Food and Drug Administration
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`(“FDA”) specifically for the treatment of the symptoms of vulvovaginal atrophy (VVA) as it would
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`have been unlawful for Cynosure to market the device for these treatments unless the FDA
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`specifically approved such marketing.
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`12.
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`At no time did Binion or any other representative for Defendant advise Plaintiff
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`that using the MonaLisa Touch to treat symptoms of VVA was an “off-label” use.
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`13.
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`Binion also represented that Plaintiff would realize well more than the lease
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`payments from using the MonaLisa Touch.
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`14.
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`Based upon Binion’s representations, Plaintiff purchased the MonaLisa Touch on
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`or about March 20, 2015, for $156,780.00.
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`15.
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`16.
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`The MonaLisa Touch was delivered to Plaintiff by the end March of 2015.
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`Given the considerable cost of the MonaLisa Touch, Plaintiff financed the purchase
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`through Oneplace Capital, a finance company arranged by Defendant.
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`17.
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`Plaintiff entered into an agreement with Oneplace on or about March 20, 2015,
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`requiring Plaintiff to pay 6 monthly payments at $99 each followed by 60 monthly repayments at
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`$3,344.51, with the last payment due in October 2020. These payments totaled $201,264.60.
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`18.
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`Binion made the representations described in the paragraphs above to Dr. Val Vogt
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`who was acting on behalf of Plaintiff in order to induce Plaintiff to finance and purchase the
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`MonaLisa Touch.
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`19.
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`On July 30, 2018, the FDA issued a warning (“July 30, 2018 FDA Warning”) to
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`“patients considering any . . . procedure or procedures intended to treat vaginal conditions and
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`symptoms related to menopause . . .” and to “health care providers who perform vaginal procedures
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`using energy-based devices” “to alert patients and health care providers that the use of energy-
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`based lasers to perform . . . non-surgical vaginal procedures to treat symptoms related to
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`menopause . . . may be associated with serious adverse events [and that] [t]he safety and
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`effectiveness of energy-based devices for treatment of these conditions has not been established.
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`(Emphasis added.).
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`20.
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`The FDA went on to state that “[t] o date, we have not cleared or approved for
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`marketing any energy-based devices to treat these symptoms or conditions, or any symptoms
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`related to menopause . . .” (emphasis added) but was “aware that certain device manufacturers may
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`be marketing their energy-based medical devices for vaginal ‘rejuvenation’” (which it defined to
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`include the typical vaginal symptoms of menopause).
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`21.
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`As succinctly explained by FDA Commissioner Dr. Scott Gottlieb, the FDA:
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`recently become aware of a growing number of manufacturers marketing “vaginal
`rejuvenation” devices to women and claiming these procedures will treat conditions
`and symptoms related to menopause, urinary incontinence or sexual function. The
`procedures use lasers and other energy-based devices to destroy or reshape vaginal
`tissue. These products have serious risks and don’t have adequate evidence to
`support their use for these purposes. We are deeply concerned women are being
`harmed.
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`Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health
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`from deceptive health claims and significant risks related to devices marketed for use in medical
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`procedures for “vaginal rejuvenation”, dated July 30, 2018, available at
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`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm; see also
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`FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal
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`Cosmetic Procedures: FDA Safety Communication, dated July 30, 2018, available at
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`https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm615013.htm (text of warning).
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`22.
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`As Commissioner Gottlieb further explained, while the FDA had cleared various
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`laser and other energy-based devices to treat such conditions as abnormal or pre-cancerous cervical
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`or vaginal tissue or genital warts, “the safety and effectiveness of these devices hasn’t been
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`evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’” Id. Nonetheless, companies who
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`produce and sell these devices make “deceptive health claims” and engage in “deceptive marketing
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`of a dangerous procedure with no proven benefit,” which he stated was, in a word, “egregious.”
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`Id. As the July 30, 2018 FDA Warning itself stated, using such devices for vaginal rejuvenation
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`“may lead to serious adverse events,” including vaginal burns, scarring, pain during sexual
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`intercourse, and recurring/chronic pain.
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`23.
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`Cynosure was one of the companies the FDA was referring to in its July 30, 2018
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`FDA Warning with regard to its marketing of its energy-based laser – the MonaLisa Touch.
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`24.
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`In a letter dated July 24, 2018 to Defendant, the FDA raised a number of examples
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`of Defendant’s improper marketing of its MonaLisa Touch to treat the vaginal symptoms of
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`menopause which the FDA could hardly have been clearer – are purposes for which it was not
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`approved by the FDA and for which its safety and effectiveness had not been established.
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`25.
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`The FDA stated that the MonaLisa Touch had only been cleared “for incision,
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`excision, ablation, vaporization and coagulation of body soft tissues in medical specialties
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`including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT),
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`gynecology, neurosurgery, orthopedics, general and thorasic surgery (including open and
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`endoscopic), dental and oral surgery and genitourinary surgery.” July 24, 2018 Letter from Cesar
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`A. Perez, PhD, Chief of the Surveillance and Enforcement Brach, Division of Premarket and
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`Labeling Compliance, Office of Compliance, Center for Devices and Radiological Health to
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`Connie Hoy, Official Correspondent, Cynosure, Inc.
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`26.
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`On or about November, 2019, Plaintiff became aware of the July 30, 2018 FDA
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`Warning, which revealed to them for the first time that the MonaLisa Touch was not FDA
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`approved for the purposes for which Defendant sold the MonaLisa Touch to Plaintiff and the
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`treatments for which Defendant's Sales Representative represented to Plaintiff, specifically the
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`treatment of the symptoms of VVA.
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`27.
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`Upon learning about the July 30, 2018 FDA Warning, Plaintiff ceased marketing
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`the MonaLisa Touch as part of its practice and, given the FDA’s warnings and lack of FDA
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`approval, has only rarely used the device.
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`28.
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`Had Plaintiff been aware that the MonaLisa Touch was not FDA approved for the
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`treatments for which Defendant marketed the device to it and its providers (the treatment of the
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`symptoms of VVA), Plaintiff would not have purchased the MonaLisa Touch or agreed to finance
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`that purchase.
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`29.
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`Plaintiff purchased the MonaLisa Touch strictly for the procedures that were
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`marketed by Defendant as being approved by the FDA (the treatment of the symptoms of VVA),
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`as set forth above, and for no other purpose. As a result, Plaintiff has suffered costs including the
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`cost of purchasing and financing the purchase of the MonaLisa Touch at issue here.
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`FIRST CAUSE OF ACTION
`FRAUD
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`30.
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`31.
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`Each of the preceding paragraphs are hereby incorporated by reference.
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`As set forth in paragraphs 9-13, above, Binion made material misrepresentations of
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`then existing facts to induce Plaintiff to purchase the MonaLisa Touch and finance that purchase.
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`Specifically, Binion promoted the MonaLisa Touch as a device to treat the symptoms of
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`vulvovaginal atrophy meaning that the MonaLisa Touch was FDA approved for that procedure.
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`Binion also made representations concerning the marketing and advertising that would surround
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`the MonaLisa Touch.
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`32.
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`These representations were intentionally made with the intent and purpose to cause
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`Plaintiff to rely upon them and purchase and finance a MonaLisa Touch. Contrary to these
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`representations, Defendant knew that the MonaLisa was not approved by the FDA to treat the
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`symptoms of VVA at the time these representations were made or acted in reckless disregard of
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`this fact based on, among other things, its communications with the FDA concerning approvals of
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`the MonaLisa Touch and its procedures.
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`33.
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`Indeed, unbeknownst to Plaintiff, Defendant was seeking FDA approval of the
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`MonaLisa Touch for VVA purposes at the time Defendant was in the process of selling the
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`MonaLisa Touch to Plaintiff for these purposes. Specifically, on or about March 17, 2015,
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`Defendant sought FDA approval to market its MonaLisa Touch laser for “the treatment of
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`symptoms related to GSM including Vaginal Dryness, Vaginal Burning, Vaginal Itching, Pain,
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`Dysuria and Dyspareunia.” These facts were not made available to Plaintiff and were not available
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`publicly.
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`34.
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`Plaintiff reasonably and justifiably relied upon Defendant’s representations given
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`Defendant’s superior knowledge as to what the FDA did (or did not) approve and the uses for
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`which the MonaLisa Touch was approved by the FDA in agreeing to purchase and finance the
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`purchase of the MonaLisa Touch.
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`35.
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`As a result of the Defendant’s false or misleading statements, Plaintiff suffered
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`damages including the costs it has incurred in purchasing and financing the MonaLisa Touch.
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`Plaintiff would not have purchased or financed the MonaLisa Touch had it not been misled by
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`Defendant that the MonaLisa Touch was FDA approved to treat the symptoms of VVA which
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`Defendant knew at the time was not true.
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`SECOND CAUSE OF ACTION
`FRAUDULENT MISREPRESENTATION
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`36.
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`37.
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`Each of the preceding paragraphs are hereby incorporated by reference.
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`As set forth and incorporated by reference in the paragraphs above, Binion made
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`material misrepresentations of then existing facts to induce Plaintiff to purchase the MonaLisa
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`Touch and finance that purchase. These representations were made with the intent and purpose to
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`cause Plaintiff to rely upon them and purchase and finance a MonaLisa Touch.
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`38.
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`39.
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`The material misrepresentations were false when made.
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`In fact, contrary to these representations, Defendant knew that the MonaLisa was
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`not approved by the FDA to treat the symptoms of VVA at the time these representations were
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`made or acted in reckless disregard of this fact based on, among other things, its communications
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`with the FDA concerning approvals of the MonaLisa Touch and its procedures. Indeed,
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`unbeknownst to Plaintiff, Defendant was seeking FDA approval of the MonaLisa Touch for VVA
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`purposes at the time Defendant was in the process of selling the MonaLisa Touch to Plaintiff for
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`these purposes. Specifically, on or about March 17, 2015, Defendant sought FDA approval to
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`market its MonaLisa Touch laser for “the treatment of symptoms related to GSM including
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`Vaginal Dryness, Vaginal Burning, Vaginal Itching, Pain, Dysuria and Dyspareunia” These facts
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`were not made available to Plaintiff and were not available publicly.
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`40.
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`The facts described above were material to Plaintiff’s decision to purchase the
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`MonaLisa Touch.
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`41.
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`Plaintiff
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`reasonably
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`and
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`justifiably
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`relied upon Defendant’s material
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`representations given Defendant’s superior knowledge as to what the FDA did (or did not) approve
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`and the uses for which the MonaLisa Touch was approved by the FDA in agreeing to purchase and
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`finance the purchase of the MonaLisa Touch.
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`42.
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`As a result of the Defendant’s false or misleading statements, Plaintiff suffered
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`damages including the costs it has incurred in purchasing and financing the MonaLisa Touch.
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`Plaintiff would not have purchased or financed the MonaLisa Touch had it not been misled by
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`Defendant that the MonaLisa Touch was FDA approved to treat the symptoms of VVA.
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`THIRD CAUSE OF ACTION
`FRAUD IN THE INDUCEMENT
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`43.
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`44.
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`Each of the preceding paragraphs are hereby incorporated by reference.
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`As set forth in the paragraphs above, Binion made material false statements of then
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`existing facts to induce Plaintiff to purchase the MonaLisa Touch and finance that purchase.
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`45.
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`Binion made such statements with knowledge of their falsity or with utter disregard
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`for their truth since at the same time Defendant was seeking FDA approval for VVA purposes.
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`46.
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`These representations were made with the intent of inducing reliance by Plaintiff
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`upon the statements such that Plaintiff would purchase and finance a MonaLisa Touch.
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`47.
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`Plaintiff reasonably and justifiably relied upon Defendant’s representations given
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`Defendant’s superior knowledge as to what the FDA did (or did not) approve and the uses for
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`which the MonaLisa Touch was approved by the FDA in agreeing to purchase and finance the
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`purchase of the MonaLisa Touch.
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`48.
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`As a result of the Defendant’s false or misleading statements and Plaintiff’s reliance
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`on them, Plaintiff suffered damages including the costs it incurred in purchasing and financing the
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`MonaLisa Touch.
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`FOURTH CAUSE OF ACTION
`UNJUST ENRICHMENT
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`49.
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`50.
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`Each of the preceding paragraphs are hereby incorporated by reference.
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`Defendant has received the purchase price it charged Plaintiff to purchase the
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`MonaLisa Touch from Oneplace Capital, the financing company Defendant recommended to
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`Plaintiff.
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`51.
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`Plaintiff would not have incurred any of the costs of both the MonaLisa Touch and
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`the financing charges had Defendant been truthful about the absence of FDA approval to treat the
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`symptoms of VVA.
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`52.
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`53.
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`Plaintiff’s purchase of the MonaLisa Touch conferred a benefit on Defendant.
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`By virtue of its obtaining these monies paid by Plaintiff to purchase and service the
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`MonaLisa Touch, Defendant has appreciated that benefit, knowingly accepted that benefit, and
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`has been unjustly enriched to the detriment of Plaintiff.
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`54.
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`Defendant’s retention of the monies it has gained through its wrongful acts and
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`practices would be unjust considering the circumstances of its obtaining those monies.
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`55.
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`It would be against equity and good conscience for Defendant to retain these funds
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`given the misrepresentations Defendant utilized to induce Plaintiff to purchase and finance the
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`MonaLisa Touch.
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`56.
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`Plaintiff was damaged and is entitled to full reimbursement of the unlawfully
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`obtained payments and finance charges.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff respectfully asks the Court to enter judgment against Defendant for all
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`of the following:
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`A.
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`For compensatory, equitable and/or restitutionary damages available under the
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`causes of action set forth herein according to proof; and
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`B.
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`For such other and further relief as this Court may deem just and proper.
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`DEMAND FOR TRIAL BY JURY
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`Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure, Plaintiff demands a trial
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`by jury on all questions of fact raised by the Complaint.
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`Case 2:21-cv-02012-MSN-atc Document 1 Filed 01/06/21 Page 11 of 11 PageID 11
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`Dated: January 6, 2021
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`Respectfully Submitted,
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`/s/ Caroline Ramsey Taylor, Esq.
`Caroline Ramsey Taylor (BPR #33919)
`WHITFIELD BRYSON LLP
`518 Monroe Street
`Nashville, TN 37208
`Telephone: (615) 921-6500
`Fax: (615) 921-6501
`Caroline@whitfieldbryson.com
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`KLAFTER OLSEN & LESSER LLP
`Jeffrey A. Klafter*
`Seth R. Lesser*
`Cyrus Kornfeld*
`KLAFTER OLSEN & LESSER LLP
`Two International Drive, Suite 350
`Rye Brook, New York 10573
`Telephone: (914) 934-9200
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` – and –
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`JAVERBAUM WURGAFT HICKS KAHN
`WIKSTROM & SININS, P.C.
`Michael A. Galpern*
`100 Century Parkway, Suite 305
`Mount Laurel, NJ 08054
`Telephone: (973) 379-4200
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`Attorneys for Plaintiff
`*Pro Hac to be Filed
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