Heather Wanke v. Invasix Inc.

CourtDistrict Court, M.D. Tennessee
DecidedFebruary 1, 2021
Docket3:19-cv-00692
StatusUnknown

This text of Heather Wanke v. Invasix Inc. (Heather Wanke v. Invasix Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Tennessee primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Heather Wanke v. Invasix Inc., (M.D. Tenn. 2021).

Opinion

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF TENNESSEE NASHVILLE DIVISION

HEATHER WANKE, ) ) Plaintiff, ) ) v. ) Case No. 3:19-cv-0692 ) Judge Aleta A. Trauger INVASIX INC. and INMODE LTD., ) ) Defendants. ) )

MEMORANDUM

Defendants Invasix Inc. (“Invasix”) and InMode Ltd. (“InMode”) have filed a Motion for Summary Judgment (Doc. No. 93), to which Heather Wanke has filed a Response (Doc. No. 107), the defendants have filed a Reply (Doc. No. 112), Wanke has filed a Sur-Reply (Doc. No. 116), and the defendants have filed a Sur-Sur-Reply (Doc. No. 119). Wanke has filed a Motion to Strike Summary Judgment Evidence and Objection (Doc. No. 103), to which the defendants have filed a Response (Doc. No. 111). For the reasons set out herein, the defendants’ motion will be granted in part and denied in part, and Wanke’s motion will be denied. I. BACKGROUND This case involves a medical device manufactured, marketed, and/or sold by the defendants under the name “Fractora.” It is used on the skin for cosmetic purposes. A detailed account of the regulatory environment surrounding the sale and marketing of the Fractora as a medical device, combined with allegations by Wanke of various instances of wrongdoing, can be found in the court’s Memorandum of May 19, 2020. (Doc. No. 87 at 1–8.) In short, Wanke alleges that the defendants marketed the Fractora improperly, including by encouraging its operation by unqualified personnel and/or in unsafe ways, leading to the device’s inflicting permanent injuries on some patients. Wanke alleges that she was injured by a Fractora procedure performed on her face by Dr. Paulino E. Goco on June 15, 2017. On January 23, 2019, Wanke and others with similar allegations

entered into a Tolling Agreement with Invasix “and any other related and affiliated corporations and businesses” covering potential claims related to Fractora. On April 17, 2019, a day before the Tolling Agreement was to expire, Wanke filed her claims in the U.S. District Court for the Central District of California, which later transferred the claims here. (Doc. No. 1; Doc. No. 80-4; Doc. No. 1071 ¶¶ 1–2, 24–25.) At issue with regard to the current motion is whether those claims were timely filed, which, as the court will discuss later in this opinion, may depend in part on the details of when Wanke became or should have become aware that she had suffered a wrongful injury, rather than the intentional, controlled physical damage inflicted during a successful Fractora procedure. Wanke described the period immediately following her procedure as follows:

55. Dr. Goco told Heather to expect less than five days downtime[,] so Heather knew something had gone terribly wrong when she remained swollen with puncture mark wounds all over her face at day 3 and 4 of her recovery. She remained housebound at day 7. Her skin looked even worse beginning at day 10—as the swelling subsided, Heather’s smooth, clear skin came to look and feel like orange peel, the skin under her eyes darkened[,] and burns left [claw- and moon-shaped scarring] on her cheeks, upper lip and chin and between her brow[s].

56. Dr. Goco shared Heather’s concern, requiring multiple follow up appointments. In notes from July 12, 2017, Dr. Goco noted “hyperpigmentation.” He repeated a VISIA Facial Assessment Report on Heather that same day. As compared to an assessment taken June 9, 2017, just before the Fractora procedure, Heather’s skin

1 For reasons that will be explained in this opinion, Wanke’s Response to the defendants’ Statement of Undisputed Material Facts (Doc. No. 105) includes two numbered sets of paragraphs—the first, representing assertions by the defendants, and the second, representing assertions by Wanke. When the court cites this document, a citation to a paragraph without a page number will refer to the first set of numbered paragraphs. If a page number is included, the citation is to the second set of paragraphs. scored 60-90% worse in assessments including “spots,” “wrinkles,” “texture” and “pores.”

57. Heather cried and cried in Dr. Goco’s treatment room. Neither the doctor nor his staff could console her. Dr. Goco became so alarmed at Heather’s distress, he left a personal voice mail message for her after the July 12, 2017 appointment. In it, Dr. Goco acknowledged that Heather would need multiple additional treatments to address the injuries sustained as a result of the Fractora treatment.

(Doc. No. 1 ¶¶ 55–57.) Wanke filed her April 17, 2019 Complaint with two co-plaintiffs, Mia Jones and Janice Newman, in the Central District of California. (Doc. No. 1.) That Complaint named only Invasix as a defendant. (Id. at 1.) On June 28, 2019, Invasix filed a Motion to Sever and Transfer Plaintiffs’ Claims. (Doc. No. 20.) Invasix noted that Wanke and Jones were Tennessee residents who had procedures performed on them in Tennessee, while Newman was a New York resident whose Fractora procedure was performed in New York. Moreover, Invasix argued, each plaintiff’s claims involved unique questions regarding each patient’s treatment, rendering joinder inappropriate. (Doc. No. 20-1 at 9.) The plaintiffs opposed the motion, arguing that their claims were based on the same course of wrongdoing by Invasix and that the Central District of California was the most convenient forum for key non-party witnesses. (Doc. No. 28 at 3, 14.) The court granted both of Invasix’s requests, severing the plaintiffs’ cases and transferring each case to the plaintiff’s home district—that being, in Wanke’s case, the Middle District of Tennessee. (Doc. No. 36.) On October 22, 2019, Wanke filed an Amended Complaint, adding InMode as a defendant. (Doc. No. 58 at 1.) On February 27, 2020, Invasix and InMode filed separate Motions to Dismiss, each of which alleged that Wanke’s claims were barred by the relevant statutes of limitations (and InMode’s arguing, in addition, that service of process on that company, which is based in Israel, was ineffective). (Doc. Nos. 67 & 69.) While those motions were pending, Wanke filed a Motion for Leave to File Amended Complaint. (Doc. No. 73.) The proposed Second Amended Complaint included several new paragraphs under the heading “Facts Concerning Statute of Limitations,” the first of which explained as follows: The Fractora procedure involves the intentional destruction of tissue so that new collagen will form, tightening and otherwise resurfacing the skin. All Fractora patients experience an injury and [patients] heal at different rates. Plaintiff was told by her treating physician that her procedure had gone normally and that her skin was and would continue healing. Subsequently, another physician told Plaintiff that she could expect her skin to continue healing for up to a year and that it would be impossible to determine whether she had any actual injury (as opposed to the intentional tissue damage and expected healing time for the Fractora) for at least a year after the procedure. Thus, based on a doctor’s expert opinion, Plaintiff did not and could not through exercise of reasonable diligence [have] known she suffered a cognizable injury as a result of the Defendant’s wrongful conduct until June 15, 2018.

(Doc. No. 89 at 2–3.) Wanke also excised her previous description of the days following her procedure, in which she described knowing that something had gone awry nearly immediately and tearfully complaining to Dr. Goco, who shared her concerns. (See Doc. No. 107 ¶¶ 8, 14 (conceding that relevant paragraphs were removed).) On May 19, 2020, the court entered a Memorandum and Order, granting Wanke leave to file the Second Amended Complaint. (Doc. Nos.

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Heather Wanke v. Invasix Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/heather-wanke-v-invasix-inc-tnmd-2021.