Foran v. Ulthera, Inc.

• Decision Date: 17 February 2022
• Docket Number: 1:20-cv-00267-DAD-BAM
• Parties: ELIZABETH FORAN, Plaintiff, v. ULTHERA, INC., et al., Defendants.
• Court: U.S. District Court — Eastern District of California

ELIZABETH FORAN, Plaintiff,
v.
ULTHERA, INC., et al., Defendants.

No. 1:20-cv-00267-DAD-BAM

United States District Court, E.D. California

February 17, 2022

ORDER GRANTING IN PART DEFENDANTS' MOTION TO DISMISS

(Doc. No. 23)

This matter is before the court on the motion to dismiss filed by defendants Ulthera, Inc., Merz Inc., and Merz North America (collectively, “defendants”) on June 5, 2020. (Doc. No. 23.) Pursuant to Local Rule 230(g) and General Order No. 617, defendants' motion was taken under submission without a hearing for decision on the papers. (Doc. No. 26.)^[1] For the reasons

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explained below, the court will grant in part defendants' motion to dismiss.

BACKGROUND

Plaintiff filed the operative first amended complaint (“FAC”) in this action on May 22, 2020. (Doc. No. 21.) Therein, plaintiff alleges as follows.

Defendants manufacture and sell a medical device, the “Ulthera System” or “Ultherapy, ” that uses focused ultrasound to heat tissue to cause mechanical cellular disruption and that is marketed as a non-invasive alternative to face lifts. (Id. at ¶¶ 8, 10.) To market certain devices in the United States, one can obtain clearance from the United States Food and Drug Administration (“FDA”) through a premarket notification process as set forth in section 510(k) of the Federal Food, Drug, and Cosmetic Act. (See id. at ¶ 9.) The Ulthera System is cleared by the FDA via the 510(k) premarket notification process for the following uses: to lift the skin on the neck, lift skin under the chin, lift skin on the eyebrow, and to reduce lines and wrinkles on the chest. (Id. at ¶ 9.) On their website and in the marketing, training, and instructional materials distributed to clinicians, defendants market the Ulthera System for use on the entire face, despite the FDA denying clearance for use of the Ulthera system on the full face and neck. (Id. at ¶¶ 22-27, 30- 34.)

Defendants represented to the FDA that no permanent injuries to facial nerves have been reported as associated with the use of Ultherapy, that Ultherapy uses safe ultrasound energy, and that Ultherapy has been established as safe and effective in clinical studies and half a million treatments worldwide. (Id. at ¶¶ 35-37.) According to plaintiff, defendants had actual, direct knowledge of permanent nerve injuries associated with the use of the Ulthera System but failed to report such injuries to the FDA, including in the following instances: (1) on April 10, 2012, a member of defendant Merz Inc.'s advisory board reported a permanent and serious nerve injury to defendant Ulthera, Inc.'s vice president of medical and clinical affairs; (2) on April 17, 2014, defendants and the FDA received a report that a neurologist had confirmed that a patient suffered damage to the trigeminal nerves after receiving Ultherapy treatment; (3) on December 18, 2017, a plaintiff filed the complaint in Zhu v. Ulthera, Inc., No. 2:17-cv-09057 (C.D. Cal. 2017) alleging that she had sustained serious and permanent facial injuries as a result of Ultherapy; and (4) on

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March 5, 2018, a dozen plaintiffs filed a consolidated amended complaint in Foresee v. Ulthera, Inc., No. 16-cv-15444 (Ariz. Super. Ct. 2018) alleging serious facial nerve damage, scarring, discoloration, and elasticity injuries which were not disclosed as potential risks of Ultherapy. (Id. at ¶¶ 38-39, 41, 52, 55-56.) Thus, plaintiff alleges that defendants had actual knowledge of “reports of permanent facial scars, discoloration, damage to the skin including tone, elasticity and appearance, and related damages and risks associated with the Ulthera System prior to plaintiff's Ultherapy procedure” in 2019. (Id. at ¶ 40.)

On April 24, 2019, plaintiff received Ultherapy treatment at a beauty salon called Body Del Sol in Fresno, California. (Id. at ¶ 64.) Prior to receiving treatment, Body Del Sol personnel informed plaintiff that Ultherapy was a “non invasive, rejuvenating skin treatment” and was “safe, ” “FDA-approved, ” had only “temporary side effects, ” had “no long-term risks, ” and could be used on the “entire face, ” as advertised in an email that Body Del Sol sent to plaintiff promoting the use of Ultherapy on the full face. (Id. at ¶¶ 66-67.) According to plaintiff, the statements by Body Del Sol personnel were based on information provided by defendants- information that was inaccurate due to defendants' failure to report adverse events to the FDA. (Id. at ¶¶ 66, 69-70.) Body Del Sol personnel had also provided plaintiff with an “Ultherapy Consent Form” that stated the Ulthera System delivered a low amount of focused ultrasound energy and that bruising, welts, burns, scarring, temporary nerve inflammation, temporary local muscle weakness, temporary numbness, reduced sensitivity to touch, and pigmentation changes may occur but would resolve in days to weeks. (Id. at ¶¶ 73-81.) According to plaintiff, the information in the consent form was based on materials provided by defendants. (Id. at ¶ 71.)

Plaintiff agreed to receive Ultherapy treatment to the “full face, ” which included treatment near the eyes. (Id. at ¶ 68.) Plaintiff alleges that defendants acknowledged that Ultherapy cannot be safely used near the eyes, but failed to inform the FDA of the risks of Ultherapy treatment near the eyes and marketed the Ulthera System to clinicians and patients for use near the eyes. (Id. at ¶¶ 44-46.) Defendants also provided detailed instructions, charts, and marketing materials for performing Ultherapy directly next to the eyes. (Id. at ¶¶ 48-50.)

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Plaintiff alleges the Ultherapy treatment caused her to suffer severe and permanent facial, eye, and nerve damage, including tingling in the right arm and leg, paresthesia, bilateral uncontrolled hand shaking, facial numbness, facial pain, fat atrophy, increased wrinkles, vision loss, blurred vision, eye hemorrhage, ringing of the ears, light sensitivity, oral dryness and associated mouth and teeth pain, increased skin elasticity, and other painful, disfiguring, debilitating injuries. (Id. at ¶ 86.) Plaintiff sought medical treatment for her injuries in May 2019. (Id. at ¶ 85.)

Based on these allegations, plaintiff asserts the following claims against defendants in her FAC: (1) strict products liability based on a manufacturing defect, design defect, and failure to warn; (2) negligence based on defendants' failure to warn; (3) breach of express warranty; (4) negligence per se based on defendants' failure to warn the FDA by reporting adverse events; (5) fraudulent misrepresentation and concealment; and (6) unfair business practices in violation of California's Unfair Competition Law, California Business and Professional Code §§ 17200, et seq., (“UCL”). (Doc. No. 21.)

On June 5, 2020, defendants filed the pending motion to dismiss plaintiff's FAC, contending that plaintiff's claims are preempted by the Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”), that plaintiff otherwise fails to state a claim as to each of her causes of action, and that plaintiff lacks standing to bring the UCL claim. (Doc. No. 23.) Defendants also argues that this court lacks personal jurisdiction over defendant Merz Inc. (Id. at 32-33.) On June 22, 2020, plaintiff filed an opposition to defendants' motion to dismiss, in which she concedes that this court lacks personal jurisdiction over defendant Merz Inc., that her claim for strict products liability based on a manufacturing defect or a design defect should be dismissed, and that her claim for breach of warranty should also be dismissed. (Doc. No. 28 at 31.)^[2] On June 30, 2020, defendants filed a reply to plaintiff's opposition. (Doc. Nos. 28, 33.)

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LEGAL STANDARD

The purpose of a motion to dismiss pursuant to Rule 12(b)(6) is to test the legal sufficiency of the complaint. N. Star Int'l v. Ariz. Corp. Comm'n, 720 F.2d 578, 581 (9th Cir. 1983). “Dismissal can be based on the lack of a cognizable legal theory or the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir. 1990). A claim for relief must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). Though Rule 8(a) does not require detailed factual allegations, a plaintiff is required to allege “enough facts to state a claim for relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); Ashcroft v. Iqbal, 556 U.S. 662, 677-78 (2009). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. In determining whether a complaint states a claim on which relief may be granted, the court accepts as true the allegations in the complaint and construes the allegations in the light most favorable to the plaintiff. Hishon v. King & Spalding, 467 U.S. 69, 73 (1984); Love v. United States, 915 F.2d 1242, 1245 (9th Cir. 1989). It is inappropriate to assume that the plaintiff “can prove facts that it has not alleged or that the defendants have violated the . . . laws in ways that have not been alleged.” Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 526 (1983).

A complaint alleging fraud must satisfy heightened pleading requirements. Fed.R.Civ.P. Rule 9(b) (“In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”). “Fraud can be averred by specifically alleging fraud, or by alleging facts that necessarily constitute fraud (even if the word fraud is not used).” Kearns v. Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir. 2009) (internal quotations omitted). “When an entire complaint, or an entire claim within a complaint, is grounded in fraud and its allegations fail to...