Tesse Perez v. Apyx Medical Corporation

District Court, N.D. California·Decided September 14, 2026·No. 4:25-cv-06713·Unknown

Opinion

TESSE PEREZ, Case No. 25-cv-06713-JST

Plaintiff, ORDER GRANTING MOTION TO v. DISMISS

APYX MEDICAL CORPORATION, Re: ECF No. 22 Defendant.

Before the Court is Apyx Medical Corporation’s (“Apyx”) motion to dismiss. The Court will grant the motion. Plaintiff Tesse Perez brought this products liability and negligence action against Defendants Solta Medical, Inc. (“Solta”), Bausch Health Companies Inc. (“Bausch”), and Apyx Medical Corporation (“Apyx”) in connection with a failed surgical procedure. ECF No. 17 (“FAC”). Perez alleges that she underwent plastic surgery with Dr. David Sieber on November 17, 2022 in San Franscisco. ECF No. 17 ¶¶ 11–12. Perez alleges that that Dr. Sieber used the Solta’s VASERlipo product to perform liposuction and Apyx’s Renuvion product to perform skin resurfacing and body contouring procedures. Id. ¶¶ 13–19. As a result of the procedures, Perez suffered severe burns, related injuries, and substantial scarring. Id. ¶ 20. Perez alleges that the Food and Drug Administration (“FDA”) issued a warning in June 2022 warning against the use of Renuvion for skin contraction with liposuction. Id. ¶¶ 26–29. Perez brings claims against Apyx for strict products liability and negligence.1 Id. ¶¶ 58–70, 77–82. Perez filed an amended complaint on September 15, 2025. Id. Apyx moved to dismiss the complaint on grounds of both failure to effect service and failure to state a claim. ECF No. 22. Perez opposed the motion, ECF No. 26, and Apyx replied, ECF No. 27. In a prior order, the Court quashed Perez’s service of the complaint on Apyx for failure to properly effectuate service. ECF No. 36. Perez filed a certificate of service on June 15, 2026. ECF No. 37. The Court now addresses Apyx’s motion to dismiss for failure to state a claim. The Court has jurisdiction over this matter under 28 U.S.C. § 1332(a). To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), a complaint 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). Dismissal “is appropriate only where the complaint lacks a cognizable legal theory or sufficient facts to support a cognizable legal theory.” Mendiondo v. Centinela Hosp. Med. Ctr., 521 F.3d 1097, 1104 (9th Cir. 2008). “[A] complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “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. While this standard is not “akin to a ‘probability requirement’ . . . it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (quoting Twombly, 550 U.S. at 556). “Where a complaint pleads facts that are ‘merely consistent with’ a defendant’s liability, it ‘stops short of the line between possibility and plausibility of entitlement to relief.’” Id. (quoting Twombly, 550 U.S. at 557). In determining whether a plaintiff has met the plausibility requirement, a court must “accept all factual allegations in the complaint as true and construe the pleadings in the light most favorable” to the plaintiff. Knievel, 393 F.3d at 1072. “risk-expectation” theory; (2) strict liability under a design defect “consumer expectations theory”; and (3) negligence in the design, manufacture, marketing, and sales of Renuvion. Id. ¶¶ 58–70, 77–82. Apyx moves to dismiss, arguing that Perez’s claims are preempted and that she fails to state a cause of action. ECF No. 22 at 11. The Court address each argument in turn. A. FDCA Preemption In its motion to dismiss, Apyx first argues that Perez’s claims are claims about Apyx’s Renuvion device’s off-market marketing and are impliedly preempted by the Food, Drug, and Cosmetics Act (“FDCA”). ECF No. 22 at 7. Apyx claims that Perez’s claims are preempted because they are based on alleged misrepresentation regarding off-label use of the device in violation of the FDCA, but the FDCA prohibits private enforcement. Id. at 9 (citing 21 U.S.C. § 337(a)). Perez responds that “the allegation that the product was being used off label produces the inference that the product was not safe for use in that manner” and “the allegation of off-label marketing only serve to show that Apyx knew the product would be misused in this dangerous fashion.” ECF No. 26 at 6. In support of her argument, Perez cites Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which found that state law claims for negligence and strict liability were not expressly preempted. Medtronic, 518 U.S. at 497. Perez fails to respond to Apyx’s implied preemption argument. The Supremacy Clause of the Constitution enables Congress to enact legislation that preempts state law. See Gibbons v. Ogden, 22 U.S. 1, 211 (1824). “Federal preemption occurs when: (1) Congress enacts a statute that explicitly pre-empts state law; (2) state law actually conflicts with federal law; or (3) federal law occupies a legislative field to such an extent that it is reasonable to conclude that Congress left no room for state regulation in that field.” Chae v. SLM Corp., 593 F.3d 936, 941 (9th Cir. 2010) (citation omitted). In determining whether a claim is preempted, the Court heeds the long-established presumption against preemption. See Medtronic, 518 U.S. at 485. “Consideration of issues arising under the Supremacy Clause starts with the assumption that the historic police powers of the States are not to be superseded by . . . Federal Act unless that is the clear and manifest purpose of Congress.” Cipollone v. Liggett Grp., Inc., Even if a state law is not expressly preempted by the FDCA, it may still be impliedly preempted if it conflicts with the FDCA’s provisions. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348 (2001). There is no private right of action under the FDCA. Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1119 (9th Cir. 2013). Rather, “[t]he FDA is responsible for investigating potential violations of the FDCA.” Id. Thus, state claims that “exist solely by virtue of the FDCA . . . requirements,” Buckman, 531 U.S. at 348, are impliedly preempted as they “conflict[ ] with the FDCA’s enforcement scheme,” which entrusts enforcement to the FDA. Nidel, 711 F.3d 9 at 1119. However, as recognized by the Ninth Circuit, “Buckman . . . left the door open to state-law claims ‘parallel’ to federal requirements.” McClellan v. I-Flow Corp., 776 F.3d 1035, 1040 (9th Cir. 2015). To avoid preemption, “[t]he plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted [ ]) but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under

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