Perez v. Apyx Medical Corporation

Background

Tesse Perez brought products-liability and negligence claims against Solta Medical, Inc., Bausch Health Companies Inc., and Apyx Medical Corporation after a surgical procedure. The motion addressed Apyx. Perez alleged that Dr. David Sieber used Solta’s VASERlipo product for liposuction and Apyx’s Renuvion product for skin resurfacing and body contouring. She alleged that she suffered severe burns, related injuries, and substantial scarring.

Perez alleged that the Food and Drug Administration had warned in June 2022 against using Renuvion for skin contraction with liposuction. Against Apyx, she asserted strict products liability under risk-expectation and consumer-expectations theories, along with negligence in designing, manufacturing, marketing, and selling Renuvion.

Apyx moved to dismiss for failure to state a claim. The court had jurisdiction under 28 U.S.C. § 1332(a). The court had previously quashed Perez’s service of the complaint for improper service, but Perez later filed a certificate of service. The order addressed the motion to dismiss for failure to state a claim.

Federal Preemption

Federal preemption means that federal law displaces or prevents enforcement of state law. Apyx argued that Perez’s claims were impliedly preempted by the Food, Drug, and Cosmetics Act because they supposedly sought to impose liability for off-label marketing, even though the Act does not allow private enforcement.

The court rejected that argument. It concluded that Perez’s claims were, at their core, traditional state-law design-defect and negligence claims, not claims seeking to enforce the federal Act. The court therefore held that the claims were not impliedly preempted.

The court also rejected Apyx’s argument that the strict-liability design-defect claims were specifically preempted under 21 U.S.C. § 360k. The court distinguished authority involving a different federal approval process and found that Renuvion had been approved through the Food and Drug Administration’s 510(k) process. It held that the cited specific-preemption provision did not preempt Perez’s state-law design-defect claims in this case.

Failure to Identify a Defect

The court held that Perez did not adequately allege a defect in Renuvion. Under California law, a plaintiff bringing strict products-liability or negligence claims must allege how the product was defective. Perez alleged that Renuvion did not perform as safely as an ordinary consumer would expect and that its risks were substantial, but the court found those allegations conclusory because they did not identify the particular design defect.

The court also found that Perez did not identify a manufacturing defect or warning defect. It dismissed her strict products-liability claims because the complaint did not explain how the product was defective.

The negligence claim failed for the same basic reason. Although Perez alleged that Apyx failed to use reasonable care in designing, manufacturing, marketing, supplying, inspecting, repairing, distributing, and selling Renuvion, she did not identify the design defect that caused her injury. The court therefore found that she had not adequately pleaded negligence.

Causation and Consumer Expectations

The court rejected Apyx’s separate argument that Perez had not adequately pleaded causation. The complaint alleged that Renuvion was used during the procedure, that Perez suffered burn wounds and scarring, that the Renuvion design caused harm, and that the product’s failure to perform safely was a substantial factor in causing her harm. The court held that these allegations were sufficient at the motion-to-dismiss stage and declined to require the type of proof associated with summary judgment.

The court also declined to dismiss the consumer-expectations theory on the ground that Renuvion was used by physicians and trained medical professionals. The authority Apyx cited concerned limits on applying that theory at trial and the use of expert testimony, not whether the complaint adequately pleaded the theory.

Disposition

The court granted Apyx’s motion to dismiss with leave to amend. Within 21 days of the order, Perez may file an amended complaint solely to cure the deficiencies identified in the order. The opinion does not state that the dismissal was with or without prejudice.