Perez v. Apyx Medical Corp., 2026 WL 2691359 (N.D. Cal. Sept. 14, 2026), is a product liability suit alleging misrepresentations about off-label use of a company’s cosmetic surgery §510(k) device. That, at least, is how we read the complaint. The court read the complaint a bit differently. The opinion was authored by the Judge Tigar, who possesses a burning bright intelligence, so we must allow for the possibility (unlikely as it might be) that we are wrong. Even so, Judge Tigar dismissed the complaint (sparing us the need for despair or to pursue the Blake-ian inquiry of “What immortal hand or eye/Dare frame they fearful symmetry?”)
The plaintiff in Perez claimed that she suffered severe burns and scarring from the defendant’s medical device when it was used on her to perform skin resurfacing and body contouring procedures. The plaintiff’s causes of action included (1) strict liability under the risk-expectation theory, (2) strict liability under the consumer expectation theory, and (3) negligent design, manufacturing, marketing, and sale of the device. The defendant moved to dismiss based on preemption and failure to state a claim.
The court held that the claims were not preempted. It held that express preemption went nowhere because the device had gone through the 510(k) process, not premarket approval. We, along with at least one of our faithful readers, must grit our teeth at this semi-spurious distinction, but then we will move on to the implied preemption argument, which needed a bit more analysis. The defendant argued that the complaint was preempted because it was based on allegations of misrepresentations about off-label use in violation of the Food, Drug, and Cosmetics Act (FDCA), but the FDCA prohibits private enforcement. The court rejected that argument, reasoning that the complaint travelled on traditional state claims, not disguised attempts to enforce the FDCA. The court opined that the defendant “misreads Perez’s complaint. At heart, Perez’s claims are design defect and negligence claims, not off-label marketing claims, and therefore not preempted.” To our eyes, the court fell for the oft-used plaintiff lawyer trick of couching claims at a higher level of abstraction to avoid specific defenses. That trick did not work in the recent SCOTUS Monsanto case, and it should not have worked here.
But that high level of abstraction did end up costing the plaintiff in this case. The court dismissed the entire complaint, with leave to amend. The decision dismissed the design defect claims for failures to plead, but not because California law prohibits such claims against prescription medical products – because the defendant did not raise that argument in a timely fashion. Rather, the court focused on how the allegations that physicians misused the product in a dangerous fashion did not plead that the product had any defect. Foreseeable misuse is not enough to sustain a defect claim, whether design, warning, or manufacturing. Because the plaintiff did not identify any product defect, the negligence claim also failed: “Perez does not identify what design defect affected Apyx’s Renuvion product and only contends in conclusory fashion that the foreseeable use or misuse of the product and the fact that it caused her injury sufficiently pleads the existence of a defect.” The complaint “does not identify the design defect that caused her injury.” Goodbye, complaint (but try again).
The defendant made a couple of other arguments, on causation and consumer expectation defect, but they were denied. The court thought the causation argument was more suitable for summary judgment, after factual development, and not so much as a way to test the pleadings. The Perez court held that the consumer expectation issue would not be ripe until jury instructions would be determined.
Of course, depending on whether the plaintiff can fix her complaint, there might not ever be jury instructions.
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