Lokkart v. Aziyo Biologics, Inc., 2024 U.S. Dist. LEXIS 111265 (C.D. Cal. Might 29, 2024) is yet one more case arising from the unlucky contamination of a batch of tissue allograft with a illness. We’ve written about related instances earlier than. These instances have constantly produced favorable precedent regarding state human tissue protect statutes (on this occasion, in California).
In Lokkart, the plaintiff alleged that she was contaminated with tuberculosis from a human tissue allograft that was implanted in her foot throughout bunion correction surgical procedure. The plaintiff alleged that she suffered severe and persevering with accidents from that an infection. She and her husband filed a grievance in opposition to the defendants. The grievance included causes of motion for strict merchandise legal responsibility, negligence, and breach of the implied guarantee of merchantability.
The defendants moved for partial abstract judgment. The central authorized concern was whether or not California’s human tissue protect statute (Cal. Well being & Security Code part 1635.3) barred the strict legal responsibility and guarantee claims.
The court docket dismissed the strict legal responsibility and guarantee actions as a result of the state’s blood protect statute facially utilized. The statute characterizes the processing, storage, distribution, and many others. of tissue for the aim of transplantation to be a service that’s not topic to the gross sales and guarantee provisions of the state’s Business Code. California courts have held that the express exclusion of guarantee legal responsibility was additionally an implicit exclusion of strict legal responsibility.
Towards what seems to be controlling precedent, the plaintiffs argued that whether or not the product implanted on this case met the definition of “tissue” below the statute was open to query and required a factual evaluation that would not be resolved on the pleading stage. However the issue for the plaintiffs is that their very own pleading – the grievance – repeatedly referred to the product at concern as being a human mobile and tissue primarily based product harvested from cadavers. That description matches the language within the California protect statute.
The plaintiffs’ try to “sidestep their very own allegations” was premised on the idea that the implanted product had been so closely manipulated, altered, and processed such that it now not met the statutory definition of human cells. The court docket disagreed. That human tissue is processed right into a product earlier than getting used doesn’t make it any much less human tissue. The phrases of the statute don’t admit of such an exception, for the reason that statute really contains “processing.” Furthermore, there is no such thing as a inherent contradiction between one thing being each “tissue” and “manufactured.” Loads of different courts held that human tissue allografts fall below the California human tissue protect statute, “even after they have been processed and altered.”
Additional, the product packaging, which was quoted and included by reference within the grievance, recited that the product was regulated as a “Human Mobile and Tissue Primarily based Product” (HCT/P) below 21 C.F.R. part 1271. The one truthful studying of the federal rules is that the defendants’ product was human tissue. Beneath these rules, an HCT/P have to be “minimally manipulated,” which is outlined as “processing that doesn’t alter the related organic traits of the cells or tissues.” Provided that customary, the court docket rejected the plaintiffs’ hypothetical argument that the allograft product now not certified as a “group of [human] cells.”
Accordingly, the court docket dismissed the plaintiffs’ claims for strict legal responsibility and breach of guarantee. Presumably, all that’s left is a declare for negligence.
