Photo of Stephen McConnell

 Lokkart v. Aziyo Biologics, Inc., 2024 U.S. Dist. LEXIS 111265 (C.D. Cal.  May 29, 2024), is yet another case arising from the unfortunate contamination of a batch of tissue allograft with a disease. We have written about similar cases before. These cases have consistently produced favorable precedent concerning state human tissue shield statutes (in this instance, in California). 

In Lokkart, the plaintiff alleged that she was infected with tuberculosis from a human tissue allograft that was implanted in her foot during bunion correction surgery. The plaintiff alleged that she suffered serious and continuing injuries from that infection. She and her husband filed a complaint against the defendants. The complaint included causes of action for strict products liability, negligence, and breach of the implied warranty of merchantability. 

The defendants moved for partial summary judgment. The central legal issue was whether California’s human tissue shield statute (Cal. Health & Safety Code section 1635.3) barred the strict liability and warranty claims.  

The court dismissed the strict  liability and warranty actions because the state’s blood shield statute facially applied. The statute characterizes the processing, storage, distribution, etc. of tissue for the purpose of transplantation to be a service that is not subject to the sales and warranty provisions of the state’s Commercial Code. California courts have held that the explicit exclusion of warranty liability was also an implicit exclusion of strict liability. 

Against what appears to be controlling precedent, the plaintiffs argued that whether the product implanted in this case met the definition of “tissue” under the statute was open to question and required a factual analysis that could not be resolved at the pleading stage. But the problem for the plaintiffs is that their own pleading – the complaint – repeatedly referred to the product at issue as being a human cellular and tissue based product harvested from cadavers.  That description matches the language in the California shield statute.  

The plaintiffs’ attempt to “sidestep their own allegations” was premised on the theory that the implanted product had been so heavily manipulated, altered, and processed such that it no longer met the statutory definition of human cells.  The court disagreed. That human tissue is processed into a product before being used does not make it any less human tissue.  The terms of the statute do not admit of such an exception, since the statute actually includes “processing.”  Moreover, there is no inherent contradiction between something being both “tissue” and “manufactured.”  Plenty of other courts held that human tissue allografts fall under the California human tissue shield statute, “even when they have been processed and altered.”

Further, the product packaging, which was quoted and incorporated by reference in the complaint, recited that the product was regulated as a “Human Cellular and Tissue Based Product” (HCT/P) under 21 C.F.R. section 1271. The only fair reading of the federal regulations is that the defendants’ product was human tissue.  Under those regulations, an HCT/P must be “minimally manipulated,” which is defined as “processing that does not alter the relevant biological characteristics of the cells or tissues.”  Given that standard, the court rejected the plaintiffs’ hypothetical argument that the allograft product no longer  qualified as a “group of [human] cells.”  

Accordingly, the court dismissed the plaintiffs’ claims for strict liability and breach of warranty.  Presumably, all that is left is a claim for negligence.