Is Human Tissue A Product?

We don’t see many circumstances involving human tissue, however medical merchandise derived from human tissue are literally fairly widespread.  Pores and skin substitute merchandise, tissue-engineered cartilage, compounds for treating bone fractures and tumors.  These sorts of issues.  Simply yesterday in our annual Ten Finest/Ten Worst Instances webinar we mentioned a case involving transplanted human eye tissue.  Medical merchandise based mostly on human tissue have been round for a very long time, and they’re regulated by the FDA. 

We must always not, nonetheless, throw across the phrase “product” too freely as a result of it begs the query of whether or not human tissue is, the truth is, a “product.”  The reply shouldn’t be all the time, and never beneath Illinois regulation on strict legal responsibility and guarantee.  That’s the holding of Zydek v. Aziyo Biologics, Inc., No. 23-C-3016, 2024 WL 197264 (N.D. In poor health. Jan. 18, 2024), which utilized the Illinois statute governing blood and organ transactions to dismiss strict legal responsibility and guarantee claims.

In Zydek, the plaintiff was handled with the defendants’ surgical bone restore product, which was created from human tissue.  To make the product, the defendants acquired cadaver tissue from donor companies.  Sadly, the defendants acquired reviews that a number of sufferers who acquired product created from a specific donor lot got here down with tuberculosis, which led to a voluntary recall.  The plaintiff examined optimistic one month later.  Id. at *1.

The plaintiff sued for negligence, strict merchandise legal responsibility, and breach of assorted warranties.  It seems, nonetheless, that the Illinois Blood and Organ Transaction Legal responsibility Act expressly bars strict legal responsibility and guarantee claims for “entities typically engaged in rendering companies for blood- and human-tissue associated surgical procedures.”  Id. at *2.  The plaintiff shrewdly identified that the Illinois statute utilized solely to “companies” or “service suppliers,” whereas the FDA and NIH have labeled the Defendant’s tissue-based bone restore compound as a “product.” 

That, nonetheless, was irrelevant.  This can be a matter of state-law legal responsibility, and the Illinois legislature clearly shields “each particular person, agency, or company” that participates in creating “blood merchandise, blood derivatives and merchandise, corneas, bones, or organs or different human tissue for the aim of injecting, transfusing or transplanting any of them within the human physique.”  Id. (citing 745 In poor health. Comp. Stat. § 40/2-3).  Furthermore, the Illinois Supreme Court docket had beforehand made clear that the Illinois legislature didn’t incorporate the FDA or NIH definitions of “merchandise.”  Zydek, at *2 (citing Brandt v. Boston Scientific Corp., 204 In poor health. second 640, 653 (2003)).  Because the Illinois Supreme Court docket held in reference to a tissue-based sling, use of the defendants’ product was incidental to the plaintiff’s surgical procedure.  “Therefore, the surgical goal of the Sling reworked what would possibly ordinarily be thought-about a product right into a authorized service beneath the Act.”  Zydek, at *2.  The identical evaluation utilized right here.  The defendants developed the product from human tissue, and its use was incidental to the plaintiff’s surgical procedure.  Because of this, the product was “characteristically a service beneath the Act.”  Id.  The court docket dismissed the strict legal responsibility and guarantee claims, leaving solely negligence.  Defendants acquired all of the aid they requested, and that looks like the result that the Illinois Legislature was aiming for.