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We don’t see many cases involving human tissue, but medical products derived from human tissue are actually quite common.  Skin replacement products, tissue-engineered cartilage, compounds for treating bone fractures and tumors.  Those kinds of things.  Just yesterday in our annual Ten Best/Ten Worst Cases webinar we discussed a case involving transplanted human eye tissue.  Medical products based on human tissue have been around for a long time, and they are regulated by the FDA

We should not, however, throw around the word “product” too freely because it begs the question of whether human tissue is, in fact, a “product.”  The answer is not always, and not under Illinois law on strict liability and warranty.  That is the holding of Zydek v. Aziyo Biologics, Inc., No. 23-C-3016, 2024 WL 197264 (N.D. Ill. Jan. 18, 2024), which applied the Illinois statute governing blood and organ transactions to dismiss strict liability and warranty claims.

In Zydek, the plaintiff was treated with the defendants’ surgical bone repair product, which was made from human tissue.  To make the product, the defendants acquired cadaver tissue from donor services.  Unfortunately, the defendants received reports that multiple patients who received product made from a particular donor lot came down with tuberculosis, which led to a voluntary recall.  The plaintiff tested positive one month later.  Id. at *1.

The plaintiff sued for negligence, strict products liability, and breach of various warranties.  It turns out, however, that the Illinois Blood and Organ Transaction Liability Act expressly bars strict liability and warranty claims for “entities generally engaged in rendering services for blood- and human-tissue related surgeries.”  Id. at *2.  The plaintiff shrewdly pointed out that the Illinois statute applied only to “services” or “service providers,” whereas the FDA and NIH have labeled the Defendant’s tissue-based bone repair compound as a “product.” 

That, however, was irrelevant.  This is a matter of state-law liability, and the Illinois legislature clearly shields “every person, firm, or corporation” that participates in developing “blood products, blood derivatives and products, corneas, bones, or organs or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body.”  Id. (citing 745 Ill. Comp. Stat. § 40/2-3).  Moreover, the Illinois Supreme Court had previously made clear that the Illinois legislature did not incorporate the FDA or NIH definitions of “products.”  Zydek, at *2 (citing Brandt v. Boston Scientific Corp., 204 Ill. 2d 640, 653 (2003)).  As the Illinois Supreme Court held in connection with a tissue-based sling, use of the defendants’ product was incidental to the plaintiff’s surgery.  “Hence, the surgical purpose of the Sling transformed what might ordinarily be considered a product into a legal service under the Act.”  Zydek, at *2.  The same analysis applied here.  The defendants developed the product from human tissue, and its use was incidental to the plaintiff’s surgery.  As a result, the product was “characteristically a service under the Act.”  Id.  The court dismissed the strict liability and warranty claims, leaving only negligence.  Defendants received all the relief they requested, and that seems like the outcome that the Illinois Legislature was aiming for.