2024 was a big year for blood and tissue shield statute decisions across the country (from  Florida, California, North Carolina, Illinois, and Ohio). And it looks like we added Oregon to the tally this year, but we let Kentucky and Nelson v. Aziyo Biologics, Inc., 2025 WL 2045167 (E.D. Ken. Jul. 15, 2025) slip by us. So, on this first full day of Fall, we bring you a case from mid-summer–with a twist.

As our prior posts discuss, human tissue implant manufacturers typically can limit their liability under state blood and tissue shield statutes.  But what about intermediaries?  The organizations that harvest the donor tissue—organ procurement organizations (OPOs)?  Nelson says yes, relying on a state anatomical gift statute.

Plaintiff received a surgical implant made from human tissue and alleged that the tissue was contaminated with tuberculosis which he then contracted.  In addition to suing the manufacturer of the implant, plaintiff brought negligence, warranty and fraud claims against the OPOs who harvested the tissue.  The basis for plaintiff’s claim was that the  OPOs did not act in good faith by not screening the tissue for tuberculosis.  Plaintiff relied on the fact that the donor was Mexican-born and that statistical evidence shows higher tuberculosis rates in Mexican-born individuals; therefore defendants were on notice to screen. 

The OPO defendants moved for summary judgment on the grounds that they were immune from civil liability under Kentucky’s Anatomical Gift Act.  The Act provides that:

A person that acts in accordance with [the Act] or with the applicable anatomical gift law of another state, or attempts in good faith to do so, is not liable for the act in a civil action, criminal prosecution, or administrative proceeding.

KRS § 311.1943(1).

Which led the court to find that the plaintiff was putting the cart before the horse.  You never get to the question of good faith if defendants acted in accordance with the Act.  Which they did.  The Act requires OPOs to conduct “reasonable examination to ensure the medical suitability of the body or part for its intended purpose.” KRS §311.1935(3). What is reasonable is a question answered by federal regulations.  OPOs are federally regulated to screen and test donors for certain infectious diseases.  Tuberculosis is not one of them. See Nelson, at *2. 

Because the plaintiff could not point to any provision of the Act (or of federal regulations) that defendants violated, the court never had to get to the good faith inquiry. Defendants acted in accordance with the Act and therefore are entitled to immunity.  OPOs provide an invaluable service; immunity ensures they can continue their critical life-saving role.