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We don’t get blood shield statute cases very often, but here is one involving a human tissue-based spinal bone graft.  In Sherrill v. Spinalgraft Technologies, LLC, et al., 2024 WL 1979452 (W.D.N.C May 3, 2024), the plaintiff had undergone spinal surgery. That surgery included the use of processed bone graft material, which is “made from human tissue consisting of cancellous bone particles with preserved living cells, combined with demineralized cortical fiber.”  The plaintiff alleged that the bone graft material was infected with tuberculosis, causing her to contract that disease plus other injuries. Not too long after the plaintiff’s surgery, the Food and Drug Association issued a voluntary recall of the bone graft material in response to reports of patients testing positive for tuberculosis and other post-surgical infections following surgical implantation of the bone material.  

The defendants filed a motion to dismiss the breach of warranty claims.  The issue was whether those claims were barred by the North Carolina Blood and Tissue Shield Statute (the Statute), which shields “every participating person or institution” involved in “the procurement, processing, distribution or use of whole blood, plasma, blood products, blood derivatives and other human tissues such as corneas, bones or organs for the purpose of injecting, transfusing or transplanting any of them into the human body” from warranty liability.  A warranty claim is the only form of strict liability in North Carolina, so application of the Statute would be a very big win for the defendants.

They got that big win.  The plaintiff’s main contention was that the Statute did not shield a “tissue-based product” like the bone graft material.  The court disagreed, finding that the bone graft material was processed human tissue (remember that the Statute explicitly reaches “processing”) and was covered by the Statute.  Nor did it matter that preservatives were used.  

There was another, perhaps more interesting, support for dismissal of the warranty claims.  The bone graft’s use was “incidental” to the surgery.  Accordingly, “North Carolina law categorizes the procurement, processing, distribution, or use of human tissue for injection or transplanting as a service, precluding warranty claims.”

The plaintiff endeavored to stave off dismissal by requesting discovery to ascertain “the true composition and makeup” of the bone graft material.  But the court found the plaintiff’s argument “unpersuasive given the detailed understanding” of the bone graft material found in the plaintiff’s papers.  

We’re not sure whether that last bit means that the plaintiff erred by inserting too much detail in its argument, or whether there was no other way for the plaintiff to argue its way out of the Statute.  Either way, the court dismissed the warranty claims.