This has been a big year for blood and tissue statute decisions. Given their subject matter, we’ve previously lamented that the decisions didn’t fall closer to Halloween. While not quite coinciding with our doorbells ringing and handing out candy to the little ones, today’s decision is close enough for a little seasonal digression.
One of our favorite Halloween stories is the origin of the jack-o’-lantern. As the tale goes, a long time ago a man named “Stingy Jack” was drinking whiskey with the devil. Not wanting to pay for his whiskey, Jack convinced the devil to turn himself into a coin to pay for the drinks. Jack put the “devil-coin” into his pocket next to another coin with a cross on it, and the cross prevented the devil from changing back into his original self. Jack (who must not have been the brightest) decided to let the devil go on the condition that the devil wouldn’t take him to hell if he died within a year. The devil agreed, but Jack didn’t die within the year. Though not the smartest, Jack was a trickster, and he next convinced the devil to climb a tree to get some fruit. Jack quickly etched the sign of the cross onto the trunk of the tree, preventing the devil from climbing down. Knowing he couldn’t keep the devil trapped for long, Jack struck another deal. If the devil wouldn’t claim his soul if he died within the next ten years, then Jack would let him out of the tree. Jack continued his life of drinking and sin, and this time he died within the term of the deal. The devil honored his deal and didn’t take Jack’s soul to hell. But having lived his life of debauchery, Jack couldn’t get anywhere near heaven. His spirit was cursed to wander the earth for eternity. Spiteful for not being able to take his soul to hell, the devil hurled a ball of hellfire at Jack. Still the trickster, Jack managed to take the coal from the hellfire and place it into a hollowed-out turnip to use as a lantern. Originating from the fires of hell, the coal glows eternal, and Jack and his lantern continue to wander the earth looking for a place to rest. Pumpkins are bigger and apparently easier to carve than turnips, so our pumpkins replace turnips as our modern-day jack-o’-lanterns (and child-safe lights replace the embers of hellfire to keep them lit).
Although today’s decision involves a blood and tissue shield statute, it isn’t spooky for the defense. Instead, it adds to the count of more favorable blood and tissue statute shield decisions (from Florida, California, North Carolina and Illinois) this year than we’ve seen in the past decade.
The plaintiff in Pierson v. Elutia, Inc., No. 1:24-CV-368, 2024 WL 4494243 (S.D. Ohio Oct. 15, 2024), alleged she was implanted during spine surgery with bone grafting material that was contaminated with the tuberculosis bacteria. Plaintiff tested positive for tuberculosis after the surgery. The defendant raised Ohio’s blood and tissue shield statute and moved to dismiss plaintiff’s strict liability and warranty claims. Ohio’s statute provides as follows:
[T]he procuring, furnishing, donating, processing, distributing, or using of human whole blood, plasma, blood products, blood derivatives, and products, corneas, bones, organs or other human tissue except hair, for the purpose of injecting, transfusing, or transplanting the fluid or body part into another human body, is considered for all purposes as the rendition of a service by every person participating in the act and not a sale of any such fluid or body part. No warranties of any kind or description are applicable to the act.
Id. at *2 (quoting Ohio Rev. Code § 2108.30). A strict liability claim in Ohio requires a sale, and the statute expressly states that the implant of human tissue is “not a sale.” Same for warranties – the statute says there are none. Accordingly, the court agreed with the defendant that plaintiff could not maintain claims for breach of warranty or strict liability.
As we’ve seen in other blood and tissue shield decisions this year, the plaintiff tried to argue that the product involved processed tissue and that the statute shouldn’t apply. Relying on a pelvic mesh decision from West Virginia and Florida and North Carolina cases we’ve blogged about here and here that involve the same product in Pierson, the court rejected the plaintiff’s argument. There simply wasn’t a credible argument that the Ohio statute didn’t cover the implant used in plaintiff’s surgery.
The court found support for its decision in the categorization of the tissue product as an HCT/P under the Code of Federal Regulations. Those regulations define an HCT/P as an article “containing or consisting of human cells or tissues that are intended for implantation . . . into a human recipient.” Such tissues are minimally manipulated, meaning that any processing did not “alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair or replacement.” Id. at *7 (citing 21 C.F.R. § 1271.3(d)). Plaintiff sought leave to take discovery into the exact composition of the tissue to support her argument that the statute shouldn’t apply, but given the CFR’s guidance, the court found that any such discovery would be “gratuitous.” Id. at *3.
Finally, plaintiff claimed the statute shouldn’t apply to for-profit entities like the defendant. But the statute addressed that claim too—it specifically applies to “every person participating” in the process. And, the court noted that “there is a nationwide antipathy over applying products-liability or strict-liability concepts to body parts such as blood and tissue. Indeed, no court has ever applied strict liability to the distribution of human tissue.” Id. We don’t find that scary at all.