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From Products Liability Law Daily, January 15, 2014

Allograft was not a “product” for purposes of product liability claims against tissue bank

By Pamela C. Maloney, J.D.

An allograft that was implanted in a patient’s knee during surgery was not a “product” for purposes of claims made pursuant to the Mississippi Products Liability Act (MPLA), the Mississippi Court of Appeals ruled in a case of first impression. Based on this finding, the court dismissed the patient’s strict products liability and products liability negligence claims, along with the simple negligence claims against the tissue bank that supplied the allograft (Palermo v. LifeLink Foundation, Inc., January 14, 2014, Fair, E.).

Background. A patient, Richard Palermo, injured his right knee and underwent an anterior cruciate ligament construction and medical meniscus repair using a tibialis tendon-anterior allograft (a body or tissue from another human being) supplied by LifeLink Foundation, Inc. After the surgery, the patient’s knee began to show signs of infection and the allograft had to be removed. The patient filed strict product liability, products-liability negligence, and breach-of-warranty claims against the tissue bank. The trial court granted the tissue bank’s motion for summary judgment on the ground that Mississippi’s Products Liability Act (MPLA) did not apply. The patient appealed.

Application of MPLA. The patient argued that because human tissue is not excluded from MPLA, it should be considered a “product” for purposes of his strict liability claims. However, the state supreme court had never addressed the issue of whether, in light of Mississippi’s public health law, human tissue donated through the services of a tissue bank could be considered a product. Mississippi’s public health statute specifically provides protection for persons or entities that use human tissue for medical purposes. In addressing this issue of first impression, the court explained that in enacting the public health statute, the state recognized a strong public policy interest in protecting persons and entities that facilitate blood, blood products, human tissue, and organ donations from claims brought under MPLA or similar products liability statutes. The court went on to note that nearly every state had a “blood shield” law similar to Mississippi’s statute, reflecting a nationwide aversion to applying products liability or strict liability concepts to body parts such as blood or tissue.

The court also referenced the products liability provisions found in the Restatement (Second) of Torts, which has been recognized by Mississippi courts, as well as the updates contained in the Restatement (Third). The Restatement (Third) clarifies that human tissues, like the allograft in this case, are excepted from designation as a “product.”

Based on Mississippi’s public health law and the strong nationwide policy exhibited in both statutes and case law against strict products liability protection for the distribution of human tissue for medical procedures, the court determined that human tissue used in medical procedures was not a product and its distribution did not constitute a sale for purposes of strict liability.

Negligence claims. In accordance with its rejection of the patient’s MPLA claims, the court determined that the patient’s products-liability negligence claims also failed. Turning to the patient’s simple negligence claims, the court found that the patient failed to offer any evidence that the tissue bank breached a duty of care owed to the patient. There was no evidence that the tissue bank did not comply with requirements and guidelines set by the U.S. Food and Drug Administration (FDA) and the American Association of Tissue Banks with regard to testing, packaging, and distributing human tissue. The record, however, did contain evidence regarding the processing methods employed by the tissue bank in preparing the allograft used in the patient’s surgery, and the patient’s own expert testified that the tissue bank was a good company that complied with FDA regulations. The expert further stated that he could not criticize the company because he was unaware of the methods taken by the tissue bank to avoid contamination.

The case number is 2012-CA-01228-COA.

Attorneys: Frank G. Vollor (Warren Co.) for Richard Palermo and Shelia Palermo. Mark C. Carlson (Hinds & Madison Cos.) for LifeLink Foundation Inc.

Companies: LifeLink Foundation, Inc.

MainStory: TopStory DesignManufacturingNews MedicalDevicesNews MississippiNews

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