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VERY, VERY DREADFULLY NERVOUS

Judge Robert E. Beach Jr. granted summary judgment to CryoLife Inc., a processor of human tissue, holding that tissue for transplantation falls within the state’s blood-shield statute and is therefore not a product under Connecticut’s product liability law. Miller v. Hartford Hospital, No. CV04 4003261 S (Sept. 19).

The ruling has spurred debate over accountability in cases of negligence in handling human tissue. It also leaves the plaintiff with no remedy for damages allegedly caused by the heart valve.

The underlying idea of strict product liability is that a manufacturer is liable for a defect that can be taken out of a product if appropriately designed or manufactured. The FDA-regulated products like tissue are marketed by huge businesses that take tissue and transform it, and the multibillion-dollar tissue industry, under this ruling, will fall outside the product liability and personal injury statutes because of old blood-shield statutes that were enacted before anyone anticipated the scope of preservation or manipulation of tissue.

Plaintiffs lawyers, however, say state blood-shield statutes like the one at issue in Miller were never intended to immunize companies like CryoLife from liability for alleged negligence. Such companies process human cadaver parts and are more than tissue banks, they contend.

Miller was brought by the administrator of the estate of Leonard Klein, who received an aortic valve harvested from a cadaver and prepared for transplantation by CryoLife, a Kennesaw, Ga., company that processes, preserves and distributes human tissue for cardiac and vascular surgeries, according to its Web site. Eight months after his March 2002 transplant, Klein died because the valve was infected with a fungus when transplanted, the plaintiff alleged. The administrator sued the surgeon, hospital and provider of the valve.

In granting summary judgment to CryoLife, the court rejected the plaintiff’s claim that the company’s processing of the valve transformed the tissue into a product. “This suggestion, though imaginative, is implausible,” the court said. “There is … no question but that human tissue forms the basis” for the medical procedure at issue.

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