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product_liability cryolifeThe FDA ordered Cryolife Corporation on August 14, 2002, to immediately recall distributed human tissue processed from October 3, 2001 to the present. Cryolife was unable to adequately assure patients that its soft tissue products were free of deadly bacteria and fungi. As the biggest supplier of human tissue used in implants, Cryolife is responsible for supplying about half of the soft-tissue implants needed in the 650,000 annual surgical procedures in the U.S. alone.
The FDA recall includes all soft tissues, including tendons, ligaments and cartilage that has been widely used in elective orthopedic surgery to repair worn out knees as well as other joints. A Cryolife heart valve recall is also being considered by the FDA due to similar contamination risks found to occur with the soft tissues. Identical technology is used when Cryolife processes the soft tissues and heart valves. Processing 70% of the nation''s heart valves and 90% of vascular tissue, Cryolife obtains the tissue from cadavers.
Associated with the November 7, 2001 death of a 23-year old patient who had received a soft issue implant during reconstructive knee surgery, the FDA continued to find numerous and significant violations of regulations that led up to the agency''s recall of all soft tissues. The Centers for Disease Control and Prevention (CDC) learned shortly after the death of the young man that the donor providing the knee tissue had committed suicide in October and the body had not been refrigerated for 19 hours after being picked up by a tissue bank, significantly outside the time allowed by industry standards. The patient had died just four days after his knee surgery due to a rare bacterium, Clostridium sordelli. Ten other patients received grafts from Cryolife taken from the same donor.
These findings led to a larger investigation of bacterial contamination and uncovered that of 26 infected tissues implanted into patients, half of them came from Cryolife, later increased to 54 infections with half still from Cryolife. Cryolife was given recommendations from the CDC stating the tissues should be tested for microbes before soaking in antibacterial and antifungal solutions because the failure to do so could result in a creation of superbugs, a type of bacteria and fungi that acquires resistance to antibiotics and antifungal agents. The FDA was not satisfied with Cryolife''s response to its June 17th issued warning letter, alerting the company they had "neither adequately investigated its validation of processing and testing methods, nor implemented recommendations from the Centers for Disease Control and Prevention, or any other procedures, to ensure that tissue processed by the firm is not contaminated."
The CDC has received complaints about Cryolife heart valves and the future of these tissues is still uncertain.
CryoLife Inc. said it has agreed to settle a shareholder lawsuit for more than $23 million that accused the company of not disclosing enough information to investors before a 2002 government issued tissue recall.
The settlement must be appr...