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FDA Stops Tainted Tissue Shipments

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FDA Stops Tainted Tissue Shipments

FDA Stops Tainted Tissue Shipments

August 15, 2002

WASHINGTON (AP) - A Georgia tissue bank whose products are linked to a death and numerous serious infections is appealing the government's order that it quit distributing cadaver tissue because it can't guarantee the grafts are free of fungus or bacteria.

The family of the 23-year-old man whose death was linked to apparently tainted cartilage implanted during a knee surgery welcomed Wednesday's surprise partial shutdown of CryoLife Inc., the nation's largest supplier of living human tissue for implantation.

But the Kennesaw, Ga., company argued its tissue is safe. It urged the Food and Drug Administration to reconsider and allow at least shipment of some tissues, such as blood vessels, used in lifesaving operations.

The FDA charged that CryoLife has refused to adopt and follow procedures to prevent contamination of donated soft tissue, from cartilage to tendons. It ordered the company to recall all soft tissue processed since Oct. 3, a month before the Minnesota knee patient's death, and said it can't resume distribution until it meets federal safety standards.

Among the FDA's top charges is that CryoLife sent out tissue from a cadaver even after it had confirmed the presence of harmful germs in tissue samples from the same donor.

The order does not recall CryoLife's cadaver heart valves, but FDA inspectors are studying whether they also may pose a risk.

"This order not only protects patients from the unacceptable level of risk associated with tissue processed by CryoLife, it sends a clear signal that FDA stands ready to take whatever action is necessary to ensure the safety of human tissue," said FDA acting commissioner Lester Crawford.

CryoLife quarantined all its in-house tissue Wednesday even as it appealed FDA's crackdown. But officials declined to estimate how much would have to recalled from hospitals, or how much the action would cost the company. CryoLife charges hospitals for the cost of processing and transporting donated tissue.

"We are confident about the quality and safety of CryoLife processed tissue," said company chief executive Steven G. Anderson.

Malarkey said FDA would expedite the appeal request, which would be CryoLife's last recourse, short of going to court, to stave off the tissue sales shutdown.

Patients who have received grafts sold by CryoLife should not panic, Malarkey said. Any infection associated with tissue should occur within days or weeks of the transplant. But she urged doctors to be aware of signs of infection that might be linked to a contaminated graft.

The death of Brian Lykins of Willmar, Minn., touched off an investigation by the Centers for Disease Control and Prevention that concluded that infections from cadaver tissue used in orthopedic implants are more widespread than previously thought.

The CDC so far has uncovered 54 infections associated with soft tissue grafts, 26 of them involving tissue from CryoLife.

"We applaud the FDA action and would hope that this is the final wake-up call to CryoLife to clean up its house," Lykins' family said in a statement issued by attorney Don Keenan of Atlanta.

Health investigators found a bacterium called Clostridium sordellii in Lykins' body and in the cadaver from which the cartilage was donated. Lykins' family sued CryoLife last month, charging the company left the cadaver unrefrigerated for 19 hours and failed to test it for the germ. Several other lawsuits connected to graft infections also have been filed; CryoLife has declined comment on pending litigation.

The CDC said the infections, while fairly rare compared to the hundreds of thousands of grafts performed, show an urgent need to update federal regulations and industry standards for preventing tissue contamination.

"We don't feel there, at this time, is an industrywide problem," countered FDA's Malarkey. She said CryoLife's procedures to prevent contamination are different from most of the industry's and have not been proven effective - even when the company followed them.

CryoLife's stock dropped 41 percent, down $3.90 to $5.60 in afternoon trading on the New York Stock Exchange.

The FDA's consumer inquiry line is 1-888-463-6332.


On the Net:

Food and Drug Administration: http://www.fda.gov

CryoLife Inc.: http://www.cryolife.com/

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