Cryolife in business despite recall

10/01/2002

By Mark A. DeSorbo

ROCKVILLE, MD—IT'S BUSINESS AS usual for the nation's largest supplier of living human tissue for implantation now that it can continue supplying specimens in emergencies amid a recall of potentially tainted tissue.

The U.S. Food and Drug Administration (FDA) extended the permission to Cryolife Inc. for 45 days on Sept. 6, saying the risk of some patients not receiving the tissue in emergencies outweighs the danger of potential contamination, agency spokeswoman Lenore Gelb says.

Calls placed by CleanRooms to CryoLife were not returned, but the company, which is also under investigation bythe Securities and Exchange Commission, referred inquiries to a recent press release.

"We remain confident in the safety of our processed tissues and continue to cooperate fully with the FDA," says Steve Anderson, CryoLife's chief executive.

CryoLife can supply veins, arteries and non-valved cardiac conduits and patches, which accounts for about 80 percent of the company's tissue business, Ashley Lee, CryoLife's chief financial officer, told Reuters.

"We are happy that we've got this interim agreement in place right now and we are fully committed to fully cooperating with them to address the issues that are remaining," Lee says.

On Aug. 13, the FDA ordered CryoLife to stop distributing cadaver tissue, saying the Kennesaw, GA-based company failed to follow contamination control protocols to keep fungus and bacteria from infesting soft tissue.

The FDA ordered CryoLife to recall all soft tissue processed since Oct. 3, a month before a Minnesota man died from tainted tissue he received in a knee operation. The death of Brian Lykins touched off an investigation by the Centers for Disease Control and Prevention (CDC) that concluded infections from cadaver tissue used in orthopedic implants were more widespread than previously thought.

The agreement requires CryoLife to obtain prescriptions from surgeons who want to use company tissue, and it says patients must be advised of a risk of infection from the tissue, which is under recall.

CryoLife also must determine if the tissue had been tested after it was procured. If not, the tissue must contain additional warning labels.

The FDA also required CryoLife to establish new culture testing protocols and to file a corrective action plan. CryoLife is appealing the order.

At the time of this report, CryoLife laid off 105 employees because of the FDA order and restated its second-quarter results to show a $5.5 million loss instead of the $2.8 million profit it had recorded previously. CryoLife reports that it has supplied more than 41,000 heart valves and 48,000 grafts since its 1984 founding.

The CDC, so far, has uncovered 54 cases of infections associated with soft tissue grafts during orthopedic surgery, 25 of them involving tissue from CryoLife. The CDC has said the infections show an urgent need to update federal regulations and industry standards for preventing contamination.

Meanwhile, Lykins' family last month sued CryoLife. Health investigators found a bacterium called Clostridium sordellii in his body and in the cadaver from which the cartilage was lifted. The suit charged CryoLife left the cadaver un-refrigerated for 19 hours and failed to test it for the pathogen.