CryoLife Heart Valve Recall

CryoLife Heart Valve Recall in the Future?

-CBS News reviewed FDA records and found according to the documents there have been 110 CryoLife heart valves recalled in the past three years for different problems.

The CDC has been receiving complaints about CryoLife heart valves, in addition to their human soft tissue, but at the time of the CryoLife recall, only the soft tissue was ordered destroyed. The FDA recall stated that "CryoLife cannot ensure that the human tissue it processes is free from fungal and bacterial contamination," but the FDA did not recall heart valves as well. This left many heart valve patients upset and confused, wondering how heart valves were allowed to remain when CryoLife processes them identically to the soft tissue. There are 33 infections linked to CryoLife heart valves since 1996, with most cases unreported. Of the 33 CryoLife heart valve infections, four patients died.

Currently, the Centers for Disease Control and Prevention are investigating cases of bacterial or fungal heart valve infections that have been reported by both physicians and patients since March. Opposed to soft tissue, heart valves are often necessary to save lives, especially with babies, which is why the CDC is investigating heart valve infection claims as it remains on the market. CryoLife supplies 70% of the heart valves implanted in the U.S., making a CryoLife heart valve recall especially impacting. Dan Jernigan, of the CDC, stated that "these tissue heart valves are something that are needed by patients, and CryoLife has a very large part of the market and it is important to make sure we can treat patients appropriately" (cbsnews, 8/27/02).

The FDA has only issued a warning to heart surgeons to watch for bacterial or fungal infections in patients that have received CryoLife heart valves. For patients that are going to undergo heart valve surgery, the agency advised the doctors to consider using heart valves from a company other than CryoLife. While information on what companies provided the heart valves that are being investigated for the current appearance of infection, the FDA did say at least two of the heart valves were from CryoLife. Since 1984, CryoLife has provided 41,000 patients with human heart valves and is the only company that has been noted to be under investigation.

While the FDA does require processors to follow written procedures, there has not yet been a strict guideline for harvesting or processing human tissue for both heart valves and soft tissue. There are technical guidelines for handling tissues that the American Association of Tissue Banks has come up with in addition to regular inspections of the members' operations, but CryoLife does not belong to the American Association of Tissue Banks and has its own procedures. CryoLife had been sent reports from doctors, labs, and the CDC yet the company denied contamination existed when talking to their investors.

The Securities and Exchange Commission is investigating CryoLife after company records showed key corporate officers and directors stopped buying and started selling millions of dollars worth of stock when health investigators began sending letters to CryoLife regarding the increasing number of infection cases associated to their human tissues.

If you have received a heart valve implant and would like to know your legal rights, please contact us to speak with a heart valve attorney.