Eye bank denies fault in transplant infections

The South Dakota Lions Eye and Tissue Bank is citing a number of reasons for why it isn’t responsible for two corneal transplants that infected the recipients.

In its response to a federal lawsuit, the eye bank denies that it was negligent when it sent two corneas to Palestine that were used in transplants on two youths. Both of them developed severe infections that caused blindness.

RELATED:Lawsuit alleges decaying corneas used in eye transplants

In their lawsuit, the plaintiffs contend that the corneas should not have been used because they were recovered from a 58-year-old Duluth, Minn. man who had severe health problems and who suffered an unattended death in July of 2015 in his hot apartment, which did not have air conditioning.

Testing of other tissues and organs showed the donor was “systemically infected” with bacteria that start developing when tissue begins decaying. The lawsuit alleges that the South Dakota Lions Eye and Tissue Bank – which changed its name to Dakota Lions Sight & Health – was aware of the test findings several days before the corneas were used in the transplants.

In its response, the eye bank acknowledges that testing of other tissues revealed that it was infected, but it says the eye bank “was eventually notified that said testing showed signs of” infection and did not admit it knew of the results before the corneal transplants.

The eye bank argues that it was not responsible for the injuries caused by the transplants. It also argues that the youths don’t have standing to sue in the United States because Palestine is not recognized by the United States. The reply also contends that the damages were contributed to or caused by third parties over which the bank has no control.

Dr. John Berdahl, who serves as the volunteer medical director of the eye bank, said ultimately it’s up to the surgeon who is doing the transplant to approve whether to use the corneas. In the United States, he said, there are strict protocols for corneal transplants.

“I don’t know for sure if Palestine has the same process we do, but the process we go through is a pretty rigorous one,” he said.

Adverse incidents, he said, are reported to the Food and Drug Administration and the Eye Bank Association of America, which accredits eye banks.

“Basically, everything was done the way it was supposed to be done,” Berdahl said.

The FDA last inspected the eye bank in March and April, according to an FDA spokeswoman.

Jennifer DeMatteo, the director of regulations and standards for the Eye Bank Association of America, said in an email that her organization collects information about reported adverse reactions. The data is reviewed by the Medical Review Subcommittee of the EBAA Medical Advisory Board.

“However,” she said, “we do not provide public information about individual adverse events or the results of our accreditation inspections.”

Adverse reaction in the United States are rare in corneal transplants, according to an EBAA study of transplants from Jan. 1, 2007 to Dec. 31, 2014. Over that period, there were 354,930 transplants but just 494 case of adverse reactions.