BTSB negligent, says US blood expert

 

The Blood Transfusion Service Board's conduct between 1977 and 1991 in its testing procedures was negligent, irresponsible, unjustifiable and beyond explanation, a US expert on the management of blood transfusion systems told the High Court yesterday.

Prof Steven Kleinman was continuing his evidence in the action by Ms Eleanor Healy (51), Dublin, against the BTSB, the Minister for Health and the State. Ms Healy contracted hepatitis C after receiving an infusion of infected anti-D plasma manufactured by the BTSB.

The court has heard that three doctors expressed concerns as far back as 1977 that the jaundiced condition of four of their patients was connected with those women having had infusions of anti-D plasma.

Prof Kleinman gave evidence on Tuesday regarding patient X whose plasma was used in the manufacture of anti-D plasma in 1976. He agreed documents showed the BTSB at that time was aware the patient was jaundiced with a question mark of having infective hepatitis.

Yesterday, he was asked about donor Y, whose plasma was also used in the manufacture and distribution of anti-D plasma. It is alleged on behalf of Ms Healy that she received an infusion from a "probable batch number 611", manufactured by the BTSB, which was administered to her on October 1st, 1993, and that this batch was manufactured from plasma taken from Y after it had been established the batch was likely to have been infected with hepatitis C.

Ms Healy alleges that in July 1992, samples of plasma taken from Y tested positive for hepatitis C but, despite the positive results, the BTSB had continued to distribute anti-D manufactured from Y's plasma. Prof Kleinman said two tests were done in October 1991 on frozen samples taken in 1989 from Y and they came out positive.

Mr John Rogers SC, for Ms Healy, said it was contended by the BTSB to date that the tests results on Y were in fact "false positives". The BSTB claimed two tests carried out in October 1991 were on an unsuitable sample and that the repeat fresh test was negative. They also claimed that two tests carried out in July 1992 produced "false positive" results. These were carried out on samples taken in August 1989 and Y did not become infected until September 1989.

The board also claimed the two samples tested in July 1992 had been subsequently found to be negative. However, the board accepted that plasma taken from a person who had received a transfusion during the preceding 12 months should not have been used for the production of anti-D.

Prof Kleinman said that if, as was documented, the board had in 1977 already received a letter indicating their "fractionation procedure" allowed hepatitis C to be transmitted, that would be all the more reason why the board would have to take a most cautious approach in 1991, 1992 and 1993.

The board knew it could not "inactivate" the virus. By 1991, it knew there was much more knowledge about the detrimental outcome of hepatitis C infection. That additional information, in a sense, made them even more culpable for releasing something in 1992 and 1993. They should have learned from their mistakes which had been documented and pointed out to them, he said.

Mr Rogers said that in terms of notification, the board had a doctor's letter from September 1977 and had seven reports from GPs in 1977/1978. The board also had its own rule and the knowledge that a plasma exchange patient of 1977 had become jaundiced and that hepatitis was the probable source of infection. He asked Prof Kleinman to characterise the board's attitude from January 1991 onwards when it produced plasma from Y and 13 other plasma exchange patients following four positive test results.

Prof Kleinman said he was trying to find "the right words". The BTSB had a duty and responsibility not to do what it did and had not acted on that duty and responsibility.