THE woman known as Patient X was never asked, nor did she give her consent, to have her plasma used for the production of anti D, nor was her doctor informed, the tribunal heard yesterday. She was infected with hepatitis C through a transfusion.
Another woman, Patient Y, whose infected plasma was also used, was infected through a transfusion in 1989. But she was not told of her infection until January of this year.
Over 863 Irish women who received anti D during pregnancy became infected with hepatitis C, said Mr James Nugent SC, counsel for the tribunal.
Patient X commenced plasma exchange treatment in Crumlin Hospital on September 28th, 1976. On November 4th that year she received a blood transfusion, to which she had a bad reaction.
"The blood transfusion itself would have meant she should not have been a donor," said Mr Nugent.
On November 17th she was diagnosed for infective hepatitis. Mr Nugent said her consultant gynaecologist, Dr Eamonn McGuinness, would give evidence that he told Dr Terry Walsh, chief medical consultant infective hepatitis.
Samples were sent to the specials investigation laboratory in the BTSB to see what might have caused Patient X's bad reaction. A test was done but nothing of significance turned up.
Mr Nugent explained that each test carried out would have a doctor's report attached. However, in this instance the doctor's report was missing.
Mrs Cecily Cunningham, principal biochemist with the BTSB, was told by Dr Walsh that the stocks made from Patient X's plasma were not to be used. This accounted for more than half of the stock of anti D available at the time.
In early December samples were sent to the Middlesex Hospital in London for testing.
The result was negative for hepatitis B. Dr Walsh gave Ms Cunningham the "all clear" to issue the anti D.
"It is clear now from the records that Patient X herself was infected with the hepatitis C virus in the course of her treatment," said Mr Nugent. The BTSB accepts it was "probable" that the supply to the Crumlin hospital was what infected Patient X.
Mr Nugent said that the Rotunda Hospital reported to the BTSB in July 1977 that three women who had anti D treatment from a certain batch had developed jaundice. A fourth person was also mentioned.
"The doctors of these patients were linking the anti D to the jaundice", said Mr Nugent.
Samples were sent to Middlesex Hospital for testing, and samples of every batch which contained Patient X's plasma. "It is clear that in July/August, 1977 the BTSB knew that Patient X was where the problem lay."
On July 25th or shortly before it Dr O'Riordan, the chief medical consultant, told Mrs Cunningham that she was not to use any of Patient X's plasma to make anti D.
However, he did not give her a direction not to issue the anti D which had already been made using Patient X's plasma. It was significant that at the time of the scare the only person to whom the BTSB turned its attention was Patient X, he said.
"While they were sending the samples to London for testing 596 doses of anti D were issued to various hospitals and nursing homes around the country."
At the time the BTSB's stock sheets show that of the 2,911 doses of anti D in stock, only 928 did not contain Patient X's plasma.
Word came back from London that the tests were negative. Mr Nugent said that a letter from Professor D.S. Dane of Middlesex Hospital showed he "clearly left there was something amiss".
But the BTSB continued to issue anti D.
On November 5th, 1977 Mrs Brigid McCole, who died earlier this year, received a dose of antiD which "ultimately led to her death".
Patient Y began plasma exchange treatment in 1989 at St James's Hospital. It appears that on September 13th, 1989, she received a unit of plasma which it is "now reasonably clear" was itself infected with hepatitis C.
Following that, 12 further donations of plasma were taken from her but were then frozen.
In February 1991, it appeared, Ms Cunningham sent a memo to Dr Walsh indicating that she wanted to use this plasma and asked that Patient Y be contacted so that she could be tested for HIV and hepatitis C.
It was clear from the record that without waiting for clearance she went ahead and made the anti D using Patient Y's plasma.
In July 1991 Dr Walsh told Ms Cunningham that all the donors to Patient Y's batch had been infected. But it was not until November 8th, 1991 that Patient Y presented herself to be tested.
"It is alarming to note that they knew she was infected but that nobody told her. It was not until she presented herself for further donations on January 10th, 1996 that she discovered," said Mr Nugent.