A PLASMA exchange donor who, a it was alleged, was the source from which a woman was infected with the hepatitis C virus in 1976 and 1977 was now believed to be just a link in the chain of infection, it was claimed in the High Court yesterday.
Mr Michael Cush, counsel for the woman, who is taking an action against the Blood Transfusion Service Board and others, said that, if the evidence was correct, his client was further away than ever from finding out the source of the infection.
He was seeking answers from the BTSB to more than 50 questions in the form of interrogatories, relating to the issues in the main hearing of the action, which is due to begin on October 8th. He said that if answers were given, it would save costs and dispose of much of the proceedings.
Mr Donal O'Donnell SC, for the BTSB, said it was suggested by Mr Cush that there was a source prior to the plasma exchange donor, known as Donor X, but the trial of the issues was not a form of resolving the mystery. It was not contended in the pleadings prior to Donor X that there was any negligence.
Ms Bridgid McCole is suing five defendants, BTSB, the Minister for Health, the National Drugs Advisory Board, Ireland and the Attorney General. She claims the BTSB used plasma in 1976 and 1977 from a female plasma exchange patient who, to its knowledge, had been clinically diagnosed as suffering from infective hepatitis and had become jaundiced.
She alleges the exchange donor's plasma was used without her knowledge and consent for the production of Anti D Immunoglobulin and without the knowledge of her treating clinician.
Yesterday Mr Cush said that in an affidavit the solicitor for Ms McCole, Ms Tara Meagher, said the state of knowledge of the BTSB was an issue in the proceedings.
An expert group established by the Minister for Health in 1994 concluded that the infection of women with hepatitis C in 1977 was most likely caused by the administration of Anti D Immunoglobulin to which Donor X had contributed. The BTSB had described Donor X as suffering from "jaundice of unknown origin".
There was now available to Ms McCole, arising from the discovery of documents from the BTSB, compelling evidence to indicate that Donor X did not suffer from jaundice of unknown origin but rather that she had been clinically diagnosed as suffering from infective hepatitis before contributing batches of the Anti-D Immunoglobulin, doses of which were ultimately given to Ms McCole. Furthermore, there was compelling evidence to indicate the BTSB was made aware of this fact.
If Ms McCole was correct in her belief that Donor X was clinically diagnosed as suffering from infective hepatitis around November 1976, then the question arose as to how she contracted it.
"There is reason to believe that in fact Donor X contracted her hepatitis from the administration of blood or blood products manufactured and produced by the first named defendants (BTSB).
"If this is correct, the position is radically different from that suggested by the expert group by the first named defendant," the affidavit stated. "Instead of Donor X suffering from jaundice of unknown origin caused by environmental factors, Donor X suffered from infective hepatitis caused by the administration of blood or blood products manufactured and produced by the first named defendants (BTSB)."
There was evidence to indicate that batches of Anti-D Immunoglobulin manufactured from plasma taken from Donor X in September 1976 tested negative to the hepatitis C virus. Donor X was clinically diagnosed as suffering from infective hepatitis about November 1976, less than two months later. Between September and November 1976, Donor X underwent one or more plasma exchange treatments.
If Ms McCole was correct in believing that Donor X contracted hepatitis through the administration of blood or blood products manufactured and produced by BTSB, the question arose as to how those blood or blood products became infected with hepatitis.
Mr O'Donnell said there were allegations which could seriously affect the standing of the BTSB and its ability to continue its work. It had always co-operated.
The trial of the issues was not a form of resolving the mystery of where the source of infection came from. It formed no part of the action. The negligence action allegedly arose after the use of the Donor X product.
Miss Justice Laffoy said fundamental issues were being questioned and she would reserve her judgment.