The Blood Transfusion Service Board manufactured and distributed anti-D in 1991 from plasma taken from a donor without carrying out any testing for hepatitis C and B or HIV, the High Court was told yesterday.
A year later, the same donor's plasma samples tested positive for hepatitis C but the BTSB continued to manufacture anti-D from that plasma, it was claimed.
Mr John Rogers SC was continuing his opening of an action for exemplary damages taken against the Blood Transfusion Service Board, the Minister for Health and the State by a woman who contracted hepatitis C after she received an infusion of infected anti-D plasma manufactured by the board.
At the start of Ms Eleanor Healy's case on Tuesday, counsel for the BTSB apologised unreservedly on its behalf to Ms Healy (51), who lives in north Dublin, for the injury she had suffered due to the fault of the board and said the board was very anxious to do everything possible to minimise the worry and stress for her in presenting her case to the court.
In his opening yesterday, Mr Rogers said the BTSB had in January 1991 manufactured and distributed anti-D from plasma taken from donor Y without carrying out any testing for hepatitis C, hepatitis B or HIV.
In July 1992, samples of plasma taken from donor Y in 1989 tested positive for hepatitis C but the BTSB still continued to manufacture and distribute anti-D manufactured from donor Y's plasma.
Mr Rogers said it was being claimed the Minister for Health had failed to revoke anti-D manufacturing licences and product authorisations when he knew or ought to have known that the best available methods of testing and treating blood products so as to minimise the risk of contamination with hepatitis C were not being used by the BTSB.
He was also contending that the Minister had granted the BTSB a manufacturing licence without either having requested and received sufficient information from it and without requesting or receiving sufficient advice from the National Drugs Advisory Board to enable him to make an informed decision.
In its lengthy defence, opened in court yesterday, the BTSB denies it knew the production of anti-D from the plasma of a patient who had been diagnosed as suffering from infective hepatitis and jaundice gave rise to a grave risk for recipients of anti-D as alleged or at all.
The BTSB also denies it persisted in using the plasma of another patient - patient X - in the production of anti-D, notwithstanding reports between August 1977 and February 1978 that women had developed hepatitis following the administration of anti-D manufactured from plasma taken from that patient, as alleged.
The State defendants also deny Ms Healy's claims. They deny that the personal injuries, loss, damage and expense which Ms Healy is alleged to have suffered were due to the negligence of the Minister or to breaches of duty or of Ms Healy's constitutional rights.
It is pleaded that four of the batches of anti-D were administered to Ms Healy between 1977 and 1984 before the identification of the hepatitis C virus. Hepatitis C screening was introduced in or around October 1991. At all material times to Ms Healy's action in respect of the batch administered after 1991, the hepatitis C screening procedure was operative, it is claimed.
The hearing before Mr Justice Johnson has been adjourned to April 9th. It is expected to last five weeks.