A product deemed to have been possibly unsafe by the Blood Transfusion Service Board was returned to the manufacturer, which subsequently issued it to St James's Hospital, Dublin, it emerged at the tribunal yesterday.
The batch of Factor 8 made by Armour Pharmaceuticals Ltd for haemophilia A patients ended up infecting at least one patient in the State with HIV.
The tribunal heard that batch A28306 had been heat-treated at 60 degrees Celsius for 30 hours to inactivate viruses and was made from donations which had not been individually tested for HIV antibodies.
Mr John Trainor SC, counsel for the Irish Haemophilia Society, said questions had to be answered on whether the company knew when it issued the product that there was doubt about the efficacy of its particular formula of dry heat treatment in eradicating the HIV virus.
A letter to the Lancet from a prominent virologist, Mr Alfred M. Prince, in May 1986 was opened to the tribunal which cast doubt over this heat-treatment.
Dr Emer Lawlor, deputy medical director of the Irish Blood Transfusion Service (formerly the BTSB), said it was now known that Mr Prince had done his study earlier and was "forbidden" from publishing it by Armour.
In March 1986, the company wrote to Prof Ian Temperley, former director of the National Haemophilia Treatment Centre at St James's, about the effectiveness of its heat-treatment and stating that all its plasma donors underwent thorough medical examination.
Mr Trainor suggested it may have known at the time of writing the letter that there was doubt about the safety of its products. Dr Lawlor agreed. She said Armour products were not issued by the BTSB after 1985, but one patient at St James's Hospital who got a single dose of the product in February 1986 tested HIV-positive in December 1986.
Asked by counsel about the batch, Dr Lawlor said 350 vials were received by the BTSB from Armour in December 1985 and were sent back because the BTSB had started to stock what was believed to be a safer product made from Irish plasma. The Armour product was made from the blood of paid donors in the US.
She said 100 vials of the same batch had also been issued to the BTSB in November 1985 but because the board's dispatch records covering the period were shredded, they could not be traced. She didn't believe they went to St James's.
Asked by Mr Trainor how some of this batch then infected a patient at St James's in 1986, Dr Lawlor said she assumed the product returned to Armour by the BTSB was then sent out to St James's.
All Armour Factor 8 was recalled from the UK and Ireland in a product recall in September 1986 and in February 1987. The company issued a press statement in response to publicity concerning the recall.
It claimed a number of newspaper articles gave a "false and misleading" impression about the procedures used in the manufacture and distribution of Armour products. The stories referred to three haemophiliac boys testing HIV-positive. "These patients have not died nor have they been diagnosed as having AIDS," the statement said.
Mr Trainor suggested to Dr Lawlor this was a somewhat bland statement. She replied that even at the time the whole statement was extraordinary. "I would certainly take anything that particular company was saying at that particular time with reservations", she said.