Product liability had become a major headache for the Blood Transfusion Service Board by January 1988.
The agency was feeling the reverberations of the discovery 18 months earlier that one of its blood products had caused the infection of seven haemophiliacs with HIV. The government was in the process of drafting new legislation on product liability to comply with an EEC directive on the issue. And, to make matters worse, the board was undergoing serious financial problems as the economy went into recession.
The last thing the agency needed, then, was to receive a letter from the manufacturer of its blood-clotting products for haemophiliacs, saying it was no longer willing to continue production unless the board indemnified it from legal action. But that is exactly what happened as Armour Pharmaceutical, which had been making Factor 8 and Factor 9 from Irish plasma at a plant in Germany, said it would no longer carry liability for the products.
The letter came just one month after the voluntary withdrawal by Armour of a similar product in Canada which was linked to hepatitis C infections.
In something of an understatement, former BTSB chief executive Mr Ted Keyes said the letter caused him "problems".
Contradicting the evidence of Dr Emer Lawlor, the blood bank's chief expert medical witness, Mr Keyes agreed the infections in Canada were part of the reason for Armour's decision to seek to be indemnified. Mr Keyes said both the drugs company and the board would have been worried about the safety of the products.
(Dr Lawlor had rejected the claim that there were safety fears over the products, saying that Armour's request to cease production was "a commercial decision as much as anything else".)
Given the implications of Armour's letter seeking indemnity, the question arises as to why the board agreed to sign it.
Mr Keyes pointed out that there were few other options available. The BTSB could have asked Armour to make Factor 8 using a safer monoclonal technology which it was developing. But this would have taken some time as the drugs company had yet to receive a licence for the technology in Europe.
The board could also have opted for pasteurisation, a proven method of viral inactivation. But, said Mr Keyes, this could not have been done at existing plasma donation levels without jeopardising the State's aim of being self-sufficient in blood products. While these were the only methods considered, it is clear other options were available.
For one, the board could have examined the possibility of having Factor 8 produced in Scotland under super-heat treatment procedures which had been shown to eliminate the risk of hepatitis C and HIV infection. Mr Keyes conceded this option was not investigated but that was because he believed the Scottish blood transfusion service did not have the capacity to cater for the BTSB at that stage.
Another option was to produce Factor 8 using the "solvent detergent" method which the French and Swiss blood banks had been using since 1986. The BTSB ultimately adopted this method in 1989 but not before four haemophiliacs had become infected with hepatitis C through Factor 9 returned from Armour and heattreated at Pelican House. Three of the four were children.
Mr Keyes stressed that, ultimately, the decision to continue importing from Armour was Prof Ian Temperley's, the head of heamophilia treatment services in the State who was also sitting on the board of the BTSB at the time. Prof Temperley's evidence is eagerly awaited. Mr Keyes begins his third day in the witness box today.