November, 1985. She further accepted that the records of the Laboratory indicated that an aliquot from a sample taken from “Andrew” in January 1985 had been received by the VRL on the 3 December 1985 and that notification of a negative result was given on the 5 December 1985. Mr. Seamus Dooley, the Laboratory Manager of the Virus Reference Laboratory, proved the records of the Laboratory in respect of Andrew in evidence before the Tribunal. He said that the VRL had been unable to find any record of a sample taken from “Andrew” in July 1985, having being tested by the Laboratory and of a result being notified to Cork University Hospital. There is therefore a divergence between the records of the VRL and that of the Hospital in respect of this sample. The absence of any record of a July 1985 sample in respect of “Andrew” in the Virus Reference Laboratory must throw some doubt on the accuracy of the hospital records in respect of this sample but the Tribunal does not think that it is necessary for it to reach any concluded view as to which is correct. Having regard to Dr. Cotter’s evidence and to the records of the Virus Reference Laboratory as proved before the Tribunal it is probable that by early December the Cork unit had received the results of tests which indicated that “Andrew” had been negative for HIV in January 1985 and had become positive for HIV by November 1985. Dr Cotter acknowledged that when she received the positive result in November and the confirmatory negative result in early December she realised a patient with Haemophilia B had seroconverted. The circumstances of this seroconversion were such that it should have been clear that it must have been due to BTSB non heated Factor IX, since that was the only Factor IX product that was being used for the treatment of persons with Haemophilia B in the Cork Centre. If such non-heated Factor IX had been the cause of infection of a patient in Cork, it is the view of the Tribunal that it should have been obvious that its use may have caused infection elsewhere and that its continued use could be the cause of future infection. In these circumstances Dr. Cotter should have realised that the situation was a serious one and taken appropriate action. She should have ensured that the BTSB non heat-treated Factor IX was recalled and no longer used in the Cork Centre. She should also have informed the BTSB and Professor Temperley so that a similar recall could take place in other centres and the source of the infection could be investigated. Instead it would appear that Dr. Cotter acted on the basis that a recall of BTSB product had taken place which she erroneously believed would have included the infected product. It would appear from the terms of a letter written by Mr. Stephen McGrath, a Chief Technologist in the Blood Bank in Cork University Hospital to Dr. Lawlor on the 14 October 1997 (See copy of this letter at Appendix 34.) that BTSB non heated Factor IX and in particular Batch No 90633 continued to be used in the Hospital until the 19 December 1985 Further, on the basis of other evidence to the Tribunal, including Dr. Lawlor’s evidence, it would seem that BTSB unheated Factor IX continued to be used by at least one patient of the National Haemophilia Treatment Centre until the month of February 1986. The Tribunal accepts that it is likely that Dr. Cotter was carrying out a very heavy caseload at the end of 1985 and that what seems obvious now may not have seemed as obvious at the time. However, since Dr. Cotter realised that “Andrew” was the first Haemophilia B patient that she had encountered who had seroconverted it should have set off alarm bells as to what had occurred and was occurring. The Tribunal cannot accept on the basis of her evidence that she took sufficient steps to stop the use of a potentially infected product in her own hospital or to inform the BTSB and Professor Temperley so that its use could be stopped elsewhere and a proper investigation take place. The Tribunal accepts that it is likely that the BTSB became aware in early January 1986 from information supplied by Professor Egan that one of his patients, Fionn, had been infected by the use of BTSB Cryoprecipitate and that this should have raised the possibility in the minds of the officials
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