[2] In 1970 the BTSB began manufacturing anti-D human immunoglobulin for intravenous application at its Dublin laboratory using a process developed in 1967 by Professor Hans-Hermann Hoppe of Hamburg's Central Institute for Transfusionmedicine, one of the founders of the German transfusion service, StKB.
Despite all senior medical staff at the BTSB being aware of this infection, they continued to take plasma donations from Patient X throughout January 1977 and include these in the pools used to make 16 batches of anti-D which were distributed to maternity hospitals for administration.
Between August and December 1977, the BTSB received notifications of similar cases from the maternity hospitals at the Coombe and Holles Street in Dublin indicating contamination amongst two other batches of anti-D.
In August 1989 a pregnant woman (referred to as "Donor Y" in the report of the Finlay Tribunal[1]) began a course of plasma exchange transfusions at St. James's Hospital in Dublin.
[citation needed] The BTSB's protocol for recall of its products consisted of the sending of a notification letter to each maternity hospital or GP that had been supplied with anti-D and a follow up phone call two weeks later.
As the BTSB records were not up-to-date and letters were addressed to named individuals some of whom were no longer working, some of the hospitals did not receive notification and continued to dispense their stock of infected anti-D in 1994.
The BTSB launched its HCV National Screening Programme and set about trying to identify and contact all women who had received anti-D injections since it had begun issuing it in 1970.
[citation needed] The development of ultra-sensitive HCV tests since the 1990s has made it possible to detect markers for the disease in people who seem to be fully recovered from hepatitis.
[citation needed] Having tested positive for HCV, the journalist Jane O'Brien made a request to the BTSB to put her in contact with other women in the same situation.
These included people who had been in accidents, had surgical operations or were suffering from other illnesses such as haemophilia or kidney disease and need regular blood transfusions, which prior to 1994 had not been screened for hepatitis C (and several other viruses).
[citation needed] On 5 March 1994, Minister for Health Brendan Howlin announced the establishment of an Expert Group under the leadership of Miriam Hederman O'Brien, with the following terms of reference:[3] 1.
As a result, the following were introduced:[citation needed] Positive Action criticized the "ad hoc" nature of the proposed tribunal, which meant that any government could take a decision to simply wind it up without a vote in the Dáil.
They felt that the purpose of the tribunal was to enable the state to never admit its culpability in the case and to force women to accept smaller sums than would be awarded through a judicial process.
[27] In December 1995, despite the misgivings of the representative groups, the government announced the establishment of the tribunal to award compensation to those infected with hepatitis C through BTSB products (anti-D and transfusions) under the chairmanship of former Supreme Court judge Mr. Justice Seamus Egan.
Throughout the following weeks stories began to emerge of an aggressive legal strategy being pursued by lawyers acting for the Department of Health and opposition politicians accused the government of trying to bully the women into settling with the compensation tribunal.
On 28 July 1995, lawyers acting for a HCV-positive Donegal woman with advanced liver disease who had received anti-D treatments during her 12 pregnancies made an application to the High Court to pursue for damages against the BTSB and the Irish State using an assumed name.
[43] The woman decided to continue with her case for damages against the BTSB, the NDAB, the Minister for Health, the Attorney General and the Irish State using her real name Brigid Ellen McCole.
Given the advanced nature of her disease and poor prognosis, her legal team applied to the High Court to set a date for her action to be heard in June 1996.
While adjudicating on the issue on 26 April, Mr Justice Costello, President of the High Court, asked if granting the request would mean 400 similar applications would follow and fixed 8 October as the date for the trial, which was expected to take six weeks .
Ms. Justice Laffoy ruled that the woman was entitled to seek information from the board's employees relating to the case dating back to 1976 and gave the BTSB until 19 July to answer certain questions about its documentation.
The fact that the 1991 contamination of anti-D was not publicly announced until the report of the Export Group undermined confidence in the commitment of the BTSB and Department of Health to full transparency.
The legal case taken by Brigid McCole had led to the discovery of additional facts (such as the scope of the Therapeutic Substances Act, 1932 and the labelling of Patient X's blood tests as "infective hepatitis") which had been kept from the Expert Group and contributed further to the public disquiet.
[citation needed] In a statement to Dáil Éireann on 3 October 1996,[50] Minister Noonan revealed that the BTSB had agreed to admit liability in the McCole case on 20 September but when Maire Geoghegan-Quinn demanded an full judicial Inquiry, he cited the huge legal costs and lack of clarity that resulted from the Beef Tribunal.
At the final hearings on 4 February 1997, Justice Finlay expressed his deep admiration for those victims who had given evidence and for the manner in which they had contributed to the tribunal with rare courage and great moderation.
[74] In a series of heated Dáil debates that followed the death of Brigid McCole,[50][75][76] the influence of the Government on the BTSB's legal strategy towards her case and those of other women seeking compensation came under scrutiny.
[citation needed] In his statement to the Dáil on 16 October 1996,[76] Mr. Noonan suggested that Mrs. McCole's legal team had not properly represented her interests asking: "Would not the solicitors for the plaintiff have served their client better if they had advised her to go to the compensation tribunal early this year?
The minister returned to the house later that evening to issue an unreserved apology,[77] for any offense his statement may have caused but the episode would dog him for the remainder of his political career.
were responsible for the Department of Health or any of its client organizations (BTSB/NDAB) when the contaminations occurred, their management of the crises and treatment of victims was subject to severe criticism by witnesses to the tribunal of inquiry chaired by Justice Finlay.
[48] These revealed that the BTSB had information since 3 April 1995 that they were negligent, had no defence in the McCole case, but continued to fight her application for anonymity and sent her a threatening letter on her death bed.
A Garda investigation began in late November 1997 which in 2003 resulted in charges being brought against two former employees of the BTSB - Dr. Terry Walsh and Ms Cecily Cunningham (Dr. Jack O'Riordan had since died) - on seven counts of Grievous Bodily Harm.