Expert says BTSB wrong to have used risky donor

A US expert on transfusion medicine told the High Court yesterday there was "absolutely no justification" for the BTSB using blood units from Patient X in the manufacture of Anti-D plasma in 1976. Using the plasma was in breach of the BTSB's own rules and international practice.

Prof Steven Kleinman said it must have been clear to anyone involved in the blood management service in 1991 that there was a "serious crisis" in the service but this was not addressed. He could only guess the failure to deal with the crisis was because it was "too unpleasant, too emotional and too difficult". Such an explanation was "totally inappropriate".

Three doctors told the court they had expressed concerns as far back as 1977 that the jaundiced condition of four of their patients was connected to those women having had infusions of Anti-D plasma.

The witnesses were giving evidence at the resumed hearing of an action by Mrs Eleanor Healy against the Blood Transfusion Service Board, the Minister for Health and the State. Mrs Healy (51), with an address in Dublin, contracted hepatitis C after she received an infusion of infected Anti-D plasma manufactured by the BTSB.

To reduce the risk of infection from blood transfusion, the philosophy was "safe blood in, safe blood out", Prof Kleinman said. Bad blood in meant bad blood out, and donor selection was very important.

The risk of hepatitis infection was known since the 1940s and hepatitis B was identified from the end of the 1960s. Anyone who ran a transfusion service should have known of the hepatitis risk.

Prof Kleinman said the BTSB had taken plasma from three types of donors, including pregnant women who were in danger of experiencing "blue babies". Those women should never have been used as donors.

Regulations in the late 1960s said blood should not be used from persons who had had transfusions within the previous 12 months. The BTSB itself had a rule, set out in a note for the guidance of medical officers and dated January 1972, that persons who got transfusions should not be used as donors.

Patient X had had 187 transfusions within six months, was at a very high risk of contracting hepatitis and was a "risky donor". It was wrong to use her blood.

Asked to comment on various documents, Prof Kleinman said these showed the BTSB was aware from 1976 Patient X was jaundiced with a question mark over her having hepatitis. There was no doubt that by November 1976 senior BTSB officers must have known there was a very high index of suspicion she had infective hepatitis. Once that was known, she should not have been used as a donor and all products containing her plasma should have been recalled. However, it was known plasma was taken from her again in January 1977.

Batch 252 of anti-D, containing plasma from X, was manufactured in July 1977. Sixteen batches in all were manufactured. That "absolutely not should have happened", was "unacceptable", "irresponsible" and a violation of the principles of transfusion medicine.

Prof Kleinman said two major additional errors were that there was no record Patient X was ever questioned about her medical history or that she was ever qualified as a donor.

He agreed a letter to the BTSB in 1991 revealed in a conclusive way there had been an outbreak of hepatitis C in Anti-D product in 1977. That letter, from Middlesex Hospital, asked Dr Walsh, medical director of the BTSB, for more information. That was not not provided.

Prof Kleinman said anyone reading the letter should have investigated the situation and it was "terribly irresponsible" that nothing happened. He could not see how anyone in Dr Walsh's position could not have known the letter was important.

When the hearing opened last month, counsel for the BTSB apologised unreservedly to Mrs Healy for the injury she had suffered due to the board's fault. The BTSB has said liability is not an issue in the case but is disputing that Mrs Healy was infected by a second batch of Anti-D. It also denies she is entitled to aggravated or exemplary damages.

Yesterday, Dr Dermot Carroll said a woman attended him in July 1977 with jaundice. She had had a baby in the Rotunda Hospital in May 1977 and received an injection of Anti-D. She attended him again in August and was very sick. He referred her for blood tests and also to a consultant.

Dr Carroll said he expressed concern to the BTSB about the possibility of Anti D being a factor in the illness and notified the Eastern Health Board. He spoke to two other doctors who had had cases of hepatitis after Anti-D administration and had concluded there was a link with Anti-D in three cases in Sutton-Raheny area.

He arranged for blood samples from the woman to be sent to the BTSB but did not hear anything back. He first learned of the results in 1994 after the samples had been re-tested in Middlesex Hospital and tested positive for hepatitis C.

The hearing continues today.