The Group Action (the Action) which is the subject of the Group Litigation Order (GLO) was put in place in the latter part of 2017. Following a brief run of correspondence with the Government Legal Department the Application was lodged with the High Court on 4th July 2017. Some 7 days later Teresa May announced the Public Inquiry on 11th July 2017. Despite opposition the High Court made the Order on 26th September 2017.
For all practical purposes the aim of the Action is to set aside the Terms of Settlement (the Settlement) of the HIV Litigation agreed in 1991. From that point onward although attempts were made to circumvent these terms they were largely if not entirely unsuccessful and the response of Central Government has always been that the Settlement was and remains binding; any payments were made without admission of liability and were discretionary.
In order to overcome this position the Action seeks to set aside the Settlement in its entirety, imposing in its place a system of full and proper compensation. Here in particular it must be remembered that the Settlement was shoehorned into a limited lump sum which Central Government was prepared to provide at the time. Here the purpose of the Action is to ensure that whatever sums are provided by Central Government they are sufficient in themselves to ensure that full and proper compensation is in fact put in place and not artificially restricted. For these purposes in due course it is intended that compensation is provided pursuant to normal legal principles rather than within the confines of a Government straightjacket.
The Action remains in place but is currently “frozen” to allow the Inquiry to report. Given the wide Terms of Reference this position was pretty much inevitable. Once the Inquiry reports we will review the position and in particular the recommendations it provides and then advise as to whether the Action should be brought back on stream.
Jenni Richards QC, Counsel to the Inquiry, read the lengthy presentation which focused on Prof Bloom’s role at Cardiff. The Chair was taken to the relevant medical literature about state of knowledge in relation to both hepatitis and HIV during the relevant period, to Prof Bloom’s public advice both to patients and colleagues at the Cardiff Centre, and to his views expressed at UKHCD meetings and the written guidance that he produced and disseminated to the Directors of other UK Haemophilia Centres. There is a clear argument that his advice was not consistent with the state of scientific knowledge as at specific dates.
The presentation discussed Prof Bloom’s approach to treatment and the use of concentrates. The Inquiry was taken to the various policies/guidance notes prepared by Prof Bloom and to the treatment that he gave to specific patients who were the subject of impact evidence heard by the Inquiry last year and how the treatment provided did not follow the policies that were in place at the time.
The Inquiry was referred to the following key documents:
The Inquiry also heard how he prepared a statement for the Haemophilia Society in which he confirmed that he was unaware of any “proven” cases of AIDS in the UK when a communicable disease report issued the same week confirmed the first UK case of AIDS in one of Prof Bloom’s Cardiff patients.
The Chair was also taken to the Litigation Report prepared by Prof Bloom for the HIV Litigation.
Ms Richards QC made it clear that the presentation was not intended to be the last word in relation to Prof Bloom and that more relevant material was likely to be gathered as the work of the Inquiry continues and that the presentation would be updated accordingly as matters develop.
Dr Mark Winter was the first clinician to give evidence to the Inquiry. As a junior doctor at Guys and St Thomas’ Hospital (1979-1983) he was aware that there was insufficient NHS factor concentrate to meet the needs of those being treated and that commercial factor products were used to “top up”.
He was aware of various studies in 1978/9, especially Professor Preston in Sheffield and said this “blew out of the water” the idea that there was nothing to worry about – in fact his view was this was a really serious evolving clinical problem they had to look very hard at. He stated this was a key moment when doctors should have been very concerned about chronic liver diseases which were not demonstratable by LFT changes and that every haemophilia doctor should then have appreciated that the rules had changed and that chronic liver disease was a major problem in haemophilia. He also eventually accepted that patients should have been advised of this as well at that time.
He said that they tried to limit patient exposure to FVIII concentrates and to avoid using commercial concentrates wherever possible. At that time patients were not given any say in the treatment they received.
His evidence was that in the 6 month period between July 1982 and December 1982, as a haemophilia doctor looking at the available literature, one would have to conclude ‘I’m really concerned this new disease is something that is in the blood. This must be a virus or something like that, we urgently need more info … to know how to respond ..”
When he became a consultant at the Kent Haemophilia Centre in Margate in 1983, Dr Winter described the “hardest decision of his life” in opting to give his patients unlicensed American heat treated factor VIII in May 1984. This set him apart from many of his colleagues and Professor Bloom in Cardiff described his decision as “mad”.
Dr Winter subsequently discovered that all but one of his patients tested for HIV were positive and had been infected before he had started using heat treated concentrates.
He said it would probably have prevented HIV if taken early enough, but would not have stopped hepatitis C. Dr Winter said: "If you were a haemophiliac patient in Britain and you had factor VIII once, it was extraordinarily likely that you would have hepatitis C. I do not believe hepatitis C was avoidable in regularly treated patients." He agrees that ALL alarm bells should have been ringing for haemophiliac clinicians at this stage (ie by 1982) and that the evolving knowledge on the risk of AIDS should have been shared with patients.
Dr Winter was taken to correspondence produced by Prof Bloom and the minutes of UKHCDO meetings from that period and agreed that the advice was wrong in that it was not a “remote possibility” that AIDS was a blood borne virus. He was also critical of the lack of any central guidance from Government. He concluded that if self-sufficiency in blood products had been achieved in 1977, the “catastrophic” rate of HIV infection in haemophiliacs may have been avoided.
Dr Winter spoke about his time as a medical trustee with the Macfarlane Trust from 1995 and the difficulty of communicating the new risk of vCJD to his patients.
Dr Brian Colvin was the director of the Royal London’s haemophilia centre from 1977— 2007.
During his evidence he was taken through key documents and medical journals relevant to the state of knowledge regarding hepatitis infections in the 1970s and HIV in the early 1980s. Dr Colvin said that he was aware of NANBH but that it was hoped it would not be a big problem.
He maintained his position that it was not realistic to suggest that patients could revert to treatment with cryo as concerns grew about the risks of treatment with factor products. He said that this would have been a step backwards. He also said that he was not aware that some centres were using heat treated products by May 1984 (as described in Mark Winter’s evidence).
He spoke of his treatment policy of using cryo where possible for children, NHS FVIII for home treatment wherever possible and commercial concentrate for hospital treatment and emergency surgery.
The Inquiry heard that by 1987, 41 of his patients were diagnosed with HIV, including six children. He was quick to say that some of those patients were treated at other centres or came to him already infected.
80 of his patients were infected with HCV.
The issue of consent for testing was discussed in detail. Dr Colvin used stored samples for HIV testing and did not ask for consent from patients prior to testing. He maintained that this was acceptable practice at the time. In 1991 he effectively repeated this process for HCV testing and whilst he seemed to accept that the requirement for consent to medical treatment had moved on by that time he again stood by his decision not to ask for consent on the basis that testing for HCV was really no different to doing liver function tests which had been carried out for years on patients on a regular basis. He considered the testing to be “routine”.
He gave evidence that his patients were informed of their diagnosis personally by him.
In conclusion he said that he “deeply regretted” that any of his patients were infected.
The presentation focused on Prof Savidge who was the Centre Director from 1979 to 2006. Prior to that the Centre was run by Prof Ingram. Prof Savidge previously gave evidence to the Archer Inquiry in 2007 and this evidence formed the basis of Counsel to the Inquiry’s presentation.
It was acknowledged that the Inquiry did not yet have a complete picture of the care provided by St Thomas’ and that there were still gaps which would need to be filled either by other witnesses or possibly by further documentation which would come to light during the Inquiry’s continuing disclosure process. Ms Richards QC made the point that there were fewer documents available than in relation to the Cardiff and Oxford Centres.
In particular there was very little information about how care was organised for those who were diagnosed with either HIV or HCV as a result of treatment with contaminated blood products.
Jenni Richards QC confirmed that the presentations in respect of individual Haemophilia Centres were evolving documents which would be added to if/when additional relevant evidence came to light.
The presentation in relation to Oxford focused heavily on Dr Charles Rizza. No clarification has been given by the Inquiry at this stage as to why Dr Rizza has not provided any direct evidence.
Oxford was the largest haemophilia treatment and fractionation centre in the UK between the 1960s and 1990s. Dr Rosemary Biggs and Dr Rizza were the main figures at the Centre during this period.
Ms Richards QC confirmed that Oxford made the switch from cryo to factor concentrates earlier than most of the other UK Haemophilia Centres. She took the Chair to a 1977 article by Dr Biggs which discussed donor pool sizes for freeze dried concentrate and how some donations were made by prisoners or paid donors.
The Inquiry heard that Dr Rizza was present at the Hepatitis Working Party Group meeting in January 1983 when the first case of AIDS in an American haemophiliac was discussed. At around the same time Dr Rizza identified the need to use large pool factor concentrates on previously untreated patients in order to determine the risk of contracting NANBH and assess any hepatitis reduced concentrates.
By 1985 135 haemophiliacs treated at Oxford had tested HIV positive.
Ms Richards QC referred to the report produced by Dr Rizza for the HIV Litigation in which he stated that NANBH was not considered a long term problem in the 1970s. In the 1990 report he also stated that there was a lower risk of contracting HCV from cryo than from factor conentrates.
Prof Lee jointed the Royal Free Haemophilia Centre in 1983 to complete a research project on liver disease in haemophilia. She returned as a consultant in 1987 and took over as Director in 1991 following Prof Kernoff’s inability to continue in the role due to illness.
Prof Lee relied heavily on the evidence that she gave to the Lindsay Tribunal.
Prof Lee described her initial role as 80% “analysing” the data of haemophilia patients. In 1983 she did not have any clinical responsibility.
When Prof Lee returned as a consultant in 1987 she said that Prof Kernoff remained responsible for the treatment of haemophilia patients although she did hold an HIV testing clinic.
When asked about treatment policies at the Centre, Prof Lee said that it was the Centre policy to keep patients on the same batch of concentrate if possible and that between 1983 and 1984 mild and moderate haemophiliacs were treated with DDAVP. If a patient required surgery, then it would be usual for cryo to be saved up and administered to the patient prior to and following the scheduled surgery. It was also the Centre policy to give children NHS factor.
With regards to HIV Prof Lee accepted that there was some evidence of AIDS being present in blood products by 1983. The Centre carried out HIV testing in 1984 and 111 haemophiliac patients tested positive.
When asked about tests carried out on sexual partners Prof Lee said that blood sera samples of partners were kept at the Centre and these were tested for HIV with the individuals’ knowledge but that the same individuals were not told if their samples were being tested for HCV.
Prof Lee accepted that clinicians knew about NANBH in the late 1970s but that there was no appreciation of how severe the problem was. She told the Inquiry that all patients between 1978 and 1983 would have been told they had NANBH. This was disputed by victims who were present in the Inquiry hearing room.
Prof Lee said she was “frustrated” by calls for compensation, which she thought was the wrong thing to do. She said: “It suggests liability and I truly believe that people at that time were doing what they thought was the best.”
Prof Tuddenham was Co-Director of the Royal Free Haemophilia Centre from 1978—1986 with Dr Kernoff and Director between 2006- 2011.
During his time as Co-Director Dr Kernoff managed the clinical aspect of the Centre and Prof Tuddenham managed research.
When asked about treatment policies he said that there was a preference to give NHS concentrate to children. He agreed that they were aware of the risk of treatment in respect of hepatitis but that he had no undue concern about transferring patients on to commercial concentrates because they had already been exposed.
Mild haemophiliacs were also treated with concentrates.
Prof Tuddenham accepted that by the mid-1970s both he and Dr Kernoff were aware NANBH was a serious illness with potential long term consequences. He said he had not been aware of the poor screening processes for US blood donors.
When asked about the purchase of blood products and the relationship between Haemophilia Centre Directors and pharmaceutical companies Prof Tuddenham said that he thought commercial incentive had “overwhelmed” safety issues and that safety should always be considered first.
Ms Richards QC asked about the emerging knowledge regarding HIV. Prof Tuddenham stated that, by 1984, the risks of treatment were well known and suggested that there was a secrecy amongst the pharmaceutical companies producing commercial concentrates when trying to inactivate the viruses. He believed this could have been achieved earlier.
The role of UKHCDO was also considered. Prof Tuddenham described the organisation as a “talking shop” whose role was limited to making presentations and recommendations to the Government.
When the UKHCDO updated its treatment guidelines in mid-1983 as AIDS emerged, Prof Tuddenham said they would have been viewed by colleagues as “a polite suggestion”.
Prof Tuddenham confirms that he was not aware of the letter from Dr Galbraith to the Department of Health in June 1983 which recommended that all blood processed after 1978 should not be used. He agreed this information should have been available to clinicians.
He said that Dr Kernoff dealt with the introduction of heat-treated concentrates at the Centre but accepted that patients should have had the opportunity to decide what treatment they wanted to be receive having been fully advised of the risks/benefits.
The presentation focused on Prof Frank Hill and his role at both Birmingham Children’s’ Hospital (BCH) and the Queen Elizabeth Hospital (QEH). Again, at this stage, it is not clear whether Prof Hill will be called to give evidence.
Prof Hill was Co-Director of the Centre from 1976 before moving full time to BCH in 1992.
The Birmingham Centre was not a Reference Centre.The presentation focused on a number of key areas as with the previous presentations. This included the supply of blood products in the West Midlands, treating policies adopted at the Centre, Prof Hill’s knowledge of and response to the risks of Hepatitis and HIV and issues around patient consent.
Ms Richards QC also covered Prof Hill’s relationship with the pharmaceutical company Armour, which was the sole commercial supplier to BCH in the early 1980s and contributed to a “research fund” through Birmingham Health Authority.
The main focus of the presentations was the late 1970s and early 1980s as the later period was covered by the live evidence from Prof Franklin and Dr Wilde.
Prof Franklin joined QEH as Director in 1983. He was Co-Director of the Birmingham Haemophilia Centre with Prof Hill until 1992 when he was succeeded by Dr Wilde.
Prof Franklin described how he worked with Prof Hill and that, particularly in the early days in the post, he was guided by his experience.
Prof Franklin talked about the policies in place at QEH which including keeping patients on the same batch of product in so far as possible to reduce the risk of viral infection.
He spoke about wanting to do his best for his patients and the sense of denial that pervaded the relevant period in relation to NANBH which included the belief that NHS concentrate was safer because it was produced from volunteer donors.
Ms Richards QC also covered how those infected with HIV and HCV were informed of their diagnoses and the issue of consent for testing.
As the AIDS crisis emerged, Prof Franklin was critical of the lack of psychological support for his patients which he said, “added to the tragedy”.
At the conclusion of his evidence Prof Franklin paid tribute to the fortitude of those who had been infected and affected by this tragedy.
Dr Wilde took over as the Centre Director in Birmingham from Prof Franklin in 1992 and remained in post until 2016.
Dr Wilde’s evidence covered the period of HCV testing and the introduction and use of treatments for HCV at the Centre. Ms Richards also questioned him on consent and record keeping.
At the conclusion of his evidence Dr Wilde said that this was a massive tragedy and that he was privileged to have cared for such a wonderful group of patients.
Professor Liakat Parapia took over as Director of Bradford Haemophilia Centre in 1982 as a relatively inexperienced consultant. He described the facilities at that time as “abysmal”.
When he joined the Centre virtually all patients were treated with cryo. Prof Parapia described how this lead to other Centre Directors regarding Bradford as “inferior”. Prof Parapia made the decision to switch to concentrates in 1982 and described his guilt at making this decision which ultimately resulted in some of his patients becoming infected with HIV.
At the conclusion of his evidence he was very emotional and said that the scandal should never have happened.
Prof Preston was the Director at Sheffield Haemophilia Centre from around 1980 until he retired in 2000.
He gave his evidence remotely and was assisted by his wife to locate the documents referred to by Ms Richards QC during questioning.
Prof Preston was taken to the Centre’s annual returns which showed that by 1976 NHS and commercial FVIII were already being used and that by 1982 a home treatment programme had been established but that hardly any cryo was being used. Prof Preston also described the use of Porcine FVIII for patients with inhibitors.
Prof Preston stated that the treatment policy was to use DDAVP for mild and moderate haemophiliacs where possible. He also confirmed that NHS factor concentrates were used in preference to commercial concentrates where supply allowed because he thought NHS factor was safer due to the size and voluntary nature of the donor pool.
Prof Preston was taken to his evidence to the Lindsay Tribunal where he said that he believed Sheffield had used less concentrate than other centres and that this had resulted in a lower infection rate than elsewhere.
Prof Preston was instrumental in research into NANBH in the late 1970s/early 1980s and was taken through his various publications relating to this. He was asked whether he had reverted to using cryo once the serious nature of NANBH became apparent. He confirmed that, in his opinion, this was not an option as cryo could not be used predictably to treat severe haemophiliacs.
Prof Hay worked at Liverpool Haemophilia Centre between 1987 and 1994 having spent the early part of his career at Sheffield under Prof Preston between 1979 and 1987.
Prof Hay is the current Director of the Manchester Haemophilia Centre having taken over this post in 1994.
As with a number of the previous witnesses, Prof Hay relied heavily on the evidence he gave to the Lindsay Tribunal in 2001.
He covered knowledge of hepatitis C, his response to the AIDS crisis, recombinant products, the threat of vCJD and his thoughts on campaigners and a public inquiry.
It was apparent that he lacked direct knowledge in relation to a number of the issues covered in his written evidence that he was taken to by Ms Richards QC.
He said that by the early 80s there was an “international consensus” that HCV was a relatively benign condition. When questioned it was apparent he was relying on 3 particular papers to demonstrate this “consensus”.
He was also asked about the National Haemophilia Database and his role in the same. He said that from 2000 “implicit consent” was obtained from patients in respect of their data. It was clear from his evidence that he is producing a further written statement in relation to the UKHCDO.
Prof Hay said he and other clinicians were surprised by claims of a “conspiracy of silence” by campaigners. He said: "When patients said "we want to know the truth", we werent quite sure what truth they were after..we felt that we had been quite open."
The full transcripts of the evidence are available at: http://www.infectedbloodinquiry.org.uk/evidence
The You Tube video of the evidence can also be accessed here.
The Inquiry has now released an updated timetable as follows:
We consider that the Inquiry will focus a significant period of evidence on Scotland because the Chair will need to consider the conclusions of the Penrose Inquiry when looking at the recommendations that he makes in this Inquiry and, if he reaches a different conclusion, he will need to have evidence upon which to base this.
The oral evidence hearings are now completed for the summer.
The Inquiry has announced the extra week in October as Tuesday 29 October to Friday 1 November.
There will then be hearing on 21, 22, 26, 27 and 28 November where experts from the psychosocial and clinical groups appointed by the Inquiry will give evidence on the following topics:
You can now register to attend any of the October and November hearings on the Inquiry website.
At this stage we have not been informed if/when written reports from the Inquiry’s experts will be disclosed to Core Participants for consideration. We will of course push for disclosure of any such reports in good time prior to the November hearings.
We are aware of the ongoing problems with access to medical records experienced by a number of our clients and have raised this repeatedly with the Inquiry Team. We have sought to agree an approach with the Inquiry as to the access clinicians are allowed to individuals’ records but without success. As we understand it clinicians are still being allowed to access patient records direct in circumstances where the Inquiry perceives there are criticisms of that clinician in the patient’s written statement. We have advised the Inquiry that we disagree with this approach.
Despite repeated requests we have not had any further information about how/when the Inquiry intends to deal with disclosure.
We will publish a further update prior to the October hearings. If you want any further information in relation to the Infected Blood Inquiry please contact a member of our team on 01923 223324 or by email at email@example.com
The Inquiry has now completed hearings in London, Belfast, Leeds and Edinburgh with the Cardiff hearings scheduled to take place from 23 to 26 July. The Inquiry will then return to London for three weeks in October. At present the dates for the third, added, week in London have not been confirmed.
The evidence heard to date has covered a range of issues. The Inquiry has heard from those infected as a result of treatment with contaminated blood products and transfusions as well as those affected by the loss of a loved one or living with and supporting someone who has been infected. We are currently carrying out an analysis of the evidence heard to date which we will complete following the Cardiff hearings and report on in due course.
The Inquiry states it has completed its hardcopy search of 2.5 million pages of documents provided by the Department of Health and the Medicines and Healthcare Products Regulatory Agency as well as 3 million pages of material provided by NHS Blood and Transplant. The next step will be to search the electronic material held by these agencies.
Electronic searches and hard copy searches have also been completed for the following:
You will also be aware that there is a specific Inquiry Team based at the National Archives reviewing the documentation held there.
What is less clear is when and how the Inquiry envisages sharing the results of its disclosure investigation with the Core Participants and their legal teams. We are in correspondence with the Inquiry in relation to this issue which we know is of concern to our clients.
The Inquiry Team has indicated that there will be further oral hearings in November where a panel of experts will give evidence in relation to the effects of HIV and Hepatitis C both in relation to the infections themselves but also in respect of other conditions linked to the infections and the side effects of the medications used to treat each infection.
If you want further information in relation to the Infected Blood Inquiry please contact a member of the Contaminated Blood Team.