HIV Haemophilia Litigation | |
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Court | Court of Appeal (Civil Division) |
Full case name | AMcG002 v Central Birmingham Health Authority (1),... [1] |
Decided | 20 September 1990 [2] |
Citations |
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Case history | |
Appealed from | High Court of Justice |
Court membership | |
Judges sitting | |
Keywords | |
The HIV Haemophilia Litigation [1990] 41 BMLR 171, [5] [1990] 140 NLJR 1349 (CA), [6] [1989] E N. 2111, also known as AMcG002, [1] and HHL, [7] was a legal claim by 962 plaintiffs, [8] mainly haemophiliacs (but also their wives, partners and children), who were infected with HIV as a result of having been treated with blood products in the late 1970s and early 1980s. [9] [10] The first central defendants were the then Department of Health, with other defendants being the Licensing Authority of the time, (MCA), the CSM (the Committee on the Safety of Medicines), the CBLA (Central Blood Laboratories Authority), and the regional health authorities of England and Wales. [8] [11] In total, there were 220 defendants in the action. [12]
The litigation commenced around April 1989 [13] and by 7 July 1989, at least 300 plaintiffs had joined the action. [14] Within four months another 300 haemophiliacs had joined the action, [11] however, by this time, (November 1989) 163 haemophiliacs had already developed full-blown AIDS and 107 had died. [15] There was an initial deadline of 2 February 1990 imposed, but this was extended in order to permit 200 haemophiliac children to sign up to the action. [16]
The plaintiff's principal allegations were that the UK government had been negligent in failing to become sufficient as a country in the supply of blood products at an earlier point, and in delaying the implementation of heat-treatment of clotting factors in order to inactivate HIV. [16] It was further alleged that the defendants did not respond correctly to the AIDS crisis, specifically, in not reacting with urgency to move to banning imported blood products which were derived from paid donors. [17] [18] Another significant ground was breach of duty as provided for in statute, for example, under the National Health Service Act 1977. [19]
On 20 September 1990, the Court of Appeal heard an appeal concerning discovery where an order of 31 July 1990 had been made by Mr Justice Rougier that required the first central defendant, the Department of Health, to surrender some, but not all of 600 files of historic papers spanning 1972 to 1986, on which they were asserting public interest immunity (PII). The appeal had been brought by the plaintiffs and was being considered in conjunction with a cross-appeal by the defendants. [2]
The documents being withheld under public interest fell into a number of categories: submissions and draft submissions to ministers, policy documents, exchanges with ministers, documents revealing the process by which policy decisions were arrived at, documents showing exchanges between senior officials, briefings to ministers, and position papers on the formulation of future policy prepared by civil servants. [20]
Part IV of the Canadian inquiry report by Justice Horace Krever provides a more specific breakdown of the subject matter of the documents which were under consideration during the appeal: documents relating to the drive for self-sufficiency, the allocation of resources, documents on the laboratory (BPL) where blood products were manufactured, on the NBTS, on the screening of donors, on steps to limit the infection with hepatitis, and on heat-treatment of blood products. [18]
No one could doubt the sincerity of the efforts of those in the Department to protect and to assist the plaintiffs as patients in the National Health Service, but on the pleaded case grave errors of judgment were made. Even if there was no grave error of judgment it appears to be not in dispute that there was in fact a failure to protect the plaintiffs from the danger of using blood products, whether imported or supplied in this country, which were infected. (...)
Ralph Gibson L.J.,HIV Haemophiliac Litigation, Court of Appeal, 20 September 1990 [20]
The three appellate judges found for the plaintiffs and ordered the PII documents to be disclosed, [2] overturning the ruling of Rougier J of 31 July 1990 [19] and at the same time, the cross-appeal by the Department of Health was dismissed. [21] [20] Lord Justice Bingham recorded in the judgment that he felt "the tragedy was avoidable in the sense that, had different measures been taken in the 1970s and early 1980s, it could, at least in large measure, have been prevented." [22] [23]
On 26 June 1990, Mr Justice Ognall took the rare initiative of issuing a handwritten note imploring the parties to give anxious consideration to settling the action out of court. [24] He stressed the moral obligation and duty that fell on the UK government toward the HIV-infected haemophiliacs. [18] However, the judge's plea was resisted for several months by the Health Secretary, Mr Kenneth Clarke, [4] and was still being rebutted on 16 October 1990. [25] The Chief Medical Officer, Donald Acheson, was also keen for the government to settle the action. [26] The haemophiliac plaintiffs were developing AIDS and 130 infected haemophiliacs had already died by 9 November 1990. [27] The next month, the action was settled out-of-court by which time the number of plaintiffs on the roll of names [lower-alpha 1] had risen to 1,217. [29]
It was reported on 4 February 2022 in the i newspaper that a Department of Health memo, [lower-alpha 2] unearthed at the National Archives, revealed that senior government officials held the belief in 1995 that the government would have been found negligent and lost the HIV Haemophilia Litigation had the case gone to full trial. [31]
On settlement, the plaintiffs were required to sign a Deed of Undertaking, often referred to as a waiver, undertaking not to pursue any further legal action against the Department of Health or other defendants with respect to infection with any other viruses contracted through contaminated blood products. The waivers effectively served as an indemnity against future legal action against the Department of Health in relation to blood-borne viruses. [32] In 2003, The Guardian reported that the waivers prevented infected haemophiliacs and other plaintiffs from suing specifically if it "was later found that they had hepatitis C as well". [33]
The validity of the waivers has more recently been brought into question in the wording of the Group Litigation Order in Jason Evans & Others [2017], where at 1.4. [lower-alpha 3] it's suggested that any undertakings given by the claimants in the HIV Haemophilia Litigation may not be binding upon the claimants, due to it now being deemed "unconscionable for the Defendant to rely upon such undertaking". [1]
The decision to implement the waivers was made during the course of the litigation by a high-powered [lower-alpha 4] government committee, the Advisory Committee on the Virological Safety of Blood (ACVSB). [35] [36] The use of the waivers has been described as controversial by the Haemophilia Society in their first written submission to the Archer Independent Inquiry because it was felt by many haemophiliacs that the government of the time was already aware of the true scale of infection with non-A non-B hepatitis (NANBH) in those who had been treated with blood products. [37]
During the course of a meeting of the AIDS Group of the Haemophilia Centre Directors held on 12 February 1990, a question was posed as to whether hepatitis was likely to become "another item for which haemophiliacs would seek litigation" and whether it was advisable for the Haemophilia Centre Directors to continue to collect data. Later in the same meeting, Dr Simpson confirmed that the Haemophilia Society should not be given hepatitis data. [38]
On 19 May 2022, The Daily Telegraph reported that during the HIV litigation, information had been withheld from litigants and that a requisite undertaking had been inserted into the legal proceedings which served to exclude future legal action if plaintiffs were later found to be infected with hepatitis C. [39]
On 10 May 2022, oral evidence was given to the Infected Blood Inquiry by haematologist Dr Andrzej Rejman, [40] a former Senior Medical Officer from March 1989. [41] He admitted that the Department of Health had asked Health Authorities at the time to alter the reports of expert witnesses [lower-alpha 5] called by the defendants in the HIV Haemophilia Litigation. These experts included the late Professor Arthur Bloom, [lower-alpha 6] and according to Dr Rejman's testimony, this was done in order to tone down certain parts or change the emphasis. [47]
Criminal transmission of HIV is the intentional or reckless infection of a person with the human immunodeficiency virus (HIV). This is often conflated, in laws and in discussion, with criminal exposure to HIV, which does not require the transmission of the virus and often, as in the cases of spitting and biting, does not include a realistic means of transmission. Some countries or jurisdictions, including some areas of the U.S., have enacted laws expressly to criminalize HIV transmission or exposure, charging those accused with criminal transmission of HIV. Other countries charge the accused under existing laws with such crimes as murder, manslaughter, attempted murder, assault or fraud.
In the 1980s, between one and two thousand haemophilia patients in Japan contracted HIV via contaminated blood products. Controversy centered on the continued use of non-heat-treated blood products after the development of heat treatments that prevented the spread of infection. Some high-ranking officials in the Ministry of Health and Welfare, executives of the manufacturing company and a leading doctor in the field of haemophilia study were charged for involuntary manslaughter.
The tainted blood disaster, or the tainted blood scandal, was a Canadian public health crisis in the 1980s in which thousands of people were exposed to HIV and hepatitis C through contaminated blood products. It became apparent that inadequately-screened blood, often coming from high-risk populations, was entering the system through blood transfusions. It is now considered to be the largest single (preventable) public health disaster in the history of Canada.
Factor 8: The Arkansas Prison Blood Scandal is a feature-length documentary by Arkansas filmmaker and investigative journalist, Kelly Duda, released in 2005. Through interviews and the presentation of documents and footage, Duda alleged that in the 1970s and 1980s, the Arkansas prison system profited from selling blood plasma from inmates infected with viral hepatitis and HIV. The documentary contends that thousands of victims who received transfusions of blood products derived from these plasma products, Factor VIII, died as a result.
Kelly Duda is an American filmmaker and activist from Arkansas best known for the 2005 documentary, Factor 8: The Arkansas Prison Blood Scandal.
Contaminated hemophilia blood products were a serious public health problem in the late 1970s up to 1985.
The Lindsay Tribunal was set up in Ireland in 1999 to investigate the infection of haemophiliacs with HIV and Hepatitis C from contaminated blood products supplied by the Blood Transfusion Service Board.
In April 1991, the doctor and journalist Anne-Marie Casteret published an article in the French weekly magazine the L'Événement du jeudi showing that the Centre National de Transfusion Sanguine knowingly distributed blood products contaminated with HIV to haemophiliacs in 1984 and 1985, leading to an outbreak of HIV/AIDS and hepatitis C in numerous countries. It is estimated that 6,000 to 10,000 haemophiliacs were infected in the United States alone. In France, 4,700 people were infected, and over 300 died. Other impacted countries include Canada, Iran, Iraq, Ireland, Italy, Japan, Portugal, and the United Kingdom.
The HIV-Tainted Blood Case is a Supreme Court of Japan case that resulted in a landmark decision regarding criminal responsibility for administrative negligence. The Court upheld the conviction of Akihito Matsumura, former director of the biologics division of the old Health and Welfare Ministry, for his failure to prevent the use of HIV-contaminated blood products in the 1980s that resulted in the death of a patient. According to the two lower court rulings, Matsumura caused the death of a patient with liver disease in December 1995 by failing to stop the use of unheated blood products contaminated with HIV. The decision marks the first time that a government official has been held criminally responsible for administrative negligence. The decision finalized a verdict of 1 year in prison, suspended for two years, for Matsumura.
From the 1970s to the early 1990s, tens of thousands of people were infected with hepatitis C and HIV as a result of receiving infected blood or infected clotting factor products in the United Kingdom. Many of the products were imported from the United States, and distributed to patients by the National Health Service. Most recipients had haemophilia or had received a blood transfusion following childbirth or surgery. It has been estimated that more than 30,000 patients received contaminated blood, resulting in the deaths of at least 3,000 people. In July 2017, Prime Minister Theresa May announced an independent public inquiry into the scandal, for which she was widely praised as successive governments going back to the 1980s had refused such an inquiry. May stated that "the victims and their families who have suffered so much pain and hardship deserve answers as to how this could possibly have happened." The final report was published in seven volumes on 20 May 2024, concluding that the scandal could have been largely avoided, patients were knowingly exposed to "unacceptable risks", and that doctors, the government and NHS tried to cover up what happened by "hiding the truth".
Patrick McGuire is a Scottish solicitor and solicitor advocate. He is a partner with personal injury law firm Thompsons Solicitors Scotland.
The Penrose Inquiry was the public inquiry into hepatitis C and HIV infections from NHS Scotland treatment with blood and blood products such as factor VIII, often used by people with haemophilia. The event is often called the Tainted Blood Scandal or Contaminated Blood Scandal.
Arthur Leslie Bloom FRCP, FRCPath (1930–1992) was a Welsh physician focused on the field of Haemophilia.
R (March) v Secretary of State for Health was a 2010 judicial review which challenged the UK Department of Health's decision not to implement Recommendation 6(h) of the Archer Independent Inquiry. The case was important in developing the doctrine of error of fact in public law which previously had not readily been the subject of judicial intervention.
M.C. and Others v Italy is a case decided by the European Court of Human Rights (ECHR) on 3 September 2013 in which Article 1 of Protocol 1 (A1P1) was engaged due to the applicants not being afforded annual uprating which the court deemed damage to their property of a disproportionate character in the form of an exorbitant charge. The Strasbourg ruling sets an important precedent for higher monthly compensation payments to be paid to the 60,000 or so victims of contaminated blood transfusions in Italy. The effect of this ruling increased payments to the applicants by 40%.
A and Others v National Blood Authority and Another, also known as the Hepatitis C Litigation, was a landmark product liability case of 2001 primarily concerning blood transfusions but also blood products or transplanted organs, all of which were infected with hepatitis C, where liability was established under the Consumer Protection Act 1987 and the Product Liability Directive (85/374/EEC) even in the absence of the ability to test to ascertain which blood transfusions were defective. The claimants were 114 individuals, six of whom were considered lead plaintiffs and given close consideration by the judge, Mr Justice Burton. Several of the claimants were minors who had become infected with Hepatitis C in the course of their treatment for leukaemia. The defendants were the National Blood Authority (NBA) and in respect of Wales, the Velindre NHS Trust, Cardiff. The court found that the UK government should have implemented measures to screen donated blood for HCV by March 1990, rather than September 1991, and that surrogate testing should have been introduced within the United Kingdom no later than 1 March 1988.
The Advisory Committee on the Virological Safety of Blood, often abbreviated to ACVSB, was a committee formed in March 1989 in the United Kingdom to devise policy and advise ministers and the Department of Health on the safety of blood with respect to viral infections. The scope of the ACVSB concerned areas of significant policy for the whole of the United Kingdom and operated under the terms of reference: "To advise the Health Departments of the UK on measures to ensure the virological safety of blood, whilst maintaining adequate supplies of appropriate quality for both immediate use and for plasma processing." Of particular emphasis to the remit was the testing of blood donors using surrogate markers for Non-A Non-B hepatitis (NANBH) and later on, HCV-screening of blood donors.
CN v Secretary of State for Health and Social Care [2022] EWCA Civ 86 was an appeal against the refusal of permission to apply for judicial review to challenge the infected blood support scheme administered by the NHS Business Services Authority (NHSBSA) for non-inclusion of those infected with chronic Hepatitis B virus. The appeal was based on the grounds that the exclusion of those infected with HBV from the England Infected Blood Support Scheme (EIBSS) was unreasonable and discriminatory, contrary to article 14 when read in conjunction with article 8 and article 1 protocol 1 (A1P1) of the ECHR. The appellant also claimed that there was different treatment and that the failure to include those infected with HBV was unreasonable, and that the original application for review should not have been deemed out of time.
In 1994, the Irish Blood Transfusion Service Board (BTSB) informed the Minister for Health that a blood product they had distributed in 1977 for the treatment of pregnant mothers had been contaminated with the hepatitis C virus. Following a report by an expert group, it was discovered that the BTSB had produced and distributed a second infected batch in 1991. The Government established a Tribunal of Inquiry to establish the facts of the case and also agreed to establish a tribunal for the compensation of victims but seemed to frustrate and delay the applications of these, in some cases terminally, ill women.
The Irish Haemophilia Society (IHS) is an organization that represents the interests of people with haemophilia, von Willebrand disease and other inherited bleeding disorders.
"HIV Haemophilia Litigation" refers to the case AMcG002 v Central Birmingham Health Authority (1), Coventry and District Health Authority (2), West Midlands Regional Health Authority (3), Oxfordshire Health Authority (4), Oxfordshire Regional Health Authority (5), The Attorney General on Behalf of the Committee on Safety of Medicines (6), The Attorney General on Behalf of the Licensing Authority Pursuant to the Medicines Act 1968 (7), Secretary of State for Health (8), Department of Health (9), North West Thames Regional Health Authority (10) and Central Blood Laboratories Authority (11); case reference 1989 E N. 2111.
Their lawyers argued that the Government was guilty of negligence and breach of statutory duty in importing contaminated supplies of the blood clotting product, Factor 8, from the US and allowing British-made Factor 8 to become infected with the virus.
The victims, who had taken a legal class action against the government...
Re HIV Haemophiliac Litigation [1990] 140 NLJR 1349 (CA)
Near the end of the HHL, Mr Justice Ognall allowed the plaintiffs' lawyers to act in the forthcoming Hepatitis Litigation, using the knowledge acquired when acting in the HHL, particularly resulting from the disclosure provided by the various defendants.
The 962 plaintiffs brought action against, inter alia, the Department of Health, the licensing authority under Medicines Act 1968, the committee on the safety of medicines, all regional and district health authorities in England and Wales, and the central blood laboratories authority.
1.4. Whether any undertakings given by the Claimants or any of them, directly or indirectly, to the Defendant at any time arising out of the HIV Haemophilia Litigation or otherwise are binding upon the Claimants, and in all the circumstances whether it is unconscionable for the Defendant to rely upon such undertaking.
Some 600 haemophiliacs with the AIDS virus are pursuing compensation through the courts. The Department of Health, the Medicines Licensing Authority, which comprises the United Kingdom Health Ministers, and the Committee on Safety of Medicines, which gives advice to the licensing authority, are among the defendants.
The plaintiffs claim damages for personal injuries which they allege were caused by the negligence and breach of statutory duty of the 220 defendants.
...in April 1989 a number of hemophiliacs brought a civil action against the Department of Health, the Medicines Licensing Authority, the Committee on Safety of Medicines, the Blood Products Laboratory, and the regional health authorities.
Of 1200 haemophiliacs with HIV, only 300 have initiated claims for compensation.
Towards the end of November 1989,... ...A hundred and sixty-three haemophiliacs had developed full-blown AIDS and 107 were dead.
18. The AIDS crisis. Secondly, we criticise the defendants for failing to react quickly to the AIDS crisis from 1982. We allege that they took an unjustifiably optimistic attitude to the epidemic, and in consequence failed to ban or restrict American blood products, or introduce heat-treatment of blood or testing of donors early enough, and neglected to take a number of other measures. The defendants say that the AIDS crisis happened very quickly, and that they took all the precautions that were reasonable at the time.
The 962 plaintiffs (most of them with haemophilia) seek damages for personal injuries allegedly caused by breach of a statutory duty under the National Health Service Act of 1977 and in negligence over HIV-contaminated factor VIII concentrate imported into the UK from the USA.
The Appeal Court judges who yesterday ruled in favour of disclosure were clearly unimpressed by the Department of Health's arguments. Indeed, those who went to court must be encouraged by the view taken in the judgment that they appear to have "at least a good arguable case" of negligence.
The tragedy was avoidable," said Lord Justice Bingham, "in the sense that, had different measures been taken in the 1970s and early 1980s, it could, at least in large measure, have been prevented.
A plea by Mr Justice Ognall that the Government should reach a speedy settlement with haemophilia sufferers who developed Aids because of NHS treatment with contaminated blood products was rejected by Mr Clarke, Health Secretary, last night.
The chief medical officer also urged the Department of Health to settle the matter out of court.
Of the infected haemophiliacs 208 have already developed Aids and 130 have died.
First recorded in 1595–1605; special use of list2 (in the sense "roll of names," perhaps originally of contestants in the lists); ...
If ministers are having serious worries about the precedents caused by the HIV scheme there is an alternative handling option (which might also be worth thinking about if we ever need to consider compromising the current CJD litigation), and that is to admit that our legal case in the HIV Litigation was not 100% watertight. In other words, we could (at this distance in time) suggest that the government agreed to the HIV scheme not because there was anything special about that the plight of haemophiliacs, but on a straight calculation of the balance of risk that the court would in fact have found it negligent if the case had come to trial. This preserves the Government's stance on no-fault compensation, and clearly implies that every new claim has to be looked at on its legal merits.
...If ministers are having serious worries about the precedents caused by the HIV scheme there is an alternative handling option… and that is to admit that our legal case in the HIV litigation was not 100% watertight. In other words we could suggest that the government agreed to the HIV scheme not because there was anything special about the plight of haemophiliacs, but on a straight calculation of the balance of risk that the court would in fact have found it negligent if the case had come to trial...
Jenny Willott: To ask the Secretary of State for Health how many requests her Department has received for original copies of legal waivers signed by haemophiliacs undertaking not to take legal action against the Department or any other public body in respect of infection with HIV or hepatitis viruses as a result of infected blood products; how many such documents the Department has provided following those requests; and if she will make a statement. Caroline Flint: In the period April 2006 to March 2007 the Department received three requests for copies of waivers signed by haemophiliacs infected with HIV through blood products. The Department has been unable to satisfy these requests. There is no requirement for such waivers in relation to infection with hepatitis.
They also had to sign legal waivers under the Department of Health deal, promising they would not sue if it was later found that they had hepatitis C as well.
The ACVSB had advised ministers to require victims to sign a waiver agreeing not to pursue the Government over hepatitis infections when applying for compensation.
It is also believed that the committee was responsible for suggesting that those who had been infected with HIV and wanted compensation should sign a waiver agreeing not to sue if they were later found to have contracted other viruses.
This waiver is controversial because many people with haemophilia believe that the Government knew at the time that non-A, non-B hepatitis was widespread in the haemophilia community. Many patients say they were tested in secret in the 1980s but not told of the results for up to a decade.
The news comes after the revelation last week that Dr Andrzej Rejman had hidden information from victims. Dr Rejman admitted to advising the Government to add a clause to the HIV litigation that would prevent people who later discovered they had been infected with hepatitis C from suing again.
We could have obviously -- and I suspect we did -- say to the Health Authorities, "Look, we've read this expert witness report. We suggest that you ask Professor Bloom would he be prepared tone this bit down, tone that bit down, you know, change the emphasis or whatever", which is what we did with our expert witnesses if we thought they were going off tangent or whatever.
I make this statement because I was a Senior Medical Officer responsible for Haematology at the Department of Health commencing 1st March 1989. I stopped working in that role on 31 July 1997.
Dr. Savidge raised the point that one member of the AIDS Group was acting as an expert on behalf of the Plaintiffs' and wondered whether it was acceptable for him to take part in the Group's discussions on Litigation and the Defence of the main statement of claim... ...Dr. Aronstam said he was the person referred to... ...It was pointed out that Dr. Jones was acting for 5 Plaintiffs in Scotland.
I think ultimately Professor Bloom prepared an expert witness statement which was actually for the Health Authorities, which they then shared with us.
Professor Bloom was influential: he was Chairman of the Haemophilia Centre Directors, a senior member of the Society's own medical advisory panel and a member of the Central Blood Laboratories Authority (CBLA).
Professor Bloom, who was chairman of the Haemophilia Centre Directors, a senior member of the Society's own medical advisory panel and a member of the Central Blood Laboratories Authority, ...
Experts looking into the impact of the blood scandal, which saw up to 30,000 NHS patients infected with HIV and hepatitis through contaminated blood transfusions in the 1970s and 80s, were asked to 'tone down' their reports, a court has heard.