A recent court of appeal dismissal rejecting permission to apply for a Judicial Review to examine whether the government funded English Infected Blood Support Scheme (EIBSS) acted in a discriminatory way has highlighted the importance of re examining haemophilia cases already registered with the scheme. EIBSS which was set up in 2017 provides financial and other support to those infected with HIV and/or hepatitis C through blood and blood products used by the NHS and to their families. There are similar schemes in Scotland, Wales and Northern Ireland.

UK Human Rights blog wrote on the case of CN v Secretary of State for Health and Social Care [2022] EWCA Civ 86 and quoted the following decision,

In a judgment handed down on 4 February 2022, the Court of Appeal dismissed an appeal for permission to apply for judicial review concerning the lawfulness of the England Infected Blood Support Scheme (EIBSS) (the “Scheme”). The Court of Appeal concluded that the Scheme’s exclusion of those infected with hepatitis B was not discriminatory. In any event, the Secretary of State’s justification for who was to be compensated under the ex gratia Scheme was to be given a wide margin of appreciation by the courts.

However it is important to note that the case in question with regard to the dismissal centred not on haemophiliacs that received a treatment called factor concentrates made from the pooled plasma of many thousands of donors (often from the US) but on the case of a person referred to as CN who received a whole blood transfusion within the UK. These were historically totally separate legal cases relying on very different evidence only recently pushed together in the Infected Blood Inquiry chaired by Sir Brian Langstaff. The legal case statement regarding CN which was released reads,

CN put the claim on the basis that there had been a refusal to include persons in his position within the EIBSS. CN suffers from hepatitis B virus (HBV) which he alleges he contracted when he was given blood transfusions on or after 14 April 1989, when he underwent a bone marrow transplant at Hammersmith Hospital. It is now accepted that the NHS screened blood and blood products for HBV at least from the mid-1970s.^[3]

Unlike the unfortunate CN, infected haemophiliacs are ALREADY on the scheme in recognition of their HIV and hepatitis C infection which occurred in the 1970s and 1980s before viral inactivation and testing was put in place but the government has always refused to also include hepatitis B.

The recent dismissal of the whole blood case highlighted that,

“The eligibility criteria for support implemented by the Alliance House organisations were carried over to the EIBSS. [These] criteria [did] not include infection with hepatitis B because blood donors were screened for hepatitis B from 1972. There was therefore a significantly lower probability of blood being contaminated with hepatitis B in the 1980s than for HIV and hepatitis C, for which screening was introduced in 1985 and 1991 respectively”.

Although this statement may be applicable to cases such as that of CN with his whole blood transfusion, it is a complete nonsense where many haemophiliacs are concerned as it fails to address the fact that haemophiliacs not only received products manufactured using UK plasma but also treatment products manufactured in the US. It is important to note that evidence shows the collection procedures in the US during the 1970s and 80s violated almost every safety rule in the book including with regard to screening donors for hepatitis B.

The dangers of hepatitis B have long been known by UK authorities and were well recorded PRIOR to the importation of US factor concentrates in 1973. It was recognized in medical journals and by the UK government that plasma collected from remunerated donors on skid row and in Central America slum areas combined with plasma from drug users, prostitutes, gay men and prisoners in pools of up to 400,000 carried a far higher risk of transmitting hepatitis B than plasma sourced from the more carefully screened unpaid donors within the UK.

This dangerous imported treatment was even trialled on children with haemophilia at Lord Mayor Treloar College in Hampshire (a boarding school for children with disabilities) and is the subject of a newly launched legal case focusing on the alleged experimentation at the college. Before the introduction of US factor concentrates, haemophiliacs were treated with cryoprecipitate made from only a handful of volunteer donors thus keeping hepatitis infection to a minimum. Once US factor concentrates were introduced, former pupils recalled outbreaks of hepatitis B and being made to use plates in the canteen that were marked with a red dot to identify those infected.

As the Newcastle Journal “Bad Blood” campaign published in 2001,

DOCTORS were warned of the risks of using imported blood as early as the 1960s, a leading Newcastle scientist said last night.

Dr Arthur Codd, a consultant virologist in the Public Health Laboratory Service at Newcastle’s General Hospital, said he and others had warned about the risk of infection for many years.

“We had known that pooling blood from many donors increased the risk of contamination as early as the Second World War,” he said.

“Hepatitis B was transmitted to many people during this time and there was nothing we could do to prevent it.

“Crazy as it seems, a blood transfusion can seriously damage your health and our recommendations to only use blood from local donors were very clear.”

Until the UK started to import blood products from America, it had one of the lowest rates of hepatitis of anywhere in the world.

It is well documented by medical experts that haemophiliacs were infected with hepatitis B and non A non B (hepatitis C) from their first shot of commercial factor concentrates as the risks were so high.

To the editor- The probability of a recipient developing serum hepatitis (SH) is 10 to 50 times greater when the blood donor is a commercial donor. (JAMA, 24 th July, 1972, Vol 221. No 4)

Indeed as soon as commercial concentrates were introduced in the US, clusters of hepatitis B infections in American haemophiliacs were detailed in a 1972 study by Kasper and Kipnes who discussed their findings in the Journal of the American Medical Association in a letter entitled Hepatitis and Clotting Factor Concentrates, stating,

“Recent reports (listed 1-3 and referenced from 1970 and 1971) have aroused alarm about the danger of hepatitis after the infusion of clotting factor concentrates prepared from the pooled plasma of many donors. We have therefore reviewed the incidence of clinical hepatitis among 482 haemophiliacs treated here in the last 10 years (Reference to Table 1 in the article). The peak incidence occurred in 1968 in Haemophilia A and 1971 in Haemophilia B. Concentrate became the predominate mode of therapy in Haemophilia A in late 1967 and in haemophilia B in late 1969.”

They also warn later in the letter,

“We conclude that older children and adults who have had little exposure to blood products are at a high risk of developing clinical hepatitis after introduction of clotting factor concentrates. In such patients especially those with mild haemophilia, single donor products are preferable. On the other hand patients with severe haemophilia who have had many blood and plasma infusions have no increased risk of hepatitis if concentrates are used.”

However the American study did not take into account the effect on UK haemophiliacs (who did not start their imported treatment until 1973 in most cases) and the differences in collection practices and safety procedures between the UK and the US.

We now know that round 99% of haemophiliacs infected with HIV registered with EIBSS are co infected with hepatitis C and their medical records show most as having also been infected with hepatitis B, all impacting on the liver. Then there are haemophiliacs on EIBSS files without HIV but with hepatitis B and C. In addition to this haemophiliacs were re-infected over and over again further damaging their liver and immune system. Haemophilia is hereditary so you could also have (and often did) more than one family member infected. Some haemophiliacs also had the combination of hepatitis B and D as follows,

Hepatitis D is a serious liver infection caused by a virus that is transmitted through blood or bodily fluids. It can only be contracted if a person has had the hepatitis B virus and is uncommon in the United States. (Though not so uncommon in haemophiliacs.)

https://www.verywellhealth.com/hepatitis-d-signs-symptoms-and-complications-5206580 

The case for haemophiliacs is very specific as a choice was made by government to introduce the recognized more dangerous imported factor concentrates BEFORE a way was developed to virally inactivate hepatitis B. Indeed this was well documented in the 1991 HIV litigation where it was argued that had government taken more action to limit hepatitis B exposure such as holding on from introducing factor concentrates until viral inactivation was in place and not importing US plasma, many lives could have been saved with regard to HIV and hepatitis C.

Safety should have come first even if it meant delaying putting the new so called “miracle” treatment on the shelves but governments and plasma companies put profit before safety and repeatedly turned a blind eye to safety violations. So the statement on “eligibility criteria” for EIBSS and the issue of hepatitis B infection sources and failures carefully avoids addressing the haemophilia cases where they received imported plasma. So far, despite many alleged safety violations related to hepatitis B the government has denied accountability for exposing haemophiliacs to a far higher risk of contracting hepatitis viruses from US treatment compared to the UK. This was particularly of concern given the far higher number of donors (many of them considered “high-risk”) in the American plasma pools. 

Although the recent case dismissal was not successful for CN, it has certainly served to highlight the difference between haemophilia and whole blood cases in relation to hepatitis B infection and the importance of reviewing the two cases completely separately in terms of EIBSS.

The case highlighted that, as far as including hepatitis B within the EIBSS schemes,

Mr Tankel (for the defence) submitted that nothing has changed since 2004. HBV sufferers were not included then and they are not included now.

And there lies the shame, Tankel is absolutely right, to this day, the haemophilia cases have never been reviewed looking at the evidence which showed alleged negligence in the same way as the infections with HIV and hepatitis C. Tankel completely ignores the fact that former Health Minister Anne Milton removed the word “inadvertent” infection of haemophiliacs with HIV and hepatitis viruses in 2009 but the EIBSS scheme has so far failed to reflect that change and pay monthly support in recognition that haemophiliacs were also infected with hepatitis B. Exposure to v CJD is not included either.

In case Tankel is not aware, the original hepatitis payment scheme Skipton (which was scrapped and is now under EIBSS) was set up in the early 2000s to prevent haemophiliac Peter Longstaff going to court on his legal challenge to overturn the hepatitis Undertaking (waiver) in the 1991 HIV haemophilia ex-gratia settlement. A legal opinion from his then QC stated that it could not be “informed consent” as documents showed that everyone on the defence and those representing Longstaff, knew of the dangers of hepatitis viruses which they played down, keeping key evidence from Longstaff and others. Much of the HIV litigation documentation contained documents on hepatitis B and C which was seen by long standing campaigners following their own research and only some years AFTER the litigation ended in an out of court settlement withholding these important government and other papers.

Carol Grayson, Longstaff’s wife fought to legally access copies of papers that government had “inadvertently” destroyed from a solicitors office in Newcastle for her dissertation research awarded the Michael Young Prize. In response to a request from government, she returned copies in 2006 which were put onto a Department of Health website, then transferred to the National Archives Kew. However, this was not before the department lawyers had destroyed the legal letters of return through her instructions to solicitor Paul Saxon, Blackett, Hart and Pratt LLP and failed to reference Grayson as the provider. (Fortunately she retained her own copies.)

During the Archer Inquiry into contaminated blood which dealt ONLY with the infection of haemophiliacs, Lord Archer recommended haemophiliacs were paid out per virus and v CJD prion exposure. This should have been fully in place starting from 2010 but was blocked by the misinformation coming from Lord Warner. Compensation on a parity with Eire was blocked due to lies told by members of the British government regarding the Irish settlement. The Infected Blood Inquiry chaired by Sir Brian Langstaff have been asked to investigate this. 

The UK Government continues to operate a “3 viruses for the price of 2” scheme to avoid accountability from the very beginning of the use of factor concentrates where there was almost non -existent safety screening in relation to hepatitis B in the US. This as mentioned formed a major part of the1991 HIV haemophilia litigation.

The question is… Was Tankel, the QC who represented government in the CN case commenting out of ignorance? Did he really have no understanding of the history of haemophilia infection compared to whole blood cases and safety issues over US treatment or is he carrying out more “damage limitation” for government so they can limit compensation payments? The Haemophilia Society represent haemophiliacs whilst the Hepatitis C Trust represents whole blood cases. Indeed, Charles Gore, former CEO of the Hepatitis C Trust recognized the differences between the 2 cases in writing within a journal article, evidence presented to the Infected Blood Inquiry.

 It is important that whole blood cases do receive compensation but the facts surrounding infection are very different from haemophiliacs and there is no escaping the legally documented facts. Levels of payment should reflect multiple infections and EIBSS payments should reflect that. 

The case for haemophiliacs receiving US plasma was always reported as the strongest case legally due to the fact for example that legal depositions highlighted that gay men were targeted for their “hepatitis B” rich plasma to be used in research …however the surplus was then added to top up the plasma pools for factor 8. Plasma wagons were in fact stationed outside the gay bath houses in San Francisco in the then notorious Tenderloin area specifically to bring in gay men for donation. From the early 1980s, hepatitis B came to be known as a warning sign for potential AIDS infection in the homosexual population. In addition to this, US prisoners who were administering the paperwork related to the plasma programmes at prisons such as Arkansas, falsified the names of inmate donors (known drug users) infected with hepatitis viruses and having unprotected sex (whilst waiting to donate) using names from a local telephone directory so they could sell their blood spreading infection with hepatitis B, C and then HIV. Thus infection of haemophiliacs was almost guaranteed with the use of commercial factor concentrates.

In some haemophiliacs you also had the combination of hepatitis B and D as follows,

Hepatitis D is a serious liver infection caused by a virus that is transmitted through blood or bodily fluids. It can only be contracted if a person has had the hepatitis B virus and is uncommon in the United States. (Though not so uncommon in haemophiliacs.)

https://www.verywellhealth.com/hepatitis-d-signs-symptoms-and-complications-5206580

It is clear that the recent dismissal case fails to understand the unique position of haemophiliacs living with hepatitis B, C, D and HIV all interacting with each other along with exposure to different competing genotypes, which can make treating haemophiliacs quite a challenge. This is very different to a one off infection from whole blood. Campaigners hope that Sir Brian Langstaff along with Sir Robert Frances also looking at compensation for Contaminated Blood victims will review hepatitis B infection in haemophiliacs in relation to EIBSS payments as well as compensation and end the government “bargain basement” style payment schemes for multiple viruses. If government wanted to avoid compensation payments, they should have done a far better job in protecting those now infected and affected through this scandal.

Carol Anne Grayson is an independent writer/researcher on global health/human rights/WOT and is Executive Producer of the Oscar nominated, Incident in New Baghdad.  She was a Registered Mental Nurse with a Masters in Gender Culture and Development. Carol was awarded the ESRC, Michael Young Prize for Research 2009, and the COTT ‘Action = Life’ Human Rights Award’ for “upholding truth and justice”. She is also a survivor of US “collateral damage”