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April 2007
Introduction
The History
Alder Hey
The Human Tissue Act 2004
Litigation
The BNFL Enquiry
The issue of organ retention has again resurfaced, as the Trade and Industry Secretary Alistair Darling last week announced there would be an official enquiry into the revelations that body parts had been removed from 65 deceased British Nuclear Fuels (BNFL) employees without the consent of their families.
The Human Tissue Act 2004, came into force as a result of the events which occurred at Bristol Royal Infirmary and Alder Hey and now regulates this area of the law. It is a criminal offence to remove human tissue after death unless appropriate consent from relatives is given, or it is done under the authority of the coroner or the courts.
However the information disclosed by BNFL last week shows that this practice has occurred in other areas again without consent being requested.
The evidence of organ retention at BNFL came to light as a result of a request made by Westlakes Research Institute, located in Cumbria. They wished to re-examine the historic research data produced by government scientists in the 1970s and 1980s, which measured plutonium levels in human tissue to determine whether employees of BNFL were being exposed to highly radioactive material.
Sixty five cases have been highlighted where tissue samples were taken from autopsy material of deceased workers between November 1962 and August 1991. Fifty seven workers were employed at Sellafield in Cumbria, whilst the other cases involve one employee who transferred from Sellafield to a nuclear site at Capenhurst, Cheshire, six employees working at the Atomic Weapons Establishment in Aldermaston and one worker employed at Springfield in Lancashire.
In fifty six cases the tissue sampling was linked to coroners’ post mortems or inquests. Five further cases involved sampling which was done on a legally correct basis, for example with the consent of family members. One case also involved a biopsy taken from a living person. However, there are four remaining cases where there is no record of instruction or consent and it is unclear how the request to obtain and retain the human tissue arose.
BNFL commented “The issue of tissue sampling is an historic issue, not a current one, however our prime concern is for the feelings of family of those involved.”
This is not the first time this issue has been highlighted in the press. In 1998 it became apparent that the hearts of patients were being retained from patients at the Bristol Royal Infirmary who had undergone surgery at the hospital. Consequently a government enquiry was commissioned where Prof RH Anderson, a Professor of Morphology at Great Ormond Street spoke in September 1999 of the benefits of retaining hearts for the purpose of study and teaching. He identified collections at various hospitals around the country and referred to the largest collection at the Royal Liverpool Children’s Hospital NHS Trust, also known as Alder Hey Children’s Hospital.
Investigations immediately commenced and it became apparent that under the guidance of Professor van Velzen an established practice of retaining and stockpiling organs without consent had developed at Alder Hey between the years of 1988 and 1995. Once the organs were taken many remained untouched, with histological examinations not being carried out and post mortem reports often being left incomplete. Many organs were rarely examined or used as part of medical research.
The Alder Hey Enquiry was subsequently commissioned in December 1999, chaired by Michael Redfern QC. Its aim was to investigate the removal, retention and disposal of human organs and tissues following post mortem examinations at Alder Hey and to make recommendations for the future. It also reviewed the law regulating tissue retention and how this could be developed.
As a result of the enquiry, recommendations were made in a number of areas. The major development resulting from the enquiry was the creation and implementation of The Human Tissue Act 2004, which replaced the Human Tissue Act 1961.
The 1961 Act provided that doctors could not make a decision to retain organs, without consulting the family of the deceased, unless the patient was a child who died after pregnancy lasting less than 24 weeks. In all other circumstances they were required to make reasonable enquiries of parents and relatives.
The fundamental principle of the entire 2004 Act is the issue of consent which is dealt with in Part I. Appropriate consent must now be obtained from a ‘nominated representative’ before any activities regulated by the Act are undertaken. Regulated activities include the storage and use of whole bodies, the removal, storage and use of human material (including organs, tissue and cells) from the bodies of deceased persons and the storage and use of material from living persons.
Part II of the Act set up the Human Tissue Authority (HTA) which is now responsible for regulating the removal, storage, use and disposal of human material. It lays out a range of activities which require a licence from the HTA and establishes penalties for conducting these activities without a licence.
Part III deals with other various supplementary issues including how to dispose of human material which is no longer to be kept. It also makes it an offence, with specified exceptions, for a person to have human material with a view to analysing its DNA without consent.
Ultimately the Act has aimed to balance the rights and expectations of individuals and their families against the broader interests of the general public and the need to continue with the development of education, training and scientific development.
Following the outcome of the Alder Hey Enquiry bereaved families rightfully sought compensation. After a hearing at Nottingham Crown Court a group settlement of £5 million was accepted, which amounted to approximately £5000 per child. The settlement also included letters of apology to parents, a memorial to the victims, a donation to charity and a meeting with parents to discuss changes at the hospital.
Since this settlement further litigation has been undertaken against 146 NHS Trusts, in the form of group litigation. This group action became known as “The Nationwide Organ Retention Litigation” and the matter was heard in March 2004 at the Royal Courts of Justice when three lead cases were considered. A year later in November 2005 a settlement of £3.6million was accepted by more than 2000 claimants, who received compensation of approximately £2,900 per family.
It is of course worth noting that whilst approximately 37,000 people were affected by the organ retention scandal, only 2000 pursued their claims.
The enquiry into the conduct and practices at BNFL will now be led by the experienced Michael Redfern QC. GMB National Officer Gary Smith commented “The Trade Unions at Sellafield welcome the inquiry announced by the Government today and we appreciate the way the Government has dealt with the issue so quickly. The joint trade unions have asked for transparency and the Government has committed itself to that.”
The enquiry is likely to ask why tissue was taken, whether the deceased’s next of kin were informed and if proper procedures were followed. More specifically it is essential to establish how many families were affected and who they were. These families are then entitled to be told how long the organs were retained, what tests took place, what happened to the test records and what has since happened to the organs.
Since the revelations last week the UK Atomic Energy Authority (UKAEA) said they would review the medical records of 20,000 workers who had died. However some have suggested that BNFL should be instructed to review medical records of other deceased employees.
There must also be the suspicion that similar practices may have occurred in other industries which remain as yet undisclosed. Transparency is necessary to restore confidence, not only within the current enquiry, but also regarding similar industries.
Janet Allan, Clinical Negligence Partner at Thompsons Solicitors Newcastle office said “We appreciate how difficult and upsetting this issue is for the families involved. Despite the lessons learned from Alder Hey it appears that appropriate procedures have not been followed and this must cause extreme distress to relatives. Industries should now be forced to confirm their practices are in keeping with the detailed procedures laid down in the Human Tissue Act to avoid any further mistakes.”