Clinical_crossroads

Clinical negligence lawyers around the country are awaiting the governments response to the existing law on consent in the wake of the Alder Hey organ...Clinical negligence lawyers around the country are awaiting the governments response to the existing law on consent in the wake of the Alder Hey organ scandal.

The full extent of the scandal was revealed in January with the publication of the report of the Alder Hey inquiry, chaired by Michael Redfern QC.

Alder Heys hospital trust accepted full responsibility on 30 January.The recommendations of the report, being studied by lawyers, include, in particular, amending the Human Tissue Act 1961 to provide a test of fully informed consent for lawful post-mortems and retention of body parts, the imposition of criminal sanctions by way of a fine for breaches of the Act to encourage compliance, and provisions for disciplinary proceedings in the instance of a breach of the Act which could lead to suspension, dismissal or a financial penalty.

In practice, comprehensive information must be given to the next of kin for doctors to obtain valid consent.

The Redfern report acknowledges that it may be unpleasant for clinicians to provide detailed information and that the issue of consent arises at a time of extreme grief.

Therefore, a bereavement adviser must also jointly complete the consent form and this will go towards satisfying the requirements of the Act.Robin Makin, a partner at Liverpool firm E Rex Makin acting for around 200 families affected by the scandal, is not happy with the scope of the report.Redfern failed to address the failings of the administration [in the medical profession] particularly higher up in the system, in particular the NHS executive, especially with regard to the mishandling of affairs since last September, he says.

One really needs to look at the responsibility and structure higher up.Ian Cohen, a partner at Liverpool law firm Goodmans, has represented the Alder Hey families support group Pity II (Parents Interning Their Young Twice) since it was set up in November 1999.

Last month a court appointed him ahead of Mr Makin as lead solicitor in the impending group action for psychiatric trauma brought by the families.He says the existing best endeavours requirement in the Human Tissues Act (which simply requires a no objection response to constitute consent) will no longer be sufficient.

Mr Cohen would like to see the emphasis on consent changed whereby the patient must actively consent and that consent is positively sought by the receiving doctor.

He adds: It is essential that the patient who is giving the consent must be fully informed as to the full effect and the implications of that consent and, secondly, that the doctor receiving that consent must be satisfied that the patient has understood the effect of that consent and that the patient is the appropriate person to have sought that consent from.Mervyn Fudge is the partner at Devon firm Toller Beattie who represents the Bristol Heart Childrens Action Group and is solicitor to the National Committee for Organ Retention.

He says that if a relative consents to the retention of organs the use should be specified and regulated and monitored by an ethics committee.

He says that if a wrong use of organs occurs, any consent should be invalidated.

Monitoring is very important, he adds.The rights of parents and others will therefore now be increased as a result of the report.

Mr Fudge says: Both the revelations of Bristol and Alder Hey should change the perceptions of the medical profession as to how they deal with deceased people, he says.

For too long they have treated dead people as an artefact, to do what they will with their dead bodies.He explains that parents would have been happy for organs to have been retained had proper reasons been given for the purpose of their retention and the organs had been used correctly in accordance with any consent.In reality, the matter has to be dealt with with compassion, full consent and with knowledge and with a dexterity that has to be shown by the medical profession.The recommendations of the Redfern report point out that the Human Rights Act 1998 makes provision for an effective remedy without criminal proceedings.

So if breaches of the Human Tissue Act amount to a human rights breach, it is recommended that consideration be given to incorporating a financial remedy in the Human Tissue Act itself with the involvement of the Law Commission if that is considered necessary.However, Ian Cohen would like to see harsher criminal sanctions for breaches, such as imprisonment, to constitute an appropriate deterrent for doctors.

He says: Fines are insufficient because the commercial value of human tissue becomes relative and could, eventually, encourage breaches if the benefits outweigh the risks.Melvyn Fudge agrees.

If anyone [in the medical profession] goes against the statutory format, he says, this should be a criminal offence and lead to striking off if necessary.Mr Makin says: We raised very important issues with Redfern including the issue of possession of body parts.

I would like created an offence of unlawful retention and use of human body parts.

A full-scale review of the law is needed, he argues.The immediate effect of the reports recommendations will be felt in a matter of months.

However, the primary legislation required to change the existing law will involve a full consultation period and it will take up to two years for the recommendations to be fully operative.

In the meantime, where does that leave the grieving families as far as the law is concerned? Limitation periods will exclude many from taking action.

For those covered by the group litigation order, Mr Cohen expects general damages to be claimed in the region of 10,000 to 20,000 each and, in appropriate cases, special damages in such sums as would have to be determined by the courts.

As a result of the Alder Hey report, health secretary Alan Milburn has announced changes in the law governing consent by amending the Human Tissue Act, making it illegal for clinical staff to ignore informed consent, together with the introduction of a revised consent form and the issue of a code of practice on the use of organs for pharmaceutical companies.

Rex Makin is not impressed.

He says: They still havent dealt with the psychology of it all.

The parents are too upset to be faced with such a decision.

You need to look at the wider issues.

Its all very well having a beautiful form but its just not practical.The issue of informed consent goes to the heart of the recommendations and is a vexed issue for litigators directly involved in such cases.David Towns, a spokesman for the NHS Litigation Authority, which represents NHS trusts, says: We are looking at the report in the context of potential litigation.

If the law is changed with regards to informed consent, it will certainly have an impact on the way litigation is conducted.Mr Towns comments that it is too early at present to say how far-reaching the effects will be but says: The Department of Health is reviewing the current guidelines on consent with a view to providing a more consistent approach.

Anything to extend the Sidaway principle will place a wider duty on doctors and may provide more grounds for litigation.Of the potential claims arising out of the Bristol and Alder Hey scandals, Mr Towns says: The claimants have to prove there is legal liability.

Only then can compensation be considered.

He does not know what the measure of damages will be at the present time.Mr Cohen notes there is another casualty in this affair.

The vast majority of parents that I represent do not wish to see Alder Heys reputation suffer more than it has already as they recognise that the hospital does have a worldwide reputation for its treatment of sick children, he says.But the impact of the Redfern report cannot be overstated, he adds: It is widely accepted by most people that because of the issues arising out of the Alder Hey report, there will be a long-lasting effect on the NHS which will result in a substantial change in the law in this area.

Nicola Laver is a freelance journalist