R (Cavanagh) v Health Service Commissioner

All three claimants, by way of separate claims seek to challenge by way of Judicial Review the report of the Health Service Commissioner dated 2 ^nd October 2003 permission having been granted by Owen J.

The first claimant is Dr Nicholas Cavanagh Consultant Paediatric Neurologist at the Chelsea and Westminster Hospital.

The second claimant is Dr Hashumukhray (Ray) Bhatt a medical practitioner with expertise and specialisation in the treatment of vitamin B 12 disorders.

The third claimant is Frank Redmond the father of Tess Redmond born on the 10th of January 1992 who is now 12 years old.

Since the age of 2 ¹/₂ years old Tess has experienced uncontrolled seizures. She had severe learning difficulties and a severe communication problem. For many years she has been under the care of Dr Cavanagh. In 1995 Dr Cavanagh referred Tess to the B 12 unit which operated at the Chelsea and Westminster Hospital and following tests Tess was diagnosed as having a B 12 disorder. The evidence of her parents is that the B 12 treatment has greatly enhanced her life. On assessment she had a mental age of 4 ¹/₂ and her behaviour is challenging. She had seizures from the age of 2 ¹/₂ with neurological difficulties prior to that. On one occasion she fractured her skull when she fell during a seizure. She finds much in life to enjoy. She plays and listens to music and after difficulties with her education entered a special school in Westminster. Information before me indicates that Mr and Mrs Redmond are devoted parents who derive great joy from caring for Tess.

In October 1999 Tess was having considerable difficulty managing at a school in North London. The head teacher wrote that but for the possibility of treatment being effective, Tess would simply no longer be at the school.

A local authority review dated the 21st of August 2003 described Mr and Mrs Redmond as demonstrating a dedicated and committed approach to supporting Tess at home having endeavoured to ensure that her educational, social and health needs have been met in the most appropriate way. She requires constant support and supervision. Mr and Mrs Redmond demonstrate insight into the impact of having a disabled child and both take an active role in providing care and support for Tess.

On the 30th of September 2003 a Principle Family Support and Child Protection Advisor wrote after concerns had been expressed by the Chelsea and Westminster Healthcare NHS Trust (The Trust) in which he said 'my impression was of two loving and committed parents who are driven to provide their daughter with the most effective healthcare. They are clearly convinced that the B 12 treatment is effective from their own experience. I explored with them whether this was a fixed idea, whether if the B 12 treatment ceased to work or became harmful they would seek appropriate medical help I felt reassured by their response in accessing A&E Services for Tess at Chelsea and Westminster Hospital I felt that in other circumstances these parents would require convincing by expert medical opinion of changes to a regime that to them appears to be working. The test for a child protection conference is 'is the child at continuing risk of significant harm?' In my judgment and as a chair of many conferences over the years, on the evidence that I have heard, that is not the case for Tessa Redmond'.

In early 1995 when Tess was 3, Dr Cavanagh was first asked to take over Tess's care by a general paediatric colleague. In August 1995 he referred Tess to Professor Neville from Great Ormond Street who recommended a trial of Vitamin B6, which was without benefit.

In August 1995 Dr Bhatt's opinion was sought at the request of Mrs Redmond who had come across the Bl2 unit when she was in hospital an approach which coincided with Dr Cavanagh's views. Dr Bhatt requested blood and urine samples to be sent for analysis and he reported that the results of the tests suggested an underlying disorder of Vitamin B 12 requiring treatment with a special form of Vitamin B 12. The results of those tests are not available for consideration. Their existence and/or whereabouts is an important factor. At that point with the agreement of Mr and Mrs Redmond Dr Cavanagh referred the management of Tessa's Vitamin Bl2 problems to Dr Bhatt and has never rescinded that referral.

The B12 Unit.

In December 1995 the B 12 Unit closed. An independent external inquiry was conducted by Professor Gianfranco Bottazzo MD, FRCP, FRCP (Path) who had reviewed and evaluated the scientific work and contribution of the B 12 Unit on several occasions between 1986 and 1993 as a joint reviewer with the late Professor Dorothy Hodgkin, Sir Peter Tizard, Sir Douglas Black, Lord Walton and Professor Herbart.

The conclusion and recommendation was that 'this unrivalled unit must not disappear. In the tragic event that independent providers and extra contractual referrals should become post medical history it must be funded directly by the Department of Health. It has performed vital pioneering work for B 12 patients worldwide under Dr Bhatt's leadership and I fervently hope that it will continue to flourish for many years to come. Dr Bhatt is presently the only British B12 expert whose dedication and reliability for sound opinion are internationally acknowledged'.

At the same time The Institute of Child Health carried out a Report of the Inquiry into the Vitamin B 12 Unit and concluded inter alia:

i) That the Trust was correct in grasping an issue, which appeared to have major implications for the delivery of a safe and effective clinical service for children.

ii) The Trust was correct in demanding clarity on the presence, ethicality and quality of any research being undertaken on its patients by the B 12 Unit and a clearer understanding of the nature of Dr Bhatt's work and the extent of his clinical involvement with patients.

iii) The Trust was justified in seeking to review Dr Bhatt's contract and to define his responsibilities. In the circumstances the conditions associated with the offer of a new contract were reasonable.

iv) The Vitamin B 12 laboratory did not meet the standards that would be required for NHS accreditation and the Unit's communication with parents and referring medical staff fell below the standard required.

There does not appear to be any systematic process for the audit of the quality of documentation in the Trust's records of patient care.

After the closing of the Bl2 Unit Dr Bhatt did not continue to treat Tess throughout. When he was asked so to do he did often informally and pro bono. Tess was only under his care whilst the B12 Unit was open until the end of 1995. Thereafter he gave some specialist advice but there was no NHS arrangement other than for 4�6 months at the end of 1999.

In November 1999 the Chief Executive of the Trust wrote to Mr Redmond saying 'I can confirm that the Trust has no evidence of any unsafe procedures carried out by Dr Bhatt and that the Trust has no knowledge or evidence of any incompetence by him professionally or otherwise'.

It is manifest that in 1995 the B12 diagnosis was accepted. Urine was sent for analysis on three dates in June 1995, on two occasions in August 1995 and on several occasions in September 1995.

It should be noted that high levels of MMA �a fatty acid in urine is central in pointing to a disorder of Vitamin B12 metabolism. Injections of B12 Vitamin reduces those levels and renders any subsequent urine test unreliable since the Vitamin remains in the system. A period of 3 months abstinence is required prior to any testing. Such abstinence exposes the patient to the risk of fits and deprives the patient during such period of the beneficial affects of the B12 treatment. For that reason ongoing testing does not take place. For it to do so B12 injections must cease and no B12 food supplements can be taken. During such 3-month period the patient has an enhanced vulnerability to fits and seizures and in Tess's case suspension of the B12 treatment could put her life at risk assuming of course that the diagnosis is accurate.

In late 1995 the Chelsea and Westminster Healthcare NHS Trust directed that consultants should not refer patients to the B 12 unit. This decision caused Mr and Mrs Redmond to experience difficulties in obtaining treatment for Tess. Accordingly they complained to the Health Commissioner in May 1996. Reporting on that complaint in 1997 the then Commissioner Sir Michael Bucksley urged all concerned to resolve the problems in providing Miss Redmond's treatment.

Thereafter Mr and Mrs Redmond complained that satisfactory arrangements were not made. In November 1999 plans were made to provide appropriate care but were never fully implemented.

On the 24th of May 2001 Mr Redmond made a further complaint against the Trust, which the Defendant resolved to investigate namely...