AVS v A NHS Foundation Trust & Anor

This is a case about providing medical treatment for a patient who has been declared to lack capacity to make decisions as to his treatment and care. The problem in the case is that at the moment there is no medical practitioner ready and willing but also able to provide the treatment which the patient’s next friend considers should be given to him.

The patient is 57 years old. He led a full, active and happy life until his health began to fail in 2008. In May 2008 his rapidly deteriorating condition was diagnosed by Dr DH, a consultant neurologist at the hospital whose Foundation Trust is the first respondent. I shall refer to the hospital as “the treating hospital” or simply “the hospital” and following the example of the President I shall direct that no person other than the advocates and solicitors instructing them (and any other person identified by name in the judgment itself) may be identified by name or location and that in particular the names of the patient and his family and all the doctors concerned must be anonymised.

The diagnosis made by Dr DH was that the patient was suffering from sporadic Creutzfeldt Jakob’s Disease (“sCJD”). This is a very aggressive, but fortunately very rare, disease. Prions (proteinacious infectious particles) attack the structure of the brain and cortical tissue – which is essential for consciousness – is progressively destroyed by the spread of prion protein. It is a fatal disease and there is no known cure. The diseases have different origins, produce different symptoms, affect patients differently. It is the hospital’s case that medical information, whether individual or derived from research, in respect of patients with vCJD and their treatment is of limited assistance in considering a patient with sCJD.

The prognosis for the patient was poor. It was thought at the time that he had three to four weeks only to live. The median survival rate is about four months. Only about 5% of sufferers live for two years or longer from onset. In this case the patient’s deterioration was rapid but, while still in full command of his mental faculties, he executed a Lasting Power of Attorney in favour of his brother (whom I shall refer to as such or as “the applicant”), a practising solicitor. There is a very close bond between the brothers and in discussion in those early days the patient expressed the wish to live and for every effort to be made to prolong his life. The brother believes it is his bounden duty to ensure that this wish is carried out. Discharging the trust he implacably believes was imposed upon him is the fuel which drives this litigation.

Applying himself assiduously to his task, the brother conducted his own research into the ravages of CJD. He discovered that in 2002 a distinguished Japanese neuropathologist had published a paper entitled “Intraventricular infusion of PPS as a treatment for prion disease” demonstrating how the injection of PPS (Pentosan Polysulphate) into the prion affected brain tissue of rodents and dogs affected with prion disease appeared to slow down the rate at which the brain tissue was damaged by prion disease. PPS is a naturally occurring compound which is derived from the shavings of the bark of the beech wood tree. It has anti-coagulant and anti-inflammatory properties and as such is commonly administered orally for cystitis and inflammation of the bowel. It has no known side effects and is not expensive. Because it offered a chance of slowing down the inexorable deterioration of the brain, the brother was most anxious that the patient be treated with it. The hospital was not prepared to do so because it considered that the treatment was experimental. Nevertheless the hospital co-operated fully when Dr K (now Professor K) indicated his willingness to treat the patient at Professor K’s hospital. In June 2008 the patient underwent surgery at that hospital to place a bi-lateral intraventricular catheter into the patient’s brain, the catheter being connected to a pump subcutaneously implanted in the chest, the pump being filled with PPS approximately every three months. Although there may be some uncertainties about it, there is a very tenable view that PPS has indeed prolonged this patient’s life far beyond the expectation held in May 2008. But its effect is only to slow down the progression of the disease: it does not halt it. The medical opinion of those treating the patient in the hospital is that if he is not already in a vegetative state, he is very close to it. This is passionately denied by the family who are totally convinced that their loved one, whom they visit daily, can and does respond to them from time to time, albeit not always, by opening or closing his eyes or turning his head on request.

Sadly the pump failed at the end of July 2010 and all infusion of PPS ceased early in September. The hospital have refused to undertake the necessary surgery to replace the pump. The hospital is not willing to continue treatment with PPS. Dr DH explains why in a report dated 13th October 2010. Although conceding “the obvious possibility that PPS may have played a part in this survival” for longer than had been expected, he is nonetheless of the view that “although there is no reliable evidence to suggest that PPS is effective in sporadic CJD, there is no evidence to suggest that it is ineffective.” He believes that the patient’s current condition is now so poor that any further treatment with PPS is futile. The recent assessments of the patient suggest that he is either near a vegetative state or in a vegetative state with additional evidence of brain stem dysfunction as swallow and cough are impaired. These findings are entirely consistent with very advanced prion disease. No change has been observed in his clinical condition since the PPS infusion ceased early in September which is further evidence of the fact that PPS is no longer having any effect in this case. His view is that the evidence that PPS can benefit patients with sporadic CJD is unquestionably weak. In any case, there is no evidence anywhere in the published literature that PPS can benefit a patient in a vegetative or near vegetative state. Thus there is a complete lack of evidence to provide a rationale for continuing treatment now the patient has reached that state. His conclusion is that there is no benefit in replacing the pump or resuming the infusion.

Nonetheless the hospital approached Professor K who came down to London on 13th September, held discussions with Dr DH, the ward staff and the brother and had a full opportunity to assess the patient. He then delivered a report dated 16th September 2010 in which he dealt with a number of matters including questions put to him on behalf of solicitors for the brother. He stated his personal background to be one with approximately thirty years in Clinical Neurology and with over sixteen years particular experience with prion disease. He says his professional profile is primarily that of the patient-centred physician and secondarily that of a prion disease academic. He was not certain that one could say that the patient was in an absolutely unequivocal vegetative state but if not, he is very nearly in such a state and he did not believe there was any meaningful, organised, time-extended conscious experience. Asked about the proven benefit of PPS in general, he considered that the evidence such as it is for PPS treatment would suggest that any benefit would be in slowing disease progression rather than halting disease progression and it is certainly in no way a cure. He understood that the Japanese have now stopped using that treatment. There is, therefore, no organised evidence for efficacy of intraventricular PPS in sCJD. Such evidence that does exist from individual case treatments does not suggest efficacy in sCJD. Any efficacy that is expected would be some slowing of disease progression. Asked what the benefit of PPS has been for this patient his conclusion was that he simply did not know whether the treatment has had any efficacy. The available evidence is certainly consistent with it having slowed disease progression (but not having any more profound effect). The patient’s clinical course is also consistent with what may happen in a significant minority of individuals with sCJD without treatment. He was of the view that the present decision should not be based on the failure of the pump which should be regarded as an incidental problem which has arisen for uncertain reasons. It serves to refocus attention on the need for continuing treatment. The fundamental question was whether it was in the best interests of the patient to replace the pump and continue PPS indefinitely and his final view was that it would not be reasonable to continue with treatment. He did not think this would be in the best interests of the patient. He said:

The hospital also provided a report from Professor R, a professor of clinical neurology who assessed the patient on two occasions in August 2010. His conclusion was:

This was all bitterly disappointing news for the brother and the family. He reiterated to Professor K that he was acting on the certain belief that his brother would want what he had asked of him in 2008, namely to do whatever was possible for him, to pursue any treatment options and not to give up on him. Driven by that determination he began the proceedings which bring the matter to this court. On 8th October 2010 he, acting as the patient’s next friend, issued an application in the Court of Protection inviting the court to make declarations that it is in the best interest of the patient for the infusion pump necessary for the administration of intraventricular PPS to be replaced, and that it is in the best interests of the patient for the administration of intraventricular PPS to continue. He supported that application by filing a long witness statement. It clearly demonstrates his and his family’s devotion to the patient and their unceasing ministrations on his behalf. The applicant and his mother are daily visitors. The brother has quite clearly devoted all his energy to do all he can for his brother. It has led him, perhaps, into confrontations with Dr DH in whom he has lost confidence. For the present purposes of this appeal those matters are immaterial. There is no doubt whatever that the brother holds the unwavering belief that replacement of the pump and the continuation of treatment will benefit the patient but, being a solicitor and not a neurologist, his opinion is of less weight than qualified medical opinion. It is, therefore, necessary to examine the medical support he has for his case.

Professor NR has experience from 19 years clinical and academic neurosurgery operating from his clinic in Germany. He can only report on the papers, not having seen the patient. He considers that a permanent vegetative state with complete functional destruction of the cerebral cortex and cessation of all higher cerebral activity cannot be proven without further diagnostics such as functional MRI or functional PET. He agrees that administration of PPS is able to slow down to a high degree the progression of the disease whilst it does not represent a cure. In his opinion there cannot be any doubt that the replacement of a malfunctioning pump is in the best interests of the patient. He considers the interruption of treatment by pump malfunction is not the appropriate time at which to make an assessment that treatment should be discontinued. Discontinuing the delivery of PPS to the brain for longer than a few weeks would be expected to result in tipping the equilibrium towards increased quantities of pathological prion protein being produced and therefore towards increased damage and death of previously functioning cells. He concludes:

Dr McC is a general practitioner whose patient is JS, the longest surviving vCJD victim in the world, having survived some nine years since he was diagnosed to be suffering from that disease. On 11th December 2002 the President Dame Elizabeth Butler-Sloss granted declarations that it would be lawful and in the best interests of that patient to receive medical treatment for the condition variant CJD by intracerebral infusion of PPS and to undergo surgical and other ancillary treatment to enable that to happen. All Dr McC can say is that in his opinion PPS therapy has been demonstrated to be in his patient’s best interests. This view was supported by JS’s father who founded the Human BSE foundation, the CJD Alliance and the International CJD Support Alliance. In a long witness statement he sets out the struggle he has had on behalf of his son and his absolute conviction that his son has benefited from the infusion of PPS.

Dr CP is a lecturer in neurophysiology who has taken a keen interest in the JS case which leads him to conclude that:

Professor IB is a consultant neurologist who believes that a decision to continue or stop treatment should not be dictated by “hardware” failure but should be based on an ongoing evaluation of efficacy or side effects. That evaluation should be combined with discussion with family members on progress and their and others’ perception of benefits of such treatment. The replacement of the pump would not present any serious risk to the patient. He says:

Dr SW is a consultant neurologist who acknowledges that most of his opinion would be “very general and not specific to the patient concerned.” His view is that in the absence of any other cure or treatment it would be reasonable to consider PPS as treatment for patients with CJD. He agrees that one needs to consider individual cases on their own merit. But he acknowledges that he has not been able to study this case and the circumstances in detail.

Finally Mr NT, a consultant neurosurgeon and spinal surgeon who was able to consider the reports of Dr DH and Professor K. He acknowledges that failure of the pump can prompt reconsideration as to whether that device should be replaced to permit continued treatment or not. He says that he treated the first two patients in the world that were treated with intraventricular Pentosan but “For various reasons I was obliged to stop treating other patients after those first two patients.” He seems to agree that intraventricular Pentosan does not prevent the progressive neurological deterioration that is associated with CJD/vCJD: whether it halts the rate of neurological deterioration is unknown. The potential further surgery that would be needed would in neurosurgical terms lie somewhere between minor and moderate surgery but the risks of surgery are small. There would be some moderate cost implications. His conclusion is:

That apparently was the state of the evidence when the matter first came before the President Sir Nicholas Wall on 14th October 2010. The solicitors for the hospital had in their correspondence with the applicant’s solicitors pointed out that there was no evidence from any clinician who would take over the management of the PPS regime. At the hearing the point was taken by counsel for the hospital, as the President put it, “that there was no essential lis or issue for the Court to resolve.” Accordingly the President adjourned the application to 26 October for the applicant to produce evidence from a neurologist to counter that of Dr DH, Professor K and Professor R, directing that the applicant file and serve the expert evidence upon which he seeks to rely in support his application by 25th October 2010.

The matter came back to the President on 26th October 2010. In his judgment dated 2nd November 2010 the President explained what happened at that hearing:

The President reserved judgment in order to give himself time to read the voluminous evidence thoroughly and he handed down that judgment on 2nd November and ordered that:

No such report was filed by Dr P by 16th November. Thus the matter came before Ryder J. on 16th November who ordered:

No such report was filed and as a result the claim stands dismissed. The applicant now seeks permission to appeal both the orders made by the President on 2nd November and by Ryder J. on 16th November 2010.

The letter to which the President was referring (see [17] above) was from Dr P to Dr DH saying simply:

The correspondence from Dr P has been produced. On 9/11/10 he wrote to the brother following his visit to Dr P’s neurology clinic. He said:

On 17/11/10 Dr P wrote again to Dr DH saying:

The first question the President considered was whether or not the brother should continue to be the patient’s next friend in the proceedings. He concluded that whilst making every allowance for the high level of emotion which his brother’s condition generates, it was plain that the applicant did not retain the objectivity which was necessary for the proper conduct of proceedings as next friend. The relationship of trust and confidence between him and the clinicians treating the patient had broken down completely and the nature of his criticisms and the way in which he made them did not serve to address the critical issue in the case. For that reason he concluded that the patient needed a different next friend for the purposes of the litigation and so he invited the Official Solicitor to act as the patient’s litigation friend, the brother being joined as a respondent to the proceedings.

The really critical issue in the President’s judgment was whether the administration of PPS was in the best interests of the patient because if it were it would certainly be in his best interests to undergo the surgery which would permit that to happen. In the President’s view it was immediately apparent that the clinical opinions of Dr DH, Professor K and MR were “all one way”.

He then gave his directions. He referred to the Court of Protection Rules giving him the power to control the evidence that is given and the other wide case management provisions in the Rules. He recognised the duty under Article 6 to ensure a fair hearing and he recognised that dealing with matters of life and death inevitably aroused strong emotions. Bearing all that in mind he gave permission to the Trust to call Dr DH, Professor K and Professor R. As for the claimant’s witnesses, their principal witness would be Dr P. Dr McC, Dr CP and Mr S talking about his son’s case added nothing. The points made by Dr IB could be made by others so there was no point in his being called. Professor MR is a neurosurgeon who considered that surgery would be easy and relatively risk free which did not add much to the case so he should not be permitted to give evidence. A nurse could be called. The main medical witness tendered by the brother was Mr NT whose evidence was “thoughtful and well-argued” so permission should be given for him to be called. Permission should also be given for Dr SW to be called.

The President was not asked for permission to appeal but, after a lengthy hearing, Thorpe L.J. adjourned the application for permission to appeal to the full Court with the appeal to follow if permission were granted. He allowed two and a half hours for the hearing of that appeal and this Court was urgently assembled to deal with it before the end of term.

The first submission is that the President was wrong to find there was no relevant lis pendens: the evidence submitted by the brother was sufficient to reveal a live issue as to what was in the best interests of the patient. The second submission was that this was not one of those wholly exceptional cases where the court might properly make an unless order. The third submission, closely allied with the first, was that the President had incorrectly analysed the evidence in giving directions as to what evidence was to be called. The fourth point was that it was wrong to substitute the litigation friend. Finally it was submitted that having regard to the urgency, a final hearing ought to have been fixed for resolution of the issues before the court.

Dealing first with the position of the brother as litigation friend, Rule 140 of the Court of Protection Rules 2007 provides that:

As to whether there was a lis, I again see the force of the argument that however weak the claimant’s case may seem compared with that of the hospital, there was, at least for the purpose of a directions hearing, enough division of medical opinion which, combined with the family’s own view of where the patient’s best interests lie, would justify the matter going forward for resolution of the issue of where the patient’s best interest lay. This is not a case for an interim hearing because once the pump is replaced, it is not likely on a full hearing that a court would order a further operation to remove it. The proper course would be to convene an urgent final hearing and the court’s resources are sufficient to ensure such a hearing in a truly urgent case. The court undoubtedly has the power to make an unless order in an exceptional case and it may be that there could be arguments about whether or not this was indeed that truly exceptional case.

Whilst, therefore, it may be that there was a real prospect of success for each of those arguments and thus scope for granting permission to appeal, I would nonetheless refuse permission because like the President, but for slightly different reasons, I regard these proceedings as “doomed to failure”.

I reach that conclusion for these reasons. It is well established that the court does not decide hypothetical questions. R v Home Secretary ex parte Wynne [1993] 1 W.L.R. 115 is one of the line of authorities establishing that proposition. R v Secretary of State for the Home Department, ex parte Salem [1999] 1 A.C. 450 is another. In the latter case Lord Slynn of Hadleigh said at p. 456/7:

In R (Burke) v General Medical Council [2005] EWCA Civ 1003, [2006] Q.B. 273 the claimant suffered from a congenital degenerative brain condition which would at some time in the future inevitably result in his needing to receive nutrition and hydration by artificial means. He was concerned that a decision might be taken by medical practitioners responsible for his care to withdraw that treatment from him when he wished to continue to receive it, regardless of his pain or suffering. In order to obtain clarification as to the circumstances in which treatment might lawfully be withdrawn, he claimed judicial review of guidance issued by the General Medical Council by way of declarations to the effect that the guidance was incompatible with his rights at common law and under the ECHR. Munby J. granted the declarations. On appeal, Lord Phillips of Worth Matravers M.R., giving the judgment of the Court held:

The most recent in that consistent line of authority is Gawler v Raettig [2007] EWCA Civ 1560.

In my judgment this case raises just the kind of academic or hypothetical appeal which we should decline to entertain. The relief being sought is that the court grant declarations:

Section 1(5) of the Act sets out the principles underpinning the Act and provides:

Even if, as the applicant contends, there is a sufficient dispute about whether or not the continued infusion of PPS is in the best interests of the patient and whether, therefore, the pump should or should not be replaced, there is no question of the respondent hospital hindering or preventing the transfer of the patient to the care of any physician or surgeon who, contrary to their own views, sincerely believes that the procedure is in the interests of this patient and is willing to provide it. If Mr NT is prepared to operate and can find a hospital where the operation can take place, the respondent hospital will co-operate in the transfer of the patient. If Dr P can provide the treatment, the hospital will discharge the patient from their care to his. The fact that the respondent hospital does not believe that the placement of the pump and the continuation of infusion are in the patient’s best interest simply does not matter if a medical practitioner who takes the other view will accept responsibility for the patient. The transfer of the patient to another’s care would take place co-operatively and no approval from the court is required to enable that transfer to take place.

The harsh fact is that, although Mr NT and Professor R are willing to replace the pump, there is no evidence of their present ability to do so. No hospital has been identified where that surgery can be undertaken. Without a new pump being inserted, there is nothing Dr P can do. This litigation is going nowhere. What the court is being invited to do is no more nor less than to declare that if a medical practitioner is ready, willing and able to operate and if a medical practitioner is willing, ready and able to replenish the supply of PPS, then it would be in the best interests of the patient to do so. The President was correct to identify the need for evidence from Dr P to plug this gap in the claimant’s case. Without that evidence that someone is “able and willing to take over the care of [the patient] and treat him with PPS”, we are dealing with a purely hypothetical matter. A declaration of the kind sought will not force the respondent hospital to provide treatment against their clinicians’ clinical judgment. To use a declaration of the court to twist the arm of some other clinician, as yet unidentified, to carry out these procedures or to put pressure upon the Secretary of State to provide a hospital where these procedures may be undertaken is an abuse of the process of the court and should not be tolerated.

Like the President, I have also reached the conclusion that the continuation of this litigation by permitting a lengthy hearing to be urgently arranged for numerous busy medical practitioners to be cross-examined truly would be “doomed to failure”. If there are clinicians out there prepared to treat the patient then the patient will be discharged into their care and there would be no need for court intervention. If there is no-one available to undertake the necessary operation the question of whether or not it would be in the patient’s best interests for that to happen is wholly academic and the process should be called to a halt here and now.

For those reasons I would refuse permission to appeal. I have set the matter out at greater detail than would ordinarily be necessary for the refusal of permission because, if Patten and Black L.JJ. agree, I would give permission for this judgment to be reported and cited in future.

I agree.

I also agree.