EXPERIMENTAL TREATMENT - BEST INTERESTS AND MENTALLY INCAPACITATED PATIENTS.

ADENIPEKUN OLUWATEMILORUN ADEPEJU

EXPERIMENTAL TREATMENT - BEST INTERESTS AND MENTALLY INCAPACITATED PATIENTS.

B v D [2017] EWCOP 15

I. INTRODUCTION

The court in B v D has to decide as to the proper approach to determining whether a particular life-sustaining treatment is in the best interests of a mentally incapacitated patient. The Mental Capacity Act deals with the procedures for decision-making on behalf of mentally incapacitated adults. The Act is intended to encompass people who suffer from such a degree of mental illness or disability that they are incapable of taking decisions for themselves. Incapacity can arise in a wide variety of mental conditions such as mental handicap, mental infirmity, mental illness, brain damaged, physically ill or handicapped people. 

The legal decision for D was based upon an assessment of his mental capacity, best interests and the medical treatment. The central question is whether it would be best to provide the experimental treatment D, or to withdraw treatment and allow him continue living his life with his mental condition. On one hand experts feel that it is likely that D would experience pain and discomfort from continued treatment which would most likely not make a difference to his health. On the other hand, going for the experimental treatment might not be so terrible as there is chance of recovery which would greatly alleviate his suffering.  

Usually, patients are offered experimental procedures because there are no other alternatives for them, these involve those who are terminally ill and are at a risk of dying and have no alternative treatment available and they may accept because of the chance that they would benefit from it, even though it is more likely that the results will benefit others but at the same time, should those with no other hope be denied the smallest, remotest chance of benefit, or is it discriminatory and unethical to automatically exclude them from experimental procedures? 

I don’t agree that the court should stop people who are willing to subject themselves for experimental treatment especially if that seems to be their only hope. This is in a way based on the argument that we are all obliged to participate in research and that where there is some reasonable likelihood of a beneficial effect, it is appropriate for risky research to proceed. And especially where they have supportive family and personal funds. Someone has to be the experiment so why not allow these patients pave the way for experimential treatment. It will be understandable if this treatment has to be funded by NHS, then the courts out of their own discretion can decide to refuse to allocate funds to such treatment. Where the patient has the funds to go abroad for this treatment, has shown a great desire to be subjected to this treatment and also has a family who is ready to support him fully, then he should be allowed to take the risk.

II. The Factual Background and Decision in B v D

The issue in this case was whether it was in the best interests of D who lacks capacity as a result of a traumatic brain injury to receive Stem Cell Treatment. The court held that it was.

D was born in Eastern Europe in 1990 and moved to this country with his family at the age of ten. He became a British citizen in 2006 and shortly afterwards joined the Army. In June 2013, while serving abroad, D was assaulted in a bar by another member of the regiment and knocked unconscious. He was admitted and found to have sustained substantial injury in his brain. He was then transferred to a rehabilitation hospital and in 2014 moved to a military rehabilitation centre, where he remained for over two years, apart from a short unsuccessful move to another brain injury centre. Despite undergoing an extensive multi-disciplinary rehabilitation programme incorporating physical mobility therapy, cognitive/neuropsychological input and speech and language rehabilitation, he continued to suffer, however, from very significant disabilities, including extensive physical disabilities, and global cognitive impairments including reduced attention, concentration, information-processing capacity, memory, executive functioning, and receptive and expressive language. He has reduced intelligibility when tired and it is said that he is highly impulsive when emotionally aroused and his behaviour became increasingly difficult to manage at various times during his admission to X House.

Mrs B had extensively researched treatment options for D and identified stem cell therapy as a possible way forward. She initially approached a clinic in Germany but it transpired that the establishment was unable to provide appropriate stem cell therapy tailored to D’s particular traumatic brain injury. After further research, Mrs B identified a clinic in Moscow, as a safe and appropriate clinic. The medical staff at X House, however, opposed this proposal on the basis that the use of stem cell therapy for patients such as D was not yet established in this country and that there was insufficient evidence to suggest that the benefits outweighed the risks. In response, Mrs B filed an application in the Court of Protection for declarations and orders pursuant to ss 15 and 16 of the Mental Capacity Act 2005 to determine D’s capacity and, in the event that he lacked capacity, to make best interests declarations, in particular regarding his medical treatment, and further for an order appointing Mrs B as his health and welfare deputy. The application included an assessment by his treating neuropsychologist to the effect that, as a result of the impairment to his brain, D lacked the capacity to make decisions concerning his medical treatment. In particular, he lacked the capacity to understand, use and weigh the relevant information. The neuropsychologist expressed the opinion that, due to his cognitive difficulties, D was not able to understand more complex information. He was able to say that the stem cells will make him “normal” but was not able to follow the description or the rationale of how they work. Furthermore, as a result of his difficulties, he was unable to use or weigh up the options as part of the decision- making process. His rigid thinking patterns made it impossible for him to think flexibly about the pros and cons of the treatment. The neuropsychologist added that D was assessed as being vulnerable to being suggestible to others. He said that his mother thinks the treatment will make him “normal” and therefore he will do it.

When objection was taken to the proposed treatment in Moscow, Mrs B identified an alternative Swiss Medica clinic in Belgrade. It is that proposal which is now before the court.

Baker J thus had to consider whether it was in the best interests of D, to travel to Serbia to receive the stem cell treatment. The major arguments the other party made were that the treatment was unsupported by any, or at least any significant, body of research, that it had not been subjected to clinical trials and that the evidence that it was, or might be, an effective treatment for traumatic brain injury was almost entirely anecdotal. As D had resources to pay for the treatment from a compensation payment, this was not a case of if there was lack of public funding. Instead the question for the court was whether it was in D’s best interests to get this treatment. It was clear that D did not have the capacity to make the decision. His mother served with her application evidence from D’s treating neuropsychologist to the effect that, as a result of the impairment to his brain, D lacked the capacity to make decisions concerning his medical treatment:

Baker J knew that D very much wanted this treatment. He was able to deduce this from his conversation with him. He knew that D will be much more than miserable if he is denied the opportunity to have stem cell treatment and so having appraised the risks and considered the advantages and disadvantages of the options in this case, Baker J ultimately reached the clear conclusion that this court should give its provisional consent to D travelling to Belgrade to receive stem cell treatment subject to a stringent series of conditions that would have to be met before he could give final approval.

III. Discussion

A. Mental Capacity

The Universal Declaration on Bioethics and Human Rights, adopted by the UNESCO General Conference in 2005, laid out in Art 7 the conditions for providing treatment to a person who lacks the capacity to consent. It states:

'[A]uthorisation for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law…'

The proviso thus is that if the authorisation obtained is not in accordance with the best interests of the patient concerned, then it will not be regarded as valid consent.

Similarly, in the Council of Europe Convention on Human Rights and Biomedicine, known as the Oviedo Convention. Article 6(1) of this instrument states that 'an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit'.

Persons suffering from brain damage may have suffered an injury resulting in mental incapacity which renders any ability to make decisions. During the recovery process, cognitive, emotional and behavioural problems can make it impossible for brain injury survivors to understand the consequences of their decisions and so health personnels and the Court might try to step in and make decisions on behalf of the patient where there has not been any long-term arrangements put in place to enable decisions to be made in the patient’s best interests. The MCA provides that 

‘the Court may make declarations as to whether a person has or lacks capacity, either in relation to a specified decision or in relation to specified matters, and as to the lawfulness of any act done or yet to be done in relation to that person.’ 

The Court can only do for a person what he could lawfully do himself if he had mental capacity. In effect the Court stands in the mentally incapacitated person’s shoes.  

How do we then determine when a person lacks mental capacity? The MCA states that; a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain”.

This case sheds no new insights on the concept of incapacity, but it is important in relation to the determination of best interests. For the purposes of the Mental Capacity Act 2005, a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain. It does not matter whether the impairment or disturbance is permanent or temporary. A lack of capacity cannot be established merely by reference to a person's age or appearance, or to a condition of his, or an aspect of his behaviour, which might lead others to make unjustified assumptions about his capacity.

As D lacked capacity, the doctors had a power and a duty to give whatever treatment was necessary in their best interests. Assessing best interests involves two stages. The first stage is to consider what treatments would be supported by a responsible body of medical opinion as required by the Bolam test. For example, doctors in an intensive care unit might hold a multi-disciplinary meeting to discuss a patient’s treatment, and whether it is worth continuing. If they all agree that treatment isn’t helping, they may then seek to withdraw life support. Unfortunately, in medicine, and perhaps even more so in ethics, there are situations where agreement is not possible, and reasonable people may reach different conclusions. 

The second stage was to choose from that range of treatments which was best for the mentally incapacitated patients. The doctor or court would remain free to choose any of a range of Bolam-supported options, but would then have to weigh the actual and potential benefits and the risks of adverse consequences. The doctor or court must take into account social as well as purely medical interests in determining which course would be best. The decision-maker should then be prepared to give reasons why the course chosen is thought to be the best.The problem was that the treatment was untried and there was so far no validation of the experimental work done abroad.

Given that the treatment was experimental, it was always going to be difficult to find staunch support for it as being in the best interests of the patients. Dame Elizabeth Butler Sloss paved the way to such a solution by emphasising the point from Re A (medical treatment) (male sterilisation) that social interests as well as medical interests need to be considered under the rubric of best interests. Medical issues were not the only matters to which the court should have regard in considering the outcome of these cases. Dame Elizabeth Butler Sloss P was concerned to ensure that the Bolam test ought not to be allowed to inhibit medical progress. She held that:

'On the medical evidence, and consistent with the philosophy that underpinned the test, it would not in itself have been irresponsible or unethical to give the treatment to the patients, although the requirement for surgery raised issues as to the assessment of the risks involved.'

Although the risks are easily identified, potential benefits are very difficult to assess, given the experimental nature of the treatment, and indeed, there might even be none. Some of the benefits a patient might get are that; allowing the patient go along with his desired treatment will accord with the patients’s wishes and feelings and, knowing that what he sees as a potential treatment avenue has at least been tried. Therefore, the treatment will not be futile as the slightest chance of benefit to D from the experimental treatment will justify its use. Accordingly, the proposed treatment complied with the Bolam test. It thus remains to consider whether the treatment was in the patient's best interests. The issue is simplified by the fact that this is the only treatment available to D, there is no other alternative.

Baker J’s judgment validates a number of well-established recommendations concerning the MCA 2005 and, in particular, medical treatment decisions; that the MCA 2005 is concerned with enabling the court to do for the patient what he could do for himself if of full capacity, but it goes no further. On an application under the Act, therefore, the court has no higher powers than the patient would have had if he were of full capacity. Patients cannot demand that doctors administer treatment which the doctor considers is not appropriate; as any treatment which the doctors do decide to give must be lawful. The question for the Court of Protection is not whether it is lawful to withhold treatment, but whether it is lawful to give it, since without consent medical treatment of any sort cannot be administered and P’s own wishes are of central importance in best interests decision making, although the MCA 2005 does not impose a test of substituted judgment. There is a need to see the patient as an individual, with his own values, likes and dislikes, and to consider his best interests in a holistic way.

Generally, for treatment to be provided lawfully to a competent adult patient, he must consent, that is, agree to and acquiesce in the treatment being proposed. This requires an intention on the part of the patient to consent. However, intention may be inferred from words or conduct which the reason observer would construe as manifesting intentional consent. D due to being incapacitated by his brain damage obviously cannot explicitly state what treatment he wants, but it has been proved he has a significantly limited understanding of what the Stem Cell treatment entails and of the possible risks, and  it is obvious from the tests Baker J carried out that D wants the treatment very much.

B. Best Interests

Was the decision in D’s Best Interests? The focus of the judgment deals with how to determine what is in a patient’s best interests. The first thing to note is the strong presumption that it is in a person’s best interests to stay alive. His wishes and feelings are an important factor in any analysis of what constitutes best interests. The court understands that D will be much more than miserable if he is denied the opportunity. It was noted that D will likely demonstrate an adverse reaction in his behaviour which may ultimately impede his rehabilitation. It was clear that although D did not have the mental capacity to make the decision as regards the best treatment for himself, but he had his mother ready and willing to seek out the best treatment for him. 

What is entailed in assessing Best Interests? The MCA gave limited guidance as to what constitutes best interests. S.4 though stipulates the process that must be considered when determining P’s best interests. It might best be considered as a process of construing a decision on behalf of the person who cannot make that decision themselves. The court is the decision maker and thus has to make the decision by considering all relevant circumstances and taking out the steps set put in section 4(3) to (7). There are no limits played on the nature or type of circumstances which may be relevant to the decision. It all depends on the facts of the case. As observed from Hayden J in M v Mrs N & Ors, in order to take a decision properly which considers all relevant circumstances, the decision maker must undertake a proper inquiry into both P’s circumstances and the type of decision that the decision maker is being called upon to make. The Mental Capacity Act though does not of course say that P’s wishes are to be paramount, nor does it lay any express presumption in favour of implementing them if they can be ascertained. The main objective is that of D’s best interests and thus due regard should be given to it. 

As the Supreme Court emphasised in Aintree University NHS Hospitals Trust v James 

“The most that can be said, therefore, is that in considering the best interests of this particular patient at this particular time, decision-makers must look at his welfare in the widest sense, not just medical but social and psychological; they must consider the nature of the medical treatment in question, what it involves and its prospects of success; they must consider what the outcome of that treatment the patient is likely to be; they must try and put themselves in the place of the individual patient and ask what his attitude to the treatment is or would be likely to be; and they must consult others who are looking after him or interested in his welfare, in particular for their view of what his attitude would be.”. 

Clearly, the exact nature of the medical treatment in question, along with its prospects of a successful outcome, would have to be analysed appropriately when weighing up best interests. Consultation of friends, family and those looking after him will also be highly relevant in this assessment.Therefore the Court is expected to arrive at the right decision for P as an individual human being and not the decision that best fits with the outcome that the professionals desire. This is exactly what Baker J sought to do. 

The Mental Capacity Act Code of Practice para 5.31 provides for a limited number of cases where it may be in the best interests of a Patient, in certain circumstances, for life-sustaining treatment to be withheld ‘where treatment is futile, overly burdensome to the Patient and where there is no prospect of recovery.’ Baker J thus considered opinions from experts who were opposed to the treatment. Some of the reasons the experts gave were that the efficacy of this treatment has not been established through any clinical trials and that D will be exposed to both known and unknown risks associated with the procedure and that travelling to undergo the treatment risks disrupting his rehabilitation programme. 

Despite the resolute and unanimous medical view, the judge decided against the trust and refused to grant the declaration sought to allow the withholding of treatment. Although Baker J accepted all of the medical opinions and concluded that the Patients condition was almost bleak, he was not persuaded that the treatment to the Patient would be futile or that there was no prospect of recovery and so he ultimately decided to go with the wishes, feelings, beliefs and values of D and his understanding of the prospects of success and risks of the treatment. He concluded: 

‘But all life is an experiment. In my thinking about this case, I have repeatedly come back to those words of Munby J in [Re MM; Local Authority X v MM (By the Official Solicitor) and KM [2007] EWHC 2003 (Fam), [2009] 1 FLR 443 at [120]] and to the rest of the passage, in particular: “Physical health and safety can sometimes be bought at too high a price in happiness and emotional welfare. The emphasis must be on sensible risk appraisal, not striving to avoid all risk, whatever the price, but instead seeking a proper balance and being willing to tolerate manageable or acceptable risks as the price appropriately to be paid in order to achieve some other good – in particular to achieve the vital good of the elderly or vulnerable person's happiness. What good is it making someone safer if it merely makes them miserable?’

The treatment is experimental with unknown risks and benefits and so it begs the question; should it be allowed to be given to an incapacitated patient? Could it be said to be in their best interests? Should such desperate remedies only be given where a patient with capacity consented to them?

This question of uncertainty was raised by Lady Hale in Aintree University Hospitals NHS Foundation Trust v. James (by his litigation friend, the Official Solicitor) and others. This case centred on whether withholding specified life-sustaining interventions was in the best interests of Mr James, a 68-year-old man receiving intensive care. The Court of Protection had determined that whilst the proposed treatment offered no prospect of a cure, it did bring with it the opportunity to resume 'a quality of life that [Mr. James] would regard as worthwhile'. The benefits of the proposed treatment outweighed the potential unpleasant consequences associated with it. The treatment would therefore not be futile, and it would be in Mr James' best interests for doctors to proceed with it, should the need arise.

D has no alternative treatment, although his disease was neither progressive nor fatal, and the risks and benefits of this proposed treatment is uncertain, still it is reasonable to expect the parties in this instance to consider such treatment in case there is some chance of a benefit to D. 

It would be best to take an expansive approach in order to interpret best interests in the wildest possible way. Baker J adopted the balance sheet approach to best interests from Re A (medical treatment) (male sterilisation). This took into account not only of the medical and non-medical benefits and disadvantages, but also of the broader welfare issues of the two patients. Perusing through the balancd sheet would also consider their abilities, their future with or without treatment, the views of the families, and the impact of refusal of the applications. All of these matters had to be weighed up and balanced in order for the court to come to a decision in the exercise of its discretion.

Since the treatment was untried, it was not known what the likely benefits would be, and, following the Re A approach, the court had to weigh up the possible benefits against the possible risks. On the benefit side, his Lordship (at [54]), recognising that the patient had a consitient and strongly-held wishes and feelings was careful not to falsely inflate his hopes and then have to dash them completely. There was a slight but not non-existent chance of improvement, which actually ought to regarded as unlikely but not impossible, since no-one knows the outcome. The medical evidence showed that there was a potiential for improvement, although the evidence for this is only the anecdotal evidence of Dr. Bulboh unsupported by any research or by the opinion of Prof Martino. Regardless of the outcome of the treatment Baker J noted that there may be a psychological benefit to D arising from (1) his having his wishes respected and (2) knowing that what he sees as a potential treatment avenue has at least been tried.

By allowing D to go abroad for the experimential treatment, this will be in support of upholding his right. Each patient is entitled under the European Convention on Human Right to the right to life. The convention also gives each patient the right to respect for his family life, thus by allowing D to go for further treatment, it give him a worthwhile life worth leaving for. Lord Donaldson in Re J (a minor) (wardship: medical treatment) made a statement that ‘there is a very strong presumption in favour of a course of action which will prolong life’. In addition, D explicitly was able to convince Baker J of his vested interest in the  positive outcome the experimental treatment would have in his life, a view supported by Hoffmann LJ in Airedale NHS Trust v Bland when he said: ‘It is demeaning to the human spirit to say that, being unconscious, he can have no interest in his personal privacy and dignity, in how he lives or dies.' 

This combination of Art 2, Art 8, the common law recognition of the sanctity of life, and the recognition of an interest in dying with dignity was used to support the case for treatment and also the need to afford recognition and strong weight to the views of Mrs. B (the patient’s mother). Mrs B acknowledges that the treatment will not miraculously cure her son, but strongly believes that D’s health will improve after the treatment and it doesnt matter how minute the improvemnt is as long as there is one. It was clear that the view of the family was afforded great weight as they are deeply and sincerely committed to this treatment and if the treatment was refused, they would be greatly distressed. Of course this would not affect their commitment to helping D live with his illness. Baker J noted in his balance sheet that one of the advantages to him refusing D’s treatment is that ‘the progress he has made through rehabilitation will not be put at risk.’

In cases like this where the proposed remedies for mentally incacipated patients seem desperate and far-fetched, the court may have to weigh the possible benefits to be derived from undergoing the treatment against the more quantifiable risks. Where the results is equally balanced, the court should give the views of the patients (and the family) and the effect of a refusal great weight in the wider considerations of the best interests test which the court has to apply to each patient. 

The purpose of the best interest test is to be subjective and consider matters from the patients point of view. It is not for others ( the health personnels here) to say that a life which a patient (D) would regard as worthily is not worth living. Lady Hale in Aintree v James also gave a compelling argument on the approach a court should take when considering best interests and best treatment. She stated that the starting point was the strong presumption that it was in a person’s best interests to stay alive. She ruled that the fundamental question is whether it is in the Patient’s best interests and therefore lawful to give the treatment, not whether it is lawful to withhold it.

C. Medical Treatment

Judicial decisions on providing experimental procedures in England and Wales are limited, but in Simms v Simms, we see something similar decided here by the court. The patients suffered from probable variant Creutzfeldt-Jakob disease, and, at that time, there were no recognized effective drugs to halt neurological deterioration or prolong life. Because of their illnesses, the patients were unable to consent to the treatment, and so their parents sought a declaration that it would be lawful to provide it to them in their best interests. Dame Elizabeth Butler-Sloss P. stated that the patients lacked the capacity to decide for themselves and that “[w]here there is no alternative treatment available and the disease is progressive and fatal, it seems … to be reasonable to consider experimental treatment with unknown benefits and risks, but without significant risks of increased suffering to the patient, in cases where there is some chance of benefit to the patient.”

Furthermore, “[a] patient who is not able to consent to pioneering treatment ought not to be deprived of the chance in circumstances where he would have been likely to consent if he had been competent.” 

Participation in experimential treatment was thus appears open to all, but Dame Butler-Sloss was unclear whether providing these kinds of treatment to those without capacity would fall within the Bolam test. Nevertheless, she noted that it could not be allowed to inhibit medical progress, and if one waited for the Bolam test to be complied with to its fullest extent, no innovative work … would ever be attempted. Thus, although there was not a professional body of opinion endorsing these treatments, there was evidence from responsible medical opinion which does not reject the research, so it would not in itself be irresponsible or unethical to give the treatment to these patients. 

The decision in Simms v Simms is important because it involves what Dame Butler-Sloss variously termed “experimental,” “pioneering,” and “innovative” “treatment” that had not previously been used on humans, and the intended recipients were in a terminal, no-other-hope situation. The precedent value of this case is unclear because the extreme nature of the circumstances alone means that similar facts are likely to arise only rarely, nevertheless, it indicates that a court can approve the use of an experimental procedure for those with no other hope outside a clinical trial.

Best Interests and Mental Capacity in relation to Medical Treatment now fall under the Mental Capacity Act, 2005. Where there is a dispute as to the treatment to be provided, then such decisions should be referred to the Court of Protection for a declaration. 

For consent to Medical Treatment to be a valid defence to a claim for battery before a court, it has to be shown that the patient’s consent was real in that he could understand in a general sense what he was consenting to be involved in. The degree of capacity required to consent in Medical Treatment is either the patient must have the capacity to understand the nature and effect of the treatment proposed or the capacity to understand the explanation given by the doctor. Therefore, the more serious the decision, the greater the capacity required. The Mental Capacity Act 2005 now requires that where it is proposed to provide or secure the provision of serious medical treatment for a person lacking the capacity to consent to the treatment an independent mental capacity advocate must be instructed to represent that person.

Where there is no alternative treatment available and the disease is progressive and fatal, it is reasonable to consider experimental treatment with unknown benefits and risks, but without significant risks of increased suffering to the patient, in cases where there was some chance of benefit to the patient. A patient who is not able to consent to pioneering treatment ought not to be deprived of the chance in circumstances where he would have been likely to consent if he had been competent. The professional standard test ought not to be allowed to inhibit medical progress.

The good news as Butler-Sloss P. Put it in Simms v Simms, is that “It is the judge not the doctor who makes the decision that it is in the best interests of the patient that the operation be performed or the treatment be given.” 

III. Conclusion

This case deals with how the best interests of a patient who lacks capacity should be assessed, within the framework of the Mental Capacity Act 2005. When it came to conducting the best interests test in light of these considerations, the court came to the clear conclusion that withdrawing the stem cell treatment would not be in D’s best interests.  His conclusions in this regard makes it clear the extent to which the judge sought to recognise D as an “individual human being”. The Court in effect decided that a treatment will not be futile as long as it will benefit the patient, even if it has no effect upon the underlying disease or disability. Recovery does not necessarily mean a return to full health, it simply means the resumption of a quality of life that the patient himself would regard as worthwhile; “it is not for others to say that a life which the patient would regard as worthwhile is not worth living” 

The most significant element of this judgment is the weight placed on of the role of the patient’s (or their family’s) wishes in determining what constitutes a worthwhile recovery, and what is in their best interests. A patient’s best interests involves not only medical interests, but also the patient’s physical and mental welfare in the long run.