Royal Courts of Justice
Strand, London, WC2A 2LL
Before:
MRS JUSTICE McGOWAN
Between:
GRIMSTONE | Claimant |
- and - | |
EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST | Defendant |
Miss Caroline Hallissey (instructed by Cogent Law) for the Claimant
Miss Camilla Church (instructed by DAC Beachcroft) for the Defendant
Hearing dates: 09/11/2015 - 13/11/2015
Judgment
Mrs Justice McGowan:
INTRODUCTION
The Claimant, Rosalyn Grimstone, was referred to Mr Richard Field, (now Professor and referred to as such in the trial), in late 2007. She was then in her mid-50’s and led a very active life; she was a keen sportswoman and, in particular, enjoyed horse riding. Professor Field is a renowned specialist orthopaedic surgeon with a specialism in hip replacement surgery. He is employed by the Defendant, the Epsom & St Helier University Hospitals NHS Trust, (“the Trust”). The Claimant had been suffering from pain and stiffness in both hips. Surgery was recommended and carried out. There is no complaint about the manner in which the surgery was completed. After the operation the Claimant began to suffer a series of complaints which have required repeated surgical interventions and have caused her great pain and continuing suffering. This action relates only to the consultations carried out before the first surgery.
The Claimant alleges negligence under the three following headings;
That Professor Field failed adequately to advise the Claimant about the surgical options available to her,
That he failed to obtain her informed consent for the operation which he performed and
That he failed to advise the Claimant of the alleged lack of data about the failure and survival rate of the components used in the procedure he performed.
This is a preliminary trial on liability only relating to the advice given by Professor Field about the surgery performed by him. The events after the initial operation are generally agreed but in any event are not in issue in this trial.
ISSUES
The issues to be determined have been variously described but seem to be capable of resolution into the following questions;
What did Professor Field say to Mrs Grimstone about the procedure to be carried out?
Did he do what was reasonable to ensure she understood?
Which procedure would she have chosen in any event?
Was he obliged to tell her about the limited data available on the device used?
BACKGROUND FACTS
The following are agreed facts which cover a narrow compass;
Mrs Grimstone had developed problems in her hips. She researched the availability of the best treatment and accordingly went to the South West London Elective Orthopaedic Centre, (“EOC”).
Family members, her father and mother-in-law, had undergone hip replacement surgery in the past with varying degrees of success. Her father had received an implant, which had been used over many decades and was generally referred to as the “Charnley”, named after its designer.
The first consultation with the Professor was on 23 January 2008. During the consultation he dictated a letter to her GP. Mrs Grimstone was also given a booklet entitled, “An Information Booklet – A New Joint” and a DVD containing patient information on hip surgery.
Professor Field sent that letter to Mrs Grimstone’s GP on 29 January 2008 in the following terms,
“Mrs Grimstone is a keen horsewoman. Her father underwent a hip replacement in his 50’s….. I have advised Mrs Grimstone that she has clearly reached the stage when hip replacement would be her best option. In view of Mrs Grimstone’s relative youth, I would advocate the use of bone conserving replacements, preferably with large diameter metal on metal bearings so that she has maximal joint stability.”
A consent form was completed by the Professor with Mrs Grimstone and signed by her during a consultation at the clinic before surgery.
The bi-lateral hip operation was carried out on 22 April 2008, the operation implanted Mitch PER devices. These were a relatively new device designed to conserve as much bone as possible, it involved the resurfacing of the thigh bone with a metal cap on a thinner socket than had been conventionally used. It fitted into a new metal socket component also implanted into the pelvic bone.
The surgery was performed properly.
On 24 September 2010 Professor Field at the EOC wrote to Mrs Grimstone asking her to participate in a follow up programme for patients who had undergone the same form of surgery as she had,
“As you know the implant we used for your operation in April 2008 was a bone conserving design. To date, almost all the patients who have undergone this operation have enjoyed an excellent outcome and are not experiencing any problems. However the long-term results of your bone-conserving and other resurfacing hip designs remains unknown. This information would be helpful to surgeons seeking to identify the safest and most effective implants and patients who want to know how long their hip replacement was likely to last. I am writing to ask you to help us gather the data to answer these questions. As the centre with the largest experience of you type of implant, we are visited by surgeons from other hospitals who want to use this hip. We are also being invited to report our results to the orthopaedic community at national and international meetings. To address these demands we have decided to set up a formal follow-up programme to monitor patients with your type of hip replacement.”
There was a failure of the prostheses and revision surgery was required after two years.
THE LAW
The Supreme Court has provided definitive guidance in Montgomery v Lanarkshire Health Board [2015] UKSC 11. The Court conducted a review of the authorities as part of its history of the development of the way in which the relationship between doctor and patient has changed. As unhelpful as it sometimes can be to recite very long passages of other judgments, such a definitive statement of the law is of direct assistance in illustrating the bald statement that for consent to be of any value it must be informed.
“Conclusions on the duty of disclosure
The Hippocratic Corpus advises physicians to reveal nothing to the patient of her present or future condition, "for many patients through this cause have taken a turn for the worse" (Decorum, XVI). Around two millennia later, in Sidaway's case Lord Templeman said that "the provision of too much information may prejudice the attainment of the objective of restoring the patient's health" (p 904); and similar observations were made by Lord Diplock and Lord Bridge. On that view, if the optimisation of the patient's health is treated as an overriding objective, then it is unsurprising that the disclosure of information to a patient should be regarded as an aspect of medical care, and that the extent to which disclosure is appropriate should therefore be treated as a matter of clinical judgment, the appropriate standards being set by the medical profession.
Since Sidaway, however, it has become increasingly clear that the paradigm of the doctor-patient relationship implicit in the speeches in that case has ceased to reflect the reality and complexity of the way in which healthcare services are provided, or the way in which the providers and recipients of such services view their relationship. One development which is particularly significant in the present context is that patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices: a viewpoint which has underpinned some of the developments in the provision of healthcare services. In addition, a wider range of healthcare professionals now provide treatment and advice of one kind or another to members of the public, either as individuals, or as members of a team drawn from different professional backgrounds (with the consequence that, although this judgment is concerned particularly with doctors, it is also relevant, mutatis mutandis, to other healthcare providers). The treatment which they can offer is now understood to depend not only upon their clinical judgment, but upon bureaucratic decisions as to such matters as resource allocation, cost-containment and hospital administration: decisions which are taken by non-medical professionals. Such decisions are generally understood within a framework of institutional rather than personal responsibilities, and are in principle susceptible to challenge under public law rather than, or in addition to, the law of delict or tort.
Other changes in society, and in the provision of healthcare services, should also be borne in mind. One which is particularly relevant in the present context is that it has become far easier, and far more common, for members of the public to obtain information about symptoms, investigations, treatment options, risks and side-effects via such media as the internet (where, although the information available is of variable quality, reliable sources of information can readily be found), patient support groups, and leaflets issued by healthcare institutions. The labelling of pharmaceutical products and the provision of information sheets is a further example, which is of particular significance because it is required by laws premised on the ability of the citizen to comprehend the information provided. It would therefore be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent upon a flow of information from doctors. The idea that patients were medically uninformed and incapable of understanding medical matters was always a questionable generalisation, as Lord Diplock implicitly acknowledged by making an exception for highly educated men of experience. To make it the default assumption on which the law is to be based is now manifestly untenable.
These developments in society are reflected in professional practice. The court has been referred in particular to the guidance given to doctors by the General Medical Council, who participated as interveners in the present appeal. One of the documents currently in force (Good Medical Practice (2013)) states, under the heading "The duties of a doctor registered with the General Medical Council":
"Work in partnership with patients. Listen to, and respond to, their concerns and preferences. Give patients the information they want or need in a way they can understand. Respect patients' right to reach decisions with you about their treatment and care."
Another current document (Consent: patients and doctors making decisions together (2008)) describes a basic model of partnership between doctor and patient:
"The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice. The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one." (para 5)
In relation to risks, in particular, the document advises that the doctor must tell patients if treatment might result in a serious adverse outcome, even if the risk is very small, and should also tell patients about less serious complications if they occur frequently (para 32). The submissions on behalf of the General Medical Council acknowledged, in relation to these documents, that an approach based upon the informed involvement of patients in their treatment, rather than their being passive and potentially reluctant recipients, can have therapeutic benefits, and is regarded as an integral aspect of professionalism in treatment.
Earlier editions of these documents (Good Medical Practice (1998), and Seeking patients' consent: The ethical considerations (1998)), in force at the time of the events with which this case is concerned, were broadly to similar effect. No reference was made to them however in the proceedings before the Court of Session.
In addition to these developments in society and in medical practice, there have also been developments in the law. Under the stimulus of the Human Rights Act 1998, the courts have become increasingly conscious of the extent to which the common law reflects fundamental values. As Lord Scarman pointed out in Sidaway's case, these include the value of self-determination (see, for example, S (An Infant) v S [1972] AC 24, 43 per Lord Reid; McColl v Strathclyde Regional Council 1983 SC 225, 241; Airedale NHS Trust v Bland [1993] AC 789, 864 per Lord Goff of Chieveley). As well as underlying aspects of the common law, that value also underlies the right to respect for private life protected by article 8 of the European Convention on Human Rights. The resulting duty to involve the patient in decisions relating to her treatment has been recognised in judgments of the European Court of Human Rights, such as Glass v United Kingdom (2004) 39 EHRR 15 and Tysiac v Poland (2007) 45 EHRR 42, as well as in a number of decisions of courts in the United Kingdom. The same value is also reflected more specifically in other international instruments: see, in particular, article 5 of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, concluded by the member states of the Council of Europe, other states and the European Community at Oviedo on 4 April 1997.
The social and legal developments which we have mentioned point away from a model of the relationship between the doctor and the patient based upon medical paternalism. They also point away from a model based upon a view of the patient as being entirely dependent on information provided by the doctor. What they point towards is an approach to the law which, instead of treating patients as placing themselves in the hands of their doctors (and then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices.
In the law of negligence, this approach entails a duty on the part of doctors to take reasonable care to ensure that a patient is aware of material risks of injury that are inherent in treatment. This can be understood, within the traditional framework of negligence, as a duty of care to avoid exposing a person to a risk of injury which she would otherwise have avoided, but it is also the counterpart of the patient's entitlement to decide whether or not to incur that risk. The existence of that entitlement, and the fact that its exercise does not depend exclusively on medical considerations, are important. They point to a fundamental distinction between, on the one hand, the doctor's role when considering possible investigatory or treatment options and, on the other, her role in discussing with the patient any recommended treatment and possible alternatives, and the risks of injury which may be involved.
The former role is an exercise of professional skill and judgment: what risks of injury are involved in an operation, for example, is a matter falling within the expertise of members of the medical profession. But it is a non sequitur to conclude that the question whether a risk of injury, or the availability of an alternative form of treatment, ought to be discussed with the patient is also a matter of purely professional judgment. The doctor's advisory role cannot be regarded as solely an exercise of medical skill without leaving out of account the patient's entitlement to decide on the risks to her health which she is willing to run (a decision which may be influenced by non-medical considerations). Responsibility for determining the nature and extent of a person's rights rests with the courts, not with the medical professions.
Furthermore, because the extent to which a doctor may be inclined to discuss risks with a patient is not determined by medical learning or experience, the application of the Bolam test to this question is liable to result in the sanctioning of differences in practice which are attributable not to divergent schools of thought in medical science, but merely to divergent attitudes among doctors as to the degree of respect owed to their patients.
A person can of course decide that she does not wish to be informed of risks of injury (just as a person may choose to ignore the information leaflet enclosed with her medicine); and a doctor is not obliged to discuss the risks inherent in treatment with a person who makes it clear that she would prefer not to discuss the matter. Deciding whether a person is so disinclined may involve the doctor making a judgment; but it is not a judgment which is dependent on medical expertise. It is also true that the doctor must necessarily make a judgment as to how best to explain the risks to the patient, and that providing an effective explanation may require skill. But the skill and judgment required are not of the kind with which the Bolam test is concerned; and the need for that kind of skill and judgment does not entail that the question whether to explain the risks at all is normally a matter for the judgment of the doctor. That is not to say that the doctor is required to make disclosures to her patient if, in the reasonable exercise of medical judgment, she considers that it would be detrimental to the health of her patient to do so; but the "therapeutic exception", as it has been called, cannot provide the basis of the general rule.
It follows that the analysis of the law by the majority in Sidaway is unsatisfactory, in so far as it treated the doctor's duty to advise her patient of the risks of proposed treatment as falling within the scope of the Bolam test, subject to two qualifications of that general principle, neither of which is fundamentally consistent with that test. It is unsurprising that courts have found difficulty in the subsequent application of Sidaway, and that the courts in England and Wales have in reality departed from it; a position which was effectively endorsed, particularly by Lord Steyn, in Chester v Afshar. There is no reason to perpetuate the application of the Bolam test in this context any longer.
The correct position, in relation to the risks of injury involved in treatment, can now be seen to be substantially that adopted in Sidaway by Lord Scarman, and by Lord Woolf MR in Pearce, subject to the refinement made by the High Court of Australia in Rogers v Whitaker, which we have discussed at paras 77-73. An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.
The doctor is however entitled to withhold from the patient information as to a risk if he reasonably considers that its disclosure would be seriously detrimental to the patient's health. The doctor is also excused from conferring with the patient in circumstances of necessity, as for example where the patient requires treatment urgently but is unconscious or otherwise unable to make a decision. It is unnecessary for the purposes of this case to consider in detail the scope of those exceptions.
Three further points should be made. First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.
Secondly, the doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.
Thirdly, it is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests.”
The consultation process complained of in this case took place in 2008 but the principles from Montgomery can be expressed on these facts quite simply.
Mrs Grimstone had a fundamental right to be properly informed of the nature and risk of the procedure proposed,
The passing of that information should have been carried out in a way that was comprehensible by her,
This was not a case in which the withholding of any information about risk could be justified on clinical grounds.
These questions are entirely fact specific.
THE EVIDENCE
23 January 2008 Consultation
The Claimant’s evidence,
That she was very active and had some knowledge of hip surgery as her father had had surgery which lasted 30 years, whilst her mother-in-law had suffered eight dislocations after surgery. She was keen to avoid similar dislocation problems.
That she told the Professor of her active life and said that she wanted the option that gave her the quickest recovery time, was as good an option as possible and lasted as long as possible.
That she was told by the Professor that both hips were equally bad, and given her age at some point in the future there would have to be further surgery.
That she was never told of any disadvantages, she was simply told that the proposed option was the most suitable.
She was given the leaflet about the surgery but could not remember if it was at the consultation or on the day of surgery but given that she accepted she took it away and read it, it must have been at the January consultation.
She said she did remember being told that it was a bone conserving process but thought it was a total hip replacement and that bone conserving meant there would be bone preserved for the future surgery which was very likely.
She was told that implants with a large femoral head using metal on metal parts were being recommended because they offered greater stability but she believed that she was being offered the “Charnley” which was the implant used in her father’s surgery 30 years before.
She was not told that the Professor had designed the Mitch PER implant to be used nor that it had not been in use for a lengthy period.
Asked in cross-examination whether she would have chosen the Mitch PER, if she had been told that it was the best for her and would be the longest lasting, she declined to answer, saying it was a hypothetical question. That refusal to answer the question is telling; there is no doubt she would have followed the recommended course and chosen the device that met her requirements.
The Defendant’s Evidence
Professor Field had no recollection of the consultation so gave evidence of his invariable practice, his notes and the letter to the GP which he dictated in Mrs Grimstone’s presence during the consultation. He said his practice was to invite the patient to interrupt the process of dictation if he made a mistake.
He advised that hip replacement was the best option.
That as the patient said she only wanted one round of surgery she should have one operation and on the day have a single dose of radiation to mitigate the risk of heterotrophic bone formation.
He advised, given her relative youth, that she should have bone conserving replacements, preferably with large diameter metal on metal bearings to maximise stability of the joints.
The process which he recommended was popular at the time of the consultation and had received a lot of publicity. It was his practice to make sure that patients understood that this was still a total hip replacement because it involved replacing both parts of the joint; the top of the femur and the socket of the pelvis.
There is no note or any record to suggest that Mrs Grimstone asked for a particular type of replacement, such as the Charnley.
Process of obtaining consent April 2008
The Claimant’s Evidence
The Claimant had some memory of being advised about the general risks of surgery. In her witness statement she said, “I cannot believe that the consent form in my medical records is the same one I signed”. In her evidence she accepted it must be and that her recollection was not complete.
The Defendant’s Evidence
Again Professor Field’s evidence is based on the consent form completed during his consultation with the Claimant as he has no independent recollection.
He obtained consent on a form which showed that he had taken the patients through 11 risks of hip surgery. Before going through each of those risks he would have explained that consent was being sought for replacement of both hip joints with bone conserving implants. He would tell patients that they signed the form indicating the procedure to be carried out “if possible”. That was because he warned patients that once surgery began it might become apparent that the planned procedure could not be undertaken and the conventional procedure would be completed. This is to avoid putting patients through two episodes of surgery. He also warned of the slight risk that surgery on only one hip might be possible. He was confident that the features of the Mitch PER would have been explained to Mrs Grimstone during this session but had no recollection of her asking any such questions.
His usual practice was to invite questions from the patient before signing. The Claimant signed the form.
Information about data available on the MITCH PER.
The medical world has carried out much research into replacement joints and much progress has been made since the widely used Charnley device was first developed in the 1950’s. The Professor has a special interest and expertise in this area of research and had been part of the development of the Mitch PER. By the early part of 2008 there were a number of newer devices in use in this form of surgery. There were no long term results available as these were relatively new procedures. It appears that the Claimant does not say she asked about alternative methods of hip replacement, rather she argues that the Professor should have made her aware of the lack of data for the newer alternatives. The Professor’s evidence is that there was no such request for that information and it would not be his usual practice to provide such material if not sought, he would if asked have done what he could to explain the design and performance of the devices available.
Expert Evidence
Mr Charnley, the Claimant’s expert, in his lengthy report of 1 July 2014, confirms the medical appropriateness of the type of surgery performed in this case. He queries the patient’s understanding of the procedure to be carried out but that is a matter of fact and not expert opinion. The crux of his report begins at page 40 and he expresses concern that the procedure used “experimental prostheses” and that Mrs Grimstone was not given more details about the type of components to be used and their success rates. His concern is supported by the fact that she was not recruited, at the time of the surgery, into an audit or study of the survival rates of this type of implant.
Mr Hamer, instructed by the Defendant, also agrees that the treatment given was appropriate. He concludes, at page 23 of his report, that, “A responsible body of orthopaedic surgeons at the time would not have discussed the respective merits of similar resurfacing designs……and would have simply discussed the difference in potential benefit between their own preferred resurfacing device and a “conventional” stemmed total hip replacement”.
Both experts gave a considerable amount of evidence as to the status of such information that was available in early 2008.
DISCUSSION
Taking the issues the issues identified above in turn;
What did Professor say to Mrs Grimstone about the procedure to be carried out?
Through no fault of Mrs Grimstone her recollection is unclear and unreliable in this area. She did not have to recall the detail until many years after the conversations. By then she had undergone numerous surgical procedures and had numerous similar conversations. She has an understandable sense of grievance that the original surgery has gone so badly wrong and has caused her such pain and suffering. She cannot remember things which clearly were said and finds the contemporaneous record of two conversations impossible to reconcile. On the dispute between the witnesses as to what was said about the form of surgery being proposed I have no hesitation in preferring the recorded versions attested to by Professor Field. In the first consultation he contemporaneously dictated a letter to the GP setting out the form of surgery proposed by him for Mrs Grimstone. It was designed to take account of her age and active lifestyle. It was designed to meet her desire to provide a speedy recovery with the best outcome and was almost certainly likely to need replacement in time.
Did he do what was reasonable to ensure she understood?
Mrs Grimstone is an apparently intelligent and competent woman. It could not be expected that the Professor would have taken any special measures in her case. She had sought out the EOC following her own research and she was able to discuss the difficulties in the surgery her mother-in-law had experienced. She was able to set out her hopes and wishes of the operation, in particular that it would allow her to continue to lead as active a life as previously. The Professor discussed the proposal with her, her provided a leaflet prepared for patients in her position, he dictated a letter to her GP in her presence and he invited questions form her. On the second consultation he went through the consent form with her completing it as he did so. He explained the different risks of such surgery, he also warned of the slight risk that the option proposed might be found not to be possible once surgery had begun and that the conventional operation would take place if that happened. Again the fullness of the recorded process is to be preferred over the uncertain recollection of the witness who is still very unhappy that the form she has signed properly sets out what was discussed.
Which procedure would she have chosen in any event?
Given all that Mrs Grimstone has said about what she wanted to be the result of the surgery, it is very unlikely that she would have chosen the older procedure over the option which would achieve a quicker recovery and offer greater stability. Her reluctance to answer the question when directly put in cross-examination supports the view on the evidence that she would have chosen the new option.
Was he obliged to tell her about the limited data available on the device used?
There was a great deal of evidence about the status and volume of data available on the new device that was used in this surgery. It is not necessary to assess the scientific worth of that material. The agreed fact in this case is that the Professor did not tell Mrs Grimstone anything about the success rates. It is not therefore of any value to analyse what would amount to good data if there were an obligation, at the time, to impart it to a prospective patient. The “concern” expressed by the Claimant’s expert, Mr Charnley, that the data or lack of it was not explained to the patient cannot outweigh the view of the equally expert witness called by the Defendant, Mr Hamer, that a reasonable body of doctors in the same position would not have given such information to a patient. It is not accurate to refer to the device as “experimental”, it was new. All the clinicians accepted it was an appropriate device to have used in this case.
CONCLUSION
Any one hearing the facts of this case can only have the greatest sympathy for the Claimant. She underwent surgery which was intended to restore her to a very active life. Instead she has had repeated operations and undergone great pain and disability since the original operation. It does seem as though there has been some improvement more recently. However the case that she was not properly made aware of the nature of the surgery, or any data about it, so that she did not give truly informed consent has not been made out. Accordingly the claim fails.