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Consenting to what? The issue of informed patient consent post- Montgomery
I have previously written about the issue of consent to medical treatment following the Supreme Court Judgment in the case of Montgomery v Lanarkshire Health Board .
Subsequent to the decision in Montgomery the issue of consent has been considered in a number of reported decisions. In addition, I have recently settled a claim on behalf of a client who underwent a surgical procedure on her right knee to which she claimed not to have consented.
The reported cases include: –
Connolly v Croydon Health Services NHS Trust 
Mrs Connolly was referred to hospital to undergo an angiogram which involved the insertion of a catheter under a local anaesthetic via either the radial or femoral artery. Before the procedure the Claimant signed a consent form after having a consultation with a doctor and having been given an information sheet. The catheter was inserted into the Claimant’s radial artery but that approach was abandoned when she began to suffer pain. It was decided that access would be attempted via the femoral artery.
A catheter was inserted into her leg and she was given diazepam and morphine. During that procedure the Claimant suffered a spasm in her right arm which the experts agreed was caused by the catheterisation. She complained of pain in her arm as soon as the spasm developed. She also complained of severe pain across her back, chest and jaw. The doctor performing the procedure saw that the left ascending artery from the Claimant’s heart was occluded, which was a serious and potentially life-threatening condition.
He carried out an emergency angioplasty to re-open the artery by the insertion of stent. An x-ray showed that there had been a dissection of the left main stem artery.
The Claimant claimed that (1) she had not provided valid consent for the angiogram, as she had been given misleading information before it began; and (2) the dissection had occurred only after the femoral route was undertaken by which time she had withdrawn any consent she might have given.
The Court held that a failure to provide a patient with sufficient information to permit an informed choice as to whether to consent to a procedure was capable of giving rise to a cause of action in negligence. In addition, the giving of inaccurate or misleading information to a patient might invalidate their consent and amount to negligence.
In Mrs Connolly’s case the fact that the information sheet was misleading did not negate her consent in view of the entirety of the information made available to her prior to her signing the consent form.
The weight of the evidence favoured the conclusion that the pain she experienced, and therefore the dissection, occurred before the femoral route was undertaken.
Although she had become anxious and distressed as soon as she started to suffer from pain as a result of the dissection and occlusion of the artery, there was insufficient evidence that she had withdrawn her consent. In any event, it had been reasonable for the procedure to be continued once the occlusion had been detected. Had it not been remedied, she might have died or suffered permanent damage to her heart.
Accordingly, even if she had withdrawn her consent after the radial approach had been abandoned she would have given her consent to continuance by the femoral route if the seriousness of the situation had been explained to her. The likelihood was that she would have died had the procedure been halted at any time.
The claim therefore failed on both breach of duty and causation.
Jones v Royal Devon and Exeter NHS Foundation Trust 
Mrs Jones was referred, with a history of low back pain, to the Trust’s orthopaedic department under the care of consultant orthopaedic surgeon, Mr Daniel Chan in November 2009. Although she had an epidural injection in January 2010, her back pain continued and, at a clinic in March, she was reviewed by Mr Chan and “put on his waiting list” for bilateral decompression surgery. That operation was carried out on 29 July 2010, not by Mr Chan, as the Claimant had expected, but by a more junior clinician, a spinal fellow, called Mr Sunduram.
Unfortunately, the operation did not go well. A dural tear, caused by the surgical instrumentation, left the Claimant, a previously active lady, with permanent numbness, bladder and bowel problems and a significant loss of mobility.
Mrs Jones brought a claim on three grounds. The judge, having heard expert evidence, rejected her case that the procedure had been performed negligently and an allegation that Mr Sunduram ought to have been supervised was abandoned during the trial. However, he found that the Trust had breached its duty by not informing Mrs Jones that the operation was not to be performed by Mr Chan and that causation was made out.
Mrs Jones’s case was that she had been lad to believe that Mr Chan would perform the operation and had never been told otherwise. She was particularly anxious that he should do so because, it seems, Mr Chan has a particularly impressive reputation as a spinal surgeon in the South-West and even nationally. After she had been placed on his waiting list, she went away with her husband to France for a holiday but had to return early because of her pain. She then contacted the hospital to see if she could arrange an earlier operation, only to be told that the hospital could only give her an earlier date with a different surgeon. Having discussed this with her GP, she decided to wait until Mr Chan was available. Her evidence was that the first that she heard that it was not to be performed by him was on the very day of the procedure when she asked the theatre sister where Mr Chan was, only to be told that it was not he who was to perform the operation. By then, her husband had left to go to work and she was in her theatre gown, and she felt that she had no option but to go ahead.
The Trust’s evidence was different. Mr Sundaram had performed the consent procedure a few days before the operation. His evidence was that he had provided Mrs Jones with all the information which she needed to give consent and that he had specifically told that it was to be he who was to perform the operation. She had signed the consent form, a document which set out explicitly that the Trust could not provide “a guarantee that a particular person will perform the operation”. Not only that, but Mr Sundaram said that he saw her again on the morning of the operation and repeated that he was to carry out the operation.
The Recorder resolved those factual differences in the Claimant’s favour. He did not accept Mr Sundaram’s evidence that he told her that he was to do the operation at the time of the consent procedure or even on the day of the surgery. Had he done so, in advance of the day, the Recorder concluded that Mrs Jones would have “questioned why” that was to happen, given that she had already turned down the opportunity to have the operation done earlier by a surgeon other than Mr Chan.
In deciding that a breach was made out, the Recorder said this:
“The scope and rationale of a doctor's so-called "duty to warn ", was articulated by Lord Hope (with whom Lord Walker and Lord Steyn agreed) in a passage in his opinion in Chester v Afshar:-
“I start with the proposition that the law which imposed the duty to warn on the doctor has at its heart the right of the patient to make an informed choice as to whether, and if so which and by whom, to be operated on. Patients may have, and are entitled to have, different views about these matters. All sorts of factors may be at work here – the patient's hopes and fears and personal circumstances, the nature of the condition that has to be treated and, above all, the patient's own views about whether the risk is worth running for the benefits that may come if the operation is carried out. For some the choice may be easy – simply to agree to or to decline the operation. But for many the choice will be a difficult one, requiring time to think, to take advice and to weigh up the alternatives. The duty is owed as much to the patient who, if warned, would find the decision difficult as to the patient who would find it simple and could give a clear answer to the doctor one way or the other immediately.”
Accordingly, the Recorder found the breach proved.
In relation to the issue of Causation the Trust had sought to rely upon the fact that the Claimant had been told, on the morning of the operation, that Mr Chan was not to be there and had chosen to proceed. The contention that causation was not, therefore, made out was not pursued at trial. As the Recorder made clear, any decision taken “so far down the line” was unlikely to be taken freely.
Secondly, it was contended that, if she had been informed in advance of Mr Chan’s unavailability, then she would have decided, as she did on the morning of the operation, to proceed. The Recorder, again rejected this argument, observing that:
“…the fact that Mrs. Jones originally wanted her operation to be carried out by Mr. Chan is corroborated by the reference to Mr. Chan in the GP's Note of the attendance on 9 June 2010: Mr. Chan had and has a high reputation locally and nationally: Mrs. Jones's evidence, which I accept, was that several people whom she knew had been operated on by him, and that when, in June, she raised with her GP the fact that there would be a delay if she wanted him to carry out the operation, the GP advised that it would be preferable to wait: in spite of the severity of her symptoms, and she did decide to wait until Mr. Chan was available. I therefore reject this contention.”
Thirdly, it was the Defendant’s contention that the Claimant could not prove, on the balance of probabilities, that the operation would have been performed with any better result had it been done by Mr Chan.
The Recorder found that, on the balance of probabilities, the damage would not have occurred if the operation had been performed by Mr Chan. He listed a number of reasons for coming to that conclusion, including the smallness of the risk of damage in any event, the expert evidence that “experience counts” in this operation, the absence of any pre-existing condition likely to increase that risk whoever performed the operation, the seniority and experience of Mr Chan and the statistical evidence that such complications are rare and rarer still in the hands of a surgeon of the experience of Mr Chan.
Other recent examples
As stated above, I have recently settled a claim on behalf of a 50 year old woman who underwent a procedure to her right knee to which she did not consent.
My client, who has a long history of bilateral knee pain, had previously undergone surgery on both knees. However, in approximately 2011 her symptoms started to deteriorate and she sought further advice from the orthopaedic surgeons at her local hospital in Kent. However, following a number of outpatient consultations, she was recommended to a surgeon at the Salford Royal Hospital (more than 250 miles away from her home address) for consideration of a re-alignment procedure (a high tibial osteotomy).
In April 2012 my client was seen at the Salford Royal Hospital at which time it was decided to carry out an arthroscopy and ‘washout’ of her left knee and to see whether or not she would be a suitable candidate for the realignment procedure.
The surgery was carried out on 8th June 2012. My client was delighted with the outcome and for the first time in several years experienced no pain at all in her left knee. She was discharged the following day and was able to mobilise without any assistance.
She was next seen at the Salford Royal Hospital in September 2012 when she agreed to undergo exactly the same procedure on her right knee.
The surgery was carried out on 6th November 2012. However, the original surgeon was not available and so her surgery was carried out by a different, less experienced surgeon who had never even met my client until shortly before her operation.
Following the surgery my client woke in excruciating pain. She was subsequently reviewed by the surgeon who explained to her that he had carried out a procedure called ‘microfracturing’ and that she would need to remain non-weight bearing for a period of at least 4 weeks.
My client was understandably upset as at no time prior to her surgery was the possibility of this procedure being carried out discussed with her.
She was discharged from hospital on 7th November 2012 but was unable to mobilise at all and had to be pushed by her husband in a wheelchair. Following her discharge she was reliant on the use of a wheelchair for approximately 11 weeks.
She subsequently wrote a letter of complaint to the Hospital but the Hospital refused to accept any wrongdoing and advised that the actions of the surgeon involved were entirely justifiable.
Unfortunately, despite us advising her that the issues if her case appeared clear-cut, the NHSLA continued to deny any wrongdoing on the part of the hospital and maintained that my client’s informed consent had been appropriately obtained prior to the surgery taking place (despite my client never having heard of microfracturing at any time prior to her surgery).
Eventually, more than 3 years later, and following the commencement of Court proceedings, the solicitors instructed by the NHSLA agreed to deal with the claim and accepted an offer which my client had made to settle her claim some 6 months previously.
As advised in an earlier blog, the guidance of the General Medical Council is the relevant professional standard when considering the issue of informed consent.
In this regard, the guidance states that: –
“The doctor explains the options to the patient, setting out the potential benefits, risks, burden 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."
Essentially, a doctor is 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. Failure to do so is likely to be a breach in the duty of care.
The doctor must record details of the consent process including the risks and options discussed within the clinical notes. A signature on a consent form will also not signify that a patient has been appropriately informed.
Applying this to my client’s case she clearly had the right to be advised of the possibility of the microfracturing procedure being carried out and what this was likely to mean in terms of her post-operative recovery i.e. that she was likely to be non-weight bearing for at least 4 weeks.
Of course, that is not the end of the matter as the Claimant must still prove that if they had been appropriately warned of the risks/advised of the treatment options they would not, in those circumstances have consented to the same procedure anyway (i.e. the Claimant still has to overcome the hurdle of causation in the usual way). However, in my client’s case causation was made out because: –
At the time of her surgery she was running her own out of hours school club and she would not have consented to any procedure which meant that she would be unable to weight bear afterwards;
She had recently undergone carpal tunnel surgery on her left wrist from which she was still recovering and so unable to use a standard crutch in her left hand; and
Had she been advised at any stage prior to her attendance at Hospital on 6th November 2012 that her original surgeon was not available to carry out her surgery she would have postponed the surgery to a date on which he was available. In this regard, the original surgeon would have carried out exactly the same procedure on my client’s right knee as he had carried out previously on her left knee. In other words, he would not have carried out the microfracturing procedure which the subsequent surgeon carried out.