- January 25, 2016
- By Dr Jock Mackenzie
- 0 comments
Another Montgomery case and the importance of documentation
The recent case of Grimstone v Epsom and St Helier University Hospitals NHS Trust, which was heard in November last year with the judgment given 2 days before Christmas, is another interesting case on informed consent following on from the Supreme Court case of Montgomery v Lanarkshire Health Board, which set out the requirements for informed consent in a medical setting.
The key passage in Montgomery relating to informed consent is at paragraph 87:
“The 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 or variant treatments. The test of materiality is whether, in the circumstances of the particular care, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should be reasonably aware that the patient would attach significance to it.”
It seems to me that this passage is relatively explicit with respect to a doctor’s duty and the meaning of a “material risk” to a patient in the context of informed consent, notwithstanding that it remains early days in ascertaining how the case is to be applied in the lower courts. It is, though, widely accepted that, in consent cases, Montgomery has replaced the usual Bolam test which relies upon the standard of care being measured against the appropriate responsible body of doctors, as evidenced by medical expert opinion, and which has been the accepted test of the standard of care in clinical negligence cases since 1957. Given Montgomery, Mrs Justice MacGowan’s judgment in Grimstone makes rather interesting, if not slightly confusing, reading.
The facts of the case are fairly straightforward, although very important. In essence, the claimant (G) had problems with her hips and needed bilateral hip surgery. She had had personal experience of this type of surgery, albeit vicariously through her father and mother who had undergone “traditional” hip surgery in the past, with good and not-so-good outcomes respectively. Accordingly, G thoroughly researched the appropriate surgeon and chose an orthopaedic surgeon at the defendant Trust before having her own surgery.
She attended two consultations with this surgeon. During the first consultation, the surgeon dictated a letter to G’s GP in her presence, explaining that he had advocated to G the use of a bone-conserving hip replacement device (a relatively new device known as a Mitch PER) because she was only in her mid-50s and because she had an active lifestyle, as well as for maximum joint stability. He also gave G both an information booklet regarding the new hip joint and a DVD about the surgery. A subsequent clinic appointment prior to the surgery took place during which the surgeon explained 11 risks of surgery, which were documented on the consent form, and the form was signed by G. At neither consultation did the surgeon explain to G what alternative types of procedure there were, what types of different devices were available and/or what the success/failure rates of the proposed device or alternative devices were, even though the Mitch device he proposed was relatively new (although the experts agreed it was not an experimental device). However, wisely, the surgeon documented, in some detail, the consultations: this turned out to be evidentially important as he subsequently could not remember either of them.
Unfortunately, the new device failed in G’s case, such that she needed further surgery. She claimed against the Trust on the basis that the surgeon had failed adequately to advise her about the surgical options available to her, to obtain her informed consent for the operation and to advise her of the alleged lack of data regarding the failure and survival rate of the device used.
On the face of it, it appears entirely understandable why this case was brought, as it would appear to have been a case, following Montgomery, in which G was a patient who wanted, and was entitled to, information about the various options open to her before she made a decision, that information to include material risks associated with the various options so she could compare and contrast. The judge, however, appears not to have interpreted Montgomery in this way, concluding that, whilst it was indeed applicable in this case (and, of course, it was a decision she had to follow being from a higher court and she quoted substantially from it), the principles that came out of it were: G had a fundamental right to be properly informed of the nature and risk of the procedure proposed, the passing of that information to her should have been carried out in a way that was comprehensible by her, and this was a case in which the withholding of any information about risk could be justified on clinical grounds. The judge did not, however, at least not in terms, refer to “material risks” or to “alternative or variant treatments”, and she appears to have determined the question of whether it was reasonable to fail to provide failure and success rates of the proposed procedure by reference to expert evidence and opinion of peer-related practice (viz. the Bolam test) rather than by applying Montgomery.
Ultimately, the judge concluded that the surgeon had provided sufficient information to enable informed consent to have been obtained, and G lost.
I should not be surprised if G feels somewhat aggrieved at the judgment, not least in relation to breach of duty. Whilst there can be little doubt that the judge preferred the testimony of the surgeon over that of G, whose recollection was honest but uncertain given the passage of time, and also preferred the opinion of the Trust’s medical expert over G’s expert, it remains the case that, based on reading the judgment and unless I have misunderstood it, there does not appear to have been a Montgomery-based analysis of: what alternative and variant treatments were available; what the success and failure rates of such treatments, including the Mitch device, were (irrespective of whether a responsible body of surgeons would or would not have provided such information); and whether G was likely to attach significance to the risks or whether the surgeon was or should have been reasonably aware that G would attach significance such that the information needed to be provided.
However, notwithstanding the above, the judge appears to have concluded that it was likely that, even if G had been provided with more information, she would still have elected to proceed with the Mitch device, so she would have lost on causation even if she could have established a Montgomery-related breach of duty. An important aspect of this is that G declined to confirm on cross-examination that she would not have proceeded with the Mitch device even if warned of the risks. It is also possible that the judge considered that, because G would have had the Mitch device anyway even if advised of its risks, such risks accordingly could not have been sufficiently material to G for their non-provision to have been a breach of duty; but it is not clear from the judgment whether that was indeed the case, and in any event it raises issues of causation in Montgomery breach cases.
I cannot deny that I find the judgment a slightly confusing one in this early post-Montgomery period although, as said above, it may be that I have just misunderstood it. However, whilst it may not be a judgment that will linger in the memory for its clarity on the application of the Supreme Court’s decision on informed consent, it most certainly may be remembered for its help in demonstrating the vital importance of doctors keeping very good and comprehensive notes in consent cases.
A similar form of this article was first published by LexisNexis on their website on 20.01.16.