A PATIENT'S INFORMED CONSENT MUST BE COMPREHENSIVE AND DEMONSTRABLE

Informed consent is a necessary prelude to all surgical procedures. Following the Supreme Court judgment in Montgomery v Lanarkshire Health Board [2015] UKSC 11, the term ‘Montgomery-compliant’ consent is often used. There needs to be a dialogue with the patient; and the risks, benefits and alternatives to treatment must be explained to – and understood by – the patient. Here, we discuss a case where there was an appropriate indication for surgical treatment and the operation was carried out to an appropriate standard. However, the defendant spinal surgeon was unable to demonstrate, to the judge’s satisfaction, that there had been an adequate dialogue with the patient. The judge was not convinced that alternatives to surgery (further injection therapy or physiotherapy) and a serious risk of surgery (spinal cord injury) had been explained to the patient preoperatively (Hassell v Hillingdon Hospitals NHS Foundation Trust [2018] EWCH 164). The patient (TH) was a forty-one-year-old woman who was the claimant in this case. She had a painful left C6 upper limb nerve root pain caused by a left C5/6 disc prolapse. A C5/6 anterior discectomy and anterior reconstruction was recommended and performed. TH awoke quadriparetic with a partial spinal cord injury and suffered longterm disability. The surgeon (Mr R) said there had been a full explanation of the risk, benefits and alternatives to surgical treatment. TH said she was told about a risk of infection, general anaesthesia and a hoarse voice, but she was not told that there was any risk of paralysis; nor that she had any options for continued conservative treatment; and there was a high chance that spontaneous resolution might occur with the passage of time. TH said that if she had known of these options/risks she would have declined surgery, in part because her disability was minor, she was working full-time, she was looking after her family and she could drive. We were court-appointed experts instructed by the claimant’s solicitor.

THE OUTCOME

There was a careful and detailed judgment by HHJ Dingemans. In respect of consent, he found that TH was not told about the risk of paralysis, nor was she advised of conservative treatment options including physiotherapy and further injections. He found that Mr R failed to take reasonable care and skill to ensure TH was aware of the material risks of the operation and the alternative conservative treatment options. He made these findings for many reasons: — Mr R said he understood that Mrs H had already had physiotherapy for her neck but she had not, though there had been previous physiotherapy to the low back. Mr R could not have had this misunderstanding if he had discussed other treatment options with TH. His misunderstanding would then have been corrected by TH, therefore, there had not been a Montgomery-compliant dialogue with TH;
— Mr R was not a good communicator about the risks of operations. When explaining to the court the risks of surgery in his evidence in chief, Mr R did not include deep vein thrombosis (DVT) or pulmonary embolism (PE) which he said in his witness statement he would have mentioned. Mr R said that it was his invariable practice to mention these risks for the cervical discectomy and there was no obvious reason why he should have failed to do so, other than his belief about his invariable practice and what he said sometimes differed. Mr R did not say in early correspondence after the operation that the preoperative letter dated 1 July 2011 did not record the risk of paralysis, even though he said he had mentioned these when talking to TH. Mr R’s operation note was criticised for lack of clarity – emphasising the judge’s impression of poor communication skills;
— TH gave clear evidence that she had not been warned about the risk of paralysis and that she would have been very concerned about that as the mother of three children in full-time work as a head of year. The judge acknowledged that studies showed many patients don’t accurately remember the risks of an operation as they are explained to them; and all judges had seen and heard honest witnesses fail to recall accurately and reliably conversations and events. However, TH did have particular recollection of a hoarse voice because it was relevant to her work (when she was required to shout across the playground on occasions) and asked questions about that risk. The judge considered it more likely than not that she would have had a particular recollection about paralysis had it been mentioned to her and would have asked further questions;
— In a subsequent letter, Mr R said the operation could result in paralysis and stated it was “similar to risks explained with previous spinal surgery” (low back surgery). However, the letter about risks for the low back surgery also did not mention paralysis;
— In respect of the possibility of further injections as an alternative treatment, Mr R did not record this in his witness statement but he said, in oral evidence, that it was discussed. This gave the judge no confidence in the reliability of Mr R’s recollections;
— Mr R advised TH to look at a website which did not contain information allowing her to understand fully the risks and benefits of the planned procedure. The crucial information about the risk of paralysis was not recorded on the website; and
— The risk of spinal cord injury and paralysis was not referred to in the outpatient letter which was dictated in front of TH to ensure she would know the risks which she was running. There was reference to a one in 1000 figure (which the experts agreed would be the risk of paralysis) but there was no mention of paralysis. The judge found this accorded with the fact that Mr R’s explanations about risks were not clear or consistent. The judge found that TH was told about the risk of “cord damage” on the day of surgery but that warning was not sufficient. The judge ruled that Mr R had used reasonable care and skill in carrying out the operation (the cause of intraoperative spinal injury was unknown). But he ruled that TH did not give informed consent to the operation and that if she had been given information about material risks and conservative treatment, TH would not have agreed to the operation. Judgment was therefore given in her favour.

THE IMPLICATIONS

Surgeons understand that in proposing an operation they have a duty to explain the reasons for the treatment, the benefits and risks of surgery and the alternatives. The detailed judgment by the Supreme Court in Montgomery noted the following:
— Consent is based on the right of all competent adults to autonomy in respect of a decision to have, or not have a surgical procedure. The surgeon has to have a dialogue with the patient to allow them to make a fully informed decision. That dialogue must be demonstrable. If the dialogue was not recorded, a surgeon may not be able to rely upon a statement that such a discussion was their usual practice.
— Material risks of surgery are those risks that would influence the reasonable patient to undergo (or not) surgery. The surgeon must take these circumstances of each individual patient into account. Patients do not have to ask specific questions because they may not know which questions to ask. — Surgical risks are specific to the condition and the individual patient.
— The information given should be specific, comprehensible and explained in terms that the patient will understand. Highly technical data, particularly information sheets that contain a wealth of information on different surgical procedures, may be overwhelming and unhelpful.
— If the patient is given an information sheet or directed to a website, there should be full details of the risks, benefits or alternatives to that specific surgical procedure. In the above case, the judge had to make a number of findings of fact. These included a failure to advise that further conservative treatment (including cervical physiotherapy and/or further injections) were treatment options and that the risk of paralysis was not discussed. It was the evidence of the surgeon that he had discussed these issues.

There are many medicolegal cases where there are conflicts in the evidence and in this case the conflict was in respect of the details of the consenting process. In our opinion, the greatest deficiency of the treating surgeon was the failure to record the nature of the discussion. All surgeons should have a checklist for each surgical procedure that they carry out, plus an information sheet the patient can take away and read. Had such a checklist been recorded in this case, it would probably have been powerful evidence that all relevant issues had been discussed. All surgeons must understand that a decision to operate, and the technical aspects of surgery, may be beyond criticism – but any failure fully to consent and to record the dialogue between the surgeon and the patient – can lead to the surgeon being found to be in breach of duty of care. In this case, TH was awarded damages of £4.4m solely because of the failures in the consenting process. Surgeons must not only have an appropriate dialogue with their patient – they must record it.