On 9th November 2020, new guidance from the GMC came into force with respect to informed consent. This guidance was produced after a period of public consultation on the draft guidance between October 2018 and January 2019. The draft guidance was then redrafted to take account of the evidence gathered throughout the consultation period. That draft was approved by Council in November 2019 and is now published in final form.
The updated guidance lists ‘seven principles’ of decision making and consent, including:
- All patients have the right to be involved in decisions about their treatment and care, and to be supported to make informed decisions.
- Decision making is an ongoing process focused on meaningful dialogue, based on the exchange of relevant information specific to the patient.
- All patients have the right to be listened to, and to be given the information they need to make a decision and the time and support they need to understand it.
- Doctors must try to find out what matters to patients so they can share relevant information about the benefits and harms of proposed options and reasonable alternatives.
- Doctors must start from the presumption that all adult patients have capacity to make decisions about their treatment and care. A patient can only be judged to lack capacity after assessment in line with legal requirements.
Although not one of the “seven principles of informed consent”, paragraphs 50-51 contain key guidance as to the recording of decisions which will doubtless be relevant for litigated cases:
“Patients’ medical records
50. Keeping patients’ medical records up to date with key information is important for continuity of care. Keeping an accurate record of the exchange of information leading to a decision in a patient’s record will inform their future care and help you to explain and justify your decisions and actions.
51. You should take a proportionate approach to the level of detail you record. Good medical practice states that you must include the decisions made and actions agreed – and who is making the decisions and agreeing the actions – in the patient’s clinical records. This includes decisions to take no action.”
That markedly different outcomes are possible where recording of dialogue and decision making are inadequate may be seen in the two recent informed consent cases of Alan McNab and Others v Greater Glasgow Health Board  CSOH 53 and Plant v El-Amir  EWHC 2902 (QB).
In McNab the Outer House considered the case of a woman who it was claimed did not give informed consent to the risks of ureteroscopy. She underwent the procedure on 23 September 2013 and died from sepsis, one of the known risks. The Outer House (Lady Carmichael) summarized the relevant law from Montgomery and applied it to the facts. She explained at  (uncontentiously):
“A doctor such as [the Defendant] must 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. A risk is material if in the circumstances of the case, 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 particular patient would be likely to attach significance to it. Montgomery, paragraph 87. Whether a risk is material cannot be reduced to percentages, but will reflect a variety of factors such as those mentioned in Montgomery, paragraph 89. A doctor must engage in a dialogue with the aim of ensuring that the patient understands, amongst other things, the anticipated benefits and risks of the proposed treatment and any reasonable alternatives. That duty is not fulfilled by “bombarding the patient with technical information which she cannot reasonably be expected to grasp: Montgomery, paragraph 90.”
In approaching the informed consent issue the case turned largely on the oral evidence of the Defendant surgeon who had not made any contemporaneous record of the consenting discussion. The impression which her evidence created on the judge was “of sorrow and regret, rather than defensiveness or self-justification”. The judge concluded the surgeon was generally reliable and answered the key questions as follows:
- Was there an increased risk of sepsis because of the previous episode? Answer: no because of earlier sepsis, yes because of the Deceased’s age. The increase in risk was small.
- What matters did the Defendant surgeon have a duty to discuss with the Deceased? The key (or material) matters were: the risk of infection/sepsis, the reasonable alternative of postponing and having a CT scan. Other matters were peripheral or immaterial to the key decision.
- What did the Defendant surgeon discuss with the Deceased? The key elements necessary for informed consent namely (i) the risks and benefits of ureteroscopy including an increased risk of urosepsis, and the alternative of delaying and having a CT scan.
- Did the Deceased understand any advice tendered? Yes, and chose the ureteroscopy rather than delay.
Contrast the case of Plant v El-Amir where informed consent was raised in a case concerning allegedly unnecessary (and delayed) treatment leading to eye damage. As summarized by the judge (Stacey J) the issues fell into two distinct strands:-
- a failure properly or adequately to obtain the informed consent of the Claimant for the surgery and to perform the surgery without such consent (allegations at paragraph 25(a)-(g)); and
- the failure to diagnose and treat in a timely manner the Claimant’s raised intraocular pressure (IOP) and glaucoma between 25 September 2013 (as pleaded) and 13 December 2013 said to have caused significant, permanent and irreversible damage to her right eye.
It was not said that the surgery itself had been performed negligently, but the Claimant’s challenge was to the fact that the surgery was performed at all.
In terms of the law, the issue was narrow. The Claimant’s case was that she would never have agreed to have had any eye surgery if she had been made aware of both the risks and the very limited prospect of any improvement from the operation. Thus, the potential area of legal uncertainty concerning the precise scope of the Montgomery modification of usual principles of causation (see Duce v Worcestershire Acute Hospitals  EWCA Civ 1307) was not relevant. It was also common ground that the Claimant must still both plead and prove with evidence that if the correct information had been given (in the event of the Claimant establishing liability), that she would not have had it (Correia v University Hospital of North Staffordshire  EWCA Civ 356).
The facts leading up to the surgery do not reflect well on the London Eye Hospital (now in administration) or Dr Qureshi, its director, who since been struck off the GMC register.
On 15 July 2013, after seeing an article in the Daily Mail, the Claimant and her partner travelled from their home in Tydd St Giles, Wisbech, Cambridge, approximately 100 miles to the London Eye Hospital’s premises in Harley Street, London, to attend an appointment with Dr Qureshi to discuss laser eye surgery. At that meeting, as recorded in the cursory notes made, the claimant was explicit that the purpose of her interest in the surgery was to improve her eyesight so that she could read magazines again and that she wanted the surgery on her worse left eye. Dr Qureshi assured her that he could help her see better. However, during the course of the appointment, she was persuaded to have both eyes done, because she was worried that her right eye would deteriorate and Dr Qureshi suggested it would be sensible to have both eyes treated. She was insistent and Dr Qureshi agreed that the surgery should be performed on the left eye first with the operation on her right eye to follow a few weeks later. She was clear that she did not want to risk her much better (right) eye, as if anything was to go wrong with that eye, it would be devastating.
From what she was told by Dr Qureshi, she was confident enough to agree to proceed and paid the full cost of surgery to both eyes – £11,000 per eye together with £1,500 extra for use of a femtosecond laser which she was told would reduce the risk of infection totalling £25,000 – before setting off back home to Cambridgeshire with an appointment date. She was enthusiastic to proceed. Mr Qureshi did not explain any risks of surgery beyond the possibility of infection which, he said, would be reduced by the use of the femtosecond laser for which she had paid extra. He did not effectively communicate that it might not work or that she could have any problems. He did not share with her any of what little research data there was about the limited benefits and risks of the proposed surgery for someone with her level of AMD (age-related macular degeneration) in both eyes. He told her that he was confident that he could make her sight better and she believed him. She was not informed of the inherent risks of any intraocular surgery. She was asked to sign various documents which she did not pay much attention to.
The Claimant then came to see Mr El-Amir, an NHS consultant in Reading who was practising privately at the London Eye Hospital. He reviewed the notes of the earlier appointment, and requested she attend for further tests. As a result of those tests (and despite the results being contrary to the Claimant’s experience) he suggested the right eye should be operated on first. He gave no further information about the surgery, its risk or possible benefits or the availability of any alternatives. Mr Amir was determined to operate on her right eye (her only good eye) saying that “it would help balance the vision”. In fact as a result of the surgery on 23 August 2013 her optic nerve was damaged and she lost total loss of vision in her right eye.
Mr El-Amir in his defence claimed he had gone through the risks and possible outcome of surgery with the Claimant prior to the operation in meticulous detail. This was roundly rejected by the judge based on the Claimant’s evidence :
“The statement of the Claimant made just 2 years after the surgery and the statement of Mr Gifford [her partner] had the ring of truth and were inherently plausible and were consistent with both her letter of complaint in March 2015 and her response to LEH’s reply to her letter of complaint. She had been absolutely clear throughout both that she wanted to read again and did not want to risk jeopardising the sight in her right eye. So if the first defendant [Mr El-Amir] had given an accurate assessment of the likely benefit to be obtained from the surgery and warned her of the risks, it is implausible that she would have consented.”
The judge’s ultimate conclusion was that Mr El-Amir failed to take all reasonable steps to obtain her informed consent to ensure she was aware of the very limited potential benefits of the surgery which would not have enabled her to read again, which was the reason for her interest in the surgery. Neither did he inform her of the very considerable risks and dis-benefits of operating on her only good eye. He failed properly to consent the Claimant by sufficiently explaining the risks of losing sight in her only good eye and performing the surgery without having provided her with the material information. He also failed in his duty to her by omitting to tell her on 23 August 2013 that surgery could improve the sight in her left eye.
As to causation, if she had been correctly informed that the surgery would not have enabled her to read magazines again and carried a risk of complications she would not have elected to have the operation on her right eye on that, or indeed on any other day. Liability and causation were therefore established against the first defendant, Mr El-Amir, in relation to consent.
The new guidance from the GMC to replace its former 2008 Guidance is welcome. It is likely to be the ‘starting point’ for the court in understanding the expected standards both in relation to the expected dialogue, discussion of reasonable alternatives, and the recording of the same as part of the informed consent process. But as the divergent outcomes in the cases above illustrate, ultimately these cases are very fact sensitive. If the judge forms the view that the patient has been ‘mis-sold’ a treatment of doubtful benefit she otherwise would not have undergone (Plant v El-Amir) the lack of appropriate documentation of the consenting process is likely to provide the easiest route for a finding in her favour. But if the overall impression of the evidence (despite the absence of recording of the consenting process) is that the patient probably understood the risks and would have gone ahead with the treatment knowing of those risks, then subtle differences in the nature of the risk, or aspects of the benefits of alternatives which are not included as part of the informed consent discussion, may not be material.