We have previously reported on the Supreme Court decision in Montgomery v Lanarkshire Health Board which represented a significant change in the law on consent, providing that clinicians have (emphasis added)::
“…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 treatment … 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 risk 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 if the information provided is comprehensible”.
Handed down in March 2015, the decision has become a prevalent feature in clinical negligence claims. In this article we examine how the Courts are applying the decision and consider some practical tips for practitioners to best minimise the risks.
Our update from June 2018 examined the decision in Hassell v Hillingdon Hospitals NHS Foundation Trust which reiterated the requirement for a clear and comprehensive dialogue that is specific to the patient’s individual circumstances and, importantly, documented in detail.
We know that consent is not simply limited to the form a patient signs before they go into theatre and that the process covers consultations and discussions between the practitioner and patient. However, the main stumbling block encountered when defending these allegations is a lack of documented advice. Clinicians are often clear that all the appropriate options have been discussed as this is ‘standard’ advice given but this may not be evidenced by the written notes and/or follow up letters.
Of course, the healthcare professional will be able to give evidence as to what they did or did not say. However, once it become an issue of witness evidence the Court has to weigh up whose evidence they prefer. There is therefore an underlying risk that the Court will prefer the evidence of the Claimant. The impact of well written notes can be highlighted by considering two cases:
- In Hassell v Hillingdon NHS Foundation Trust  EWHC 164 (QB) the Claimant was able to give a coherent account of what she could recall being advised of. The clinicians’ testimony by contrast was found to be inconsistent with his written evidence; suggesting to the Court that he could well have also been inconsistent with the advice given to the patient.
- By contrast, in Keane v Tollafield  8 WLUK 306 the Court held that the Defendant was not in breach of duty and had adequately discussed the risks with the patient. Factors which assisted the Court in making this decision were, amongst others; (i) a fact sheet had been drafted and provided to the Claimant; (ii) the content of this fact sheet being consistent with the Defendant’s evidence of what his standard practice was; and (iii) the risks discussed were also detailed in the consent form.
Whilst avoiding a finding of breach of duty is the best possible line of defence, the Court of Appeal’s decision in Diamond v Royal Devon and Exeter NHS Foundation Trust  EWCA Civ 585 helpfully reiterates that there is no free standing right to damages for a failure to warn as many Claimants have sought to argue.
Ms Diamond underwent spinal surgery and subsequently suffered a post-operative hernia which required repair. The surgeon opted to use a mesh-based procedure and did not advise on the possibility of a suture repair. Three years’ later, Ms Diamond consulted an alternative surgeon and was informed that the mesh-based repair procedure would carry a risk if she was to become pregnant. The Court held that the initial surgeon breached his professional duty by failing to provide the patient with appropriate information to enable her to provide informed consent. Importantly however, the Court of Appeal concluded that causation was not established. The Claimant could not demonstrate that ‘but for’ the consenting breach, she would not have undergone the same procedure.
In confirming that both factual ‘but for’ and legal ‘remoteness’ causation must be established in all but the most exceptional of cases, the Court in Diamond (and earlier decisions such as Duce v Worcestershire Acute Hospitals NHS Trust  EWCA Civ 1307) has limited the impact of Chester v Afshar. It follows that it is now only if a Claimant can demonstrate that fully informed they would have undergone the same surgery but on a different day with the exact same minimal risks, that a potential exception to the usual causation principles may apply. It is fair to say that even this minimal application is under intense scrutiny.
The future of consent
It is clear that Montgomery will continue to be a significant decision in the medical negligence sphere. Clinicians must take care to ensure that the individual patient is assessed and material risks discussed. The hardening line on causation assists in resisting these claims. The reality of the situation of course is that causation is unlikely to be tested until trial, by which point significant time and cost have been incurred by all parties.
Practical Steps to Avoid Consenting Issues
Where allegations surrounding consent are unlikely to go away anytime soon, in order to limit the risks, a professional should:
- Discuss the relevant risks and alternative treatment options in a clear and comprehensive manner with the patient at consultation. Ensure these are appropriate to the patient’s individual circumstances/needs;
- Follow up the initial consultation with a letter to the patient’s GP documenting the advice given and options discussed, and ensure this advice is also relayed or copied to the patient;
- Provide the patient with/direct them to relevant literature which they can consult further in their own time. Ensure that literature is up to date/includes all the risks which are appropriate to that patient and, importantly, confirm in the letter or in your notes what that literature was;
- If you have ‘standard advice’ that you always give around a certain procedure, ensure the details are documented in the letter or notes;
- Document the details of any further consultations or discussions (even phone calls or informal conversations) you may have with the patient ahead of the procedure; and
- Ensure that the consent form itself includes as much detail as possible.
Authors: Amy Bell & Sarah Rose