All eyes on consent: laser focus on materiality

Bevan Brittan acted for the successful Defendant in a High Court case concerning informed consent; the claim was recently dismissed after a 6 day trial in September 2024 following 6 years of litigation. Ms Rebecca Lochrie brought the claim for over £4.2 million against Mr Matthew Edwards, Consultant Ophthalmic Surgeon, after suffering a rare adverse outcome following LASIK surgery carried out in 2016. Elena Goodfellow managed the claim and Nadia Whittaker of Crown Office Chambers was instructed as Counsel for the Defendant. His Honour Judge Baddeley, sitting as a High Court Judge, dismissed the claim, handing down judgment on 7 January 2025.

Background

The Claimant underwent LASIK at the Sheffield Vision Centre in 2016, performed by the Defendant. As part of the consent process she was sent a guide on refractive surgery, attended an initial assessment and consultation with the Defendant and she was sent a detailed consent form several weeks before the surgery, which she signed on the day of surgery. The surgery itself was uneventful but some months later the Claimant began to experience dry eyes, eventually developing pain and light sensitivity that became increasingly severe. She was diagnosed with corneal neuralgia, an extremely rare condition which is poorly understood. Her claim included a loss of earnings and pension of just over £1.5 million, a claim for care, case management and accommodation of £1.6 million and a claim of over £750,000 for medical treatment.

Issues in the claim

The Claimant essentially claimed there was a failure to obtain her informed consent for the surgery, which she had chosen to have on an elective basis to remove her need to wear glasses and contact lenses. There was a dispute between the parties as to what risks of LASIK surgery were discussed. The Claimant’s case was that she was told that LASIK surgery was “a very safe procedure” and that “If there were problems, they were minor things and nothing that couldn’t be easily managed”. She alleged that the Defendant did not mention any risk that LASIK could cause either temporary or permanent dry eyes. While the Claimant signed a consent form which set out a variety of risks (signing each page of the consent form with her initials besides a declaration, “I have read and understood this page”), she alleged that she had not read it, was not asked if she had read it, and was rushed into signing it. She claimed that if she had instead been advised of any risk, whether short term or permanent, she would not have agreed to undergo surgery. 

The Defendant denied liability and maintained that he had provided the Claimant with appropriate information in order for her to provide informed consent. His evidence of the discussion he held with her at her initial consultation was that it included advice that LASIK frequently caused dry eye symptoms, that such symptoms are usually mild to moderate and treatable, that some patients experience such symptoms for longer than 6 months but symptoms were rarely permanent. He could not remember the specific consultation (a common feature in these kinds of consent claims) but relied on his usual practice as well as a checklist that formed part of the medical records, on which he had ticked off of the relevant risks discussed. The Defendant also disputed that he would have rushed the Claimant when she signed the consent form, and maintained that he would have taken time to ask the Claimant if she had read the Consent Form and whether she had any questions, explaining that if he had been in any doubt that she had read it, he would have delayed the surgery until she had done so.

One of the key issues to be determined was whether the Defendant had a duty to go so far as to advise of a specific risk of “severe permanent dry eyes” which would be “difficult to treat” or whether the explanation of the symptom of dry eyes described in his evidence was sufficient to obtain informed consent. 

Judgment

The judge preferred the Defendant’s evidence over that of the Claimant in respect of what was discussed at the consultation and when the Claimant signed the consent form. Against these factual findings, the following findings are of interest on the issue of informed consent: 

• The Judge considered extensive expert evidence from both parties’ ophthalmology expert witnesses about what should have been known about the relevant risks of LASIK in 2016, in order to apply the first stage of the Montgomery test of materiality. This is in line with Duce v Worcestershire Acute Hospitals NHS Trust [2018] EWCA Civ 1307 and other decisions which have confirmed that this is a matter falling within the expertise of medical professionals.
• The Judge found that the risk of a patient with the Claimant’s risk profile suffering dry eye symptoms which were severe, permanent and difficult to treat as a result of LASIK was “very small, the exact mathematical risk being unknown”. The best current evidence (from a paper in 2021) was that the risk was 1/900, although this would not have been known in 2016. 
• The Judge then considered whether the risk of permanent dry eye symptoms was material to the Claimant, applying the second stage in the test of materiality. He found:
  
  • that the Claimant did not have a risk profile that was different from an average patient seeking LASIK surgery;
  • that a reasonable person in the Claimant’s position (including her history of mental health issues) would not be likely to have attached significance to a risk of the magnitude he had found it to be;
  • therefore the fact that the Defendant’s discussion about the risks did not address a very small risk that was not mathematically quantifiable in 2016 did not prevent the Claimant from giving her informed consent to the procedure.
• The Judge concluded, while expressing much sympathy for the Claimant, that “No surgery is completely risk-free, however. Compensation only follows where blame is found, and I have not found that the Defendant was negligent”.

Comment

This is another helpful example of the Court applying the Montgomery test of materiality. It reiterates that just because a specific outcome is severe and life changing, it does not necessarily mean that it was a material risk as defined by Montgomery. As the Judge concluded, “the consent process would become unworkable if every single possible risk and complication had to be referred to, however remote. The line has to be drawn somewhere, and it has been drawn at materiality”.