Summary

The Claimant alleged that the Defendant acted negligently in obtaining her consent for laser eye surgery including failing to adequately investigate her ophthalmic condition prior to the surgery.

Learning points

Learning points for experts

• The relevant guidance, consenting practices and professional understanding are those which were current at the time of the alleged negligence.  

• When considering whether to accept an instruction, carefully consider your expertise and experience in the matters for expert evidence.

• If appropriate, make sure you explain clearly to your instructing party how any limitations in your expertise and experience could limit your ability to provide expert evidence on any of the issues in the case.

• If the opposing expert has greater expertise or experience than you in a matter for expert evidence, make sure your instructing party understands that the opposing expert’s evidence may carry more weight with the court on the point or points in question.

Learning points for instructing parties

• Try to instruct the expert witness with the most specific expertise and experience you can in the matters for expert evidence.

• A judge will often prefer practical, hands-on experience over academic research, although this will not always be the case.

• If the opposing expert has greater expertise or experience than your expert in a matter for expert evidence, make sure you discuss this with your expert so that you understand how it might impact the relative strength of their respective evidence.

The case

The Claimant alleged that the Defendant acted negligently in obtaining her consent for laser-assisted in situ keratomileusis (“LASIK”) laser eye surgery on 10 March 2016. There was no allegation that the surgery was performed negligently.

The claim included the allegation that the Defendant failed to adequately investigate the Claimant’s ophthalmic condition prior to the LASIK surgery. The Claimant suffered with dry eye problems and developed chronic corneal pain which had a substantial and disabling effect on her daily life.

The Defendant’s consenting process

The Defendant’s consenting process commenced with a letter to the Claimant enclosing a leaflet entitled “Your Guide to Refractive Surgery” and a “Patient Questionnaire and Registration Form.” After filing out the Questionnaire, the Claimant was assessed by an optometrist and had an examination and discussion with the Defendant, and was then sent a consent form, which she signed at the clinic on the day of the surgery.

The Claimant's evidence

The Claimant stated that she had not been asked any questions about the “possible dry eyes” condition she had stated on the Questionnaire. She said that the Defendant assured her that the surgery was safe. She had read the Guide quickly and had not read the consent form before signing it.

The Defendant’s evidence

The Defendant accepted that he did not have a good memory of his initial consultation with the Claimant and his statement was based on his treatment records and his usual  practice. He said that he would have noted that Claimant’s “possible dry eyes” comment in the Questionnaire and would have examined her for dry eyes as a result. He considered that he would have concluded that she did not suffer from dry eyes.

He said that he would have told the Claimant about the risk of suffering dry eye symptoms after surgery and that these were the most common complications after LASIK, as he did this with every patient. He would also have asked the Claimant if she had read the consent form.

The Ophthalmic Experts

Simon Walker acted for the Claimant. Mr Walker is a general ophthalmologist who had never performed laser eye surgery. He said that he could comment on the Defendant’s assessment, the Claimant’s suitability for any general ophthalmic surgery and the consent process but accepted that he was unable to comment on the surgery itself or what a reasonable body of LASIK surgeons would do, as he was not a LASIK surgeon.

Robert J Morris acted for the Defendant. Mr Morris is a LASIK surgeon who had performed over 10,000 laser procedures and had undergone the procedure personally in 2017.

Dry eyes and meibomian gland disease

Mr Walker’s view was that the Claimant had dry eyes and meibomian gland disease before the surgery and that these difficulties were exacerbated by the LASIK. The Claimant’s pain is neurological caused by the interruption of the nerves during surgery.

Mr Morris agreed that the Claimant’s issues were neuropathic, but did not consider that the Claimant had a dry eye condition or a meibomian gland disease prior to surgery, based records of her 24 appointments at Boots. He concluded that the Claimant’s dry eye symptoms were likely to be the result of her corneal neuralgia, rather than a worsening constitutional dry eye condition. He also disagreed that the Claimant’s meibomian gland disease was caused or contributed to by the LASIK surgery.

Obtaining consent

The experts agreed that consenting a patient is a process, which in this case started with the Guide and concluded with the signed consent form.

Mr Morris considered that the information set out in the consent form provided sufficient information because it stated that “dry eyes could be permanent and require frequent and long-term treatment.” His view was that the risk of corneal neuralgia was (and remains) unknown; he had never encountered a case in the 10,000 surgeries he had performed. He underwent LASIK surgery himself in 2017, and was not consented for corneal neuropathic pain, while the clinic where he worked did not include this in its consent form in 2016. In his view, a reasonable body of ophthalmic surgeons would not have advised of the risk of severe and permanent corneal neuralgia when consenting for laser surgery in 2016.

Mr Walker considered that merely saying there was a risk of dry eye and leaving it at that tended to downplay the impact of the nerve damage induced severe end of the worst discomfort pain outcome. He accepted that referring to corneal neuralgia in 2016 would been the “gold standard” and the failure to use the terms during the consent process would not amount to a breach of duty but stood by his opinion that at a minimum there should have been a reference to “severe dry eyes which could be difficult to treat” on the basis that patients have a right to know the worst case scenario. He described a satisfactory description of this risk at the time as “we don’t have a figure. It has been described as uncertain, and we are learning more about it.”

Mr Morris noted that at the time of the Claimant’s operation, The Royal College of Ophthalmologist’s “Patient’s Guide to Excimer Laser Refractive Surgery” did not refer to the risk of corneal neuralgia or to permanent dry eye problems. In his view, the Guide and the consent form, coupled with an informed dialog between the surgeon and the patient would have been an appropriate consent process in 2016.

The law

The parties agreed that the applicable law was set out in Montgomery v Lanarkshire Health Board [2015] UKSC 11. The twofold test in this case was described in the a later case as:

• What risks associated with an operation were or should have been known to the medical professional in question. That is a matter falling within the expertise of medical professionals

• Whether the patient should have been told about such risks by reference to whether they were material. That is a matter for the Court to determine. This issue is not therefore the subject of the Bolam test and not something that can be determined by reference to expert evidence alone.

The judge’s view

The judge considered that there were two key matters for expert evidence:

1. What was known in 2016 about the relevant risks of LASIK?

The judge found that in 2016, responsible LASIK surgeons would have known that there was a risk of a patient with the Claimant’s risk profile suffering severe permanent dry eyes which would be difficult to treat, but this risk was very small, the exact mathematical risk being unknown.

2. Was the Defendant negligent in failing to identify that the Claimant was a high-risk patient?

Mr Walker’s view was that the Claimant was a patient with a higher risk of suffering complications that average due to underlying dry eye condition with meibomian gland disease, as well as anxiety and depression.

Mr Morris considered that the Claimant was a patient with low risk, due to her young age and the low eyesight correction that was required. Her history of anxiety and depression was not a matter that necessitated special consideration by the Defendant.

The judge found Mr Morris’ evidence more helpful than Mr Walker’s because, as a highly experienced LASIK surgeon he was able to opine from personal experience, while Mr Walker relied on his experience as a general ophthalmic consultant and his academic research. The judge preferred Mr Morris’ evidence that the Claimant was not a high risk patient given the small correction to her eyesight that was required. He accepted his evidence that anxiety and depression are common in people seeking laser eye surgery and do not significantly increase risk. He also preferred Mr Morris’ evidence as to the date of onset of the Claimant’s meibomian gland disease, which was supported by the Boots records.