Foreword by Paul Riordan-Eva FRCOphth
Consultant ophthalmologist and MDU president
Although there is continual progress in ophthalmic practice, there are some common features to claims brought against MDU ophthalmologist members over the period of this analysis. Allegations often centre on inadequate consent, unexpected intra-operative and post-operative complications, unfulfilled patient expectations and delayed diagnosis.
It goes without saying that an uncomplicated operation with the expected successful outcome should not result in a clinical negligence claim. However, an unexpected, non-negligent complication that has been dealt with appropriately may still do so.
Claimants often allege that if adequately warned they would not have consented, and so robust documentation is a mainstay in successfully defending such claims. Before any procedure, the surgeon needs to record what information about potential risks has been provided.
The related case study exemplifies the importance of obtaining the patient's informed consent, including the remote possibility of serious sight-threatening complications, such as endophthalmitis. In the event of complications there needs to be prompt appropriate explanation and remedial action - but also corresponding documentation.
This analysis also reminds us that ophthalmology claims can be expensive, not least due to the legal costs. But for the individual doctor, the greater impact usually arises from the personal and professional ramifications.
The MDU has well over 1,000 members currently working in ophthalmology in the UK. Every year we advise or assist hundreds of those members facing issues ranging from regulatory investigations, service complaints, performance concerns, inquests and tricky medico-legal or ethical scenarios.
We also see one or more new ophthalmology clinical negligence claims notified to our claims handling team on an almost weekly basis. This article focuses on the factors driving litigation in the specialty.
A claim for clinical negligence can be brought at any time, often without warning and sometimes many years after the incident occurred. They can result from a number of causes and are not always related to surgical error.
Informed consent, dissatisfaction with the outcome and delayed diagnosis were a feature of many cases in our study of ophthalmology claims. Managing such risks is important in avoiding future claims.
While claims numbers have remained steady in recent years, the cost of claims has spiralled. This is not due to clinical standards but to a deteriorating legal environment which the MDU is campaigning to reform (you can read more on this more at themdu.com/faircomp).
The levels of compensation paid in clinical negligence claims bear little or no relation to the seriousness of the allegations. Instead, they reflect the cost of restoring the claimant to the position they would have been in if the negligence had not occurred.
When a claim is settled and damages are paid, we are also required to pay the claimant's legal costs. These can be disproportionately high and can significantly exceed the amount of damages paid.
For example, in a claim involving alleged failure to diagnose acute retinal necrosis resulting in loss of vision in a single eye, the damages paid were £125,000 while the claimant's legal costs were £150,000. This demonstrates how expensive defending and settling claims can be.
Nevertheless, over a ten year period, we successfully defended nearly 80% of ophthalmology claims made against members without paying compensation or claimant costs. The highest value settlement in the period (compensation and legal costs) was for around £1 million, from allegations of failure to appropriately monitor a patient following a Phakic lens implantation.
We will defend claims whenever possible and always involve members in how their cases are conducted, as well as the decision on whether to defend or settle a case.
Outcome of cases
Claims that were not settled were either won, discontinued by the claimant or statute barred.
A claim is statute barred if the claimant fails to bring a claim within three years from the date of the incident or the date of their knowledge of the alleged harm. This restriction does not apply to children with capacity, for whom the limitation period begins at 18 (16 in Scotland). There is no time limit for patients who lack capacity to conduct their own affairs.
Some claims were initially investigated by the MDU but successfully argued to not involve an MDU member.
Photo credit: iStock
Outcome of claims in the analysis
- Closed/discontinued - 53%
- Settled - 22%
- Statue barred (out of time) - 22%
- Won at trial - 0.5%
- Other - 2.5%
Over a ten year period, we successfully defended nearly 80% of ophthalmology claims made against members without paying compensation or claimant costs.
Reasons for claims
Most common reasons or procedures leading to claims:
- Cataract surgery - 39%
- Laser refractive surgery - 8%
- Retinal detachment - 8%
- Failure to get consent - 6%
- Delayed/wrong diagnosis - 5%
- Glaucoma - 5%
- Blepharoplasty - 3%
- Squint - 2%
- Other - 24%
By far the most common procedure leading to claims was cataract surgery, which accounted for over a third of cases. The highest amount paid in compensation and legal costs was over £700,000, in a case which also involved allegations related to glaucoma.
Common reasons for cataract claims were intra-operative and post-operative complications, resulting in deterioration of vision or the need for further corrective procedures. Post-operative infection was also a common factor, as was rupture of the posterior capsule.
Other claims involved equipment failure during surgery, incorrect medication provided post-surgery and claims for insertion of the incorrect lens.
Laser refractive surgery
The reasons for claims in this area ranged from inadequate consent and failure of treatment, to dissatisfaction with the results and post-operative complications. This highlights the importance of a stringent consent process and a realistic discussion of the risks and likely benefits of such procedures.
Allegations relating to issues of consent were directly involved in a number of cases in our analysis, but inadequate consent was also a common allegation in many other claims. In most cases, the informed consent related to allegations that if the surgeon had adequately explained the risk of the procedure, the patient would not have chosen to undergo the treatment, or may have done so at a later time.
Around a third of these cases were settled, highlighting the continued importance in making sure the patient provides proper informed consent - and that this is appropriately documented. These claims can be significant, with some settlements coming in at more than £150,000.
- In one settled case the claimant alleged there was inappropriate consent for a combined vitrectomy and cataract surgery. The claimant argued they would have preferred the procedures performed separately, as the operation had unintended consequences and they lost vision.
- However, the MDU argued on the member's behalf that the claimant would have needed the surgery in any event and that they were in part responsible for not attending follow up. The compensation was reduced as a result, although the legal fees exceeded the amount the patient received.
Failure to diagnose, delayed diagnosis and inadequate treatment of glaucoma all resulted in claims. Often, cases arose after cataract surgery, or were related to allegations of mismanagement and treatment of glaucoma.
Delay or incorrect diagnosis
Around half of allegations of a delay or incorrect diagnosis were about a missed tumour. This highlights the importance of ensuring that the examination of the eyes is considered holistically and that impairment of visual fields and acuity should be considered in light of pathology outside the eye.
Claims involving ophthalmologists are made for a wide variety of reason, but there are some common risk factors, which can help to reduce risks if managed appropriately.
- Check patients understand the potential risks and benefits of the procedure, in order to give their consent.
- Provide written information leaflets if possible. This may help the patient to remember what was said in a consultation so they can reflect on it later in their own time.
- Document discussions with patients and the consent process clearly.
- Be aware of relevant guidance, such as from the GMC on consent, royal college guidance and NICE guidelines.
- Ensure you have the appropriate training and experience to carry out a procedure. Consider referral to a specialist in those cases that fall outside your skill set or knowledge.
- If things go wrong, be transparent with the patient by providing an explanation of what has happened and the likely short- and long-term effects of this. Say sorry and get advice from the MDU if you believe the incident triggers the organisation's duty of candour requirements.
Infection following cataract surgery
The following anonymised case example illustrates the type of scenario that can evolve into a clinical negligence claim.
A member was notified of a claim from a former patient alleging he had performed inappropriate cataract surgery, which resulted in post-operative complications causing considerable loss of vision in one eye.
The patient had a history of COPD, which had worsened around the time of the procedure. While still in hospital, the patient had started to suffer pain in his eye and was discharged and advised to take simple analgesia and use topical steroid drops.
A few days later, the patient returned to hospital because of worsening vision. A vitreous aspiration was performed and a provisional diagnosis of infective endophthalmitis was made.
The patient was treated with intravitreal antibiotics and was monitored in hospital, where it was later decided he required a vitrectomy. He never fully recovered his vision in the affected eye.
The subsequent claim alleged that the member should not have performed the surgery while the patient was unwell with COPD, that he failed to diagnose the post-operative infection fast enough, and that he should not have allowed the claimant to be discharged home. The claimant was seeking around £500,000 in compensation.
Experts instructed by the MDU were not critical of the member for operating at that time, although acknowledged that consent and the records could have been more detailed. In the experts' view, the claimant may have suffered from a sterile inflammation, rather than infective endophthalmitis.
We were also able to show that the member's post-operative management was appropriate and lodged a defence to the claim denying negligence on this basis. In light of this, the claim was discontinued by the claimant's solicitors.