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An expensive lack of consent?

05 June 2020

By Dr Heidi Mounsey, medicolegal consultant, Medical Protection

 

Mr N, a 44-year-old chemical engineer, consulted Dr B seeking laser eye surgery in order to correct short sightedness. At that time, Mr N’s prescription was -6.00 in the left eye and -5.5 in the right. A mild degree of astigmatism was also noted. Mr N wore contact lenses and these provided adequate correction to his vision, with an acuity of 6/6 in both eyes.

However, Mr N reported to Dr B that he had been suffering with recurrent episodes of infection for the previous 16 months, making it difficult for him to wear the lenses. He was seeking an alternative to both contact lenses and spectacles.

Dr B took a medical history but did not appear to have elicited that a year previously, Mr N had been reviewed by a consultant ophthalmologist in his local hospital and been diagnosed with dry eyes. Mr N was prescribed lubricant drops at that time. This information was not documented in the history obtained by Dr B. There was also no contemporaneous note made in relation to whether Mr N’s tear film was normal, although in comments subsequently obtained from Dr B he stated that it was. It was not documented whether or not Mr N was using eye drops at the time of the consultation with Dr B, although a note was made of other medication.

Following discussion, Dr B considered that Mr N would be suitable for LASIK laser vision correction.

Mr N consented to bilateral LASIK surgery and this was performed without complication. The consent form was signed on the day of surgery and included the following risks:

•            Corneal scarring or haziness

•            Glare and halos

•            Infection

•            Ongoing need for glasses/contact lenses

•            Problems with the corneal epithelium causing pain or discomfort

•            Irregular healing of the cornea resulting in reduced quality of vision.

Dry eyes were not mentioned as a specific complication.

It was unclear from the medical records whether the patient had been provided with the consent form prior to the day of surgery. Mr N did, however, sign the consent form, including a statement to say that he understood that laser surgery would not prevent him from developing naturally occurring eye problems such as glaucoma, cataract, retinal degeneration or retinal detachment and that he understood if his myopia was corrected, then he would likely need reading glasses.

A week following the procedure Mr N’s vision was 6/10 in both eyes. Three weeks after the procedure Dr B considered there was evidence of punctate epithelial erosions bilaterally. He diagnosed dry eyes and inserted punctal plugs, as well as prescribing lubrication drops.

Some six months after the surgery Mr N visited his optician and his prescription was found to be +1.00/-1.75 in the right eye and -1.00/-0.75 in the left eye. Once corrected, Mr N’s visual acuity was 6/6.5 bilaterally.

Mr N expressed a desire for further correction and Dr B carried out LASEK treatment to the right eye. The consent form was signed on the day of treatment and contained similar risks to those listed for LASIK. Dry eyes were not specifically mentioned as a possible complication.

A month after the LASEK procedure Mr N complained that the vision in his right eye was very blurred. His refraction was noted to be +0.75/-2.75 with an acuity of 6/7. It was noted that his tear film was ok, but there is no record of whether or not Mr N was continuing to use lubricating drops.

Mr N continued to complain of difficulties with his vision with blurring and ghosting. It was also considered that the right eye had significant induced astigmatism following the LASEK procedure.

Ten months following the initial LASEK surgery, Dr B identified a posterior vitreous detachment in the left eye and Mr N underwent a left vitrectomy. Six months after this procedure his refraction was +1.00/-2.25 in the right eye and -1.25/-1.00 in the left eye. With correction, Mr N’s visual acuity was 6/6 in the right eye and 6/12 in the left eye, although this was noted to be variable.

Mr N continued to be followed up by Dr B, and two years after the initial LASIK procedure Mr N was noted to have bilateral lens opacities, more in the left eye than the right. Dr B discussed bilateral lens replacement using multifocal lenses. It was not clear in the medical records whether the option of a single focus toric lens was discussed with Mr N. In any event, Mr N opted to have bilateral multifocal lens replacements.

Following the lens replacements, Mr N’s visual acuity was 6/6 in the right eye, and 6/36 in the left, which improved to 6/20 using a pinhole. Dr B referred him to public health services for further review, at which point a left epiretinal membrane and an early full thickness macular hole were diagnosed. A left vitrectomy and membrane peel were performed without complications. Mr N remained under ophthalmology follow up in the public healthcare sector.

Three and a half years after the original LASIK procedure Mr N’s corrected visual acuity was 6/10 in the right eye and 6/38 in the left eye, although these acuities were noted to be highly variable with blinking. Uncorrected, his acuities were noted to be 6/15 in the right eye and 6/60 in the left. Mr N continued to complain of double vision and ghosting and that his vision was particularly poor in low light. The Schirmer tear secretion test was reduced in both eyes. It was considered that Mr N’s poor vision was due to a combination of poor pre-corneal tear film, especially in the left eye; induction of mild higher order aberrations associated with laser refractive surgery; reduced optics associated with multifocal intraocular lenses; and vitreous detachment and macular problems in the left eye.

The claim

Mr N subsequently brought a clinical negligence claim against Dr B alleging that it was a breach of duty to have performed bilateral LASIK, right LASEK, and bilateral multifocal lens replacement surgery, and that he had not been adequately consented for any of these procedures. It was alleged that the surgeries resulted in very poor unaided vision bilaterally, including ghosting effects and double vision, and that the contact lenses he now needed to wear could only be tolerated for three hours a day, leaving him with significantly limited vision for the majority of the time. He alleged he was no longer able to work as a chemical engineer due to the limitations of his vision.

Mr N alleged that, had he been more fully informed of the risks of any of the procedures he underwent, especially the risk of dry eyes in association with LASIK and LASEK, he would not have opted for the surgeries.

It was further alleged that there would have been signs of cataract at the time of offering the initial LASIK procedure and this would have been a contraindication to performing the surgery.

In addition, it was stated that aberrometry should have been performed prior to recommending multifocal intraocular lens surgery and that this would have demonstrated Mr N to be unsuitable for this procedure.

It was also alleged that although Mr N had suffered with complications likely unrelated to Dr B’s interventions, namely the posterior vitreous detachment, epiretinal membrane and macular hole, these had not impacted significantly on Mr N’s vision in his left eye. Mr N’s solicitors valued the claim, including loss of earnings, ongoing care needs and loss of pension, at a substantial amount. 

Expert opinion

The opinion of an expert consultant ophthalmic surgeon was sought following a detailed evaluation of the case by Medical Protection’s clinical and legal teams.

The expert highlighted the following:

•            A relevant history did not appear to have been taken by Dr B prior to advising and performing LASIK surgery. It was not noted whether Mr N had previously received any treatment in relation to his eyes or whether he was currently using any eye drops.

•            It was not clear from the medical records and the consent form that Mr N was fully advised of all the options available to him, including that of no surgery.

•            The consent form did not specifically include the risk of dry eyes following LASIK surgery.

•            It is unlikely that there were signs of cataracts in Mr N’s lenses at the time of the initial assessment by Dr B.

•            There was no consent form for the LASEK surgery in Mr N’s records, or evidence that the risks and benefits of this, and the other options available, were discussed with Mr N. 

•            Aberrometry should have been performed prior to recommending multifocal lens surgery. Had this been performed, it is likely Mr N would have been found to be unsuitable for this procedure. The use of multifocal lenses likely led to a worsening of Mr N’s quality of vision.

•            There were no consent forms in relation to the multifocal intraocular lens surgeries in Mr N’s records, and no evidence that the risks and benefits of such surgery (and the alternatives) were discussed.

•            Mr N’s vitreous detachment, epiretinal membrane and macular hole were not as a result of any surgery performed by Dr B and had made a significant contribution to the poor vision in Mr N’s left eye.

•            There were now surface abnormalities to Mr N’s right eye, which meant his vision could not be corrected with spectacles alone, and his dry eyes would make it more difficult for him to tolerate contact lenses.

Overall, the expert concluded that the consenting process for all procedures carried out by Dr B was inadequate, and that there was a failure to obtain a sufficient medical history and instigate appropriate tests to allow a fully informed discussion of the risks and benefits of the available options.

Outcome

After a conference and full discussion with the expert and Dr B, it was agreed that admissions of breach of duty in relation to consent for all the procedures and failure to perform aberrometry prior to offering multifocal lens exchange should be made in the response to Mr N’s solicitors.

Following this, a number of other experts were instructed by Mr N’s solicitors and by Medical Protection on behalf of Dr B in order to consider the impact of Mr N’s vision on his life, and the past and future financial losses incurred.

Expert opinions were sought in the areas of care and assistance, loss of earnings and pension loss, as well as ophthalmology and optometry.

Medical Protection was able to use the statements produced by these experts to argue that Mr N would always have suffered a left vitreous detachment, epiretinal membrane and macular hole. It was put to Mr N’s solicitors that these non-negligent events did make a significant contribution to the reduction in the vision of Mr N’s left eye.

It was further argued that there would not have been signs of cataracts at the time of the initial assessment, and therefore no contraindication for LASIK on that basis.

Medical Protection therefore considered that the claim was worth significantly less than alleged by Mr N’s solicitors, given that much of the reduced vision in Mr N’s left eye was not as a result of any procedure carried out by Dr B.

Following the admissions of breach of duty, but in light of the discrepancies in relation to causation and the value of the claim, it was agreed that Medical Protection and Mr N’s solicitors would attend a meeting, in the presence of an independent mediator, in order to determine if the matter could be settled without the need for a trial.

The meeting led to settlement of the matter for over a third less than was originally claimed, and successfully avoided the need for Dr B to attend court, at which he would have been required to give evidence in relation to the treatment he provided and the consent process he had undertaken.

Learning points

•            When taking a history, important negatives should be documented as this will help prevent any future allegations that the questions were not asked or that particular aspect of the patient’s history was not explored.

•            Ensure patients are provided with all the information they will need to make a considered decision, including the consent form, prior to the day of the surgery. A suitable cooling off period should also be given. In this case, although a month had elapsed between the consultation and the original LASIK surgery, it was unclear whether the patient had had the opportunity to fully discuss the risks and benefits of the available options and review the consent form in advance of the procedure.

•            If using a pre-printed consent form, ensure the appropriate risks are included on this and, if not, ensure that it is clearly documented when the patient is advised of a risk not listed on the form.

•            Ensure the necessary investigations are conducted and the results reviewed before deciding whether a procedure would be suitable for a particular patient.

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