QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL |
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B e f o r e :
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Claimant |
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EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST |
Defendant |
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Anna Hughes (instructed by Clyde & Co LLP) for the Defendant
Hearing dates: 21st, 22nd and 25th April 2016
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Crown Copyright ©
MR JUSTICE JAY:
Introduction
Essential Factual Background
"→converted to PPV [pars plana or primary vitrectomy], tissue cleared and retinectomised. →heavy fluid leaking through punctured site.
→attempted repair/suture. →unable to close because of tissue abnormality, tried plugging internal hole with retinal tissue, worked temporarily then leaking.
→attempted 360 retinectomy and heavy liquid up to arcade (vascular). →bleeding and loss of view due to corneal stromal oedema.
→closed with heavy oil. →sutured with 7.0 vicryl (sclerostomy port). →eye soft at the end of surgery."
The Operative Procedures Simply Explained
The Lay Evidence
"There was at the time (and in fact still is) a significant debate within the vitreoretinal surgical community as to the most appropriate means of treating retinal detachment in patients with EDS. There is not a one size fits all approach and therefore a surgeon must assess the individual facts of a case and consider them in conjunction with the advantages/disadvantages of the available surgical procedures before deciding any course of action.
In this case I considered that the "cryo buckle" technique was most appropriate as the retinal detachment was associated with an attached vitreous and atrophic retinal holes. In addition, the alternative "vitrectomy" procedure could have in turn induced multiple large new tears in the retina. The latter was especially relevant in this case as the Claimant had very poor visual acuity in his right eye."
"Before the Claimant's surgery on 7th September 2010 the Claimant was seen both by myself and my colleague Mr Schultz, consultant ophthalmologist. We both decided and agreed on the "cryo/buckle" technique for the operation as the Claimant suffered from an inferior retinal detachment secondary to a myopic atrophic hole with vitreous attached. We felt strongly that this procedure was necessary as his detachment was inferiorly located and advancing towards the macula.
I was aware of the fragility of the sclera in patients with EDS. This is an issue well recognised by vitreoretinal surgeons and we did consider whether an alternative technique, i.e. the vitrectomy technique would be suitable for the Claimant.
We came to the conclusion that under the clinical circumstances the "cryo/buckle technique" was the most appropriate procedure. Essentially, the anatomical positions of the retinal holes were within easy reach for the "cryo/buckle" technique. Also, as the Claimant had a young eye with attached vitreous the risk of causing multiple iatrogenic retinal tears with the "vitrectomy" was high; patients with collagen disease tend to have an abnormal vitreoretinal interface."
"In any event, I spoke to the Claimant prior to the operation and examined his eye. Upon examination I noticed an atrophic retinal break with attached vitreous. Also of relevance was the fact that examination of the sclera did not reveal any abnormalities or any areas of obvious thinning."
The Expert Evidence
The Evidence of Mr Rosen
"The surgeons considered pre-operatively that someone with EDS may have scleral fragility and therefore chose a procedure … which was going to be associated with more risk in this situation than vitrectomy. There was no advantage in carrying our scleral buckling, only disadvantage."
"… there is no general consensus on the best surgical approach. Recent trends seems to favour PPV over SB, especially for pseudophakic RRD. It is suggested that PPV affords a better ability to visualise all retinal breaks and tears and removal of media opacities and synechiae. Arguably, PPV also offers an opportunity to relieve the vitreous traction that is believed to result in a breach in the retina leading to a retinal detachment. With the advances of smaller-gauge … sutureless vitrectomy techniques, surgical trauma is less … However, PPV is also associated with higher rates of lens trauma, cataract progression, PVR, and iatrogenic breaks and requires postoperative patient positioning. Scleral buckling surgery has long been considered the "gold standard" in treatment of uncomplicated RRDs. Final anatomic success rates have consistently been rated as greater than 94% … Commonly reported complications of SB include [these are listed]"
It should be added that the Claimant's atrophic holes did not entail, or cause, traction of the vitreous.
"A RRD must be treated with a scleral buckling procedure or vitrectomy combined with gas or silicone oil tamponade, as for non-highly myopic retinal detachment. Scleral buckling is the first choice for retinal breaks with non- or minimal vitreous traction and vitrectomy for significant traction from the vitreous."
"The number of cases of EDS are small. The number of cases of RRD in EDS are even smaller. I am basing myself on clinical logic."
"If EDS is present without substantial scleral thickening, RRDs can be successfully rehabilitated by episcleral buckles. If scleral thinning ("blue sclerae") occurs during EDS [NB. this paper has been poorly translated from the German. This should read, "as a result of EDS"], then the buckle procedure invariably results in loss of vision or the eye due to scleral lacerations and choroidal haemorrhage."
The Evidence of Mr Cooling
"Scleral thinning is commonly encountered in the pathological or highly myopic eye and is often found to be localised and directly related to the area of retinal pathology. Pathological myopia does not exclude an external approach but is associated with an increased risk of scleral rupture or suture penetration at the time of surgery.
Scleral thinning and friability of the sclera associated with inherited connective tissue disorders and scleral inflammatory disorders is also recognised as a significant risk factor in rupture of the sclera in the course of retinal reattachment surgery (Tabandeh et al)
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The nature and extent of the scleral thinning and friability discovered in the Claimant at the time of the original surgery is unclear from my reading of the operative record and other documentation."
The Claimant's Case
The Defendant's Case
The Governing Legal Framework
"In matters of diagnosis and the carrying out of treatment, the court is not tempted to put itself in the surgeon's shoes; it has to rely upon and evaluate expert evidence, remembering that it is no part of its evaluation to give effect to any preference it may have for one responsible body of professional opinion over another, provided that it is satisfied that both qualify as responsible bodies of medical opinion."
Formulation of the Issues to be Determined
(i) did the Claimant have a PVD in his left eye in August 2010?
(ii) (only if the answer to (i) is "yes"), was it generally understood in the ophthalmic community in 2010 that EDS Type III carried with it a risk of a friable sclera?
(iii) was that risk such that it was Bolam negligent not to perform a primary vitrectomy?
Discussion, Findings and Conclusions
Issue 1: did the Claimant have a PVD in his left eye in August 2010?
Issue 2: was it generally understood in the ophthalmic community in 2010 that EDS Type III carried with it a risk of a friable sclera?
Issue 3: was that risk (sc. of scleral friability) such that it was Bolam negligent not to perform a primary vitrectomy?
Disposal