“Mr Mills was admitted with a 6-8 month history of headaches. He was found to be hypertensive with a BP pf 187/105 on admission. His creatinine was 180 on admission and the patient was reviewed by the renal team who started him on diltiazem. Systolic was 160 on discharge.”
“31.10.12 – Left frontal intrinsic lesion – Glial ?Grade3”
“For outpatients appointment with Mr Plaha and offer resection”
“Diagnosis: Left frontal likely low-grade glioma. Plan: Offered endoscopic resection and Mr Mills is keen to proceed. It was a pleasure to see Mr Mills and his wife in the neuro-oncology outpatient clinic today. Anne May, our Oncology Nurse Specialist was also present. Mr Mills presents with a long-standing history of headaches especially when lying down. He has had this for a number of years. As he felt the pressure symptoms in his headaches has got worse recently and he was taken to Wexham Park Hospital where he was diagnosed as having hypertension and is presently on Diltiazem. For the past couple of weeks he has noticed numbness and tingling in his left finger. He has no long-standing nausea, vomiting or visual disturbance. Although he says his vision is funny when he watches television nor sees bright light. He has had no seizures. His gait function is unchanged. He works as a fire-fighter He had operation on his knee three years ago. On examination he has no motor deficits. He had a CT and MRI scan of the brain performed on 31st October at Wexham Park Hospital. I showed him the scan images and explained that the lesion in the medial part of the left frontal cortex is likely a low-grade glioma. Although other possibilities like inflammation cannot be completely explored excluded. I went through the natural history of gliomas and treatment options which are (imaging surveillance, biopsy and endoscopic resection). I went through the risks and benefits of each in detail. Given the likely possibility he is quite keen to have this debulked and I went through the risk of a craniotomy and endoscopic debulking including a small risk to his life, severe disability including paralysis/stroke, cognitive and memory disturbance, speech disturbance, infection, bleeding, CSF leak, seizures, loss of smell on the left side, DVT, PE, pneumonia and other undefined risks. I have put these risks at 2-3%. He has mentioned problem with his short-term memory which is long-standing and I offered him an objective neuropsychology assessment which he is unkeen to have at the moment. I have advised him not to drive and inform the DVLA. I have added his name to the waiting list and I will bring him in for surgery soon.”
“Still has headaches. Not worse. [Glasgow Coma Scale] – 15/no deficits”
“Rediscussed Treatment Options”
“- Explained sequence of events in theatre Blood vessel within tumour retracted at time of debulking tumour -. Blood loss requiring transfusions -. Bleeding controlled by finding retracted blood vessel originating from wall of major artery (Pericallosal) -. Assisted by Mr Cadoux Hudson/Griffiths -. At closure major artery (Pericallosal) flowing well and pulsating -. At closure [normal] brain pressure 81. Presently plan to keep asleep overnight on ventilator -. Plan for angiogram in the morning -. Difficult to predict outcome 84. Could have a stroke – paralysis / speech / cognitive / memory disturbance -. May require further interventions tonight / tomorrow -. Will update her on Mr Mills’ progress”
“I myself would prefer to put it this way, that he is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art. … Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view.”
“It is therefore insufficient for a Claimant to demonstrate only that there exists a body of competent expert opinion which disagrees with the judgment which was taken upon the facts of the present case. This is no more than a recognition of the fact that in an area where professionals exercise a high degree of technical and medical expertise that there may be a range of different views all of which might quite legitimately be held about the same matter. Accordingly, if there exists a body of competent professional expert opinion which supports the decision as reasonable in the circumstances it matters not that other experts might disagree.”
“Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other: but that is no basis for a conclusion of negligence.”
“…in cases of diagnosis and treatment there are cases where, despite a body of professional opinion sanctioning the defendant's conduct, the defendant can properly be held liable for negligence (I am not here considering questions of disclosure of risk). In my judgment that is because, in some cases, it cannot be demonstrated to the judge's satisfaction that the body of opinion relied upon is reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular, where there are questions of assessment of the relative risks and benefits of adopting a particular medical practice, a reasonable view necessarily presupposes that the relative risks and benefits have been weighed by the experts in forming their opinions. But if, in a rare case, it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible. I emphasise that in my view it will very seldom be right for a judge to reach the conclusion that views genuinely held by a competent medical expert are unreasonable. The assessment of medical risks and benefits is a matter of clinical judgment which a judge would not normally be able to make without expert evidence. As the quotation from Lord Scarman makes clear, it would be wrong to allow such assessment to deteriorate into seeking to persuade the judge to prefer one of two views both of which are capable of being logically supported. It is only where a judge can be satisfied that the body of expert opinion cannot be logically supported at all that such opinion will not provide the benchmark by reference to which the defendant's conduct falls to be assessed.”
“To report a minimally invasive, nontubular endoscopic technique to resent intraparenchymal brain tumours and assess the feasibility, safety, and surgical resection margins achievable by this novel technique.”
“Our technique is significantly different from techniques described in previously published series because we do not use a rigid tubular conduit. A tubular conduit maintains the access corridor but exerts constant circumferential pressure on the adjacent, already swollen white matter fascicles in the vicinity of the tumour. … Our nontubular technique allows one to exert dynamic rather than constant pressure on the surrounding brain tissue, which continues to pulsate freely and maintain adequate perfusion. An access corridor not limited by a conduit increases flexibility and allows better manipulation of surgical instruments.”
“The advantage of using an endoscope is that it allows me to operate through a standard mini-craniotomy, a relatively smaller opening in the skull, rather than having to perform a full craniotomy – cutting and removing a larger section of bone. This is preferable both cosmetically and in facilitating a reduced recovery time given the less invasive approach. There is inherent morbidity associated with a larger incision but each neurosurgeon will have his preferred extent of access and technique. The alternative to using an endoscope would have been to use a surgical microscope combined with a more extensive craniotomy. The advantage of this option is that a microscope produces a stereo or three dimensional image whereas an endoscope, which only has one lens, necessarily produces a mono, two dimensional image but like the microscope this is a HD (high definition) image and has a better illumination than the microscope. However, with advanced endoscopy training experience, the difference in quality of visualisation between these approaches is, in practice, not relevant to an experienced and trained endoscopic surgeon. It would be similar to the choice between a telescope and binoculars; both enable you to have a clear view of the object that you want to see but the way your brain receives the image is different and the object itself does not change.”
“The substantially enhanced illumination from the divergent endoscopic light source, the proprioceptive feedback during bimanual resection, and the dynamic movement of the endoscope compensate for the loss of binocular visions. As suggested by Kassam et al, with experience, one develops a 3D perception relying on tactile feedback.”
“Mr Kirkpatrick has great difficulty in understanding how this technique can afford any gain whatsoever. He feels that the technique would only increase the operative risk over and above the standard surgical method. … He did not feel it was a reasonable approach to what traditionally is a very simple operation easily achievable in 1 to 2 hours. His concerns have been voiced by others in the literature (see commentary on Plaha’s publication: Is there a place for endoscopy in glioma surgery; Duffau. World Surgery 2014; 82: 1020-1022) where the high complication rate arising from Plaha’s series is discussed, and the cited claims in favour of the endoscopy method challenged.”
“A specialist neurosurgeon who spends at least 50% of his or her clinical programmed activities in neuro-oncological surgery and is regularly involved in dedicated specialty clinics caring for these patients.”
“In this issue of WORLD NEUROSURGERY, Plaha et al, (18) report a series with 50 consecutive fully endoscopic intraparenchymal tumor resections – most of them being a glioma. More than 95% resection was performed in 70% of patients with total resection in 48% of cases. The investigators conclude that minimally invasive endoscopic resection is technically feasible and allows the achievement of good tumour removal. They have to be congratulated for their favorable results. It is important to add new tools to the armamentarium against gliomas. However, a few issues should be extensively discussed before to claim that endoscopy has some advantages versus a traditional technique.”
“I did not cross the midline to the right side of the brain at any point during my surgery to access the tumour as my approach was along the superior frontal gyrus down to the anterior cranial fossa floor as set out in my operation note, ie to approach the tumour from the direction of the patient’s forehead towards the tumour. If I had crossed the midline, my neurosurgical colleagues would have been aware of this when they came in to assist me when surgical complications arose. Also, by this stage of the operation I had got confirmation from the neuropathologist that the sample of brain I had sent them was in fact tumour which was on the left side of the brain, indicating that I had performed the correct trajectory to reach the tumour. … Around two hours into the operation, and whilst using the CUSA to debulk the tumour, I encountered bleeding from the medial part (middle) of the tumour. … Having reflected on the reason for the continual bleeding, I can only surmise that there was a blood vessel going through the middle of the tumour itself, something which could not have been identified in advance as it was not visible. I reach this conclusion owing to the source of the bleeding appearing to be the tumour itself. If I had somehow ‘nicked’ a blood vessel before getting to the tumour, the bleeding would have started earlier, not midway through the debulking part of the surgery. … I was unable to visual the bleeding blood vessel precisely. I suspected that it may have retracted deeper into the brain as blood vessels can do as they are elastic.”
“Having reviewed the original pre-operative MRI scans, I have estimated that the pericallosal origins in the region of the anterior communicating artery, are approximately 3 cms away from the deepest portion of the tumour. It is difficult to envisage that this vessel has been damaged by means of tumour debulk within the anatomical confines of the tumour as displayed on the MRI scan. In other words, the plane of dissection was likely to have been significantly outside the anatomical confines of the tumour. … As an individual dealing with vascular pathology on a day-to-day basis, the overwhelming likelihood of Mr Mills’ anterior cerebral territory infarcts was a consequence of direct manipulation of those vessels, or high pressure caused by the haematoma secondary to the bleed, the secondary swelling within the frontal lobes which required salvage surgery, and the direct attempts to abate the frontopolar artery. It would be physiologically impossible for Flowseal or any other agents to migrate their way into the pericallosal as suggested by Mr Plaha in his witness statement, but I do accept the possibility of vascular spasm and the influence of mechanical distortion of the left pericallosal artery during the attempts to stop it bleeding. According to the witness statements, the pericallosal arteries were not involved in the salvage surgery, and the midline was not transgressed. If the Court accept this to have been the case, the only explanation for infarcts affecting that territory would have been indirect pressure to the pericallosal arteries caused by the haematoma and subsequent brain swelling. On balance, this would have been avoided with timely control of the avulsed fronto-polar artery.”
“The experts had considerable difficulty understanding the exact mechanism. Their discussions are of course speculative. We both agreed that the descriptions would be in keeping with a branch coming off the pericallosal artery which is in the midline. The description with Mr Griffiths’ involvement is that the avulsed frontopolar branch must have originated from the pericallosal artery very close to the anterior communicating complex where the hole in the side of the pericallosal artery was found. This was a considerable distance away from the posterior limits of the tumour. The experts had difficulty in envisaging this happening if the dissection remained within the confines of the tumour but Mr Grundy felt it possibly resulted from damaging a branch in a sulcus within or at the margins of the tumour.”
“Liability in cases such as this depends upon the Court being satisfied on a balance of probabilities that the defendant fell below the requisite standard and that the negligence was causative of the damage sustained. In the overwhelming preponderance of cases the facts involve a number of singular events which enable the Court with confidence to come to a clear conclusion about causation and breach of duty. However, if the evidence is equivocal, uncertain or inadequate or leaves too many loose ends, then it is no part of the judicial function to decide a case upon the basis of a hunch, educated guess or gut feel. In such cases the only correct result is that the Claimant has not proven the case to the required standard and the claim necessarily fails.”
“The correct position, in relation to the risks of injury involved in treatment, can now be seen to be substantially that adopted in Sidaway by Lord Scarman, and by Lord Woolf MR in Pearce, subject to the refinement made by the High Court of Australia in Rogers v Whitaker, which we have discussed at paras 77-73. An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”
“89. Three further points should be made. First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient. 90. Secondly, the doctor's advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor's duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form. 91. Thirdly, it is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests.”
“A person can of course decide that she does not wish to be informed of risks of injury (just as a person may choose to ignore the information leaflet enclosed with her medicine); and a doctor is not obliged to discuss the risks inherent in treatment with a person who makes it clear that she would prefer not to discuss the matter.”
“Mr Plaha discussed the results of the scan with us. He advised that a tumour had been found in the front of Adrian’s brain. He explained that it was a slow growing tumour and had probably been growing for a couple of years. Mr Plaha asked if Adrian had suffered any seizures or blackouts. We both confirmed that he had not. Mr Plaha seemed surprised that Adrian had not experienced any seizures or blackouts and said that due to the location of the tumour he thought that Adrian would have been experiencing seizures and/or blackouts. Mr Plaha brought up the scan results on his computer and pointed to the scan to show Adrian and I the location of the tumour. He explained that the tumour was in the frontal lobe and said that the location of the tumour meant that it needed to be removed. Adrian and I were both extremely concerned that the tumour was cancerous. We asked Mr Plaha if the tumour was cancerous. Mr Plaha said that he would not know if it was cancerous until a biopsy had been taken. I recall Adrian saying that he would like a biopsy to be taken. Mr Plaha said that a biopsy could be undertaken to ascertain whether the tumour was cancerous but he said words to the effect that the tumour would still have to be removed at a later date regardless of whether it was cancerous or not so he might as well remove the tumour at the same time as taking a biopsy. At no point did Mr Plaha offer surveillance. There was no suggestion at all that we could simply watch and wait. My impression was that the tumour must be removed and a resection was necessary. Adrian was not given any option regarding surgery. I recall that Mr Plaha discussed the debulking procedure with us and told us that an endoscope would be used. Not being medically aware neither of us knew what an endoscope was. Mr Plaha explained that he would open up the front part of Adrian’s skull to remove the tumour. Mr Plaha did not tell us that there were different ways to perform the surgery nor did he say anything about the surgical technique being new, novel or exploratory in nature. Adrian was not given any option about how he would like the surgery performed. He was simply told how it would be done. Mr Plaha told us that the tumour was accessible because it was at the front of the brain. He said the surgery was straightforward and should only take two hours. He told us that Adrian would be in recovery for 4 to 5 hours after the surgery because the surgery would be performed under general anaesthetic. Adrian asked Mr Plaha how long he would be off work. Mr Plaha said that he would be off for no more than 6 to 8 weeks. I recall that he advised Adrian not to drive for a period of time after the surgery. Mr Plaha mentioned risks. He said that there is always a risk with any kind of surgery but I remember him saying because of the location of the tumour, it was easily accessible and so the risks were low.”
“I met Mr and Mrs Mills in my outpatient clinic on8 November 2012 , together with neuro-oncology nurse Anne May. My out-patient appointments for new patients are 45 minutes long. … I explained the nature and prognosis of gliomas. I then outlined three alternative management solutions, namely: 1 A conservative approach combined with regular imaging surveillance; 2 A biopsy; 3 Craniotomy and endoscopically assisted resection (also referred to as ‘debulking’) of the tumour. I outlined the risks and benefits of each option in some detail. Mr Mills said that he was keen on debulking. I was careful to explain the risks. I recommended proceeding with craniotomy and endoscopically assisted resection, but explained that it was a procedure which carried significant risks… [Mr Plaha then specified the same list of risks as recorded in his letter to Mr Mills’ GP] I explained to Mr Mills that the alternative to surgery was surveillance. Mr Mills was keen to proceed with surgery as I had recommended and I recorded this in my clinic letter and notes. When discussing the proposed surgery I focussed on what I considered to be the key issues. Specifically, I explained that there was a choice of surveillance or surgery. I explained the natural history of the tumour and MDT discussions. As is my practice, I explained what the surgery would involve and explained the risks of surgery. I was content that Mr Mills appreciated the risks of the surgery and was nonetheless happy to proceed. With Mr Mills, as with most other patients, I did not go into the technical detail of how the procedure is performed apart from broadly explaining the basic relevant steps of surgery. So for example, I did not explain to him that I used an endoscope for vision and that this was a technique that some surgeons used but that there would be other surgeons who would not use the endoscope.”
“2 In terms of the advice that a responsible neurosurgeon would or should in late 2012 have given in relation to the treatment options for this tumour, are you able to agree that in accordance with a reasonable standard of care this would or should have included any/all of the following: 2.1 the likely diagnosis was that of a low grade glioma, although other more benign medical conditions could not be excluded? The experts agree, although Mr Grundy would point out that he felt that other diagnoses, although cannot be excluded, were most unlikely, say 1-2% chance in this particular case. Mr Kirkpatrick would not disagree with this but nonetheless they represent an important consideration in the investigational and treatment pathway. 2.2 the tumour would probably become symptomatic in time but on the basis of a single scan it could not be determined how long it had been there? Agreed. The experts acknowledge that the period of time before a lesion of this type becomes symptomatic, can be highly variable, but usually measured in years. Mr Grundy felt this was most likely to be 2-5 years (before progression is identified and treatment offered; consistent with recent publications on progression of incidental glioma at average time of 43 months, range 3-105 months, Opoku-Darko et al JNS 2018), in Mr Kirkpatrick’s experience this would be somewhat longer, usually over a decade. 2.3 the tumour was an incidental finding and was unlikely to be the cause of the headaches reported by Mr Mills? Agreed. 2.4 there were three options to be considered, namely regular surveillance with imaging, a biopsy and resection of the tumour? The experts agree that the three options available to an individual patient would be 1) observation with regular surveillance; 2) a biopsy to confirm the diagnosis and exclude medical causes and; 3) resection of the tumour. 2.5 the management of such low grade gliomas which were asymptomatic and found incidentally was still a matter of controversy among neurosurgeons? This is agreed. 2.6 proceeding to resection at this stage would be the approach of only a minority, the majority of neurosurgeons regarding this as at the aggressive end of the spectrum of reasonable management options? Both experts agree that the three options covered in 2.4 above should be discussed in totality for each patient. Age and patient preferences are usually the dominant factors determining which avenue is chose. The experts agree that in the past, the balance was towards a non-surgical approach whereas contemporaneous practice is towards more invasive procedures including biopsy and resection. The balance is highly variable according to individual practices and personal preference.” 2.7 In the case such as this of an incidental asymptomatic low grade glioma, in the first instance surveillance with regular imaging would be the prevailing practice? This has been answered under 2.6 above.”
“1) Surveillance: Both experts agree that although there are no immediate risks to surveillance, in a small proportion of patients, the diagnosis may be incorrect, and these will usually manifest with early tumour progression. Provided surveillance is timely, this will not usually compromise the patient’s prognosis with respect to that particular pathology. In some instances, inappropriately long intervals may allow a low grade tumour to progress to a level where they can start to cause neurological compromise. Again, accurate and timely surveillance should avoid this. The theoretical concern that a low grade tumour will be allowed to progress to a higher grade tumour is evidenced from the answers above. There are, of course, the psychological consequences for a patient not knowing exactly what they have. 2) Biopsy: This holds the advantage of tissue diagnosis, but sampling errors are recognised leading to occasional misdiagnosis. There is also a very low chance that a patient may suffer from intra-operative adverse events such as a bleed which is uncontrolled. Experts would expect that risk to be no greater than 1 to 2%. Biopsy alone will be followed by surveillance in order to pick up any misdiagnosis or tumour progression for a low grade glioma, or treatment with radiotherapy or chemotherapy for higher grade tumours. The experts note that the tumour for MR Mills was probably a WHO grade II oligodendroglioma with favourable mutation histological subtype confirming better prognosis than is average for this grade of tumour. Mr Grundy noted that biopsy clearly carries no potential to improve prognosis in its own right, whilst resection possibly would. 3) Tumour excision: The advantage of a tumour excision is that it provides the most robust way of diagnosing, histologically, the nature of the tumour. The operation also offers the greatest chance of removing the majority of the neoplastic tissues. The experts agree that the prognostic benefit of surgery has not been demonstrated in randomised trials and the evidence is variable, however, Mr Grundy noted it was of sufficient quality for NICE to recently recommend surgery as a first-choice therapeutic option for low grade gliomas and recent evidence has suggested it to be beneficial for incidental tumours (see references). The experts again reiterate the importance that there is a significant degree of uncertainty and debate as to which is the preferred option, and hence discussion with individual patients is of critical importance citing all available options, and expression clearly that there is uncertainty as to the extent of survival gain of one approach over another.”
“16. While everyone knows that memory is fallible, I do not believe that the legal system has sufficiently absorbed the lessons of a century of psychological research into the nature of memory and the unreliability of eyewitness testimony. One of the most important lessons of such research is that in everyday life we are not aware of the extent to which our own and other people's memories are unreliable and believe our memories to be more faithful than they are. Two common (and related) errors are to suppose: (1) that the stronger and more vivid is our feeling or experience of recollection, the more likely the recollection is to be accurate; and (2) that the more confident another person is in their recollection, the more likely their recollection is to be accurate. 17. Underlying both these errors is a faulty model of memory as a mental record which is fixed at the time of experience of an event and then fades (more or less slowly) over time. In fact, psychological research has demonstrated that memories are fluid and malleable, being constantly rewritten whenever they are retrieved.This is true even of so-called ‘flashbulb’ memories, that is memories of experiencing or learning of a particularly shocking or traumatic event. (The very description ‘flashbulb’ memory is in fact misleading, reflecting as it does the misconception that memory operates like a camera or other device that makes a fixed record of an experience.) External information can intrude into a witness's memory, as can his or her own thoughts and beliefs, and both can cause dramatic changes in recollection. Events can come to be recalled as memories which did not happen at all or which happened to someone else (referred to in the literature as a failure of source memory). 18. Memory is especially unreliable when it comes to recalling past beliefs. Our memories of past beliefs are revised to make them more consistent with our present beliefs. Studies have also shown that memory is particularly vulnerable to interference and alteration when a person is presented with new information or suggestions about an event in circumstances where his or her memory of it is already weak due to the passage of time.”
“The experts cannot wholly discount the possibility of a stroke with standard methods, but they agree that this is extremely rare and would usually complicate a much more complicated tumour anatomy.”
“With open operations, breaches of vessels can occur, but due to the improved access, they usually prove very simple to control”
“However, in this case, even with a conventional medial craniotomy, it may still have proven very difficult to achieve rapid haemostasis if the mechanism was retraction of the frontopolar branch of the pre-callosal back to its origin. An additional extension of craniotomy and/or further brain resection may still have been required.”