Sunday, 27 December 2015

Trial and Grimstone

As if to draw together my two blogging pre-occupations in 2015 - the Access to Medical Treatments (Innovation) Bill and consent to treatment following Montogmery - Christmas brought the judgment of McGowan J in Grimstone v Epsom & St. Helier University Hospitals NHS Trust [2015] 3756 (QB).

The Claimant, a keen sportswoman in her mid-fifties, sought out expert treatment for her problem hips. She found Professor Field who recommended hip replacement surgery using bone conserving implants, Mitch PER devices which were relatively new devices, for which there was limited evidence of longer term success and failure rates.

The Claimant signed a consent form for bilateral hip replacements, which were performed in 2008. Unfortuantely, although the operations were competently performed, they went poorly for the Claimant who had to undergo several follow- up procedures. There was no allegation of negligent surgery, but rather that the Claimant's informed consent was not obtained. Amongst the allegations made was that the surgeon failed to inform the Claimant of the limited evidence of the success and failure rates for the new devices used in her hip replacement surgery.

The Judge recorded:

It appears that the Claimant does not say she asked about alternative methods of hip replacement, rather she argues that the Professor should have made her aware of the lack of data for the newer alternatives. The Professor's evidence is that there was no such request for that information and it would not be his usual practice to provide such material if not sought, he would if asked have done what he could to explain the design and performance of the devices available.

The Judge referred to and quoted a long passage from Montgomery v Lanarkshire. A key part of that passage was the conclusion that:

"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. "

The Judge found that the surgeon had proposed surgery (using the bone conserving implants) specifically to suit the Claimant's stated needs. He found that there was ample research into the use of the implants which were "new" but not "experimental". He found that the Claimant was motivated to have the new, bone-conserving implants in preference to older Charnley implants.

In relation to the need to provide information to the Claimant of the limited evidence of success and failure rates, the Judge's conclusion at paragraph 12 (iv) was:

"Was he obliged to tell her about the limited data available on the device used?
There was a great deal of evidence about the status and volume of data available on the new device that was used in this surgery. It is not necessary to assess the scientific worth of that material. The agreed fact in this case is that the Professor did not tell Mrs Grimstone anything about the success rates. It is not therefore of any value to analyse what would amount to good data if there were an obligation, at the time, to impart it to a prospective patient. The "concern" expressed by the Claimant's expert, Mr Charnley, that the data or lack of it was not explained to the patient cannot outweigh the view of the equally expert witness called by the Defendant, Mr Hamer, that a reasonable body of doctors in the same position would not have given such information to a patient. It is not accurate to refer to the device as "experimental", it was new. All the clinicians accepted it was an appropriate device to have used in this case."

Arguably therefore the Judge did not apply the materiality test from Montgomery, even though he had referred to it in his short judgment. Instead he applied the Bolam test as to what a reasonable surgeon would have advised. It seems to me that information about the success and failure rates for the new implants was information about risk, and therefore that the Montgomery test applied and the Bolam test did not apply. However, given other findings in the judgment it is very possible that even if the Montgomery test had been applied, the Judge would have found that even it was not satisfied in this case, the Claimant would still have opted to have the bone-conserving implants.

Use of bone-conserving implants was clearly within the existing range of accepted treatments in 2008 (to adopt the test in the Access to Medical Treatments (Innovation) Bill, at least on the findings made by the Judge in Grimstone. What of the time when they were "experimental" rather than "new"? The Judge ought to have applied the same test as to the advice that a doctor should give a patient - the materiality test from Montgomery set out above. Would a reasonable patient attach significance to the fact that the devices were in a trial period with little evidence as to their effectiveness? Or should the doctor be reasonably aware that the particular patient would attach significance to that information?

In many cases new devices or treatments are subject to a controlled trial when they are at the "experimental" rather than "new" stage. Patients are carefully consented when partaking in the trial and the trial is designed to produce useful information about the effectiveness of the treatment. If doctors propose such treatments in good faith and for patients for whom they are suitable, doctors stick to well-designed trial protocols and patients give proper consent, there is no prospect of a negligence action if complications arise. I am not aware of the courts ever having had to decid such a claim.

The Access to Medical Treatments (Innovation) Bill is designed to address a very different kind of "experimental" treatment - that which is outwith a well-designed, controlled trial. Under the current law, and under the AMTIB, a doctor would have to obtain the patient's informed consent to the proposed treatment. As I think is clear, the courts will require doctors to inform patients of the fact that there is no evidence as to the effectiveness of such treatment, or to inform them of the basis on which it is thought that the treatment might be of benefit. However, under the current common law a doctor might still be found negligent for providing such treatment if no responsible body of doctors would have condoned its use on the patient, even if the patient had given her informed consent. You might think this is paternalistic, or you might think it is a reasonable protection of patients who are not in an equal relationship with doctors.

The Bill is designed to allow doctors to proceed in those circumstances without fear of litigation. The protection is removed and replaced with a series of steps which, if the doctor takes them, will prevent the courts from finding the doctor negligent for deciding on an experimental treatment, even if no responsible doctor would have supported the decision.

So, an interesting judgment with which to end 2015.

I wish all my readers a good 2016.

Thursday, 17 December 2015

Relying on Medical Records

"The Judge won't believe me. He'll believe what's in the notes".

I have heard that said by many clients who are contemplating bringing a clinical negligence claim. But it is not true. Judges take into account all the evidence. Whilst it is true to say that contemporaneous notes made by a medical professional will ordinarily carry great weight at court, where there is a conflict between a patient's recollection and what was recorded contemporaneously by their doctor, the court is not bound to find that the record is accurate and the recollection unreliable. That has been confirmed by the Court of Appeal decision in Synclair v East Lancashire Hospitals NHS Trust [2015] EWCA Civ 1283

Just as patients sometimes believe that the courts are bound to accept the truth of something recorded in the medical notes, so healthcare professionals are sometimes taught that "if it isn't recorded, it didn't happen". That is equally untrue.

It always depends on the circumstances. 

If three independent medical practitioners all separately record that the patient reported no pain, but the patient says that they told them they were in pain, the court may struggle to find that "on the balance of probabilities" the patient reported that he was in pain.

If a patient and two relatives recall that he told Dr X that he was in pain, and Dr X' cannot recall the consultation but his junior doctor recorded "All fine" and nothing more, perhaps the court will be more likely to find that the patient did report that he was in pain.

A record of a consultation cannot be a word for word account. On the other hand a doctor who does not note a matter of potential significance, even if the finding was "normal", e.g. there were no red flag signs of cauda equina syndrome, may regret having failed to do so. When asked at court why they did not check for red flag signs, a reply that "they would have done so" carries much less weight than a contemporaneous record that they had done so and there had been no such signs.

I cannot recall seeing medical records counter-signed as accurate by a patient. Consent forms are of course signed but not other records. Patients tend not to make and keep notes themselves. There is no reason why they should not do so.

Sometimes patients are convinced that a medical record has been tampered with or "doctored" (pun intended). It has been known. But the court will need to be presented with cogent and compelling evidence before it can find that medical records have been concocted or dishonestly altered after the event.

The Court of Appeal in Synclair has reviewed guidance on these sorts of issues, providing a very helpful source for clinical negligence practitioners. Tomlinson LJ said:

  1. We were shown, in chronological order: the well-known remarks of Lord Pearce in his dissenting speech inOnassis & Calogeropoulos v Vergottis [1968] 2 Lloyds Rep 403 at p 431; the guidance given by Lord Goff of Chieveley giving the opinion of the Judicial Committee of the Privy Council in Grace Shipping v Sharp & Co [1987] 1 Lloyd's Rep 207 at 215-6, in particular founding upon his own judgment in the earlier decision of the Court of Appeal in Armagas Ltd v Mundogas SA (The Ocean Frost) [1985] 1 Lloyd's Rep 1 when he said, at page 57:-

  2. "Speaking from my own experience, I have found it essential in cases of fraud, when considering the credibility of witnesses, always to test their veracity by reference to the objective facts proved independently of their testimony, in particular by reference to the documents in the case, and also to pay particular regard to their motives and to the overall probabilities. It is frequently very difficult to tell whether a witness is telling the truth or not; and where there is a conflict of evidence such as there was in the present case, reference to the objective facts and documents, to the witnesses' motives, and to the overall probabilities, can be of very great assistance to a Judge in ascertaining the truth."
    In Grace Shipping Lord Goff noted that his earlier observation was, in their Lordships' opinion "equally apposite in a case where the evidence of the witnesses is likely to be unreliable; and it is to be remembered that in commercial cases, such as the present, there is usually a substantial body of contemporary documentary evidence." We were reminded too that in "The Business of Judging", Oxford, 2000, Lord Bingham of Cornhill observed that:-
    "In many cases, letters or minutes written well before there was any breath of dispute between parties may throw a very clear light on their knowledge and intentions at a particular time."
    The essential thrust of this learning is the unsurprising proposition that when assessing the evidence of witnesses about what they said, or what was said to them, or what they saw or heard, it is essential to test their veracity or reliability by reference to the objective facts proved independently of their testimony, in particular by reference to contemporary documentary evidence.

    He noted that:

    1. In the present case it is plain that the judge recognised that the evidence of the Claimant had to be assessed in the light of the apparently contemporaneous clinical note. Indeed that note was doubly important. Not only did the Claimant's evidence fall to be evaluated in the light of it, the note also represented the full and entire extent of the evidence which Mr Zafar could give as to what was said and observed on his ward round, as he had no recollection as to what had transpired independent of what was written in the note.
    2. However it is too obvious to need stating that simply because a document is apparently contemporary does not absolve the court of deciding whether it is a reliable record and what weight can be given to it. Some documents are by their nature likely to be reliable, and medical records ordinarily fall into that category. Other documents may be less obviously reliable, as when written by a person with imperfect understanding of the issues under discussion, or with an axe to grind. I would commend the approach of His Honour Judge Collender QC, sitting as a judge of the High Court, in EW v Johnson [2015] EWHC 276 (QB) where he said, at paragraph 71 of his judgment:-

    3. "I turn to the evidence of Dr Johnson. He did not purport to have a clear recollection of the consultation but depended heavily upon his clinical note of the consultation, and his standard practice. As a contemporaneous record that Dr Johnson was duty bound to make, that record is obviously worthy of careful consideration. However, that record must be judged alongside the other evidence in the action. The circumstances in which it was created do not of themselves prevent it being established by other evidence that that record is in fact inaccurate."
      Dr Johnson, a GP, had made his own note of a consultation at an out of hours walk-in centre at a hospital. After a careful evaluation of all the evidence in the case, the judge found that Dr Johnson's oral account in evidence, based on his contemporaneous note, was reliable. In Welch v Waterworth [2015] EWCA Civ 11 a surgeon was unsuccessful in persuading the court that his own notes of a surgical procedure which he had performed, one a manuscript note written very shortly after the operation and another a typewritten note made later in the day at home, did not accurately record the order in which he had carried out the constituent parts of the relevant procedure.

    4. The real difficulty which the judge faced in the present case was that he had no evidence of the circumstances in which the relevant clinical note had been made, and no evidence from the maker of the note, who was not Mr Zafar but Dr Dal Bianco. Furthermore, it was unclear whether Dr Dal Bianco had been present when Mr Zafar spoke to and examined the Claimant at 08.10 and unclear when precisely he prepared the note relating to that ward round.
The Trust submitted that medical records carry great weight because doctors have a professional duty to provide an ongoing record and could risk professional sanctions for failing in that duty. The Court held that whilst in many cases the inherent reliability of medical records would carry the day, it all depended on the circumstances in the individual case.

The trial judge had approached the finding of fact exercise in a proper manner and his finding that the facts were other than as recorded in the contemporaneous medical record was upheld.

Friday, 4 December 2015

The Case of the Damaged Nerve

The Court of Appeal has given judgment in a clinical negligence case that concerned the use of inference to make a finding about a surgeon's standard of skill and care - O'Connor v Pennine [2015] EWCA Civ 1244.

Tracey O'Connor underwent uro-gynaecological surgery to repair a vesico-vaginal fistula. Following the operation she suffered femoral nerve dysfunction which the expert neurologists instructed by the parties agreed was due to some form of surgical trauma. She went on to develop permanent disability which was non-organic. She recovered substantial damages after trial.

The Claimant's case was that the damage had been caused during surgical dissection. The expert urological surgeons had agreed that there were two possible mechanisms of damage - by dissection, which would be negligent, and by use of deep retractors. They disagreed as to whether it would have been negligent for the surgeon to have caused femoral nerve damage by deep retraction. The Defendant sought to suggest a further possible mechanism of damage, namely through the administration of regional anaesthetic block, and had applied on the first day of trial to introduce a fresh expert to deal with that contention.

Application to Introduce A New Expert

The trial judge had refused that application. Permission to appeal was granted but the Court of Appeal termed that appeal "obviously misconceived". The circumstances of the Defendant's application had not been auspicious - it was made without notice on the first day of trial and after an unappealed refusal of permission by a District Judge a few months earlier. Jackson LJ said, "Following the civil justice reforms of 2013, that is simply not how we do things now.... I do not see how a decision to abort a clinical negligence trial on day 1 for the benefit of a dilatory defendant could possibly be justified." [53]

Inference and Res Ipsa Loquitur

The trial judge weighed all the evidence, reminded himself of the guidance of the Court of Appeal in Ratcliffe v Plymouth & Torbay HA [1998] PIQR P170 and of the Rhesa Shipping v Edmunds [1985] 1 WLR 948 ("The Popi M") trap and held that on the balance of probabilities the damage was caused during dissection and therefore was caused negligently.

The NHS Trust appealed against that finding. Jackson LJ giving judgment with which McCombe LJ and  Sir Colin Rimer agreed, referred not only to those two authorities but also to Thomas v Curley [2013] EWCA Civ 117 which I have discussed previously. In Rhesa the House of Lords condemned the adoption by the trial judge (Bingham J no less) of the Sherlock Holmes mantra that if all other possibilities are excluded, the remaining possibility, however unlikely, must be the truth. That reasoning process was invalid because there remained the legal test of whether the remaining possible explanation or cause was likely "on the balance of probabilities". A Court might well find that there one explanation is more probable than the others  put forward, but that it is still not the likely cause or explanation. More probable that the suggested alternatives is not the same as more probable than not.

Jackson LJ however held that:

"It is not an uncommon feature of litigation that several possible causes are suggested for a mishap which the court is investigating. If the court is able, for good reason, to dismiss causes A, B and C, it may be able to reach the conclusion that D was the effective cause. But the mere elimination of AA, B and C is not of itself sufficient. The court must also stand back and, looking at all the evidence, consider whether on the balance of probabilities, D is proved to be the cause." [64].

He noted that the notion of damage by deep retractor had been discounted by both parties by the close of evidence and he held that the trial judge had been entirely justified in dismissing the defendant's suggestion of damage by the administration of anaesthesia. Accordingly the "fact that the defendant had not proffered any plausible explanation for the claimant's injury consistent with the exercise of due care did not convert the case into one of res ipsa loquitur. Nor did it reverse the burden of proof. Nevertheless this was a material factor which the judge was entitled to take into account." [84]

This is very useful guidance for clinical negligence cases where the patient cannot adduce direct evidence of the negligence cause of his or her injury, for example because they were under general anaesthetic and the surgeon did not notice that anything had gone awry during the operation. The lack of a plausible explanation which is consistent with no negligence does not prove the case of itself, but it is relevant to the court's task of determining the cause on the balance of probabilities. Defendants must not be allowed to characterise a Claimant's case as one of Shorlock Holmes/Popi M reasoning or of res ipsa loquitur simply because the Claimant is alleging that all non-negligent explanations of an injury are implausible or unlikely.  That does not prove the case, but it is relevant. In some cases it will be highly relevant. Of course, as in this case, the court has to make inferences from all the circumstances, but that is not the same as adopting the doctrine of res ipsa loquitur.

Drawings and Photographs

Jackson LJ humourously teases my opponent at paragraph 44 of the judgment. He crticises the presentation of the case, complaining about the lack of drawings or photographs to show the relevant internal anatomy. To be fair photographs would not have assisted, and there were some technical drawings, albeit not very clear ones. Jackson LJ says that Mr Feeny "valiantly did his best by waving a finger around in the air to show us what was what." Taking Jackson LJ's plea a little further, there is no doubt that we could, at clinical negligence trials, make more use of models and technical drawings, perhaps even 3D modelling, to explain a case. I am sure (NOT) that costs budgeting orders will be increased to provide funding accordingly.

I appeared for the the Claimant at trial and on the appeal, instructed by Mealla Logue of McCool Patterson Hemsi solicitors.

Tuesday, 1 December 2015

Presumed Consent

From today residents in Wales are presumed to consent to the use of their organs for transplantation after they die.

During our lives we exercise control over our bodies. We have to give informed consent before any medical procedures are performed upon us. In the recent case of Montgomery the Supreme Court emphasised the importance of patient autonomy. Should the same standards apply to procedures carried out on us after we are dead?

The state has powers to exercise control over our dead bodies. It can insist on a post mortem, depending on the manner of my death. It might prevent my body being disposed of in exactly the manner I desire. In principle a law could be passsed to allow the state to remove organs for transplantation irrespective of the living wishes of the deceased, perhaps with some very limited exceptions. I am not sure that there are many persuasive, rational arguments against such a law, but my guess is that it would be deeply unpopular. Most people do care what happens to their bodies after they die and they want the autonomy to decide whether their organs are removed or not.

Instead of a law giving doctors the power to remove organs irrespective of others' wishes, in both England and Wales the state accepts that it can only remove organs after death with consent. In England the consent must be expressly and positively given. In Wales, from today, it is presumed.

Presumed consent is not consistent with informed autonomy. Of course those who truly consent will choose not exercise their right expressly to reverse the presumption, and those who do not consent will take steps to reverse the presumption by making that known. But others will be presumed to consent even though they do not want their organs to be removed or have never even given the matter any thought. They may not be aware of the new presumption, they may not get round to doing anything about it, they might be confused about the law. Not everyone reads the newspapers or watches the television news. The presumption has been introduced to increase the number of organs available for donation. If it achieves that goal then, at least in part, that will be because an increased number of organs will be removed from people who did not truly want their organs to be removed. Those people are not "donors".

If you believe that we ought to have true autonomy over our bodies even after we are dead, then a law of presumed consent is objectionable. Imagine presumed consent applying to the living patient.

Every news story about presumed consent over the last few days has focused on a patient awaiting transplantation. It is a truly awful position in which to find yourself. We desperately need more organs to be donated. At the same time, if there is a shortage, then it must be that many people are reluctant to consent to their organs being removed. I have carried a donor card since I was 18. You can register online in two minutes. It is not difficult and yet millions do not do it, presumably because they do not feel sufficiently motivated to donate.

The state can increase the number of donor organs by a campaign of information, dialogue with patients and training of medical staff, to encourage more donation with consent; by introducing a law giving the state power to remove organs from the dead even without consent; or by presumed consent. The first has the virtue of consistency with the approach to consent taken for living patients and gives full respect for autonomy. It would require an effort by the state to engage with people, explain how donation works and to allay their concerns and fears. The second would I suspect be deeply unpopular and would doubtless be characterised as Orwellian although the state already exercises other powers over our dead bodies. The third does not require the state to make the same efforts as the first - just presume consent and more organs will be "donated". It relies on ignorance and apathy to make more organs available, and sets an example of the state presuming our consent which many will hope will not be adopted in other spheres.