Latest developments in clinical negligence claims involving a lack of informed consent

Posted: 10/07/2017

In the last couple of years the scope of clinical negligence cases involving a lack of informed consent has increased considerably. Prior to the case of Montgomery v Lanarkshire Health Board in 2015, the general position on consent followed the case of Chester v Afshar – namely that if a patient could show that they had not been warned about a particular risk of a planned procedure (which later occurred) and had they been warned they would not have gone ahead with the surgery at that time, then they would succeed, but only in those circumstances.

The Montgomery case considerably widened the scope of consent cases by stating that the duty when obtaining informed consent was not just to advise on the risks but also the reasonable alternative treatment options and relative risks / benefits of each. The Supreme Court ruling also stated that if the patient was not given such information / options and would have elected for another treatment option, then they would recover from any injury flowing from the nature of the treatment undertaken. Montgomery makes clear that the doctor's obligation (apart from in cases where it would damage the patient's welfare) is to present the material risks and uncertainties of different treatments, and to allow patients to make decisions that would affect their health and well-being based on proper information. The significance of the risks and uncertainties, including the possibility of alternative treatment, is sensitive to the characteristics of the patient.

There have been several key cases this year which refine and define the appropriate tests to be satisfied by a claimant when seeking to recover damages on the basis of a case surrounding lack of consent. Until recently these cases have widened the scope for claimants to succeed, but the two most recent cases have been a reminder as to the need to satisfy the required tests on causation.

In Webster (A Child) v Burton Hospitals NHS Foundation Trust, the Court of Appeal allowed the claimant’s appeal against the previous finding in favour of the defendant hospital on causation of the claimant's birth injuries and specifically upheld that the decision in Montgomery was the appropriate approach in consent cases. The court found that the judge had based his judgment as to whether there had been negligence on the approach set out in Bolam v Frien Hospital by looking at whether the consultant had acted in accordance with a responsible body of expert medical opinion. However, the Court of Appeal decided that this was no longer the correct approach and the decision in Montgomery was the correct approach to use.

The claimant, W, was born with cerebral palsy. It was agreed between the parties that his disability had been caused by a brain injury which had occurred 48 to 72 hours prior to his birth and that had he been delivered at least three days earlier, he would have avoided the brain injury. The liability issues in the case revolved around the management of W’s mother’s antenatal care by her obstetrician at the defendant hospital after an ultrasound when W was 34 weeks. This had been arranged because of a previous observation that the placenta was low and therefore in a difficult position. The scan in fact resolved this particular concern, but identified that W was small for his gestational age. It also identified some asymmetry and polyhydramnios (an excess of amniotic fluid). Following this scan, the obstetrician made no note or mention to W’s mother of the fact that the scan had identified that W was small for his gestational age or the possible implications of this, nor the other abnormalities of asymmetry and polyhydramnios, and simply made a plan to review her at 41 weeks.

It was alleged on behalf of W that there was a failure by the obstetrician to consider the potential significance of these findings and to arrange further ultrasound scanning. Although this was admitted by the defendant, what was in dispute was what would then have happened.

In fact things did not progress to 41 weeks because W’s mother felt unwell around the time of her due date and re-attended the hospital, expecting that the baby would be delivered. She was reviewed by the same obstetrician who made no mention of the combination of abnormalities on the 34 week scan (albeit that this was a rare combination), or of the possible risks to the baby given the presence of these factors, neither did he raise with W’s mother the option of induction given these risks. W’s mother was discharged without advice to consider induction and it was some 10 days later before W was delivered – by which time he had sustained the serious brain damage.

Given the extent of agreement between the parties on the failures and the timing of the brain damage, the case ran to trial mainly on the issue of what would have been shown if further ultrasound scanning had taken place and what should have happened as a consequence.

In coming to his decision, the judge followed the approach in Bolam v Frien Hospital and found for the defendant on the basis that the defendant’s obstetrician had acted in accordance with a responsible body of medical opinion when deciding not to proceed with an induction when W’s mother re-attended at the hospital. He accepted the defendant’s case that the combination of abnormal features was rare and there was limited evidence indicating the consequent implications and risks for such a baby. It was also accepted that the consultant would have been reassured by further scans (if carried out) and examination and would therefore not have felt a need to proceed with induction. On the basis that even with further scans being completed, a responsible body would not have decided to induce the baby despite the scan findings, and in applying Bolam he thus dismissed the claimant’s case.

An appeal was brought on behalf of W in which it was submitted that in light of Montgomery, the judge had used the wrong approach and the issue was no longer whether a reasonable body of medical opinion would have followed the same course of management, but what advice should properly have been given to W’s mother, and what would have happened as a consequence. The issue therefore was not whether the obstetrician’s management plan (without consultation with W’s mother) was one that would be supported by a responsible medical body, but what information and advice he should have offered to W’s mother when she reached her due date given the unusual but potentially significant combination of features on the earlier scan – and what would then have occurred, on the balance of probabilities. The Court of Appeal accepted that there was ‘emerging but recent and incomplete material showing increased risks of delaying labour in cases with this combination of features' and that if W’s mother had been given that information, she would have wanted to be delivered at or around the due date because of the risks of delay, even though there were reasons to support delaying intervention. That decision would have resulted in W being delivered before sustaining his brain injury and on this basis the appeal was successful.

In Correia v University Hospital of North Staffordshire NHS Trust, the claim related to the treatment of a painful recurrent neuroma in the claimant’s right foot. The claimant was advised to undergo surgery on the neuroma but following surgery, rather than any improvement, she continued to suffer pain and ultimately was diagnosed with chronic regional pain syndrome (CRPS).

The claimant brought a claim alleging a lack of informed consent for the procedure and negligence in the way that it was done. The scenario was quite complicated in that there were three parts to the surgery and the surgeon only carried out the first two parts. The claimant alleged that she had not consented to a two part operation and that the surgeon was therefore negligent in doing it this way. At first instance the court confirmed negligence in the way that the third part of the operation had not been undertaken, but concluded that this negligent omission was not the cause of any injury to the claimant. The claimant appealed and focused on the consent issues on the basis that she had not been warned of the material risks of the operation if only the first two parts were carried out. She claimed that she should therefore be entitled to damages on the basis that her injury arose as a result of those risks materialising, following the case law in Chester.

The Court of Appeal heard the evidence and concluded that whilst the claimant had not specifically been advised of the risks of only two parts of the procedure being carried out, the operation that was performed was similar to that which she had consented to. The court made the point that she had consented to the operation that should have been performed and therefore the negligence was in not performing the operation as planned and discussed. To succeed in this case the claimant would have to show that had she been informed that the surgeon would not carry out the third part, she would not have proceeded with the surgery – but there was no evidence presented by the claimant to prove that this would have been the case. The key point here is that no patient consents to negligent surgery, but they may consent to surgery that is then negligently performed (as was the case here). Had that negligence then caused the damage the claimant would recover – but again the claimant failed on this point.

In Diamond v Royal Devon & Exeter NHS Foundation Trust, the claim was similar to that of Montgomery in that the claimant who attended for abdominal hernia repair alleged that she was not advised by her surgeon of the alternative of suture repair rather than a mesh repair. The mesh repair carried the specific risk of possible complications in later pregnancy, but had a much higher chance of success.

The court held that the claimant should have been advised of the risks specific to the mesh repair and given the option of a primary suture repair, and that there was a breach of duty in the consenting process. However the claimant failed on causation – whilst the court found her to be a credible witness, it was felt that her evidence that she would have chosen the procedure which did not carry possible risks to later pregnancy but had a high chance of not being successful, was said with the benefit of hindsight. On the information she should have been given, the court felt it was unlikely she would have made that choice. The case therefore failed on Montgomery grounds as it was held that she would not have taken the alternative route even with the additional information. The claimant tried to argue as an alternative that this was a Chester case because she was not warned of the risks from the mesh repair, but given that the issue was incurring a risk of future complications in pregnancy rather than an actual injury, the case failed on this basis as well.

Philippa Luscombe, partner in the clinical negligence team at Penningtons Manches, comments: “Both from this summary of case law and from the cases we are dealing with in our team, it is clear that in a number of cases patients are not being given the information they should be about risks and options before embarking on a course of treatment, particularly in the context of surgery. In all of the above cases, the court found a breach of duty and this is reflected in our work, as we often speak with claimants who have received brief and inadequate advice about the risk of complications which have later developed. Causation is often the far more difficult part of a case for a claimant, ie what would they have done if they had the correct information? In some cases there are very clear and convincing reasons why a specific aspect of omitted information or a particular risk / complication would have steered a claimant in a different direction / been a significant concern for them. However, the claimant often needs treatment and is in fact advised to undergo the most suitable form of management, meaning that they consent to a number of risks in making that decision. It is then very difficult to persuade a court (as demonstrated in the cases above) that knowledge of another risk not mentioned or another option that objectively would not have had such good prospects or carried different significant risk would, without the benefit of hindsight, meant that the claimant would not have consented to that operation at that time.

“Claimant solicitors should continue to look carefully at situations where claimants have received limited information on risks and options and suffered complications or a poor outcome as a result. They must themselves to be convinced as to why exactly a claimant would have taken a different route in order to advise pursuing such allegations. Webster is an example of a case where on careful analysis there were good reasons to conclude that the claimant would have taken a choice not offered. This good reason should be applicable without the benefit of hindsight.

“It seems likely that there will be more cases on consent whilst the scope of Montgomery and Chester as two related yet separate approaches is defined.”

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