Re-visiting Montgomery and the cases that have followed – December 2019

By Stephen Marotos and Harry Armstrong

“Doctor doctor, I’ve swallowed my pocket money!”

“Take this and we’ll see if there’s any change in the morning.”

Unfortunately, there was no change in the morning and whatever was prescribed has left some nasty side effects. The alarmed patient sues for the punchline. Unlike a joke, you should explain your treatment.

How far must a doctor go in current practice to ascertain the appropriate consent? What is the appropriate consent? The starting point is now and has been since 2015 the case of Montgomery.

The Montgomery case was thought by some to be a fundamental change in how consent was considered, but arguably brought the law in line with the GMC Guidance on consent that had been in place since the 1990s.

That said it did very much change practice, with Trusts and doctors very aware of the case with language such as “Montgomery compliant consent” being used and there being a wave of reviews across the medical profession to consider how they dealt with patients and information provided to them.

The law following Montgomery has followed the same approach of a two stage test for consent; firstly the question of objective criteria and the reasonable or ordinary person in the patient’s position and secondly the subjective aspect that this patient may not be reasonable and the Court should consider their particular requirements or fears (which the doctor is or ought to be aware of).

There have been a number of cases following Montgomery and despite the clarity of the decision from the Supreme Court there are still questions as to exactly how it applies. The case law does appear to suggest attempts to revert to a Bolam type assessment of consent and information to be provided to patients, and perhaps a move towards returning to an era when medical paternalism was considered to be acceptable; the latter is, however, highly unlikely to occur. A patient centred analysis is very much here to stay, particularly considering the increased knowledge and understanding that patients have in the modern on-line world.

A v East Kent Hospitals University NHS Foundation Trust (2015) noted that there was no suggestion there was a duty to warn of theoretical risks and did appear to reflect more closely the law pre-Montgomery. In FM (By his Father and Litigation Friend GM v Ipswich Hospital NHS Foundation Trust (2015) the focus was on the reasonable person only, rather than the subjective elements. Thefaut v Johnsone (2017) did, however, take account of that subjective element. More recent cases such as Lucy Diamond v Royal Devon & Exeter NHS Foundation Trust (2017) and Duce v Worcestershire Acute Hospitals NHS Trust (2018) have confirmed the importance of full and complete information being provided and the consideration of the particular individual circumstances of the patient.

We detail summaries from the key cases relating to consent in clinical negligence cases –

Montgomery (Appellant) v Lanarkshire Health Board (Respondent) [2015] UKSC 11

The claim related to a delivery in October 1998, during which shoulder dystocia occurred resulting in oxygen deprivation and the baby boy being born with cerebral palsy.

Antenatally, the risk of shoulder dystocia had been assessed at in the order of 9-10%, as the Natalie Montgomery (the mother) was diabetic. The doctor did not discuss the risk of shoulder dystocia or counsel the mother in relation to the option of planned caesarean section. The view was that the risk of serious injury from shoulder dystocia was small and that if advised/warned a caesarean would have been chosen, when that would not have been in her best interest (in the opinion of the clinicians).

Natalie Montgomery argued that she should have been warned of the risks and given the alternative of having the baby delivered by elective caesarean section which, it was accepted, would have resulted in the baby being delivered unharmed.

The Court of Sessions rejected the arguments made, holding that the relevant question was whether the obstetrician’s failure to advise Mrs Montgomery amounted to a breach of duty by reference to the Bolam test, i.e. whether the decision not to advise would be supported by a responsible body of medical opinion (Sidaway v Board of Governors of Bethlem Royal Hospital [1985] AC 871 followed)

Natalie Montgomery sought to appeal to the Supreme Court, which unanimously allowed her appeal against the dismissal of the claims. The Supreme Court indicated that the approach to patient treatment had moved on since Sidaway, especially taking into account the introduction of the Human Rights Act 1988.

The decision of the Supreme Court detailed that the doctor is 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.

This test of materiality is fact and patient sensitive. The test is whether, in the circumstances of the particular case, either:

1. A reasonable person in the patient’s position would be likely to attach significance to the risk
2. The doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.

Therefore to properly advise patients on consent issues it is clear that the doctor must engage in dialogue with the patient, rather than simply repeating formulaic information provided to patients previously.

It was held that a clinician could withhold disclosure of risks where they reasonably believe that disclosure would be seriously detrimental to the patient’s health, but it is important that such an exception should not be abused and is limited.

The Supreme Court was critical of the approach of the doctor in focusing too much on the risks posed to the unborn foetus rather than the risks posed to Natalie Montgomery.

Summary points –

• the wishes of the competent patient are paramount
• doctors have a duty to ensure that patients are sufficiently informed in order to make their decisions
• doctors must not censor information to lead the patient into making the decision that the doctor wants.
• Case marked a departure from the Bolam test towards patient specific material risk assessments.

A v EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST (2015)

This was a wrongful birth claim brought on the basis of the alleged failure by an to detect chromosomal abnormality in pregnancy. The mother had a scan on 13 May 2009, at 28 weeks’ gestation, which showed that the baby was small. She saw a consultant who was concerned about the possibility of placental insufficiency and that the baby might be born imminently. A further scan was carried out on 3 June, which again noted growth restriction. At neither of those consultations was any mention made of the possibility of a chromosomal disorder.

The child was born on 22 July suffering from a chromosomal abnormality which caused severe disabilities. The mother complained that there had been a failure to advise her at the consultations on 13 May and 3 June of the possibility that the baby might be suffering from that condition.

She claimed that, had she been advised of that possibility, she would have undergone an amniocentesis to prove the condition and would then have terminated her pregnancy.

Liability was denied and it was argued by the Trust that there was a risk of of 1 in 1,000 as at 13 May and 3 June that the child was suffering from a chromosomal abnormality. The mother’s expert stated that the risk stood at one to three per cent.

It was held that there was no evidence of the existence of a material risk to which the mother should have been alerted that the child was suffering from a chromosomal abnormality. The Trust’s expert evidence was preferred, noting that since very few foetuses with chromosomal abnormality are carried to term; the tests that had been carried out had excluded the risk of the type of abnormality in issue to background level; and the ultrasound scans had not detected the kind of structural abnormalities that would normally be present in a foetus with a chromosomal abnormality. On that basis, any risk was theoretical or negligible and the medical staff had been entitled to conclude that placental insufficiency was the likeliest cause of the reduction in growth. There was no authority for the proposition that medical practitioners had to warn about risks which were theoretical and not material.

The case of Montgomery was noted and the Court held that the test of materiality was determined in that case as being whether a reasonable person in the patient’s position would be likely to attach significance to the risk, or whether the doctor should reasonably be aware that the particular patient would be likely to attach significance to it.

The materiality of a risk could not be reduced to percentages, since the significance of a given risk was likely to reflect a variety of other factors such as the nature and effect of the risk and any alternatives available.

On the evidence before the Court it was stated that the mother would not have opted for an amniocentesis if she had been told about the negligible risk that the child might have a  chromosomal abnormality because the risks of having a disabled baby would have been greater from amniocentesis than from continuing with the pregnancy. Even if she had had such a test and the abnormality had been detected, in the light of her reaction when told about the risks of imminent delivery on 13 May, it was held that she would not have terminated the pregnancy.

FM v IPSWICH HOSPITAL NHS TRUST (2015)

It was held that if a claimant’s mother had been properly advised, as part of her antenatal care, of the risk of shoulder dystocia during a vaginal delivery, she would have opted for a caesarean section and the brachial plexus injury suffered would have been avoided.

The Claimant’s mother had had two previous deliveries, one by ventouse vacuum extraction after a long, painful labour and the second after a rapid and apparently uneventful labour. That second delivery had, however, been recorded as having been complicated by a “moderate degree of shoulder dystocia”.

The Claimant had been identified in utero as a potentially large baby. His delivery in February 2002 was complicated by shoulder dystocia causing a brachial plexus injury to his right shoulder resulting in permanent damage.

It was contented that the Claimant’s mother should have been advised, as part of her antenatal care, of the risk of shoulder dystocia and told of the possibility of having a caesarean section instead of giving birth vaginally. It was stated that if she had been warned of the risk, she would have opted for a caesarean section and he would have been born in that manner, thereby avoiding the brachial plexus injury.

The trust accepted that there ought to have been a discussion with the claimant’s mother about mode of delivery as a result of the occurrence of shoulder dystocia in her second son’s birth, and that that had not occurred. It asserted, however, that had such a discussion taken place, the Claimant’s mother would have been advised to proceed with a vaginal delivery and the claimant would therefore have suffered the brachial plexus injury in any event.

It was held that it was a doctor’s responsibility to inform the patient of that significant risk, so that she could determine for herself what course she should adopt. The evidence was that if advised of the risk of shoulder dystocia, the Claimant’s mother would have opted for a caesarean section rather than run any risk of repeating the birth she had experienced with her first son, even if the advice from the obstetrician would have been to proceed with a vaginal birth. It followed that the Claimant succeeded on the issue of causation.

Thefault v Johnstone [2017] EWHC 497 (QB) (14 March 2017)

Mrs Thefaut agreed to undergo discectomy under the care of Mr Johnston, Spinal Surgeon. Subsequently she suffered nerve damage and has severe and constant pain in her back and leg.

Key to the consent issue was the letter sent by the surgeon detailing the risks and benefits of surgery:

“Further to my telephone conversation with you today I am writing to confirm that I understand you have had facet joint injections which did not help with your pain. I therefore think that as your symptoms are deteriorating it would be entirely reasonable to recommend surgery to your back. By taking away part of the disc and trimming up to the bone that is compressing the nerve passing down to your left leg I think that there should be at least a 90% chance of ridding you of your leg pain. As I explained to you back pain is not quite as likely to settle, but as your symptoms have come on at the same time I think that there is every chance that your back pain will settle as well. The risks of surgery are fortunately very small. There is a 0.1% chance that I could damage the nerve (giving you weakness in cocking up your left foot) and there is a 2% chance that you could have a leak of spinal fluid which would delay your discharge from hospital by a few days but would not have any long term consequences. If you would like to go ahead you can book in for surgery by contacting Jackie on the above number and she will arrange this for you.”

The judgment specifically referenced the Montgomery case, noting the importance that the doctor should 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. It went onto note that the test of materiality is that particular patient and whether they would be likely to attach significance to the risk.

What is a ‘material risk’ was considered to be a mixture of subjective and objective:

The judgment emphasised that the actual communication of risks and treatment options must be assessed in the light of the following:

• The communication/ dialogue between doctor and patient must be ‘adequate’.
• There must be ‘adequate time and space’ for there to have been a reasonable dialogue.
• communication must be ‘de-jargonised’.
• The doctor’s duty is not fulfilled by bombarding the patient with technical information.
• The routine demand of a signature on a consent form does not by itself mean anything in terms of consent.

Here there were a number of issues with the information provided by the Defendant. He had referred to at least a 90% chance of ridding her of leg pain (the experts agreed the chances had been 85%). He had overstated her prospects of removing her back pain by suggesting that this was ‘not quite as likely to settle as her leg pain’ whereas it was properly considered to be more like 50/50. He had understated the prospects of surgery making matters worse, indicating the chances were ‘very small’, yet the experts agreed a risk of deterioration from surgery was of around 5%.

The consent process had been that there had been a 4-5 minute telephone conversation – clearly this had not provided ‘adequate time and space’ to remedy any of the shortfalls in advice from the written letter. Furthermore a conversation between surgeon and patient immediately prior to surgery was too late to remedy any defects in the consent process.

The Judge concluded that had she been advised that there was only a 50/50 chance of improving her back pain and that there was a 5% chance of her condition worsening as a result of surgery or a complication, then she would either have declined surgery or postponed to consider further and/or take a second opinion. Her claim based on informed consent therefore succeeded with damages to be assessed.

Comment

This case was a clear application of Montgomery, detailing that the patient was entitled to choose whether or not to undergo the recommended procedure and that she could not make such a decision without detailed and accurate information as to the risks and benefits of what was proposed and also as to the risks/ benefits of simply doing nothing.

The Defendant had provided information, but had overstated the benefits of surgery and understated the risks, a perhaps not unusual approach to providing information to patients. However, the law is clear that more information needs to be given, and the process of understanding needs to be considered fully, giving particular reference to the “time and space” required to consider options.

Duce v Worcestershire Acute Hospitals NHS Trust [2018] EWCA Civ 1307

The Claimant had suffered from painful and heavy periods for some time. From January 2006 she suffered from lower back pain. She sought medical advice at the end of 2007 and was seen in clinic in relation to possible total abdominal hysterectomy.

The notes explained detailed this was a “major operation with associated risks”.  A letter in the notes also detailed that the clinician had recommended she try less invasive methods.

Surgery was performed non-negligently but post-operatively she developed Chronic Post-Surgical Pain as a result of nerve damage. The question was whether she was properly consented for the risk of post-operative pain.

The notes had recorded “risks explained” and the registrar had (on the morning of surgery) warned of post-operative pain (but it was accepted did not warn about chronic pain or neuropathic pain following surgery). The RCOG guidance did not detail the risk of chronic, long term of neuropathic pain and experts agreed that it was not common knowledge amounts gynaecologists at the time.

At first instance is was held there was no duty to warn of the risk of chronic or neuropathic pain.

The Claimant appealed, on the basis that the test of materiality in Montgomery had not been applied and the judge had incorrectly applied Bolam to the consent question.

It was held on appeal that the application of the Montgomery test is two stage, firstly considering what risks were or should have been known to the medical profession and secondly whether the patient should be told of such risks (with reference to their subjective assessment in relation to materiality). The Court of Appeal held that the first question, whether or not medical profession were aware of a risk, would still be an issue for the experts and that at the time in question the profession were not aware of the risk, and as a result it was not necessary to consider the second question of whether or not the risk was (or ought to have been considered) material to this patient.

Lucy Diamond v Royal Devon and Exeter NHS Foundation Trust [2017] EWHC 1495 (QB) 23/06/2017

An NHS trust had breached its duty to a patient by failing to examine her abdomen at a post-operative review appointment, and by failing to ensure that she had given informed consent before proceeding to repair an incisional hernia with a mesh.

While the patient was entitled to damages the failure to obtain informed consent did not determine all the issues since it was held that the mesh repair would still have been undertaken even if examination had taken place and more information provided.

In December 2010 the patient had undergone spinal fusion surgery. At a review appointment in January 2011, she complained of back pain and abdominal distension.

The patient had mentioned the problem with her and, as per materiality and Montgomery, it inevitably followed that there had been a breach of duty as a result of the failure to examine the abdomen.

Ultimately further surgery was carried out in June 2011. The patient learned after having had the operation that there were adverse risks associated with the mesh repair should she become pregnant.

It was alleged that there was a failure to ensure that the patient had given informed consent before proceeding to repair the hernia with a mesh.

It was held that the surgeon had failed to discuss with the patient the potential adverse effects of a mesh repair in terms of a pregnancy in the future. Therefore there was a failure to obtain informed consent. Furthermore there was a failure to inform the patient that a primary suture repair as opposed to mesh repair was possible.

It was held that if the surgeon had turned his mind to the issue of pregnancy, he would have told the patient that there were certain risks associated with the procedure. He would, on the question of suture vs mesh, have strongly recommended mesh repair. It was held that even if the patient had been in a position to give informed consent, the mesh repair would still have been undertaken. The Court held that a mere failure to warn of risks, without more, could not give rise to a free-standing claim in damages.

Tracy Hassell v Hillingdon Hospitals NHS Foundation Trust [2018] EWHC 164 (QB) 06/02/2018

Claimant recovered £4.4 million in damages after she had been left permanently paralysed as a result of spinal surgery.

Although the surgeon had used reasonable care and skill in carrying out the operation, he had not obtained the patient’s informed consent before the surgery, and the evidence demonstrated that if the patient had been informed of the risk of paralysis and other conservative treatment options, she would not have chosen to have the operation.

The claimant argued that the surgeon had not warned her that the operation might leave her paralysed, and that he had not discussed other conservative treatments before the decision to have the operation was made. She also submitted that the operation had been negligently performed.

The Court held that the claimant had not been told about the risk of paralysis as a result of spinal cord injury, nor had she been advised of conservative treatment options including physiotherapy and further injections. Accordingly, the surgeon had failed to take reasonable care and skill to ensure that she was aware of the material risks of the operation and the alternative conservative treatment options.

Further, the evidence demonstrated that if she had been given the relevant information about the risks of paralysis and conservative treatment options, she would not have had the operation but would have opted for conservative treatment).