Consent to treatment – so, did you know the law has changed?

In March 2015, a birth injury claim changed the law in relation to patient consent. Paul Sankey, a partner in our Bristol office, was asked to reflect on this by Independent Practitioner Today and with their kind permission, his article is reproduced in full below:

In March 2015, the case of Montgomery v Lanarkshire Health Board [2015] UKSC 11 redefined the legal relationship between doctors and patients. Many doctors were concerned at its implications. Some feared it placed too high an obligation on them in warning patients of the risks of treatment. Others thought the decision simply brought the law into line with current practice. Two years on, we asked solicitor Paul Sankey to review its impact.

What was the decision about?

Mrs Nadine Montgomery gave birth to her first child, Sam, in October 1999 at a hospital in Lanarkshire.

There were three factors that increased the risk of injury to both mother and child at delivery:
 She was diabetic;
 She was also short, at around five foot tall;
 Her baby was known to be large – estimated (and, in fact, underestimated) at 3.8 kilos.

The risk of shoulder dystocia was around 9-10%, much higher than average. Shoulder dystocia increased the risks of injury to her. For instance, there was a risk of postpartum haemorrhage of 11% and of a fourth-degree perineal tear of 3.8%.# The risk of a brachial plexus injury to the baby was 0.2% and a 0.1% risk of prolonged hypoxia causing cerebral palsy or death. She was a highly intelligent woman. She had a degree in molecular biology and was capable of understanding these risks. Mrs Montgomery’s obstetrician did not advise her of these risks or invite her to consider a caesarean section. Her reasoning was that, while the risk of shoulder dystocia was high, the risk of serious injury was so small.

In the obstetrician’s words: ‘If you were to mention shoulder dystocia to every [diabetic] patient, if you were to mention to any mother who faces labour that there is a very small risk of the baby dying in labour, then everyone would ask for a caesarean section, and it’s not in the maternal interests for women to have caesarean sections.’

This rather revealing comment highlighted the key issue in the case: was it for the doctor to decide what was in the maternal interests or for the mother herself? Unfortunately, the risk of shoulder dystocia materialised. The baby suffered prolonged hypoxia and was born with severe disabilities. Mrs Montgomery sought damages against the health board responsible for her management. She alleged that she had been inadequately advised, not given informed consent to vaginal delivery and would have elected for caesarean section had she known of the risks.

In the lower court and on appeal, her claim failed. However, the Supreme Court found in her favour. It held that the failure to warn of the risks of vaginal delivery was negligent and that, with adequate advice, she would have elected for a caesarean.

How did the law change?

Until Montgomery, the courts applied the ‘Bolam test’ to a doctor’s duty to advise – following the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582

That test is whether a doctor acted in accordance with a practice accepted as proper by a responsible body of medical practitioners skilled in that particular art.

The test recognises that there are different schools of thought and different practices within the medical profession. The courts will not sit in judgment over different approaches provided they are rightly accepted as ‘responsible’, ‘reasonable’ or ‘respectable’ and capable of logical analysis (Bolitho v City and Hackney Health Authority [1997] 4 All ER 771). The Bolam test had been applied not just to diagnosis and treatment but to advice. It let the medical profession set the standard of what advice was acceptable. So long as a responsible body of similar doctors would have given the same advice, that advice was acceptable.

Mrs Montgomery’s claim failed in the lower courts because there was a responsible body of obstetricians who would not have warned of shoulder dystocia or invited her to consider caesarean section. The Supreme Court rejected the Bolam test’s application to a doctor’s duty to advise. But it still applies to diagnosis and treatment. The new test focuses on what a particular patient would want to know rather than what doctors in general would normally advise. It replaced a clinician-centred test with a patient-centred one.

What is my duty?

The Supreme Court set out what might be regarded as two principles. The first is that an adult 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. There is nothing particularly new here. It is for doctors to advise and patients to decide.

The second is more significant and sets out the nature of the duty to advise. This is where the law has changed. The wording is complex but it is worth quoting in full: ‘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.’

In short, the duty is to make sure a patient knows the material risks of the recommended treatment. It is then to make sure a patient can consider alternatives and knows the risks of those alternatives. It is not enough, therefore, only to discuss the treatment a doctor recommends. Patient autonomy entails understanding the options and being able to make a choice.

How do I know what is ‘material’?

The duty is to advise patients of material risks. This begs the question as to what is material. The starting point is that advice is specific to the particular patient.

The Supreme Court’s definition starts by referring to : ‘…the circumstances of the particular case’. The same standardised advice will not do for all patients. The risks may in percentage terms be the same, but advice must be tailored to the individual.

The wording goes on to consider whether ‘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.’

There are two parts to this.

The first is where ‘a reasonable person in the patient’s position would be likely to attach significance to the risk’.

At first sight, this seems convoluted. The key is again to consider the patient as an individual rather than as one of a group. What is material to one patient may not be material to another.

Consider two patients undergoing knee surgery. One may be elderly and in a wheelchair because of hip dysfunction. The other may be young and playing professional football.

Clearly, the potential risks and benefits of surgery will be very different to each. The benefits of successful treatment are much greater to the one than the other, although so are the risks.

The two could be considered at opposite ends of a spectrum and the example is perhaps rather extreme. However, consider two patients with no particular risk factors considering whether to deliver vaginally or by caesarean section.

One has experienced the grief of her sister-in-law’s stillbirth following complications of a vaginal delivery. She is therefore very aware not only of what can go wrong but the impact of it. She is anxious about the risk even though it is remote. The other is less worried. She regards these risks as something that happens to other people and the risk to her seems small.

The first woman is much more likely to attach significance to the risks of vaginal delivery than the second. In fact, this issue arose in one of the cases decided in the wake of Montgomery.

However, note that the test is not that this particular patient would be likely to attach significance to the risk, but that a reasonable person in the patient’s position would do so.

Interestingly, in two subsequent cases, the courts have said that a risk of 0.1% was too low to be material when the risk was, as in Montgomery, serious hypoxia during delivery.

In A v East Kent Hospitals NHS Foundation Trust [2015] EWHC, a risk of 1:1,000 was described as ‘theoretical, negligible or background’. In Tasmin v Bart’s Health NHS Trust [2015] EWHC 3135, the judge, perhaps mindful of the Supreme Court’s comments in Montgomery, preferred to formulate it as being ‘too low to be material’.

Those decisions may be regarded as a step back from Montgomery. However, they do not necessarily mean that the courts will take the same view in every case. There may be people for whom a 0.1% risk of serious injury is a material risk because of their particular circumstances. An example is the woman in labour whose relative had a stillborn baby.

The new test focuses on what a particular patient would want to know rather than what doctors in general would normally advise It is not enough only to discuss the treatment a doctor recommends. Patient autonomy entails understanding the options and being able to make a choice.

What seems like a complicating qualification, probably removes a degree of subjectivity. People are complex. There comes a point at which doctors cannot be expected to understand the idiosyncrasies of a particular patient. The test is therefore qualified to introduce an element of reasonableness into the equation.

The second part of the definition is where a doctor is or should reasonably be aware that a particular patient would attach significance to the risk.

This covers a patient who has told their doctor about particular concerns or those concerns have been recorded in the medical records. They may be unusual. They may be unreasonable. But they are important to the patient and the doctor knows about them.

The key is understanding the particular patient and being able to have a tailored discussion. You can only know what is material to a patient by spending enough time with them and engaging in dialogue with them.

Dialogue should reveal what is important to them. This might concern their work, leisure, family circumstances, interests or anxieties.

In private practice, this may be easier than in the NHS, where time is more constrained. The reaction of many is that this is precisely what they have been doing. Certainly, the Supreme Court thought that what it was doing was to bring the law into line with existing practice.

Do I have to advise of every risk, however small?

The duty is to advise of material risks. What is material cannot be reduced to a matter of percentages. The Supreme Court pointed out that the significance of a risk is likely to reflect factors other than its size.

These may include the nature of the risk, the effect its occurrence would have on the life of a patient, the importance to the patient of the benefits sought to be achieved by treatment, alternatives available and the risks of those alternatives.

The risk of shoulder dystocia in Montgomery was 9-10%. The risk of serious hypoxia was 0.1%.

Is there a risk of giving too much information?

A patient needs to be able to make an informed decision. To do so, she will need to understand the seriousness of her condition, the anticipated benefits and risks of treatment and of any alternative treatments.

The decision will only be informed if she can understand the advice. Blinding a patient with science or providing so much information that she cannot take it in isn’t helpful. As the Supreme Court said: ‘The doctor’s duty is not…fulfilled by bombarding the patient with technical information she cannot reasonably be expected to grasp…’ So there is a risk of providing too much information. How much a patient will need to know – and is capable of grasping – will vary from person to person.

Should I still use consent forms?

A consent form alone is unlikely to provide evidence of the sort of process the Supreme Court considers necessary.

It is unlikely to record the rationale for one form of treatment as opposed to another and may be geared towards generic risks rather than material ones. It is also unlikely to provide evidence that a patient has understood the significance of a risk. For instance, ‘nerve injury – 1%’ gives no indication of the severity of injury or its impact on a patient. A 1% risk of numbness is quite a different matter to a 1% risk of permanent intrusive pain.

It is much better to record not just advice but the fact of discussion in either a clinical record or a letter. The record should set out not just the advice given but also the patient’s concerns, priorities and reasons for agreeing a particular treatment.

What should my advice cover?

This depends on the condition, the nature of treatment and the patient’s concerns. However, the Royal College of Surgeons has recently produced useful guidance in line with Montgomery.

The check list comprises:
 Diagnosis;
 Prognosis;
 Options – including no treatment;
 Purpose and benefits of treatment;
 Prospects of success;
 Potential follow-up treatment;
 Material risks of the various options;
 Advice on lifestyle that may moderate the disease process;
 The clinicians involved in treatment;
 The costs and potential future costs of treatment – for private patients.
There are other guidelines. For instance, the Association of Anaesthetists of Great Britain and Ireland has recently produced new guidelines. Interestingly, the Royal College of Obstetricians and Gynaecologists has not.*

What if I think my patient is making the wrong decision?

Provided the decision is within a range of reasonable decisions, your patient has understood the issues and you are prepared to give the treatment, then the ultimate decision is your patient’s.

As the Supreme Court said: ‘An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo…’

What about patients without capacity?

The decision in Montgomery applies to patients who have capacity. However, similar principles will apply to advice given to people making decisions on behalf of patients without capacity.

Are there any exceptions?

The Supreme Court identified three exceptions, but said they were to be treated with caution:

1. The patient who does not want to know;
2. The therapeutic exception – where disclosure may be seriously detrimental to the patient’s health;
3. Necessity – for example, the unconscious patient.

Are we at greater risk of claims?

The decided cases raising issues of consent since Montgomery suggest probably not.

It is not obvious the decisions would have been different under the old law. More than half the cases concern birth injuries and it may well be that obstetrics will be the area of medicine most affected by the decision in Montgomery. Cases based on consent remain very difficult for claimants. They have the burden not just of proving that the advice they were given was inadequate, but that, putting aside hindsight, with different advice they would have made a different decision. In many cases, that is a difficult task. 

✱ Consent is an area that the RCOG is addressing at the moment. Its document, Obtaining Valid Consent, was published two months before the Montgomery ruling. The college says pregnancy and childbirth represent significant consent challenges, but if a doctor provides all options regarding treatments proposed – including no treatment, documents these discussions, obtains consent as per the GMC’s Good Medical Practice (2013), and takes into account our document, Obtaining Valid Consent, then consent will be valid. An RCOG spokesman said the college had begun a project to enhance and update its information tools to further aid patients to make decisions and to document that they have been fully involved in their decision-making. ‘After much internal discussion, we have realised that to get this right in women’s health, and especially maternity, this involves much more than re-doing our consent documents – it’s all about the communication with our patients,’ the spokesman added. ‘As part of this process, we will be involving our Women’s Network to get their input.’