Image ©

The Law on Consent to Medical Treatment: The Fate of Two Ground-Breaking Authorities

By Alexander Hutton QC, Hailsham Chambers

Issue 19

In recent years, the entitlement of individuals to make their own informed decisions about what happens to their bodies has been recognised increasingly by the courts, reflecting wider changes in society. People are less willing simply to accept the conclusion of a professional that, for instance, particular medical treatment is in that person’s interests, without being in a position to know more about it themselves, to question or challenge the professional and in some cases to reject that advice.

The principle of personal autonomy in this regard underlies what, at the time, were seen as ground- breaking decisions by the UK’s highest court in Chester v Afshar [2005] 1 AC 134 in the House of Lords and Montgomery v Lanarkshire Health Board [2015] AC 1430 in the Supreme Court. Both cases relate to allegations of non-disclosure of risk in obtaining the patient’s consent in advance to particular medical treatment where that patient then goes on to suffer the very complication they were not warned about. This article considers what the longer-term impact on the law has been of each such decision. Has each proved to have been as revolutionary and game changing as they seemed at the time?

The Traditional Approach to the Law of Disclosure of Risks in Medical Treatment

In Sidaway v Bethlem Royal Hospital [1984] AC 871 Mrs S underwent spinal surgery and suffered a non-negligent complication of surgery, namely partial paralysis through damage to her spinal cord. It was agreed expert evidence that there had been less than 1% risk of this occurring, but she had not been warned in advance of that risk. Expert spinal surgeons agreed that it was an accepted practice of a responsible body of spinal surgeons not to warn of this risk as part of the consent process. Thus, if the Bolam test, from Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 (a doctor is not negligent if he/she acts in accordance with a practice of a responsible body of doctors in that specialism) applied to the principle of disclosure of risks to the patient, then the Defendant had a good defence to the claim.

The main question thus was whether the Bolam test applied to the disclosure of risks or whether “the doctrine of informed consent” should be adopted instead, i.e.:

  1. Is the adequacy of the disclosure of risk in undergoing the recommended medical treatment a matter for the medical profession to determine itself as to what are its own acceptable standards (on the Bolam principle of judicial deference to those who undertake such treatment) – sometimes known as the “doctor-centred” approach, or
  2. Is it to be determined by the patient’s entitlement to have all the information which might reasonably be material to them in order for them to make up their own mind? This approach had been adopted in some other common law jurisdictions. This is sometimes known as the “patient-centred” approach.

By a 4-1 majority, the House of Lords decided that Bolam applied to the disclosure of risks of medical treatment just as it applied to all other aspects of medical treatment. Lord Bridge accepted that there may be an exception to this if there was an obvious risk (he gave the example of a 10% change) of a seriously adverse outcome even if a responsible body of practitioners would not have warned of that risk. But that was as far as it went.

Reading those speeches now, there seems to have been a strong hint of paternalism in their approach: Doctor knows best, it is all very complicated and patients cannot be expected to absorb and process all the information, and furthermore they may as a result make “wrong” decisions by being scared off by an endless list of seriously adverse outcomes, where in fact the chance of each would be very small.

Lord Scarman was the only dissenting voice. He would have held that (a) it was not for the medical profession to determine what should and should not be disclosed, and (b) Patients have the right to self-determination over their own bodies: so doctors are required to provide all material information as to risks of treatment and alternatives, and then it is for the patient to decide in the light of this.

The Traditional Approach on Causation

If Mrs Sidaway had prevailed on breach of duty in contending that there was a culpable failure to disclose the small risk of a seriously adverse outcome, namely paralysis, then there is no doubt that in 1985, the hurdle she would have faced on causation would have been that she would then have to prove that, on the balance of probabilities, if she had been warned, she would not have gone ahead with the operation and thus would have avoided the paralysis. This is sometimes known as “but for” causation.

Judicial Disquiet about the Traditional Approach

From the late 1990s judges in the lower courts started to undermine the Sidaway approach on disclosure of risks as they did not like it in changing times. Lord Bridge’s exception that if there was an obvious risk of a seriously adverse outcome (where he had used an example of a 10%) started to be applied in much less extreme circumstances. The language of the judges was very much of Lord Scarman’s minority approach: human rights, bodily integrity and autonomy, self- determination: i.e. the patient centred approach. But, of course, they could not overrule Sidaway itself, just find a way around it in some cases.

Chester v Afshar[2005] 1 AC 134

The traditional approach in the context of consent to medical treatment was apparently blown open by the House of Lords in this case, albeit on the question of causation rather than on breach of duty.

This was another spinal surgery case, this time the relevant risk was 1-2% chance of post-operative non-negligently caused cauda equina syndrome, a life-changing condition which impairs bowel and bladder function and can sometimes have an effect on mobility. Ms Chester had the surgery and suffered cauda equina syndrome. The trial judge found that the spinal surgeon Mr Afshar had failed to warn Ms Chester of this risk. It is to be noted that the consent was taken only three days before the surgery.

However, on causation, he could not find that, had she been so warned, Miss Chester would have refused surgery altogether. He found instead that, if she had been warned, she would have put off having surgery at the scheduled time in order to discuss with others. And if she had decided to go ahead with surgery later, it would have been at a different time and possibly with a different surgeon. But it was found that the risks of non- negligently contracting the cauda equina would have been exactly the same on such a notional later occasion.

On a traditional approach to causation, her claim would have failed on causation, as she did not satisfy the “but for” test: she would ultimately have had the same operation and the risks on that occasion would have been the same as on the occasion she did have the operation. This was acknowledged by all five law lords. But nevertheless, she succeeded in the House of Lords by a 3-2 majority. Why?

The majority created an exception to “but for” causation in these circumstances. They did so on the grounds of the need for the law to give proper effect to the principle of “personal autonomy” embedded in the principle of informed consent (and notwithstanding that Sidaway apparently remained good law at that time on the duty of care). As Lord Steyn put it: “[The patient’s] right of autonomy and dignity ought to be vindicated by a narrow and modest departure from traditional causation principles.” The function of the law was to vindicate the right to self-determination. The damage was thus to be considered “intimately linked” to the duty to warn and so sounded in damages.

Lord Hope said: “I would accept that a solution to this problem which is in Miss Chester’s favour cannot be based on conventional causation principles”. But in this instance the doctor’s essential duty to warn patients of risks would be “hollow” if these principles were to be adopted here to allow her to succeed. Further, if the traditional approach was adopted, it would punish the honest claimant who wasn’t able to say that they would not have gone ahead with the operation.

Thus, the majority’s decision was explicitly an exception to traditional causation principles on the basis of policy and not, as is sometimes thought, on the same grounds as the trial judge found, namely that traditional causation was satisfied where a patient would have delayed if warned and the risk would then only have been 1-2% on that notional later occasion.

However, there were powerful dissenting voices of Lord Bingham and Lord Hoffman. Lord Bingham considered that the majority view was “a substantial and unjustified departure from sound and established principle” and that a claimant is not entitled to be compensated for damages which was not caused by the negligence complained of.

Lord Hoffman used a casino analogy to critique the trial judge’s approach that it was about as logical as saying that if one went into a casino and the chances of winning were 1 in 37, you would then go away and come back another day: “The question is whether one would have taken the opportunity to avoid or reduce the risk, not whether one would have changed the scenario in some irrelevant detail. The judge found the risk would have been precisely the same whether it was done then or later or by that competent surgeon or by another.” He considered that it undermined the law to create exceptions to established principles where such an exception is not justified.

At the time, there was a lot of discussion as to whether the majority decision meant that this was an end to the need to prove causation of injury in non-disclosure of risk cases: all you had to prove was the failure to warn of a risk which ought to have been warned about, and the claimant then succeeded automatically on causation as the damage was “intimately linked” with the breach. Or was it a case of (as suggested the minority) “hard cases make bad law.”

Montgomery v Lanarkshire Health Board [2015] AC 1430

Mrs Montgomery was a pregnant lady, and she was of small stature, she had longstanding diabetes, which made it likely her baby would be large and thus, combination with small hips, increased the risks of her baby’s shoulders getting stuck during a vaginal delivery, known as “shoulder dystocia”. Shoulder dystocia is dangerous as the baby cannot receive oxygen in that position and yet if the baby is pulled out, it can cause a brachial plexus (shoulder) injury. It was agreed expert evidence that there was, in her case, a 9-10% risk of shoulder dystocia occurring; a 0.2% risk of a brachial plexus injury, a 0.1% risk of prolonged deprivation of oxygen, and a less than 0.1% risk of cerebral palsy or death.

Mrs Montgomery had a vaginal delivery and her child suffered shoulder dystocia delaying delivery for 12 minutes and resulting brachial plexus injury and cerebral palsy. She alleged a negligent failure to warn her of the risks of vaginal delivery in her case, and that if she had been warned, she would have opted for a Caesarean Section.

The obstetrician in question had not warned her of the risk of shoulder dystocia, let alone the risk of a brachial plexus injury or cerebral palsy. She argued that if you to warn diabetic patients of such a risk, “then everyone would ask for a Caesarean Section and it’s not in the maternal interests for women to have Caesarean Sections.” The lower courts in Scotland applied Sidaway/Bolam and found that a responsible body of obstetricians would not have warned of any of these risks and, even if she had been warned, she would have opted for vaginal birth anyway.

The Supreme Court disagreed. They finally adopted the doctrine of informed consent on the basis that things had moved on in society since Sidaway:

  1. Patients are now accepted as having rights (including human rights), rather than merely being “passive recipients of care from the medical profession”;
  2. They are consumers who exercise choice;
  3. Patients have more information from the internet: there can no longer be a default assumption of ignorance;
  4. GMC guidance about the doctor-patient relationship has changed (since at least 1998): it is a partnership founded on the basis that the doctor provides options with risks and benefits, and the patient decides.


Thus, the test in a claim which relies on non- disclosure of risk was set out at paragraph 87 of the Montgomery judgement:

“The doctor is under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in the 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.”

Thus, Bolam is not a test that applies to all aspects of a doctor’s duty to a patient in relation to treatment: it no longer applies to disclosure of risk/consent. There are further points to note about the judgment:

  1. The approach to whether a risk is material cannot be reduced to mere percentages: the “materiality” of it varies, including the seriousness if it occurs – e.g. eye surgery on one eye when the other eye is already blind suggests an even greater need to disclose even tiny risks of blindness in such circumstances as the consequences are so much more serious;
  2. The information provided must be comprehensible so that the patient understands and is in a position to make an informed decision.
  3. Therapeutic exception – that the disclosure of the risks would harm the patient – is limited and should not be abused. It is rarely relied on.


The ultimate conclusion in the case was that, while the risk of brachial plexus injury or cerebral palsy was too small to need to warn about, the 9-10% of shoulder dystocia in that case should have been disclosed: it is a medical emergency in itself.

It is important to recognise that the duty probably goes beyond traditional negligence: even if the doctor has not disclosed a particular risk because, for instance, they were extremely busy dealing with an unexpected surge in patients and they did not have time to run through all the risks, and such an approach would be supported by a responsible body of such doctors, the doctor would nevertheless still be liable under the test in Montgomery. And it imposes on the doctor an obligation to assess what a reasonable patient would want to be warned about, which may be difficult for them to judge.

On causation, the Supreme Court found that, if Mrs Montgomery had been warned of the significant risk of shoulder dystocia in her case, she would probably have opted for a Caesarean Section and the shoulder dystocia (and consequential injuries) would never have occurred. Indeed, that is what her obstetrician had said would happen if you warn diabetic patients of the risks of shoulder dystocia. They applied traditional “but for” causation. They stated specifically that it was unnecessary for them to consider whether “she might establish causation on some other basis in the light of Chester v Afshar”. Thus, they gave no endorsement of Chester v Afshar.

Various criticisms have been made of Montgomery, including:

  1. It is unfair to apply it retrospectively to consent taken before the decision in March 2015. But is that really true? The Supreme Court was relying on GMC guidance in place since the 1990s;
  2. It works fine for elective surgery but what about the dynamic situation of labour: does the doctor have to outline the option of a Caesarean Section every time he/she reviews the patient? Undoubtedly the onus is greater in such moving situations.
  3. Is the doctor obliged to outline all alternative treatments, even those they positively do not recommend just because another doctor might? The courts have yet to fully grapple with this.


But it is to be recalled that (subject to the courts approach to Chester discussed below), the Claimant has to prove causation: they would not have gone ahead with the treatment if they had known. And that is often a very difficult hurdle to clear, particularly where emergency treatment is required.

What is clear is that the old days of sending the SHO down to see the patient 10 minutes before the anaesthetic to get a piece of paper signed should be long gone. Consent matters, it needs to be taken seriously.

How have Chester and Montgomery worked in practice?

In Duce v Worcestershire Acute Hospitals NHS Trust [2018] EWCA Civ 1307 the claimant underwent a hysterectomy but had not been warned of the risk of suffering chronic pain, which she then went on to suffer. The gynaecological experts said that the risk of chronic pain after hysterectomy was not widely known by gynaecologists. The Court of Appeal held there was a two-fold test in this situation:

  1. What risks were or should have been known by the medical professional in question. If not, there is no liability. That is a matter for the Bolam test;
  2. If the risks should have been known, then whether the patient should have been told such risks by reference to whether they are material: that is a matter for the Montgomery test.


The Court of Appeal also considered the application of Chester v Afshar. The claimant failed on the “but for” test but argued that Chester applied. It was held Chester was limited to facts very similar to Chester, namely if they had been warned of it, they would have delayed treatment to think about it. Here, it was found the claimant would have gone ahead anyway on the same occasion.

In Correia v University Hospital of North Staffs NHS Trust [2017] EWCA Civ 356, the claimant had a neuroma in his foot, the surgeon set out a 3-stage treatment, with the third stage involved surgery with relocation of proximal nerve. However, when the surgery went ahead, the surgeon then failed to do the third stage. The claimant argued that Chester applied because the defendant had not performed the operation that the claimant had consented to, so that the claimant recovered damages without the need to prove any causation.

The Court of Appeal (Simon LJ) found:

  1. The facts of Chester were unusual as the claimant had been “consented” on the Friday and had had the operation on the following Monday, and the finding was that the operation would have been delayed if there had been proper consent;
  2. The application of Chester was limited to its own facts, that if warned, the claimant would have deferred the operation. It did not apply more generally;
  3. Here the consent was appropriate when it was given, so the fact that the surgeon negligently omitted to move the neuroma did not vitiate her consent to the operation.
  4. The omission in the operation was a separate breach of duty which could sound in damages if it was proved that it caused her injury.
  5. If the claimant had been correct, there would have been far-reaching consequences about vitiation of consent, assault etc in relation to many operations;
  6. If Chester is to be relied upon, it must be pleaded and supported by evidence. The injury here was not “intimately linked” with the duty to warn, and so Chester did not help the claimant.

Similarly, in Brint v Barking, Havering & Redbridge University Hospitals NHS Trust [2021] EWHC 290 (QB) HHJ Platts held that without the claimant proving deferral of the procedure if properly warned, Chester does not apply: the “But for” test applied as normal.

In Mills v Oxford University Hospitals NHS Trust [2019] EWHC 936 (QB) a surgeon recommended removal of a brain tumour by minimally invasive keyhole surgery without mentioning the option of the standard open operation, let alone the relative risks of each. Karen Steyn QC (as she then was) held that there was a duty under Montgomery to tell the patient your recommended treatment was new and the limitations of the research into it: you can recommend it, but you must balance it by telling them of the alternative and the relative risks and benefits. There was a breach of the duty to warn, and it was held the patient would have opted for the standard operation so he succeeded.

In Price v Cwm Taf University Health Board [2019] EWHC 928 (QB) Birss J (as he then was held that there was no strict principle that a doctor must warn the patient that their technique was not recommended in the NICE Guidelines: the consent process had to be looked at in the round and as a whole to see if it was adequate.

It is clear that a warning of the risks, even if the content was sufficient, given for the first time immediately before undergoing an elective procedure was not sufficient under Montgomery: see Thefaut v Johnson [2017] EWHC 497 (QB). The pressures of time and the psychological commitment to undergo the operation by that stage made it not compatible with informed consent. The position of course may necessarily be different in emergency situations.

One issue that has not been fully clarified in the authorities is the extent on the doctor to discuss alternatives, which the doctor reasonably thinks would be totally inappropriate, but which some surgeons might recommend.

Conclusions

Two cases, both revolutionary, but it appears only one has stood the test of time. Chester seemed to open a motorway for claimants but has turned out to be a cul-de-sac: judges don’t like it because it conflicts with underlying established principles, and it has been confined to its particular facts (deferral of surgery). It is difficult to understand why, if it still exists, it should apply where the patient decides to defer surgery only for a day but not if the patient would have thought about it further but opted to go ahead at the planned time. It is to be wondered whether, if the point ever reached the Supreme Court, Chester might be put out of its misery.

In contrast, Montgomery has transformed the landscape and is raised in almost every clinical negligence claim. It has turned out to be a better expression of the patient’s rights of autonomy. But while it is raised in many cases, often the challenge of traditional but for causation is the hardest to surmount.