Supreme Court reverses informed consent ruling: Sidaway is dead
13 March 2015
Montgomery v. Lanarkshire Health Board [2015] UKSC 11, 11 March 2015 – read judgments here
James Badenoch QC of 1COR was for the mother in this case. He played no part in the writing of this post.
An important new decision from a 7-Justice Supreme Court on informed consent in medical cases.
In the mid-1980s a majority of the House of Lords in Sidaway decided that it was on the whole a matter for doctors to decide how much to tell patients about the risks of treatment, and that therefore you could not sue your doctor in negligence for failing to inform you of a risk if other reasonable doctors would not have informed you of the risk. Thus the principle that the standard of medical care is to be determined by medical evidence (which all lawyers will know as the Bolam principle) was extended to the quality of information to be provided to a patient about a given treatment.
The Supreme Court, reversing the judgments at first instance and on appeal, has now unequivocally said that Sidaway should not be followed.
The facts
In 1999, Mrs Montgomery gave birth to a baby boy. Unfortunately, he was starved of oxygen during the delivery and sustained severe brain damage. The principal claim was against her obstetrician for failing to give proper warnings. This was because the mother was small and diabetic, and diabetes tends to lead to larger babies. In the event, the shoulders of the baby got stuck during delivery (known as shoulder dystocia) and there was a 12 minute delay in freeing the shoulders during which her son sustained the brain injury. He also sustained paralysis of an arm caused by the force used in pulling him out.
The mother said she should have been warned of the risks of shoulder dystocia, and her evidence was that, had she been so warned, she should have been offered and would have asked for a caesarean section.
The Sidaway point
The obstetrician said she did not warn about shoulder dystocia because the risks of a serious problem ensuing from it were very small, and in this she was supported by some of the experts who gave evidence at trial.
But was this the right approach, namely for the decision about the information to be provided was to be left ultimately to the doctor’s clinical judgment?
The majority decision in Sidaway supported this, though, as the current Supreme Court explained, the reasoning of the House of Lords was rather more nuanced than has been often stated.
The Scottish courts decided that Sidaway was determinative of the question.
The Supreme Court, after an exhaustive review of the post-Sidaway cases, disagreed. In particular, the Court noted that the English courts (in cases such as Pearce and Chester v. Afshar) had eroded the supposed certainties of Sidaway and have tacitly ceased to follow Sidaway‘s adoption of the Bolam test in this context. Australian and Canadian courts had taken the same view.
The justification for this change of approach will be obvious. A patient has her own right to make her own decision based upon sufficient information. A doctor must respect that right if there were material risks which a reasonably prudent patient would think were significant. Medical evidence would of course be relevant to that decision, but the decision was ultimately legal rather than one for the doctors. As the main judgment puts it at [75]
….patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession.
Times have moved on from the “doctor knows best” approach of Sidaway. There are so many other sources of information available to patients (the internet, patient support groups, drug labelling etc) and hence
It would therefore be a mistake to view patients as uninformed, incapable of understanding medical matters, or wholly dependent upon a flow of information from doctors. The idea that patients were medically uninformed and incapable of understanding medical matters was always a questionable generalisation….. To make it the default assumption on which the law is to be based is now manifestly untenable.
This default assumption does not accord with GMC guidance to doctors, nor indeed with other developments in the law:
80. Under the stimulus of the Human Rights Act 1998, the courts have become increasingly conscious of the extent to which the common law reflects fundamental values. As Lord Scarman pointed out in Sidaway’s case, these include the value of self-determination….. As well as underlying aspects of the common law, that value also underlies the right to respect for private life protected by article 8 of the European Convention on Human Rights.
The Court noted that the resulting duty to involve a patient in treatment decisions has been recognised in Strasbourg cases such as Glass v United Kingdom (2004) 39 EHRR 15 and Tysiac v Poland(2007) 45 EHRR 42, as well as in a number of decisions of UK courts.
So the move is away from a model of medical paternalism. Social and legal developments point towards an approach to the law
which, instead of treating patients as placing themselves in the hands of their doctors (and then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices.
This rule comes with an important caveat, known as the therapeutic exception. A doctor is entitled to withhold from the patient information as to a risk if she reasonably considers that its disclosure would be seriously detrimental to the patient’s health. But the Court stressed the limited nature of this exception. It should not be use to subvert the principle in circumstances where the doctor thinks that the patient is liable to make a choice which the doctor believes in contrary to her best interests.
The Court went on to decide that the obstetrician should have warned the mother about the risks of shoulder dystocia and discussed the alternative of an elective caesarean section.
Causation on the facts
A claimant still has to show that she would have made a different decision, had she been properly informed. Here, the first instance judge had concluded that, with full advice about shoulder dystocia, the mother would not have opted for an elective caesarean.
It is usually extremely difficult for an appellate court to reverse that sort of decision on the facts. However, the judge’s conclusions contained two errors, according to the Supreme Court. It focussed on the very small risk of grave consequences from shoulder dystocia, rather than the considerably greater risks of shoulder dystocia itself (9% to 10%). It also omitted one important bit of evidence from the obstetrician herself, who, when explaining why she did not warn about shoulder dystocia, said that most women would actually say, ‘I’d rather have a caesarean section'”.
The obstetrician added
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.
So the obstetrician herself accepted that mothers would generally opt for a caesarean if so warned; that was a reason for not warning.
The Supreme Court noted that the judge had concluded that the obstetrician was an impressive witness. To find that she was wrong in her evidence on this point does strike one as a little inconsistent.
Hence, taking the mother’s evidence with the obstetrician’s evidence, the Court concluded that it is probable that the mother would have chosen caesarean section had it been offered to her with a proper explanation of the risks of shoulder dystocia.
Lady Hale, in her concurring judgment, pointed out that the obstetrician’s view did not appear to be a purely medical judgment.
It looks like a judgment that vaginal delivery is in some way morally preferable to a caesarean section: so much so that it justifies depriving the pregnant woman of the information needed for her to make a free choice in the matter. Giving birth vaginally is indeed a unique and wonderful experience, but it has not been suggested that it inevitably leads to a closer and better relationship between mother and child than does a caesarean section.
The first is indeed a telling point. As for the second, the only HRB editor with direct experience of childbirth would herself not go quite as far as describing vaginal delivery as a “unique and wonderful experience.”
Conclusion
The Supreme Court has now cleared up the inevitable arguments which occurred from time to time in UK courts as to how Sidaway could be reconciled with the later cases, and has brought Scots law into harmony with the recent English cases. The present judgments show a rather more modern and enlightened approach to the doctor-patient relationship than that adopted 30 years ago in the House of Lords.
And so for the two people shown in my pic above, a successful claim in damages.
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Where does this leave the wording on Advance Directives? These allow you to refuse treatment ‘even if this risks hastening my death’, but Macmillan are still advising you that you cant refuse pain relief and sedation in advance…we all know morphine and midazolam will kill you, so in effect, they are advising the public to give consent to being killed!
Shouldnt hospices tell you that they’re about to kill you, rather than ‘keeping you comfy’ nowadays?
I profoundly agree with Lady Hale’s reasoning as it appears that the obstetrician was more concerned about the bonding of the child with his mum, than giving the relevant information to the mum from which she would have been able to make a reasonable decision taking into account her life and the risks to her unborn baby. Wonderful
great decision; having worked as a doctor for many years which included six month stints on obstetric, paediatric and mentally handicapped units (where there were a large number of birth-trauma related children) I have no doubt at all that this is the right decision… whatever you feel about “natural deliveries” (& you only have to look at the mortality/morbidity stats from any third world countries where good obstetric care is not available to at least begin to question this paradigm); maternal interests alongside a right (or at least one would hope for an informed choice) to a vaginal delivery also include a right (or at least a fighting chance) of a healthy non-brain damaged infant…
I still think my late husband, a hospital consultant, was right in maintaining that 90% of making a good diagnosis was spending time talking to the patient, while only 10% was involved in actually making that diagnosis.
For too long, too many patients have been treated like rather necessary nuisances at best, or naive nincompoops at best – who were expected to do exactly what they were told by doctors, or the nurses following doctors’ orders.
Again I refer to my husband who firmly believed that, (outside and emergency) time was well spent in explaining, as simply and clearly as possible, exactly what treatment was being considered, and why. In this was, he obtained the cooperation of the patient as well as their family and the benefit of no lawsuits.
In response to the writer above’s comments: “I could go and read the academic literature and decide that while the standards of the insurance might not be met, it was enough to convince me. But the portion of the population able to do that is slim”.
Human understanding is not deficient in capacity to take on board and evaluate, these simply a question of presentation and a time factor. But other principals are at stake: patients’ ‘information’ arises from and belongs to that attached patient, the codification of a persons’ condition arises from that person, not from the doctor who only analyses the condition. The doctor comes in at the point where it is considered his skills are required. The skills belong to the doctor, the information as to the condition belongs to the patient. Keeping information about conditions and solutions ‘Esoteric’, away from the patient, alters the balance of power between the doctor and the patient. The doctor ought to do what is best for his patient, regardless of financial liabilities, which insurance risk factor should not be the governing factor as to who owns the information and the legal rights to determine remedies applied a ‘body’.
The financial insurance implications as to unknown natural risks, or risks arising from ‘botched jobs’ because the rest of the profession practice ‘botched jobs’ and this acceptable by the professional standards of the time, is separate from whether or not a patient is or is not allowed access to his/her own information about his/her own condition, with access or not to help determine solutions as to their own remedy. Liability and information ‘ownership’ are wholly distinct matters. The ownership factor introduce commercial property ownership rights vis who has or does not have ‘property’ rights over a persons own medical condition. On what moral or legal principals should the doctor or health service own a persons information and have sole rights to determine treatment? Obviously the doctor requires legal rights of access to acquire information so as to solve the matter at issue.
This is politically charged and critical since politicians are aiming to privatise our NHS, so that our medical information, our medical notes could become a corporations private commercial property to dispose of as they will. This could of itself pose grave political risks, by reason that all knowledge is power. He who controls the knowledge has the power.
“Human understanding is not deficient in capacity to take on board and evaluate, these simply a question of presentation and a time factor. ”
There are concepts which do require above average cognitive capabilities, and anyone who ever tried to wrap their head around quantum mechanics can attest to that. In any case, however, the time to understand a certain topic can go way beyond what is feasible for an average patient. Patients with chronic disease will usually invest a great deal of time over many years to understand their condition and can indeed come to a good layman’s understanding. But when it comes to one-shot issues, it’s simply not feasible for the average patient to pour hundreds of hours into the decision.
But what if I told you that even GPs regularly lack fundamental understanding of the conditions they are dealing with? Because physicians are first and foremost trained to diagnose and treat a disease, and the training of physiology is ancillary to that. More, the understanding of statistical concepts necessary to both write and read (properly) modern academic medical literature is even rarer. The consequence is not just a flood of low-quality publications but also a huge number of physicians unable to recognise that low quality.
I’ve seen pharmaceutical companies organise statistics seminars for their customers just so that they are actually able to talk with physicians as to the different relative risks for different patient populations between their drug and the competitor’s. Just to enable physicians to make an informed decision as to for what patients which drug is more suitable, as they had different risk profiles depending on other diseases and conditions the patients might have had.
So if even physicians often struggle to understand the conditions they are treating, how do we expect them to convey information on actual risks and benefits to patients in what little time they have?
Patient directed treatment has gone too far. Our “choices” as patients are not always rational and objective–particularly in the stress, fearfulness and emotion of a pregnancy–and that’s where professional advice should be respected and heeded.
As a MCA trainer this is a most welcome ruling and marks yet another important step away from a paternalistic model of decision making based on “doctor knows best” to a rights based model. Doctors will need to up their game and be able to explain risks ans benefits to patients in a way that the patient understands and be prepared to invest more time in discussing risks and alternative treatments. Let’s hope it does not lead to an unwelcome rise in the already unacceptable number of capacity assessments that are triggered simply because the health professional is of the view the patients decision is unwise.
Excellent comment , for most people tossing a coin is most probably as good a way as any when having to decide what action to take.
Sad but true. My father, an engineer for forty years, had an inguinal hernia. He was treated by Leicester Royal and died of peritonitus. We sued but were quoted Bolam. We were very disappointed we couldn’t persue a negligence claim. The Coroner ruled Misadventure.
Appalling attitudes still abound in NHS End of LIfe Care if you read through their current documentation, ”Actions for End of LIfe Care 2014-16” you’ll see that Mrs Neubergers clique are still being trained that a Dr does not even have to discuss a patient’s medical condition with them, on the subjective assessment that it would harm them!
p,28 ” The person must have full access to this information (unless
that is likely to cause him or her harm).” http://www.england.nhs.uk/wp-content/uploads/2014/11/actions-eolc.pdf
Couple this to the fact that LiverpoolCarePathway v.11(those drugs kill you whether you’re imminently dying or not folks) broke the World Health Organisation analgesic ladder, and had no informed consent process on it until 2 years after the MCA came into force, and recommended prescribing practices for which other doctors have been struck off for ‘reckless prescribing’ by the GMC (because those drugs kill you whether you’re imminently dying or not folks!),
I think the State is rather fortunate that no one can afford to go to court with a low quantum case and no one seems interested in a corporate manslaughter case..
..and as for ‘quality of information’, the NHSEngland are still advising patients they CANNOT refuse pain control and sedation in an advance directive – so the LiverpoolCarePathway drugs (which kill) are compulsory – p.2 of http://www.nhs.uk/ipgmedia/National/Macmillan%20Cancer%20Support/assets/AnadvancedecisiontorefusetreatmentMCS6pages.pdf .!
On the main site of the new NHS EOLC contractor Macmillan, this information even bears a Government ”Information Standard” Stamp http://www.macmillan.org.uk/Cancerinformation/Livingwithandaftercancer/Advancedcancer/AdvanceDecision.aspx
Reblogged this on International Law Matters.
[…] Supreme Court reverses informed consent ruling: Sidaway is dead Thus the principle that the standard of medical care is to be determined by medical evidence (which all lawyers will know as the Bolam principle) was extended to the quality of information to be provided to a patient about a given treatment. The … Read more on UK Human Rights Blog (blog) […]
The issue is a bit more complicated, alas. Accurately assessing risk is tough for people for whom it is professionally relevant but not the main task, it is that much harder for people to assess who have no specific training. There are plenty of studies showing that the average person often grossly misinterprets statistical data, especially when it comes to risk of disease or medical complication. While that is of course no reason to withhold information, accurately explaining the risks and benefits of various choices is something that requires both training in communication and time – neither of which is in ample supply for physicians. Take the caesarean mentioned – in the end, it IS an invasive procedure with its own risks. And telling the patient more about the risks of vaginal delivery doesn’t mean she will fully understand the risks of a caesarean. The only real solution is to take care of the two scarce resources I mentioned. But sufficient patient time is lacking left and right, so it’s unlikely that actual understanding of the risks can be reasonably verified any time soon.
Yes, patients have lots of resources they did not use to have – but can they use them? When a physician in Germany gave me an option between two procedures, one of which was paid for by the healthcare system and one I would have had to pay for out of pocket, as the deciders were not yet convinced of the long-term chances of success, as a trained biomedical scientist, I could go and read the academic literature and decide that while the standards of the insurance might not be met, it was enough to convince me. But the portion of the population able to do that is slim. And the other extreme is just as frightening: When I once went to a new physician telling him that a slight asthma had been diagnosed in the past by the doc at my last location and I now needed medication, he signed the perscription without even checking me or getting the file from the old doc. Given the abuse possible with asthma medication, I was baffled.
Yes, patients should be aware of the risks and benefits, but I’m afraid this judgment does little to tackle the actual problem. Telling isn’t hearing and hearing isn’t understanding and just because a patient signs that they understood something doesn’t mean that’s the case. And understanding the risks of one procedure doesn’t mean understanding the risks of the alternative.
I should express an interest in this matter. I appeared for the GMC in the Montgomery case as interveners. I should say that the performance by James Badenoch was outstanding and it was a pleasure to work with him.
The GMC prepared detailed submissions on the issue of consent, and pointed out that the idea of the patient having to provide consent predated the second world war; but it was a consequence of the atrocities in concentration camps when doctors carried out procedures to without any consent that spurred the profession (worldwide) into action. The GMC has been seeking to change Doctors’ attitude and practice for many years and I am hopeful that now things will have to change.
I fully appreciate the comments by tyelko above: but what the formulaic approach of trying to have a series of tick boxes on issues to be discussed ignores (and I am sorry if that is not what is the ultimate result from the comments) is that the GMC is anxious that patients are involved in a discussion, that reaches the point where there is a mutual understanding of what can be done, what cannot be done, and what the relative risks are. As Lord Reed and Lord Kerr point out, barraging a patient with statistics will not fulfil the duty now clear; nor will pointing to a signature on a consent form.
The great advantage of consensual medicine, in which the patient truly understands the risks and makes the choice, is that it will reduce litigation: the patient who truly chooses, and takes a risk, can hardly complain that the surgery went wrong for that reason. On the other hand a physician concealing or failing to advise of a risk will be exposed to criticism.
I am not as a lawyer ignorant of the challenges to medicine: I lecture regularly to one of the Royal Colleges of Physicians and Surgeons on consent (although my lecture notes now require hefty rewriting). A recurrent theme for them is lack of time and resources – patients being “consented” [a phrase I deplore as it reduces it to a form signing exercise] some weeks prior to the surgery and by another doctor. What of the patient who is having second thoughts? How does the operator know what was discussed? Tales of doctors “consenting” for anaesthesia when they are not experts in that field? But the recurrent complaint is “I don’t have the time allocated to me to enter into a chat with the patient”.
There are challenges ahead for the doctors and lawyers. There are no right answers, only wrong ones and those that may be right. I suspect that lack of consent cases will be those that “you know it when you see it” and in reality by the law of averages the tiny risks of slight harm will never end up in court at all. Lord Neuberger in the course of discussion pointed out the (with respect fairly obvious) point that a 1% risk of earache for an hour is very different to a 1% chance of risk of death. The former may not be that important; but the latter of course it is. But how many would litigate over the former, if not advised of the risk? De minimis non curat lex.
Andrew Smith QC
Compass Chambers, Scotland and Crown Office Chambers, London.