Montgomery v Lanarkshire (2015) – what are the implications for research nurses?

There is much in the medical and nursing press about this case and the implications of it particularly on receiving consent from patients and what we should be disclosing about specific risks.  This blog is to explore some of the reasons why this is such an important judgement by the Supreme court and what it means for us as research nurses.

The Case

In 1999 Mrs Montgomery gave birth to a little boy in Bellshill Maternity Hospital, Lanarkshire, Scotland.  Her pregnancy was identified as “high risk” due to Insulin Dependent Diabetes Mellitus (IDDM) and she was under the care of a consultant throughout.  This consultant was to be the focus of 2 negligence charges, both of which were initially rejected in 2010, before the case was considered again on appeal by the Supreme Court in 2015.

It’s a hard and sad case to read through; the decision to carry on with a vaginal delivery rather than an elective Caesarean Section led to the child being born with severe disabilities following the known risk of complications arising from shoulder dystocia partly due to the size of the baby and partly due to the height of the mother.  The judge was clear – had the child been born by caesarean section he would have been born “uninjured”.  There were numerous opportunities for the decision to have been changed throughout the pregnancy; there were multiple scans performed throughout and these were only terminated at 36 weeks by the consultant as she felt that her patient was getting to anxious about the size of the baby and her ability to deliver vaginally.  However, even at this stage the consultant did not disclose the specific risks of harm and she still recommended vaginal delivery.  During the delivery, the baby did suffer these complications and was born with severe complications.  Interestingly, the original judgement in 2010 was that in order for a duty to explain risks to arise, Mrs Montgomery would have had to have “raised questions of specific risks” involved in vaginal delivery, a judgement that would later be overturned.

The judgement from the Supreme Court

The case went to the Supreme Court, who were invited to “re-consider the duty of a doctor towards a patient in relation to advice about treatment”.

Whilst considering other case law and what had come before, the judge made an important point that has implications for future cases.  He said:

One development which is particularly significant in the present context is that patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices: a viewpoint which has underpinned some of the developments in the provision of healthcare services. ” Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) (2015)

He also emphasised the ease at which patients can now get hold of information via patient leaflets, the internet etc and that is it no longer acceptable to see patients as being ill-informed and incapable of understanding medical concepts.  He refers to a document called “Consent: patients and doctors making decisions together (2008)” and comments:

In relation to risks, in particular, the document advises that the doctor must tell patients if treatment might result in a serious adverse outcome, even if the risk is very small, and should also tell patients about less serious complications if they occur frequently (para 32)” Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) (2015)

He goes on to warn that we no longer have a paternalistic doctor-patient model where the patient is entirely dependent on the information given them by the doctor.  He instead asserts that the model is treating patients “so far as possible” as adults who can understand that medical treatment may involve risks, who are able to weigh up those risks themselves and live with the consequences of those decisions.

The implications for research nurses

While the medical world is recovering from initially reeling from the potential impact of this judgement – particularly in relation to the implication for the Bolum test that’s been relied on for many years by doctors and nurses alike (“Bolum test is out”),  I don’t think many health care professionals would disagree with the judgements made and the practical increase in patient empowerment it brings. It is clearly a landmark case and challenges the way we have maybe traditionally been taught to think about what should be disclosed and leaves no defence for the old-fashioned paternalistic view if the doctor m-patient relationship.  In reality though, the judgement not only reflects how the society has moved on, it is also in step with how many forward thinking medical professionals practice anyway, as can be seen reflected in the NMC Code of Conduct for example.

As research nurses, we are already well used to ensuring that patients are aware of any risks and these have been part of research requirements for many years; The Declaration of Helsinki (2013) states that:

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. ”

However, there is still the question of how much is too much information to give to our patients?  The defence of the consultant in Montgomery v Lanarkshire (2015) was that “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 does the ruling from the trial mean that we need to explain all risks to every single person we come across in explicit detail? Well, to put it simply, no.  One of the clear themes emerging from the case is that each person should be treated as an individual and the amount and specifics of the information given is dependent on what information the clinician feels that the patient may attribute importance to and this requires skill on the part of the person doing the assessing.

the skill and judgment required are not of the kind with which the Bolam test is concerned; and the need for that kind of skill and judgment does not entail that the question whether to explain the risks at all is normally a matter for the judgment of the doctor. That is not to say that the doctor is required to make disclosures to her patient if, in the reasonable exercise of medical judgment, she considers that it would be detrimental to the health of her patient to do so; but the “therapeutic exception”, as it has been called, cannot provide the basis of the general rule.”

So, what exactly has this to do with us?  We’ve been doing this for years, right?  Well, yes and no.  Practically we probably are doing all of this in our day to day practice and so nothing has changed. However, everything has changed. The fundamental legal basis on which we will be judged for our practice has shifted. Bolum was such important case law, however, we must appreciate the changes in focus that have come about as a result of this case in order to absorb the implications for the future.  Isn’t this all just for doctors? We’re nurses, this doesn’t apply to us…  Actually, it does.  The judge makes this very clear:

“…a wider range of healthcare professionals now provide treatment and advice of one kind or another to members of the public, either as individuals, or as members of a team drawn from different professional backgrounds (with the consequence that, although this judgment is concerned particularly with doctors, it is also relevant, mutatis mutandis, to other healthcare providers)…” Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) (2015)

Chan et al (2017) highlighted the case law that has subsequently tested the Montogmery v Lanarkshire (2015) ruling, including one that did involve a research participant, and the results of these.  Interestingly, even 2 years after the ruling, and despite an initial very prompt response from the British Medical Journal to the ruling, Chan and her colleagues pointed out that doctors at the coalface had received little guidance on the implication the case has on their practice something that does now seem to be trickling through.

Most of us will just need to keep doing what we are doing; that’s the good news. We do need to ensure that we have the necessary skills to be able to carry out the consent process and training is carried out to help with this in England and Wales.  I’m not sure what training exists in Scotland but please do let me know and I can add it in!  If you want to read more from the Supreme Court ruling you can do so here: Montgomery v Lanarkshire – Supreme Court Judgement

In closing here are just a few of the summary points made by the judge in the case:

Three further points should be made. First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.
90. Secondly, the doctor’s advisory role involves dialogue, the aim of which is to ensure that the patient understands the seriousness of her condition, and the anticipated benefits and risks of the proposed treatment and any reasonable alternatives, so that she is then in a position to make an informed decision. This role will only be performed effectively if the information provided is comprehensible. The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp, let alone by routinely demanding her signature on a consent form.
91. Thirdly, it is important that the therapeutic exception should not be abused. It is a limited exception to the general principle that the patient should make the decision whether to undergo a proposed course of treatment: it is not intended to subvert that principle by enabling the doctor to prevent the patient from making an informed choice where she is liable to make a choice which the doctor considers to be contrary to her best interests.”

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