Consent claims: themes and their implications for healthcare practitioners and insurers

Consent is a common theme on claims in clinical negligence and is a challenging issue for both practitioners and their insurers. From a practitioner’s perspective, it’s vital to know about the consent elements of claims as the relationship between a patient and clinician is often quite intimate and both parties are seeking a good outcome. From an insurer perspective, it is essential to aid their understanding of how consent forms a crucial part of the overall relationship between a clinician and a patient. 

This article will help clarify the key points to consider when consent is raised as well as providing some pointers which may avoid common pitfalls. 

What is the law? 

Clinical Negligence 

Montgomery -v- Lanarkshire Health Board [2015] UKSC 11

The law around Montgomery is well known, and we have covered this previously. Further detail can be found in our video resource here.

In summary, the Claimant’s child had an elevated risk of shoulder dystocia due to her diabetes and her being of a small stature. She was not informed of the risk of this complication materialising and advised of the option of an emergency caesarean section. Sadly, the baby suffered shoulder dystocia being born with severe disabilities.

The Court concluded, 

"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…”

In defining what would be considered to be “material risk” the Court determined it was whether, in all the circumstances, a reasonable person in the patient’s position would likely attach significance to the risk or the doctor is or should reasonably be aware that the particular patient would likely attach significance to it. 
It is crucial to be aware that consent for whatever procedure is specific to the circumstances of the individual patient. A consenting process with minimal application to the individual patient is unlikely to be sufficient to meet the test of materiality. 

However, there was concern the test was too broad, as seemingly it would require the patient to be advised of treatment where the clinician applying their expertise considered there would be no benefit. Clarity was required as to the doctor’s obligation in such circumstances. Fortunately, this was provided in: 

Mccullough And Others -v- Forth Valley Health Board [2023] UKSC 26

A doctor’s obligation did not go beyond informing the patient of reasonable treatment options. Further, whether something was to be considered “reasonable” was determined by applying the classic Bolam test (that of a group of similarly qualified reasonable practitioners). The Court said:  

1. The doctor cannot simply give the options they prefer; 

2. Once a range of reasonable treatments have been identified, the doctor must explain all those alternatives (and risks involved) to the patient. The doctor is not obliged to explain treatments they consider unreasonable (subject to Bolam reasonableness); and  

3. Most importantly, there is no obligation to inform the patient of treatment options which they consider unreasonable, even when they are aware there exists an alternate body of opinion which considers the treatment to be reasonable. 

Aesthetic market

The rules governing informed consent are predominantly cases involving medical practitioners.

Currently, aesthetic practitioners are not formally regulated and there is no formal duty of care beyond providing treatment with reasonable care and skill. 

It is crucial to be aware that despite this the principles of informed consent still apply as set out above, albeit on the facts perhaps less strictly. 

The Joint Council for Cosmetic Practitioners confirmed in May 2021 that: 

"Whilst many aesthetic consultations and procedures performed by suitably qualified Health Care Practitioners are deemed to be ‘medical’ or ‘medically related’ in nature, the JCCP acknowledges also that there are occasions when members of the public elect to seek aesthetic treatments that are deemed not to be either ‘medical’ or ‘medically related’. The latter are considered by definition to be purely ‘cosmetic’ in nature’ and not to be associated with a medically determined diagnosis or resultant clinical therapeutic benefit. The JCCP is of the opinion that only designated registered healthcare professionals (within the limitations of their competence), following the undertaking of an informed pre-treatment consultation and the exercise of assessment and clinical judgement with the patient, can determine whether a consultation and/or a procedure is ‘medical’ or ‘medically related’. Patients/members of the public present with a wide variety of physical, psychological or psychosocial symptoms and effects that relate to pre-disposing conditions. Having performed a diagnostic assessment of the patient, a practitioner should be able to demonstrate whether there is a physical, psychological or psychosocial therapeutic benefit arising from either the consultation and/or the treatment of that condition or its associated presentations. If there is a demonstrable clinically determined therapeutic benefit to the person, then that treatment episode is deemed to be ‘medical’ or ‘medically related’. The procedure could be delegated under supervision to a non-Health Care Professional."

Therefore, the scope for who can administer treatments can be quite wide ranging, but it is important that practitioners cover all aspects in the consenting phase as well as in the administration of treatment. 

Issues we see commonly 

1. The patient’s concerns not being addressed specifically in relation to what might be considered “material” for them.

2. The treatment benefits and risks are confined to a consent form only and not discussed in any detail. 

3. Consent forms relating to one set of treatment (for example, facial injections) are used for a whole range of other treatments without amendment (lip fillers).

4. The time between the initial consultation and treatment is too short. 

5. Reasonable alternative treatments are not considered in any detail or at all.

6. There is an inclination from the treating professional to promote a certain type of treatment. 

How can you avoid being challenged that there was a lack of informed consent? 

The failure to obtain informed consent could potentially mean that the practitioner could be committing assault/battery as well as promoting a claim if anything goes wrong (at all), therefore, the following tips are of upmost importance to avoid being challenged: 

• Consider whether the patient is of age and with capacity to have the desired treatment. 

• Ensure consent is in writing and clear.

• Consider the basis for wanting the treatment. 

• Did the patient have any specific fears or desires that need to be discussed and recorded?

• How the patient approached similar medical decisions previously (where appropriate if the same treatment had been done before)?

• What treatment has the patient had before? Iit is important to avoid assuming the patient may know what the treatment involves, even if they have had it previously (risks develop/change over time for patients. 

• Has the Claimant highlighted something of particular concern? Consider with care whether the treatment is right for them even if this may mean not proceeding.

• Are life events influencing their decision-making capabilities?

• How would you define and described the particular risk?

• What do patients normally do in the circumstances?

It is accepted that practitioners will be unable to discuss every single concern/risk that may be present, but time spent in a good consultation which addresses the key points will likely save a considerable time avoiding complaints and potential litigation. 

Fundamentally, practitioners should cascade down the risks from the most serious (even if they are rare) to the most common but less serious and ensure they are patient specific.

Next steps

Our team of health litigation lawyers regularly advise clients on the issues of consent and make legal arguments for clients on the same which includes pragmatic, client centred advice as to the merits of making these arguments.

Please do not hesitate to get in contact if you would like to discuss this further with anyone in our team.