Recent shifts in the concept of informed consent have exacerbated the likelihood of medical professionals failing to consent patients adequately. These professionals thereby face a heightened risk of suffering an expensive medical negligence claim.
Consent-related claims a common occurrence
All medical professionals operating in the UK must obtain a patient’s informed consent before undertaking a medical procedure. For consent to be informed, patients must be provided not only with all relevant information relating to a procedure, but also with the information that is particularly relevant to them as an individual, in terms of their lifestyle, health, and personal preferences.
To take all this into account can be difficult, and in recent years, the profession has faced an increasing number of successful medical negligence claims in which it has been deemed that patients did not give their informed consent prior to treatment. The seminal case of Montgomery vs Lanarkshire Health Board, brought to the Supreme Court in 2015, was the turning point in this regard.
Nadine Montgomery gave birth on 1 October 1999 at Bellshill Maternity Hospital, Lanarkshire. As a result of complications during delivery, the baby was born with severe disabilities. The issue presented to the Court was whether Montgomery had been adequately advised about the risk of these disabilities prior to giving birth, and the alternative possibility of delivery by elective caesarean section.
In determining that, had she been warned of the risk, consequences, and alternative treatments, Montgomery would probably have chosen delivery by caesarean, the ruling signalled a growing appreciation of patient self-determination and their ability to understand the consequences and risks of a particular treatment.
How this plays out in litigation, is that if a claimant can prove they were not consented properly, they will say that they would never have undergone that specific procedure. Whilst there are ways of disproving these arguments, this is often a slam-dunk argument for the claimant.
The dramatic impact of the ruling is borne out in research from Queen Mary’s University London (QMUL), which revealed that while the overall rate of negligence claims against the NHS remained steady after the Montgomery ruling in 2015, consent-related cases had risen fourfold by March 2020.
Such claims may only represent a small percentage of those brought against the NHS, but they are expensive. Between 2015-2019, lack-of-consent claims cost the NHS £62m per year – an increase of £34m compared to the four years prior, reflective of the rising number of claims.
This of course does not even begin to consider the number of private treatment cases where consent has been successfully pleaded, nor does it reflect the frequency of claims in other clinical areas such as dentistry or alternative therapies such as acupuncture.
Consent cases since Montgomery
Earlier this year, the Court in Snow v Royal United Hospitals Bath NHS Trust (2023) gave a damning judgment, observing that negligent failures of clinical governance, informed consent, and surgical technique in 2015 resulted in a rectal cancer patient suffering devastating pelvic nerve injuries following the use of a new laparoscopic surgical technique to access the pelvis.
Specifically, it was accepted that the claimant was not informed of six out of seven material risks identified by the National Institute for Heath and Care Excellence (NICE). The operating professional accepted that his consenting process was substandard and not in accordance with General Medical Council (GMC) guidance. This, in turn, had meant that the patient was unable to make an informed decision on the care being provided – and specifically in respect of the new technique offered – thus contributed to the very serious negligent or substandard care and outcome.
The case comes as a stark reminder that as techniques and technology develop, medical professionals have to be highly cognisant not only of the benefits brought, but also of the significant risks posed as refinements are made to the process or technique. There are specific further requirements around the employment of novel methods – very carefully mandated by the NICE guidelines amongst others – and as such it is arguable that consent requirements in this arena are even higher.
Among various cases that Lockton has dealt with in recent years, one involved a claimant who underwent a surgical insertion of standard grommet, despite a signed consent form expressly referring to the insertion of a T-tube. When the grommet fell out after 11 weeks, the claimant had to undergo another surgery to have another t-tube inserted.
In this case, it was found that the claimant did have a valid claim against the surgeon for inserting grommets without consent, and the matter was settled unilaterally. It highlights the importance not only of ensuring the correct equipment is available at the start of a procedure, but of always going through the consent form ahead of the procedure and ensuring that the products or devices being used match what you have discussed exactly with the patient and that the patient fully understands the associated benefits and drawbacks.
When is a patient ‘informed’?
As above, for consent to be informed, patients must be provided not only with all relevant information relating to a procedure, but also with the information that is particularly relevant to them as an individual, in terms of their lifestyle, health, and personal preferences.
In practice, this should include:
• Diagnosis and prognosis
• All available treatment options, including non-operative options and the option of doing nothing
• Risks and benefits of treatment along with the likelihood of success, and possible side effects and complications
• Risks should a patient decide not to proceed with treatment
• Potential follow-up treatment
• Patients must also be aware that they are able to withdraw their consent if they change their mind before their procedure, even if they have already signed the consent form
Consent must be given on a voluntary basis, free of influence from friends, family, medical professionals, or others. Patients should also have the capacity to do so – that is, they must be capable of understanding the information given to them, in order to make an informed decision regarding their treatment.
Conversely, informed consent can be deemed not to have been given for a number of reasons. Most obviously, any misrepresentation of the nature or purpose of the procedure will be deemed a breach of duty to the patient and will invalidate consent.
Likewise, where a medical professional fails to elicit the full spectrum of relevant health information from a patient, and the ensuing procedure leads to complications, the professional may be accused of not having obtained consent. Failing to keep records or documentation of consent may also lead to that consent being deemed invalid.
In all cases, failure to obtain informed consent may be a factor in a claim of negligence against the medical professional involved.
Mitigating the risk from lack-of-consent
To reduce the risk of lack-of-consent scenarios, it’s vital that medical professionals ensure they are operating a robust consent procedure. This in turn will help to mitigate against the threat of negligence claims.
Actions to ensure informed consent is obtained include:
• Setting out the risks and benefits of treatment, potential side-effects, complications, as well as alternative treatments, including the options of doing nothing
• Specify personal considerations in respect of the specific patient as an individual and separate these clearly from the more general limitations and considerations
• To elicit the above information, get to know the patient and what is important to them
• Encourage patients to ‘tell back’ the information to which they are consenting to aid understanding
• Where medical professionals take over a patient from another colleague, never assume they have consented adequately – always double check
• Never assume patient understanding
• Where consent is given, ensure thorough records and documentation are taken and maintained securely for reference in the event of a claim
• Keep abreast of the significant risks posed by new technologies and procedures, and update consent protocols accordingly
For further information, please contact:
Flora McCabe Head of Advocacy and Risk Management – Healthcare
T. +44 (0)20 7933 2516