Consent-related negligence claims & new technologies

Flora McCabe, Head of Advocacy and Risk Management in Healthcare at Lockton, explores informed consent in hospitals & the risks posed by new technologies

Recent shifts in what is understood as “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. 

It is, of course, mandatory for all medical professionals to obtain a patient’s informed consent before undertaking a medical procedure. For consent to be informed, patients must be provided with all the relevant information relating to a procedure, as well as the information particularly relevant to them as an individual patient – in terms of their lifestyle, health and personal preference. For example, they must be aware of their diagnosis and prognosis, all available treatment options (including doing nothing), the risks and benefits of treatment along with the likelihood of success, as well as potential follow-up treatment required. Patients must also be aware that they are able to withdraw their consent if they change their mind before the procedure, even if they have already signed a consent form. Consent must be provided voluntarily, free of influence from friends, family and medical professionals. 

Taking all of this into account can be difficult and in recent years, the profession has been met with an increasing number of successful medical negligence claims in which it has been deemed that patients were not given the ability to give informed consent prior to their treatment.

 

Informed consent is an ongoing concern as technology develops

One example is the seminal case of Montgomery vs Lanarkshire Health Board, brought to the Supreme Court in 2015. Nadine Montgomery gave birth in October 1999. The baby was born with severe disabilities as a result of delivery complications and the Court determined that Montgomery was unable to give informed consent, as she had not been adequately advised about the risk of these disabilities prior to giving birth, nor the alternative possibility of delivery by elective caesarean section. 

The dramatic impact of this 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. They are also expensive: between 2015-2019, lack-of-consent claims cost the NHS £62m per year – nearly double the amount four years prior.

Earlier this year, the Court in Snow v Royal United Hospitals Bath NHS Trust (2023) gave a damning judgement, 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.

It was accepted that the claimant was not informed of six out of seven material risks identified by the National Institute for Health and Care Excellence (NICE) and that the operating professional’s consenting process was substandard to General Medical Council (GMC) guidance. This meant, therefore, that informed consent could not be provided by the patient.

The case provides a stark reminder that even as techniques and technology develop and are refined, medical professionals must be highly cognisant of both the benefits brought, as well as the significant risks posed, by certain procedures. There are specific further requirements around the employment of novel methods, making consent requirements in this arena even higher.

In our experience here at Lockton, one case 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. The matter was settled unilaterally, but highlights the importance of being vigilant when it comes to new equipment and agreed processes with patients prior to procedure.

 

How to mitigate against consent-related risks in hospitals

In order to protect yourself from lack-of-consent scenarios such as those outlined above, it’s vital that medical professionals operate a robust consent procedure – which will also mitigate against the threat of negligence claims.

Actions to ensure informed consent is obtained include setting out the risks and benefits of all available treatments, including potential side effects, risks and complications. This must also include the option of doing nothing. Specifying personal considerations pertaining to the specific patient is also vital and must also be communicated beyond more general limitations. To elicit this information, a medical professional should seek to get to know the patient and what is important to them.

A key method through which to generate greater understanding of the above, and in turn elicit informed consent, is to encourage patients to ‘tell back’ the information to which they are consenting. Patient understanding should never be assumed. This is also true when a medical practitioner takes over a case from another colleague: always double check that they are consenting.

Where consent is provided, ensure thorough records and documentation are taken and maintained securely, for reference in the event of a claim. Finally, you should keep abreast of the significant risks posed by new technologies, procedures and methods, to ensure these can be communicated clearly to patients.


Flora McCabe, Head of Advocacy and Risk Management in Healthcare at Lockton.

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