Following a ground-breaking decision by the Supreme Court in 2015, Montgomery v Lanarkshire Health Board [2015] UKSC 11, the High Court has recently given detailed consideration to the type and quality of information to be included in letters of advice for elective surgery to be sufficient to obtain informed consent. Mr Justice Green in the Queen's Bench Division of the High Court at the Royal Courts of Justice delivered judgment in Thefaut.

The issues in Thefaut v. Johnston [2017] EWHC 497

The case of Thefaut v. Johnston concerned surgery performed by the defendant to treat the Claimant's back and leg pain. Following the surgery the Claimant's leg pain was generally exacerbated and her back pain did not resolve. She underwent revision surgery in February 2013 and continues to suffer from disabling leg pain, altered sensation and weakness in her left foot and ankle. She also experiences altered sensation of bladder fullness and reduced sexual sensation and continues to suffer from back pain.

The Claimant alleged that the surgery on 17 May 2012 was negligently performed. On analysis of the evidence it was held that this aspect of the claim was not made out.

As a second limb to the claim, something we are seeing with increasing regularity, the Claimant alleged that she would not have consented to the surgery had she been properly advised of the risks. The Claimant was advised that the surgery carried a 90% chance of resolving her leg pain and every chance that her back pain would settle too. The Claimant was told that the risks of the surgery were very small, with a 0.1% risk of nerve damage and a 2% chance of spinal fluid leakage.

The experts agreed that, in fact, the chance of the surgery resolving her leg pain was circa 85% and the chance of the surgery ridding or improving the back pain was circa 50%. In addition, the experts agreed that the surgery carried an up to 5% chance of exacerbating the condition and the risk of nerve damage from non-negligent surgery was more accurately 1%, rather than the 0.1% the Claimant had been advised. The pre-surgery advice also failed to mention the option of having no surgery.

The judgment in Thefaut

It was held that in consenting the Claimant for surgery the Defendant fell below the standard of care that the law, according to Montgomery, requires of a doctor obtaining informed consent from a patient to elective surgery.

In judgment the Court was clear that Montgomery is the applicable test for determining whether informed consent has been obtained. Montgomery provides that the doctor is "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. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient's position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it".

Mr Justice Green was clear that this test is a mixture of the subjective and the objective. The subjective element of the test should extend quite far and risk should not be reduced to percentages. The significance of the risk to the individual patient will be determined by individual evidential mix factors, such as the effect that the risk's occurrence would have on the life of the patient.

Mr Justice Green was at pains to highlight good practice in obtaining informed consent. The process of obtaining consent should be a communication in the form of a dialogue. This communication should be de-jargonised to ensure the message is conveyed in a comprehensible manner. "This can include caution in the use of percentages. There is the risk that they can convey false degrees of certainty where, in truth, none really exists". In other words, bearing in mind the subjective element of the test for informed consent, clinicians must be cautious of presenting risk in black and white terms when the significance of the risk becomes a subjective question. A 0.2% risk of mobility impairment may seem a small risk to someone with a sedentary lifestyle but could well be an insurmountable risk to an Olympic athlete.

Observations

The option of having no surgery should be included for consideration. Montgomery requires the patient to be aware of any alternative treatments and Thefaut makes it clear that no treatment is an alternative treatment, especially in cases of elective surgery for the purpose of alleviating pain.

The pre-surgery discussion took place in a 4-5 minute phone call (according to the Defendant) or a 5 minute phone call according to the Claimant. Following this call the Defendant sent a letter of advice confirming the substance of the telephone call and this was the key evidence in assessing the consent process in this claim. Mr Justice Green found that the letter recommending discectomy to the Claimant made material overstatements of the chance of resolving back pain and failed to mention the option of having no surgery. This letter and the pre-surgery information provided to the Claimant was not sufficient to obtain informed consent. Further, a signed consent form was not to be taken as an acceptance of risk and was considered to be of no real significance on the facts of the case, although it was indicated that a consent form would have greater significance in emergency cases involving no prior contact between the patient and clinician.

Mr Justice Green held that had the Claimant been properly advised she would either have rejected the option of surgery altogether or at least she would have deferred the surgery until she had received a second opinion. Mr Justice Green held that, on the balance of probabilities, the Claimant's present condition was attributable to the surgery. The Claimant had consented to surgery with the aim of resolving her back pain and had been given a very high degree of reassurance that her back pain would resolve more or less completely, when in fact the chance of resolution was 50:50, without considering the option of the pain resolving within 12 months with conservative management and without being warned of the 5% risk of non-negligent surgery exacerbating her condition. Following the index surgery the Claimant suffered worse leg pain and her back pain did not resolve. She was left with a weak left leg, reduced sensation in her vulva and surrounding area as well as bladder symptoms. The Claimant underwent revision surgery in February 2013 and the impairments continue. It was held that if the surgery had not taken place or if it was deferred, either the Claimant's condition would have recovered naturally over time or, alternatively, if the Claimant had the surgery at a later date, in all probability, the damage would not have occurred.

What can we learn from Thefaut?

Thefaut again makes clear the importance and potency of the Montgomery test in determining the test to be applied when determining whether consent to treatment has been properly obtained.

Previously the test was a more objective one, based on risks perceived to be material by those securing the consent. In addition, there was a readiness to conclude that had a risk not mentioned been mentioned, patients are likely to have proceeded in any event. There is now much closer scrutiny.

Montgomery requires the patient to be made aware of any alternative treatments. Thefaut makes it clear that no treatment is an alternative treatment, especially in cases of elective surgery for the purpose of alleviating pain. This is a logical analysis based on Montgomery and should not be regarded as an extension of the principle.

Finally, in Thefaut Mr Justice Green gave great weight and detailed consideration to the letter recommending the surgery to the Claimant. The discussion on the risks/benefits of surgery took place in a 4 to 5 minute phone call and the sections on the consent form in relation to the attendant benefits or risks of surgery were not completed. This serves as a reminder of the importance of maintaining good documentation - a point applicable to treatment as well as consent.