Lack Of Informed Consent To Spinal Surgery Article Featured in Medico-Legal Magazine

Paul Sankey - Enable Law

The following article was originally published in issue 8 of Medico-Legal Magazine, and is reproduced here in full with kind permission:

By Paul Sankey, Partner, Enable Law

Paul Sankey is a Partner in the Medical Negligence team at Enable Law. Paul regularly writes on cases of note and developments in healthcare.

Hassell v Hillingdon Hospitals NHS Foundation Trust is a successful claim for damages by a patient who was inadequately advised of the risks of spinal surgery. During the operation she suffered an injury to her spinal cord. She was left with permanent disability in the form of tetraparesis (weakness of all 4 limbs). She recovered damages of £4.4 million.

Tracy Hassell v Hillingdon Hospitals NHS Foundation Trust [2018] EHWC 164 (QB)

The Facts

Mrs Hassell was 41 at the time of surgery to her neck in 2011. She worked full-time as head of year for years 7,8 and 9 at a secondary school and had 3 children.

Prior to her surgery she had undergone 2 previous operations. In June 2009 she had undergone spinal surgery for pain in her back, left leg and foot. The operation involved decompression and transforaminal interbody fusion in her lower spine. Her surgeon, Mr Ridgeway, explained the risks of surgery but not including injury to the spinal cord. On the day of surgery, she signed a consent form which included a number of risks including ‘nerve damage (numbness)’. In evidence Mr Ridgeway said that ‘nerve injury’ could include numbness, weakness or paralysis.

The operation improved her back pain but not her left foot and leg pain. She underwent physiotherapy.

By July 2010 she had developed pain in her left groin and hip. She saw an orthopaedic surgeon who arranged a steroid injection and then carried out a left hip arthroscopy in May 2011. She signed a consent form which included risks of no improvement, infection, DVT/PE, haematoma, nerve injury and the need for further treatment.

In the meantime, she saw Mr Ridgeway again on 25 January 2011. Although her main problem was groin pain, she also reported pain in her left arm. She struggled to hold a steering wheel whilst driving because of reduced strength and pain. Mr Ridgeway arranged an MRI scan which showed a left paracentral disc lesion at C5/6, some deformity of the dural sac and flattening of the spinal cord on the left. A CT guided injection failed to relieve her symptoms.

Mrs Hassell saw Mr Ridgeway again on 28 June 2011. What happened at this consultation was an important issue in the subsequent claim. She complained of neck pain radiating down the C6 nerve distribution. Her surgeon advised an anterior cervical discectomy with either fusion of C5 and C6 or disc replacement depending on the surgical findings. There was a conflict of evidence as to what was said about the risks of surgery and about alternative conservative treatments.

On 27 July 2011 she had a pre-operative assessment. The record shows a tick by the heading ‘no limitation of physical activity’ and a handwritten comment ‘limited by back/neck problems only’. There was a statement next to the airway assessment, ‘very limited neck movement – hence planned op!’.

On the day of surgery, 3 October 2011, she signed a consent form. The form listed among the risks ‘cord injury’. She had been expecting to be second or third on the list but Mr Ridgeway arrived with a porter to take her to theatre earlier than expected. Her husband was elsewhere and she had not been able to say goodbye to him. She felt nervous and that everything was done in a rush.

Unfortunately, she woke from the operation with tetraparesis. She was told that the spinal cord had been damaged although Mr Ridgeway did not know why. She was left with a severe disability.

The Claim for Damages

Mrs Hassell brought a claim for damages against the hospital trust responsible for her care. She alleged breach of duty in the performance of the operation. She also alleged that she had not given informed consent to the procedure, having not been advised of alternative treatments or warned of the risk of spinal cord injury. With adequate advice she would not have agreed to surgery.

Damages were agreed at £4.4 million subject to liability. The issue of liability was tried between 15th and 23rd January 2018 before Mr Justice Dingemans. Judgment was given on 6th February 2018.

Mr Justice Dingemans found that there the operation had been performed to a reasonable standard and Mr Ridgeway was not to blame for the spinal cord injury. The cause of that injury was unknown. However, he found that Mrs Hassell had not given informed consent to surgery and, given proper advice, would not have gone ahead. He found that she had neither been warned of the risk of spinal cord injury nor advised of alternative treatments.

The Surgeon’s Advice: The Conflict of Evidence

According to Mrs Hassell, Mr Ridgeway did not discuss alternative treatments in the form of analgesia or physiotherapy during the appointment of 28 June 2011. He warned her of the anaesthetic risk and the risk of infection. He mentioned the risk of a hoarse voice for a couple of weeks which he put at 1 in 1,000. This was a matter of concern to her because of her work and the need to shout across the playground at times. He did not mention DVT, PE, nerve damage, risks to the spinal cord or paralysis. She said that had she been advised of the risk of paralysis at 1 in 1,000 she would have asked more and opted for alternative treatment.

Mr Ridgeway said that he discussed alternatives but Mrs Hassell felt she had exhausted those options. He wrongly thought she had had physiotherapy on her neck. He had explained the risks including hoarseness at 2 in 100 (and not 1 in 1,000 as she said) and paralysis at between 1 in 500 and 10,000. He said that he encouraged patients to carry out their own research and directed them to his website which contained ‘all the relevant information to enable them to fully understand the risks and benefits of the planned procedure’. In fact, the website did not mention the risk of paralysis.

He then dictated a letter of 1st July 2011 in front of Mrs Hassell. The letter gave the risk of a hoarse voice at 1 in 1,000 and did not mention the risk of paralysis. At trial he said in effect that there was a transcription error because 1 in 1,000 was the risk of paralysis not hoarseness. Unlike other letters, it was not marked ‘cc patient’ and Mrs Hassell did not know whether she had seen it prior to the operation.

Informed Consent

The judge found that Mrs Hassell had not been told of the risk of paralysis from spinal cord injury or advised on conservative treatment options. Montgomery v Lanarkshire Health Board [2015] UKSC 11 required Mr Ridgeway to take reasonable care to ensure she was aware of the material risks of surgery and alternative treatment options. He had failed to do so.
There were several reasons for his findings.

1. Mr Ridgeway was mistaken in thinking Mrs Hassell had previously undergone physiotherapy to her neck. Montgomery requires a dialogue between patient and doctor. Had there been a dialogue Mrs Hassell would have corrected his misunderstanding.

2. The judge formed the view that, whatever his surgical skills, Mr Ridgeway was not a good communicator about the risks of operations. There were inconsistencies between his evidence at trial and his witness statement as to what his normal advice would be.

3. Mrs Hassell’s gave clear evidence that she had not been warned. Although there is evidence that patients do not always have an accurate memory of what they are told about risks, she had a clear recollection. She was concerned at the risk of a hoarse voice and asked questions about it. As the mother of 3 children and a full-time head of year this would have concerned her.

4. Mr Ridgeway said in a subsequent letter that surgery could result in paralysis and that this was ‘similar to risks explained with previous spinal surgery’. In fact, his letter explaining the risks of lower back surgery did not mention paralysis.

5. His website, to which he said he referred patients for ‘all the relevant information’, did not mention the risk of paralysis.

6. The letter of 1 July 2011, which he dictated in front of Mrs Hassell, did not mention the risk. The judge did not accept that this was because of a transcription error. Further, the absence of ‘cc patient’ suggests that it was not sent to her.

Although she was told about the risk of ‘cord damage’ on the day of surgery 3 October 2011, a warning then was not sufficient. Her mind was not engaged on the consent form on the day.

Causation

The judge also found that, with proper advice, she would have elected for conservative treatment rather than surgery. Having had surgery to her lower back in 2009 and to her hip in 2011, she was prepared to undergo operations. She was prepared to run risks. She had considered the risk of a hoarse voice and was prepared to run it but this was very different from permanent disability. She had also benefitted from conservative management in the form of osteopathy before. She was 41 at the time of surgery and surgery with a risk of paralysis would have been a frightening prospect to her. Her evidence on that point accorded with the judge’s findings that she was able to assess risks that were significant to her.

Comment

This is one of a number of cases exploring the implications of Montgomery v Lanarkshire Health Board [2015] UKSC 11. Montgomery requires a doctor 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’.

Various points of interest arise:

1. It seems that spinal surgery – with its risk of cord damage – is an area where the adequacy of consent has generated litigation. The other main area is obstetrics. Other spinal surgery cases include Jones v Royal Devon & Exeter NHS Foundation Trust [2015] (a County Court decision) and Thefaut v Johnston [2017] EWHC 497. The claimants succeeded on all 3.

2. The Montgomery duty requires patients to be given choice. It is not enough to advise of the risks and benefits of a recommended treatment. Patients must be told of the risks of ‘the recommended treatment, and of any reasonable alternative or variant treatments’. The failure to advise about conservative treatment gave rise to a successful claim in Thefaut v Johnston as well as Hassell.

3. Warnings on the day of surgery are risky. As in Jones v Royal Devon and Exeter NHS Foundation Trust, the court was not persuaded that a consent form signed on the day of surgery indicated informed consent. Mrs Jones felt committed to go through with surgery by the time she found out that her operation would be performed not by the consultant she was expecting (and had chosen) but by his registrar. Mrs Hassell was feeling nervous, being unable to say goodbye to her husband and her mind was not engaged on the form.

4. Consent forms are only part of a process of advising and providing consent. As in Jones v Royal Devon and Thefaut v Johnston, the claimant was found not to have given informed consent despite having signed a consent form.

5. Unusually this is an area of clinical negligence litigation where witness evidence is crucial. The judge considered very carefully and gave detailed reasons for rejecting the surgeon’s evidence in favour of that of the claimant.

6. The court considered expert evidence in relation to consent. The role of experts is to give evidence as to the reasonable range of treatments and the medical risks and benefits of those options. However, whether a risk is material or advice is adequate is not a matter to be judged by the standards of the medical profession. It is for the court. Experts should not be commenting on these issues. It is surprising therefore that the judgment records an agreement between the experts that ‘if the risk of cord damage had first been mentioned to Mrs Hassell on the day of the operation that would not be sufficient in order to obtain informed consent…’