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Mother dies after hospital’s failure to treat TB following drug treatment known to increase risk

Posted: 22/11/2017

  • Norma Donohue was at increased risk of developing tuberculosis (TB) following Infliximab treatment – known to compromise the immune system – and showed signs of the disease within months of first receiving the drug.
  • Doctors at Aintree University Hospital failed to correctly diagnose and treat her condition and she subsequently died.
  • Mrs Donohue’s family believes the hospital has not learnt from her death and want to raise awareness of the signs and symptoms of TB and the connection with Infliximab.

Penningtons Manches’ clinical negligence team has recently settled a claim against Aintree University Hospitals NHS Foundation Trust after Mrs Norma Donohue, a 72 year old mother of six, received negligent treatment from clinicians at Aintree University Hospital who failed to correctly diagnose and treat her tuberculosis, despite obvious warning signs.

The case highlights critical failings in her care, which ultimately led to her death. It underlines the importance of recording previous treatments that the patient has undergone, in order to more effectively diagnose them at a later stage. It also underlines the importance of considering a patient’s history and being aware of the associations between various medications and related diseases.

Warnings of Infliximab’s connection to tuberculosis

Mrs Donohue suffered from severe ulcerative colitis. In July 2014 her doctors recommended the use of Infliximab, a drug used to treat ulcerative colitis but which is also an immunosuppressive (a drug which leads to the reduction in a person’s immune system). The risk of tuberculosis is well documented in the medical literature relating to the drug. However, Mrs Donohue and her family were not informed of the risk of tuberculosis by her doctor and were therefore never conscious of looking out for any signs or symptoms.

There was no evidence that Mrs Donohue was asked about any history of previous exposure to tuberculosis and she was not issued with a Patient Alert Card which would have identified that she was taking Infliximab and raised her awareness to the symptoms to look out for. If the doctors had asked Mrs Donohue about her previous exposure to tuberculosis, they would have realised that Mrs Donohue was exposed to tuberculosis for some time as a relative whom she had lived next to for many years had been diagnosed with the disease.

Mrs Donohue received three doses of Infliximab over July and August 2014. Her symptoms of ulcerative colitis improved significantly.

However, she was admitted to Aintree University Hospital on 16 September 2014 complaining of sharp chest pain, pain in her back and a fever. She had been experiencing severe night sweats and informed the doctors of this.

On her admission to hospital, there was a failure to note her recent Infliximab treatment in her notes and this was not considered by the doctors until weeks had gone past. Given the risk associated between Infliximab and tuberculosis, it was very serious that this was not recognised and recorded.

Consultant’s suggestion to investigate tuberculosis was ignored

Mrs Donohue remained in hospital for a number of days but the doctors struggled to work out what was wrong with her. They believed that she was suffering from an infection but could not work out the source of the infection despite performing numerous tests.

Throughout this time Mrs Donohue was extremely unwell and in a lot of pain without being given any pain medication. She was suffering from high temperatures and the clear effects of a serious infection. Her daughters who remained at her bedside pleaded with the doctors to give her antibiotics but they were consistently told that these could not be prescribed without knowing the source of the infection.

After being in hospital for 16 days, on 2 October 2014, a gastroenterologist reviewed Mrs Donohue and wrote in her notes that she had been given Infliximab treatment. This was the first time that any reference to Mrs Donohue’s Infliximab treatment was considered.

Four days later, Mrs Donohue was assessed by a consultant microbiologist who saw the reference to Infliximab treatment and noted an association between the drug and tuberculosis. The microbiologist wrote in Mrs Donohue’s notes that Infliximab and Tuberculosis went “hand in hand”.

Although tests for tuberculosis were then ordered, the doctors responsible for Mrs Donohue’s care thought that a diagnosis of tuberculosis was unlikely. The experts instructed as part of the clinical negligence claim however felt that this was completely incorrect and, in fact, a diagnosis of tuberculosis was very likely.

Despite the suspicion regarding tuberculosis no treatment was given and instead the doctors insisted on carrying out further tests until a firm diagnosis had been reached. Mrs Donohue’s daughters pleaded with the doctors to provide her with treatment but they insisted that it was best to confirm a diagnosis of tuberculosis first before providing any medication.

Mrs Donohue continued to suffer horrific symptoms of an infection. She became delirious, breathless and was in a great deal of pain. She suffered rigours and required significant 24 hour care.

Mrs Donohue’s children spent a lot of time at the hospital by their mother’s side but eventually two of her daughters were asked by the doctor to remain at the hospital to care for their mother on a 24 hour basis. They were told that there was not enough nursing staff to look after Mrs Donohue and they would have to do this themselves. Mrs Donohue’s daughters, Tracey and Kim, were provided with beds to sleep in the family waiting room and remained at the hospital for a number of weeks whilst they provided their mother with round the clock care.

At certain points, Mrs Donohue’s condition deteriorated so much that the doctors believed she was going to die and advised that other family should come in to see her. However, Mrs Donohue’s strong character and resilience shone through and she continued to fight on despite receiving no treatment.

On 23 October 2014, Mrs Donohue had been in hospital for over a month and her family were finally asked as to whether or not she had ever been exposed to tuberculosis. At this point, the family explained that a relative who had lived next door had been diagnosed with tuberculosis. Yet, despite this information and all of the other information that now pointed to a diagnosis of tuberculosis, the doctors still felt that there was not enough evidence to justify starting Mrs Donohue on tuberculosis treatment.

Eventually, on 27 October 2014, it was noted that a Quantiferon TB Gold Test which was taken on 17 October had come back positive. However, Tuberculosis treatment was not commenced until 31 October 2014.

A decision was taken to transfer Mrs Donohue to the Royal Liverpool Hospital on this date, where she was continued on tuberculosis treatment. Despite showing brief signs of improvement, her symptoms once again deteriorated and she sadly passed away on 15 November 2014.

Treatment for tuberculosis had given too late for it to be effective. A post-mortem examination performed on 19 November 2014 confirmed that Mrs Donohue died of miliary tuberculosis.

Death was avoidable

The expert evidence obtained as part of the clinical negligence claim revealed that there were numerous failings in Mrs Donohue’s care and a diagnosis of tuberculosis should have been reached sooner. Expert evidence also revealed that, had Mrs Donohue received anti-tuberculosis treatment on or before 16 October 2014, she would have survived.

It was of course heart breaking for the family to realise that their mother would still be with them today had she received an appropriate standard of care. Their suffering was made worse by the fact that, after the claim was put to the Trust, they sought to deny the claim arguing that it was reasonable not to have treated Mrs Donohue’s tuberculosis sooner. They recognised that there had been a short delay towards the end of Mrs Donohue’s treatment but they argued that their expert evidence suggested that there had not been any failings earlier than this and the recognised delay would not have made a difference to the outcome.

The family’s suffering was therefore prolonged whilst further discussions took place with the Trust to see if it was possible to reach a resolution to the claim. Despite the Trust’s denial of liability, it eventually made an offer to settle which demonstrated that it had dramatically altered their position on the case.

The Trust never formally admitted the failings in Mrs Donohue’s care and so was asked to provide the family with a Letter of Apology to recognise the failings that had led to Mrs Donohue’s death and to give the family some form of closure. It is disappointing to note that this Letter of Apology has still not been received.

Will the hospital learn?

It is of course hoped that the pursuit of a clinical negligence claim will lead to a hospital learning from the mistakes made to ensure that the same thing does not happen to any other family.

Unfortunately, Mrs Donohue’s family has been left feeling that their mother’s death may have been in vein and that lessons have not been learnt by the hospital.

One of Mrs Donohue’s daughters recently attended the hospital and she too was recommended the drug, Infliximab, but once again was given no information about the risks of tuberculosis.

This of course angered the family and they now feel that the only way to ensure that this does not happen to anyone else is to raise awareness of what their mother went through and the importance of considering the signs and symptoms of tuberculosis and the connection with Infliximab.

Another death due to Tuberculosis

Emma Beeson, clinical negligence solicitor at Penningtons Manches who represented the family says:

“For me, this is an extremely sad case, not only because of the very upsetting circumstances, but because the year that Mrs Donohue died, I had just settled another case for a family in Surrey who had also lost their mother and grandmother after the hospital failed to diagnose and treat her Tuberculosis.

“When Mrs Donohue’s family approached me I could not believe that the same thing had happened again at another hospital. Whilst the circumstances of the cases are slightly different, the underlying theme is the same. The patient presented with obvious signs of tuberculosis and yet the doctors refused to treat them with anti-tuberculosis medication until the disease was confirmed. Tuberculosis can be difficult to diagnose and the clear medical guidance is that, if there is a high suspicion of tuberculosis, it should be treated. If not treated, the patient will die. This is a disease that is treatable and, in this day and age, no person in the UK should die of tuberculosis.

“No sum of money will ever bring back Mrs Donohue and her family has now lost a fun and vibrant mother and grandmother. I hope that her death will not be in vain and that the hospital will learn from the mistakes in her care and ensure that this does not happen again.”

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