South Tyneside and Sunderland NHS Foundation Trust

2. Mr N complains the Trust only sought consent from his father (Mr D), who likely did not understand the risks, before administering a drug to his mother. Mr N also complains the side effects of the drug had a devastating impact on Mrs D’s health and well-being.

3. Mr N says the experience left him and his father Mr D with lasting emotional impact. Mr N feels the family’s bereavement, has been compounded by Mrs D being put on a clinical trial for an anti-sickness drug and the subsequent unnecessary suffering and ultimately death.

4. As an outcome to his complaint, Mr N would like service improvements and financial remedy.

5. Mrs D was admitted to the Trust’s Emergency Department on 6 February 2024 following a stroke.

6. On 7 February, Mr D consented to Mrs D being placed on a clinical trial. The trial was looking at whether metoclopramide (an anti-sickness drug) could reduce the likelihood of death in patients who had dysphagia (difficulty swallowing) after suffering a stroke.

7. Mrs D was diagnosed with pneumonia on 7 February.

8. Mr N says he became aware of the trial and his mother’s participation on 7 February. Following this, Mr N had concerns that his father Mr D did not have capacity to make an informed decision about Mrs D being placed on the trial.

9. Mr N also had concerns that the drug was impacting on Mrs D’s health and questioned her continued participation.

10. Mr N stated that as far as he was concerned, Mrs D was then removed from the trial on 8 February after Mr D agreed to one last dose. Due to Mr D’s lack of recollection of events, it is not clear from the evidence available whether he then agreed for the trial to continue.

11. Mrs D participated in the trial until 20 February (full 14 days). Between 20 February and 25 April, Mr N reports that Mrs D had symptoms which he attributed to the side effects of the trial, including tardive dyskinesia (a movement disorder) and swelling.

12. Mrs D unfortunately passed away on 9 May of bronchopneumonia, atrial fibrillation and non-Hodgkin lymphoma. Mr N said two of these were associated with side effects of taking the trial drug.

15. The law says we cannot investigate a complaint where a person has (or had) the option to take legal action, unless we consider this is (or was) unreasonable in the circumstances. We do not consider whether legal action would succeed but whether it would be a reasonable option to look in to.

16. Mr N’s complaint is about the consent process and the impact the trial drug had on Mrs D, which he believes caused her suffering and untimely death. By making his complaint, Mr N is seeking financial compensation. Mr N confirmed he was looking for an amount equal to or in excess of £12,500 as well as service improvements.

17. Whilst we could potentially achieve part of the outcome Mr N seeks in terms of service improvements, he is seeking a large amount of money. There is also a legal route open to Mr N in that he may be able to bring a claim for professional negligence. That claim might be able to achieve the remedy he is seeking if it were successful.

18. Mr N has shown he is able to seek legal advice and there appears to be no barrier to him taking this route.

19. At this point in time, we are satisfied there is a potential legal route available for Mr N to pursue his concerns, which is reasonable for him to pursue. As there are time limits for making a legal claim, we do not want to remove this as an option when it could potentially offer what he is looking for.

20. If Mr N is unsuccessful in his legal claim, or he still has outcomes the court does not achieve, he can ask us to consider his complaint again. He should bring his complaint back to us promptly. This is because we would need to consider our time limits.

21. We are very sorry to hear about the sad loss of Mrs D and we thank Mr N for bringing his concerns to us. We hope this statement clearly explains why we will not be considering his complaint further at this time.

1. We have carefully considered Mr N’s complaint about the Trust. We were really sorry to learn about the care and treatment received by his mother, Mrs D. We will not be looking at his complaint further at this time as we consider Mr N could take legal action on the matter he has brought to us.