Milton Keynes University Hospital NHS Foundation Trust

4. Mrs T complains about aspects of the care and treatment she received from Milton Keynes University Hospital NHS Foundation Trust from April 2014 to November 2021.

5. Specifically, she says the Trust did not address the side effects of the cancer treatment. She says the Trust continued to administer the harmful medication and did not refer her to a specialist, after the family informed the Trust of their concerns.

6. Mrs T says the prolonged administration of this medication has caused her to have Parkinsonism and other complex issues including:

• poor mobility • cognitive impairment • double incontinence • gait abnormalities • memory loss • neuropathy • loss of capacity • apathy • cortical apathy • diabetes • respiratory problems • dizziness

7. She says the effects of the medication are permanent and has resulted in her having a poor quality of life.

8. Mrs T says as outcomes, she would like an investigation on the adverse effects of the drug, and an apology. Whilst she has not provided an amount, she would like a financial remedy to support her ongoing care. She has confirmed this amount should be in line with level 6 of our severity of injustice scale.

9. In October 2012, at Milton Keynes Hospital, the Trust diagnosed Mrs T as having HER2+ breast cancer. She received chemotherapy treatment.

10. In March 2013, Mrs T successfully underwent breast surgery and returned to the oncology team for treatment and post surgery radiotherapy.

11. In October 2013, the cancer returned, and the Trust treated her with capecitabine and lapatinib (chemotherapy treatment) for T4 N2 inflammatory breast cancer.

12. In January 2014, the Trust temporarily altered the treatment by removing the capecitabine medication due to inflammation in Mrs T’s big toes, known as hand/foot syndrome, a side effect of chemotherapy. The Trust recommenced the capecitabine treatment once it resolved this issue.

13. The Trust says, although Mrs T showed a good response initially, the treatment did not prevent her cancer from spreading. The Trust identified the spread following a routine scan.

14. In April 2014, the Trust said, to prevent further spread, it started giving Mrs T a new medication, kadcyla/T-DM1. She was on kadcyla/T-DM1 for over seven years, receiving 124 cycles of the medication.

15. In November 2021, Mrs T attended the emergency department as she had increasing symptoms of tingling in limbs, collapsing and balance issues. The emergency department reviewed her, but she did not receive treatment for this.

16. In December 2021, the Trust explained the kadcyla/T-DM1 treatment had stopped as her general condition was declining. Mrs T was now requiring care for her day to day activities, her performance status increased to level three (a status for patients who have limited capabilities and limited self care). The Trust deemed her unfit for treatment, and recommended she had frequent routine scans.

17. In January 2022, the Trust reviewed Mrs T and confirmed she had shown improvement since withholding treatment, and it decided to stop kadcyla/ T-DM1 treatment completely.

18. In December 2023, after a DaT scan (brain scan to diagnose Parkinson’s disease), a neurologist confirmed Mrs T had drug-induced Parkinsonism.

22. 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 have discussed this with Mrs Y to understand Mrs T’s circumstances and the outcomes they are seeking. We do not consider whether legal action would succeed but whether it would be a reasonable option to look in to.

23. Mrs Y says the Trust treated her sister’s cancer with kadcyla/T-DM1 from April 2014 to November 2021. Mrs Y says this medication has caused Mrs T to have significant irreversible side effects which have permanently damaged her quality of life.

24. The Trust administered 124 cycles of the treatment. Mrs Y says the consultant oncologist told her Mrs T was the longest registered patient to be prescribed this medication.

25. In 2023, a neurologist confirmed Mrs T had parkinsonism. Parkinsonism is a general term that refers to a group of neurological disorders that cause movement problems similar to those seen in Parkinson’s disease such as tremors, slow movement and stiffness. Parkinsonism is sometimes the result of taking certain medications. Doctors call this condition drug-induced Parkinsonism.

26. Mrs T also has cognitive impairment, Alzheimer’s, neuropathy, gait abnormalities, double incontinence, loss of capacity, apathy, cortical atrophy, mobility issues, diabetes, and respiratory problems as well as other side effects associated with kadcyla/T-DM1.

27. Mrs T is seeking an investigation, an apology and financial remedy to support the care for her permanent symptoms.

28. As Mrs T is seeking to achieve a financial remedy. We think she potentially has a claim for clinical negligence. We can see Mrs T underwent treatment and may have been injured as a result. Courts accept that NHS bodies and employees owe a legal duty of care to patients.

29. Mrs Y has told us Mrs T wants financial remedy amount in line with level six of our severity of injustice scale. This scale allows the Ombudsman to make consistent and fair decisions across the work that we do. The scale can be found on our website. This would be to help with the irreversible damage she says the Trust caused by giving her excessive doses of the medication.

30. We do not provide financial compensation in the same way as courts do. The financial remedy we may recommend is to put a person back in a position they were before there was a cause to complain. The amounts we recommend are generally modest compared to financial awards made by the courts.

31. The costs to cover ongoing care is not something we would consider. The outcome Mrs T is seeking can be sought through the courts. In this circumstance it appears reasonable for her to pursue this route.

32. We have seen no barriers to Mrs Y seeking pursuing a clinical negligence claim. While She has issues with cognition and capacity, she has valuable support from her sister Mrs T. Mrs Y has not told us how they plan to fund a claim, but we have made her aware there are funding options available, such as no win no fee, which they will be able to explore. We have also shared information with them about independent organisations who can provide them with further support on pursuing a legal claim.

33. Should Mrs T be unsuccessful in sourcing legal representation, or if she does not achieve all her outcomes, she can return to us and ask us to consider her case again.

34. Mrs T will need to be mindful of our time limit and would need to return to us promptly, after seeking legal representation.

35. We are sorry to learn of the circumstances which led Mrs T to bring this complaint to us. We are saddened to hear about her experience and how this has affected her quality of life, as well as how this has impacted her family.

36. We understand the process of raising this compliant with us has been extremely distressful and challenging for Mrs T and Mrs Y. We will not take further action on this complaint as we think there is a legal route available. We thank them for bringing this complaint to us.

1. We have carefully considered Mrs T’s complaint about Milton Keynes University Hospital NHS Foundation Trust (the Trust).

2. We understand this complaint is very important to Mrs T. We recognise the significant effect this continues to have on her, and her family. We are very sorry to hear of Mrs T’s struggles following her cancer treatment.

3. Mrs T is seeking financial remedy as she says the Trust did not take action to address the adverse effects from the cancer treatment she received. As a result, her quality of life has diminished significantly, and she is unable to provide care for herself. We consider she could potentially take legal action, and it is reasonable for her to explore this before we do further work on his complaint.