£650,000 damages won for injuries arising from Endologix stent clinical trial

Our client had a history of non-invasive bladder cancer which was first diagnosed in 1996. Following regular treatment for this non-invasive disease, a bladder scan in June 2011 revealed a large abdominal aortic aneurysm.

She was referred to St George’s Hospital for treatment and her vascular surgeon explained that she required an operation to treat the aneurysm. Our client was advised that she was suitable for a new Fenestrated Ventana Stent Graft System, manufactured by Endologix, benefits of which included a shorter procedure and recovery time. 

Our client agreed to participate in the Endologix stent trial and she had the surgery to treat her aneurysm in October 2011. Immediately after surgery, she experienced back pain until her discharge from hospital one week later. After being discharged, her condition gradually deteriorated and she suffered from constant headaches, insomnia and high blood pressure. 

The following month, our client was advised by her vascular surgeon that there was a leak at the top of the stent which needed to be repaired. 

Our client’s condition continued to deteriorate. Her blood pressure remained abnormally high and she was told by her surgeon she was unsuitable for surgery because of her high blood pressure. 

By March 2012, our client was very unwell. She was nauseous and experienced episodes of unconsciousness. She noticed that she was unable to pass urine and went to A&E straight away where she was told she had kidney failure of both kidneys but was not suitable for a kidney transplant because of her bladder cancer. A CT scan of our client’s kidneys revealed that there had been migration of the Endologix stent graft, which resulted in compromise of the right renal artery causing renal ischemia.

We were instructed to investigate the potential claim and, following discussions with Endologix’s solicitors, it was agreed that Endologix would compensate our client for any injuries as a result of being part of the clinical trial under the Association of British Healthcare Industries (ABHI) Guidelines for compensation. These guidelines provide that compensation will be paid to a patient on a no fault basis for any injury attributable to the use of the medical device, including any clinical procedure that would not have occurred but for the participation in the trial. We were then instructed to investigate quantum and negotiate a settlement. 

As a result of participating in the trial, our client is now in established renal failure and requires regular dialysis treatment to remove waste and excess water from her blood stream. She has become increasingly frail and requires significant additional care and support. 

We instructed a number of experts during our quantum investigations, including one to advise on our client’s future care and assistance needs; one to advise on necessary alterations necessary to her home; and one to advise on the medical treatment she will need for the rest of her life. 

The evidence we obtained showed that the development of renal failure will have a significant impact on our client’s life expectancy. She experiences high levels of fatigue and her walking and standing tolerance is limited. She will, during the course of her lifetime, face a number of complications as a direct result of her renal failure and/ or the treatment associated with its management.  

Our client will require significant alterations to be made to her home so that it is habitable in her current and future condition, and she will need medical treatment and care on a daily basis for the rest of her life. 

We shared this evidence with Endologix’s solicitors, who made an initial offer of £510,000 to settle the claim in June 2015. As we felt this undervalued our client’s claim and was insufficient to cover the cost of her future needs, we advised our client not to accept it and subsequently agreed with Endologix to settle the claim for the amount of £650,000. 

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