Settlement of claim after clinical trial of Endologix Fenestrated Ventana Stent Graft

We dealt with a claim arising from our client’s participation in a clinical trial of Endologix’s Fenestrated Ventana Stent Graft System at St George’s Hospital. In May 2011 our client underwent an endovascular repair by way of an insertion of an Endologix fenestrated stent graft. A subsequent CT scan in December 2011 showed occlusion of the left renal stent graft and problems with blood pressure were noted. On 6 March 2012, our client became significantly unwell and was diagnosed as being in renal failure secondary to bilateral renal artery thrombosis. The cause of the obstructed right renal artery was thought to be migration of the graft.

Our client is now in established renal failure which will have a significant impact on her life expectancy. She requires dialysis three times a week, experiences high levels of fatigue, and her walking and standing tolerance is limited. During the course of her lifetime, she will face a number of complications as a direct result of her renal failure and/ or the treatment associated with its management.  

As this was a clinical trial, Endologix agreed to deal with the claim under the ABHI guidelines for compensation. This stipulate that compensation will be paid 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 instructed to investigate quantum and negotiate settlement. After investigation, disclosure of evidence and negotiations the claim was settled for £650,000.

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