£650,000 product liability claim settlement for client injured in Endologix clinical trial

Posted: 14/09/2015

The Penningtons Manches clinical negligence team has recently won a £650,000 claim settlement for a client who suffered injuries following her 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. These 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. A number of medical reports were required in various fields and this was a substantial claim because of our client’s significant limitations and future prognosis. 

Elise Bevan, senior associate in the clinical negligence team who conducted this claim, commented: “It became apparent quite early on in this case that it would be a product liability claim arising out of the clinical trial in which our client had participated. The situation was, however, complicated by having to consider and protect our client’s position regarding any clinical negligence claim. This was a sad case in that, over the time we were involved and partly as a result of our investigations, it became apparent that our client’s prognosis was poor. We therefore moved things as quickly as possible to reach a settlement and we hope that this will make a material difference to her quality of life as she faces her ongoing difficulties and ill health.”

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