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News Clinical Negligence 19th Feb 2018

Heater cooler victims to sue LivaNova over mycobacterium deaths

The grieving daughter of Alan Diplock, a 65 year old Brighton fisherman who died on 12 July 2016 from mycobacterium chimaera infection caught from a heater cooler unit used in a heart operation has launched court proceedings to claim compensation for her father’s death from the manufacturers, a subsidiary of the London PLC LivaNova.

Alan’s daughter Kerry-Anne (38), said:

“My father died a slow and painful death from this lethal bug. It has been over a year since the coroner established that his death was due to the contaminated heater cooler unit used in his heart operation in 2013 but the company that made it has still not acknowledged that responsibility. My father went through hell during his fight against this disease. My family and I lived through hell right along with him. After his heart operation he was initially full of hope for the future. He had even bought a new fishing boat. That future he hoped for did not come to pass. He was robbed of it and we are still devastated. The company makes great play of the alterations it has made to its machines and the compensation it is paying to the hospitals but there’s never any mention of the patients and families whose lives it has ruined.”

Paul Balen, Solicitor at Freeths LLP who is representing 14 patients and their families affected by the bug, commented:

“It is nearly a year since full details of the claim were supplied to the company. My client feels it essential that the court now sets a timetable for the company to resolve these claims. The youngest client in my group of patients affected is 36 with three young children; others who have died have left dependent children; some are struggling with the loss of their breadwinner. All are struggling with the loss of loved ones and the failure of the company to acknowledge their suffering. This company owes these victims an apology, an explanation and reasonable compensation for what they have been put through. My door has always been open. It is about time the company instructed its lawyers to walk through it and resolve these claims without causing my clients any more anguish.”

Further notes:

  1. The heater cooler units were manufactured in Germany by a wholly owned subsidiary of LivaNova PLC, a UK corporation. Sorin 3T and Stockert 3T heater cooler units (HCU) are used in hospital operating theatres principally during the course of open heart surgery.
  2. Heater cooler units regulate the patient’s blood temperature during open heart cardiac surgery by circulating water through tubes into a heat exchanger in close proximity to the patient’s blood which is circulated through the machine separately.
  3. Mr Diplock underwent valve replacement surgery on 24th May 2013 at the Royal Sussex Hospital in Brighton. During the course of the operation whilst his heart was stopped he was perfused using a Sorin 3T heater cooler unit manufactured and supplied by LivaNova.
  4. He recovered well initially but then went downhill and after numerous investigations and procedures mycobacterium chimaera infection was confirmed in May 2015. In spite of treatment the infection became spread throughout his body until after a long and painful decline he died on 12 July 2016.
  5. In January 2017 Her Majesty’s Senior Coroner in Brighton recorded that: “Mr Diplock developed deep seated mycobacterium chimaera infection following essential cardiac surgery in 2013. The infection did not manifest itself until the end of 2014. It was identified in June 2015. Mr Diplock received appropriate specialist care and treatment which sadly failed to prevent his death in July 2016. His death was caused by infection (mycobacterium chimaera) acquired by him from contaminated equipment (a heater cooler unit) used in his original surgery. This contamination existed in spite of all recommended cleansing and disinfection techniques being employed by the hospital trust.”
  6. Published scientific research has demonstrated that the genome of the infective mycobacterium chimaera has been traced to the LivaNova’s manufacturing facility in Germany.
  7. The claim is brought under product liability legislation and alleges that the fact that the heater cooler unit was contaminated with mycobacterium chimaera rendered it not as safe as persons generally were entitled to expect – the safety requirements of devices such as heater cooler units used in operating theatres being particularly high.
  8. Mycobacterium chimaera has been recognised as a human pathogen since around 2004, originally found in cystic fibrosis patients. It is a serious infection with around a 40 – 50% mortality rate.
  9. In October 2012, two Swiss patients were diagnosed with mycobacterium chimaera following cardiac surgery at Zurich University Hospital. Research revealed that since 2006, six cardiac patients there had contracted mycobacterium chimaera becoming symptomatic 1.5 – 3.6 years after surgery conducted between 2008 and 2012. The DNA of the mycobacterium chimaera were identical indicating that there was a common source which was subsequently discovered to be five heater cooler units. Mycobacterium chimaera accumulated in the heater cooler units was found to have been dissipated into the operating theatres in an aerosol like spray.
  10. In 2014 Swiss patients and doctors were notified of the problem bu it was not until March 2017 that Public Health England notified all doctors and the patients who may have been affected. Perfusionists who look after the machines had been notified in 2014 and cardiothoracic surgeons had been notified in 2015, but by then patients who were likely to have been affected were usually out of their care and being treated by doctors in the community, who until 2017 were largely unaware of the problem.
  11. In December 2015, the FDA in America banned the import of Sorin 3T machines and issued a warning letter to LivaNova about its findings related to the mycobacterium chimaera infection after inspecting the LivaNova manufacturing facilities in Munich.
  12. In March 2016 at a national meeting of perfusionists held at the Holiday Inn at Birmingham Airport, LivaNova representatives described how mycobacterium chimaera had been found in a dead leg section of heater cooler units. This dead leg was now being removed by the manufacturers when heater cooler units were returned to it for deep decontamination.
  13. In March 2017 LivaNova published its Product Remediation Plan, involving:
    • (i) Modification of the 3T heater cooler device to include internal sealing and the addition of a vacuum system to prevent aerosolisation from the heater cooler unit in the operating theatre;
    • (ii) A free deep clean disinfection service for hospitals which had reported mycobacterium chimaera contamination of their heater cooler units and the free loan of replacement machines.

For more information or if you or a family member have been affected, please contact Paul Balen at Freeths on 0776 767 3200 or email paul.balen@freeths.co.uk.

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