Legal proceedings were started in the High Court in London today by Leigh Day & Co. on behalf of Billy McCombe. He is suing St. Jude Medical for the death of his wife, Myrtle, following an implant with a failed heart valve. She died in July 1998, age 44, 10 weeks after an operation to implant the Silzone heart valve. The post mortem, carried out by Northern Ireland's State Pathologist, Professor Crane, resulted in the cause of death being defined as "Thrombotic occlusion of St Jude's medical Prosthetic mitral heart valve - Silzone coated".
St. Jude have a range of conventional, tried and tested heart valves to which they added a silver coating, Silzone. They did this to reduce the incidence of the heart infection endocarditis, a life threatening condition associated with heart surgery. European patients were the first to have these valves implanted, and since 1997, 1,300 have been distributed in the UK.
In 1998 it had been reported by a British surgeon that there was a 25% failure rate in patients with this new Silzone valve. By 1999 the Medical Devices Agency had issued a notice highlighting the risks of blood clot complications with the Silzone valves and in January 2000 they prohibited any further use of them.
A study showed an 8-fold increase in valve leakage
An international multi-centred study (AVERT) sponsored by St Jude Medical, into Silzone valves showed an eight-fold increase in leakages compared to conventional, uncoated, valves. Many patients with these valves had to have additional surgery to have them removed and replaced, others have died. "My wife's death totally devastated my family," said Myrtle's husband, Billy, "I don't think we will ever fully get over it. Myrtle was in the prime of her life. She was found dying on her bed by our 15 year old son."
An internal document produced by the marketing department of St. Jude said: "It looks like a pretty slick idea, and we are looking for our first implants on the Guinea pig continent of Europe".
"The circumstances under which Silzone was introduced into the European market by St. Jude, with virtually no clinical testing needs to be fully investigated" stated Richard Meeran, Partner at Leigh Day & Co. who is handling the case.
St Jude recalled the heart valves in 2000
St. Jude Medical began a worldwide recall of the Silzone heart valve in 2000 and recognised in it's recent financial report that it had adequate funds to cover the claims of those patients it would have to compensate. Meeran explains: "It is hard to see how St Jude can defend this case. The Consumer Protection Act imposes strict liability on manufacturers and importers of products for injuries caused by defects in those products. The very nature and purpose of heart valves makes it critical that these products are as safe as possible before they are used".
Class Actions on behalf of patients implanted with the Silzone valve are ongoing in Minnesota, US, where St Jude has its headquarters in Canada. "I feel that St. Jude have a lot of questions to answer about their conduct over this product." adds Billy McCombe.
If you or a family member has been affected by a faulty Silzone heart valve, you should contact one of our lawyers either
Gene Matthews or
Richard Meeran on 020 7650 1200.
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