The family of a Belfast woman who died 10 weeks after she was given a newly designed heart valve has begun legal action against the product's American manufacturer in a case which could lead to a multimillion-pound compensation claim involving dozens of other patients.
Myrtle McCombe, 44, died at home in July 1998 when her valve became blocked, causing her heart to fail.
The same implant, Silzone, was fitted to 1,200 patients before being withdrawn from use in 2000 after concerns over its design. In the case of Mrs McCombe, a post-mortem report specifically found that a large blood clot had formed on the silver-coated surface of her synthetic valve.
Her husband, Billy McCombe, 55, from Cookstown, Northern Ireland, is convinced that his wife died because the valve had never been sufficiently tested in this country.
Lawyers launching a test case in the UK courts, on behalf of Mr McCombe, against the American manufacturer, believe the Silzone implants represent a potential "medical time bomb" because few patients will be aware they have the valves in their bodies.
Mr McCombe's solicitor, Richard Meeran, a partner at the London law firm Leigh, Day & Co, has been contacted by four other potential claimants hoping to join the High Court action that could result in the manufacturer, St Jude Medical, facing claims for millions of pounds in compensation.
Mr Meeran said yesterday: "Many people in this country may potentially have been seriously harmed by this product. The circumstances under which the Silzone valve was introduced into the European market by St Jude, with no or virtually no clinical testing, needs to be fully investigated."
For years doctors had warned Myrtle McCombe that the rheumatic fever she suffered from as a child had left her with a weakened heart. On 23 April 1998 she had a damaged heart valve replaced by the artificial implant.
Ten weeks after leaving the hospital in Belfast where the operation was done, Mrs McCombe complained of a draining tiredness. Returning home from a short car journey, she asked her eldest son to take her upstairs and sit with her while she drifted off to sleep.
It was a sleep from which Mrs McCombe never woke.
Her husband insists he does not want to alarm people unnecessarily but hopes his case will raise awareness among hundreds of people who may not know they could have a medical problem.
For the McCombe family, the death was made more difficult to accept because, within a week of returning home from hospital, she had complained to medical staff there that the sound of the valve's clicking had become louder.
Mr McCombe said: "The doctors told her not to worry because it was only when the clicking stopped that there was any cause for concern."
Mr McCombe, a freelance photographer, said of his wife: "Myrtle was a wonderful wife and mother to our three sons and we had 24 very happy years together. She was hard-working, fun-loving and a very wonderful person.
"But I can never forget that she was cut down at the age of 44 before she could see her children grow up or enjoy her grandchildren."
Around the time of Mrs McCombe's death, a British surgeon reported a 25 per cent failure rate in patients implanted with the Silzone valve. Then in November 1999, the Medical Devices Agency (MDA) issued a safety notice highlighting possible risks of thromboembolic complications (blood clotting) among patients with Silzone heart valves. That led to a "recall" notice in 2000 prohibiting further use of the product.
Mr Meeran said: "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."
Silzone was adapted from an existing artificial heart valve and so did not require full medical trials. The silver coating was added to help to combat infection and reduce the rate of endocarditis (inflammation of the membranes lining the heart's chambers), one of the most common and dangerous complications of artificial valve implantation. It was introduced in Europe before being made widely available in the United States, leading Mr McCombe to claim that "people in Europe were used as guinea pigs" for the Americans.
Peter Gove, vice-president of St Jude Medical, told The Independent that the company had not been served with the High Court claim form and therefore could not comment on the McCombe case. But he acknowledged that the company was facing litigation from the relatives of patients who had died after being given Silzone implants in America.
"It has been more than three years since St Jude Medical chose to voluntarily recall its non-implanted Silzone heart valve products. The medical complication that led to the Silzone recall is one that occurs with all mechanical heart valves, regardless of the type or manufacturer.
"It is important to understand that valve replacement procedure is major surgery and complications (including thrombus or blood clots) do occur in all surgical procedures, particularly with heart valve patients who often have multiple health challenges."Reuse content