EU 'guinea pigs' in heart valve compensation claim
A DUBLIN man who is among thousands of patients fitted with an allegedly defective artificial heart valve is a key claimant in a multi-million-dollar class action compensation case in the United States, it emerged yesterday.
Shane O'Neill, originally from Dublin but now living in Ontario, Canada, had a valve implanted at the Mater Hospital in Dublin in March 1998.
He is at the centre of a compensation claim launched in the US on behalf of hundreds of European Union patients implanted with artificial heart valves made by an American firm.
St Jude Medical used Europe as a testing ground for its Silzone valves and labelled the continent the "guinea pig" area, solicitors Leigh, Day and Co, representing the claimants, said yesterday.
A spokesman said Mr O' Neill has not suffered any adverse effects but he is typical of many of the claimants who are at risk. They claim the valve suffered from a series of fundamental defects centred around its silver coating.
It was toxic to heart tissues and responsible for causing serious and potentially fatal complications, it is alleged.
"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," said solicitor Richard Meeran. "Recipients of the Silzone valve have a right to be carefully monitored." The case will be heard at Minnesota State Court.
In a separate case launched in the UK last summer, Billy McCombe (55), from Cookstown, Co Tyrone, whose wife Myrtle (44) died after she was fitted with a Silzone valve, is seeking compensation for his partner's death, alleged to have resulted from the valve. The case is still ongoing.
Other patients in Ireland were also fitted with the valve and all were informed about its recall three years ago.
Leigh, Day and Co is representing up to 14,000 people from EU countries who received heart valves between 1998 and 2000 and have not experienced medical problems. They are fighting for compensation to establish a trust fund to provide ongoing monitoring of the heart valve for life and, if needed, its repair or replacement.