Man sues for 'negligence' over allegedly faulty heart device
Doctors for a man who is suing the manufacturers of an allegedly faulty heart defibrillator believe removing the device now would pose a greater risk than leaving it in place, the High Court heard.
Patrick McCarthy (41), a mechanical fitter of Curragh Road, Turner’s Cross, Cork, still had the cardio implant in his chest, his barrister Doireann O'Mahony said.
Ms O’Mahony said her client was suing cardiologist Gerard Fahy; South Infirmary Victoria Hospital Ltd, Cork, Medtronic Ireland Ltd, and several of its Irish associate companies, for alleged negligence and breach of duty.
Mr Justice John Hedigan granted a number of orders in relation to disclosure documents required by Mr McCarthy in advance of the hearing of the case. The discovery orders are limited to information within the remit of the defendants in Ireland.
The judge rejected demands for world-wide discovery relating to Medtronic and its associated companies.
Paul Anthony McDermott BL, for the defendants, said there had been part agreed discovery.
He said the defendants denied liability and full defences had been entered in the case.
Mr McCarthy had a Medtronic implantable defibrillator (ICD) put in in August 2007 when under the care of consultant cardiologist Mr Fahy and the Cork hospital.
Medtronic and five associated defendants are alleged to have been responsible for the design, production, manufacture, marketing and sale of the Medtronic “Sprint Fidelis” leads used in the defibrillator.
He alleges Medtronic in March 2007 had been aware of defects in its device and had issued a warning concerning the Sprint Fidelis leads but nevertheless permitted them to be used in the ICD implanted in him.
Sprint Fidelis leads tend to fracture thereby blocking or distorting their electrical flow to the heart and as a result he now had defective product devices in his heart, Ms O'Mahony told the court.
In October 2007 the Irish Medicines Board confirmed that almost 1,200 people in Ireland had been fitted with the same type of heart defibrillator that had been linked to five deaths in the US.
At the time, Medtronic voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads and recalled any unused leads - wires placed on heart muscles and attached to an implanted electrical device designed to maintain appropriate heart rhythm.
Medtronic had identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor, the company stated in 2007.
The Irish Medicines Board had advised patients to contact their cardiologists for medical advice.
*Clarification: A picture of an external AED (automatic external defibrillator) used in an earlier version of this story was used in error, and we are happy to clarify that it has no connection to the story.