Man sues over allegedly faulty heart defibrillator

The High Court has been told 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.

Barrister Doireann O'Mahony told Mr Justice John Hedigan that her client Patrick McCarthy (41), a mechanical fitter, of Curragh Road, Turner's Cross, Cork, still had the cardio implant in his chest.

Ms O'Mahony said Mr McCarthy is suing cardiologist Gerard Fahy; South Infirmary Victoria Hospital Limited; and Medtronic Ireland Limited and several of its Irish associate companies for alleged negligence and breach of duty.

Mr Justice Hedigan granted Mr McCarthy a number of orders for discovery of documents limited to information within the remit of the defendants in Ireland. He rejected demands for world-wide discovery relating to Medtronic and its associated companies.

Paul Anthony McDermott, counsel for the defendants, said there had been part-agreed discovery. The defendants denied liability and full defences had been entered in the case, counsel said.

Mr McCarthy had a Medtronic implantable cardioverter defibrillator (ICD) implanted in August 2007 when under the care of 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 issued a warning concerning the Sprint Fidelis leads but nevertheless permitted them to be used in the ICD implanted in him.

Ms O’Mahony told the court her client claimed the Sprint Fidelis leads tend to fracture, thereby blocking or distorting their electrical flow to the heart. He claims he now has defective product devices in his heart.

Mr McCarthy claims the Irish Medicines Board had in October 2007 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 — wires placed on heart muscles and attached to an implanted electrical device designed to maintain appropriate heart rhythm — and recalled any unused leads.

Mr McCarthy says Medtronic had said in 2007 that it had identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Irish Medicines Board had advised patients to contact their cardiologists for medical advice.