Man claims defibrillator fitted in heart is defective

Court has heard doctors believe removing ICD poses greater risk than leaving it there

A man who alleges he has been left with a defective defibrillator in his heart has opposed any conditions being attached to discovery of documents for his High Court action.

Patrick McCarthy, a mechanical fitter, of Curragh Road, Turner's Cross, Cork, who has a cardio implant in his chest, is suing cardiologist Gerard Fahy, South Infirmary Victoria Hospital Limited and Medtronic Ireland for alleged negligence and breach of duty.

The court previously heard doctors for Mr McCarthy believe removing the implantable cardioverter defibrillator (ICD) now would pose a greater risk to him than leaving it in place.

The case has yet to be heard and it was before the Master of the High Court Edmund Honohan on Monday when Mr McCarthy's lawyers opposed any conditions being attached to the discovery of documents being sought by him for the proceedings.


Seeking to impose restraints

Doireann O’Mahony BL, for Mr McCarthy, told Mr Honohan that Medtronic Ireland Limited and five associated companies responsible for manufacture and distribution of the defibrillator were seeking to impose restraints on discovery.

Julian Kahn, a solicitor with Coakley, Maloney and Co, said in an affidavit the defendants had demanded they be provided with a list of people who would see the documents, an undertaking the documents would be used only for the purposes of this legal action and details of storage proposals for the documents.

Jeananne McGovern BL, for the defendants, said they denied liability and full defences had been delivered.

Orla Clayton, a solicitor with Arthur Cox, which represents all of the defendants, said certain documents were sensitive and confidential in nature, with some relating to parties other than Mr McCarthy.

She said the Medtronic defendants had no difficulty in making redacted documents available for inspection and felt they had already fully discharged their discovery obligations.

Ms O’Mahony said she wanted full inspection, and the defendants were not entitled to impose preconditions.

Mr Honohan reserved his decision on the discovery dispute.

Previously, the High Court heard Mr McCarthy had an ICD implanted in August 2007 when under the care of Mr Fahy and the Cork hospital.

Medtronic and their associate companies are alleged to have been responsible for the design, production, manufacture, marketing and sale of Medtronic "Sprint Fidelis" leads used in the defibrillator.

Alleged defects

Mr McCarthy claims the Medtronic defendants had been aware of the alleged defects in its device and, while issuing a warning about them, nevertheless permitted them to be used in the ICD implanted in him.

Ms O’Mahony has told the court her client claimed the Sprint Fidelis leads tend to fracture, thereby blocking or distorting their electrical flow to the heart.

Mr McCarthy claims the Irish Medicines Board (IMB) had in 2007 confirmed almost 1,200 people in Ireland had been fitted with the same type of defibrillator, which had been linked to five deaths in the US.

Medtronic had suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads - wires placed on heart muscles and attached to an ICD designed to maintain appropriate heart rhythm – and recalled any unused leads.

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

Mary Carolan

Mary Carolan

Mary Carolan is the Legal Affairs Correspondent of the Irish Times