Epilepsy drug caused baby's neurological damage, court told

The High Court has begun hearing an action over neurological damage allegedly caused to a baby by a drug used to control epilepsy while his mother was pregnant.

The court heard that Carlow teenager Alex Fahey has autism spectrum disorder and was also diagnosed with foetal valproate syndrome (FVS) which is associated with the use of the drug sodium valproate or Epilim in pregnant women.

It is understood to be the first case of its kind in Ireland and is one of a large number of similar cases which may come before the courts.

Sixteen-year-old Alex has severe language and memory difficulties, requires round-the-clock care and will never be able to live independently, the court was told.

Through his mother Helen Maher Fahey, from Rathvilly, Co Carlow he is suing GP Patrick Feeney of Lower Kilmacud Road, Stillorgan, Dublin and Consultant Neurologist Janice Redmond of private clinic, St James's Hosptial, Dublin.

The claims are denied and are set to be fully defended in a case that is expected to last several weeks.

Opening the case before the court, Senior Counsel Aongus O'Brolchain said Helen Maher Fahey had two children while on a lower dose of the drug Epilim.

However after the birth of her first two children, the dose was increased and she was also given another anti-convulsant Lamictal.

Mr O'Brolchain said that after discovering she was pregnant in April 2005 she rang her consultant's office amid concern about Lamictal and while she cannot remember if she spoke directly to the consultant or to a secretary she recalls being "relieved" it was safe and believed she was told she would be contacted if there were any concerns.

She had no concerns about Epilim because she had been told during previous pregnancies that the drug was safe and that taking folic acid would substantially offset any risks.

The court heard that by this time it was known to medical professionals that the drug Epilim posed a risk to the neurological development of the foetus if given to pregnant women in high doses.

Ms Fahey's dose had been increased since her previous pregnancies.

Ms Fahey had a miscarriage a few days later but went on to become pregnant again later that year.

Because she had not heard anything to the contrary in the early stages of the previous pregnancy, she believed it was safe to continue on both medications.

It later emerged that after she had phoned the consultant in late April 2005, a letter was written on 10 May to her GP by Dr Redmond saying Ms Fahey needed to be told about the risk posed by the medication.

On 17 June a letter was written by the GP to an old address of Ms Fahey's asking her to contact the surgery about a communication from consultant Janice Redmond.

The court was told that Ms Fahey never received the letter as she had moved house four years previously and that she had visited the GP for a back complaint five weeks after the letter was sent and no mention was made of the letter.

The GP also had her mobile number on record, the court was told.

Her lawyers told the court that it is their case that her medication should have been kept under review because it was clear that she had been pregnant and intended to become pregnant again and was of child bearing age and that she should have been informed of the risks association with the drug Epilim allowing her to choose whether or not to reduce her dose or choose not have more children.

It was "not good enough" that the letter had been sent by the consultant to the GP as a consultant treating epilepsy would be the person to decide on any change to medication, the court was told.

Mr Justice Simons asked if Ms Fahey had contacted her consultant during her pregnancy with Alex and was told she had not.

She continued to received a prescription from her GP for both drugs, the court was told.

The judge was also told that the defence would say that following the April 2005 phone call, Ms Fahey had been invited to attend her consultant but declined.

Mr O'Brolchain said this would be denied and that it was not submitted as part of the defence until last week.

The judge will rule tomorrow on whether or not the defence can be amended to include this contention.

RTE News

Vivienne Traynor

November 2022