Calls have been made, by Epilespy Ireland, for a review of 40 cases of birth defects and disabilities that involved the use of the drug Epilim.
Epilim, a drug which the group has urged doctors not to prescribe for new child patients, is currently under review by the European Medicines Agency. Findings of the review are expected to result in new guidelines regarding its use being issue. Epilim is the brand name in Ireland for sodium valproate.
Epilepsy Ireland, and other campaigners, have asked that females being treated with the drug be considered for alternatives medications as a precaution. 1,700 female patients between the ages of 16 and 44, according to official figures released by the Health Service Executive (HSE), were prescribed Epilim during the calendar year 2016.
Issues experienced in Irish births involving the use of the drug include:
Epilim is currently being implicated in 40 cases of birth defects and disabilities, reported to the Health Products Regulatory Authority (HPRA). Lobby groups are of the opinion that this figure might actually be closer to 400 in the 43 years that the drug has been prescribed for treatment in Ireland.
Additionally it has been reported that, in France, in excess of 4,000 children have been born with malformations since 1967 when the use of the drug on children in the womb began there. Dr Mahmoud Zureik, the scientific director of France’s ANSM, said that reports have shown the possibility of experiencing significant birth defects was, worldwide, four times higher in children born to a woman treated with Valproate (Epilim) for epilepsy, when cross referencde with females who were not prescribed the drug.
Commenting on the use of Epilim, the HPRA said that it has liaised with neurologists, obstetricians, paediatricians, psychiatrists, GPs, family planning clinics, specialist epilepsy nurses, pharmacists and HSE clinical leads on an ongoing basis. Following the completion of the review by the European Medicines Agency is it expected that the HPRA will meet to review the use of Epilim in Ireland by medical professionals.
The Minister for Health, Fine Gael TD for Wicklow, Simon Harris is also due to meet with mothers of children who are believed to have suffered following being prescribed the drug to treat their epilepsy.
Roscommon nativer Bernadette Surlis, aged 60, has had hospital misdiagnosis compensation action against the Health Service Executive (HSE) settled for €5m.
The compensation action was taken after the treatment she was given at Sligo General Hospital in 2013 was found to be inadequate. Senior Counsel Mr Cush argued that, if Ms Surlis been diagnosed speedily and properly in November 2013, she would not have suffered the life changing injuries that she did. He (Mr Cush) told the court that the Health Service Executive admitted liability.
Upon attending Sligo General Hospital on November 3, 2013, Ms Surlis was suffering from a pounding headache, some vomiting and had a dilated left pupil on her eye. Despite this she was categorised as a ‘triaged’ case and had to wait to be cared for an additional three hours. ‘Triaged’ refer to the fact that she was not to be treated as an immediate need case requiring immediate attention.
She was examined for glaucoma symptoms and the allowed to return home. However, she came back to the hospital on the following day she said that the severity of her suffering was “appreciated for the first time”.
Ms Surlis, a resident at Drinaum, Strokestown in Co Roscommon, was then taken to to Dublin’s Beaumont Hospital on November 5 as she suffered a hemorrhage and severe/permanent injury. Mr Cush said the opinion of specialists was that Ms Surlis, who now needs permanent treatment, will only marginally improve over the duration of her life. She is aware of the severity of her injuries and has difficulty communicating with other, though she can do so with the help of her close family members – three grown children and four sisters who live close to her in Co Roscommon.
It was stated that if she had been transferred to Beaumont Hospital when she first attended the Sligo Hospital, she may have been treated in a proper fashion manner and experienced a complete recovery.
Judge Mr Justice Kevin Cross remarked that the medical misdiagnosis compensation settlement was a “reasonable and very good one”.
An young child, Cian Hammel (4), who was inflicted with a brain injury his mother just before his birth has had a €7.5m compensation claim approved in the High Court.
Following the car accident in which his mother was flung was a seven seat car that she was getting a lift in to her final pre delivery scan, an emergency Caesarean section had to be performed to deliver him in hospital. The High Court was advised that his mother Roisin, 17 at the time of the accident, was flung from the seven-seat car in that she was a rear-seat passenger in. The driver of the car did not have insurance to be driving the car. The road traffic accident happened at Manhanagh, Screen, Co Wexford on February 3, 2009. Cian Hammel now has trouble walking and is and also has difficulties with speaking.
In the legal action thken through his grandmother Ann, Cian Hammel of Ford Court, Kilmuckridge, Co Wexford sued the driver of the vehicle Simon Jordan, of Monaseed, High Fort, Gorey, Co Wexford for road traffic accident compensation.
The Motor Insurers Bureau of Ireland (MIBI), the body which manages compensation claim for victims of uninsured driving, was also sued for compensation following the road traffic accident.
It was argued that the car, driven by Mr Jordan, lost control and flipped over in the air resulting in Cian’s mother Roisin Hammel being thrown from the rear seat of the vehicle. Senior Counsel Rosario Boyle told the court that Roisin, who was preparing for her Leaving Cert, was being driven to attend her final pre-delivery scan.
Additionally it was claimed that Mr Jordan had overtaken another car when it was dangerous to do so and that he was driving too fast in the weather conditions at the time. These claims were argued by the Defence.
Ms Boyle stated that Roisin Hammel was not wearing her seat belt when the accident occurred. However, the MIBI later agreed that, had she been wearing her seat belt, the outcome for her child would not have been any more favourable.
Following the accident Ms Hammel’s waters broke and, due to foetal distress, she had to have an emergency caesarean section in hospital. When Cian Hammel was delivered he had to be resuscitated and experienced multi-organ failure.
Mr Justice Kevin Cross approved the €7.5m compensation settlement and said he hopes it will provide for Cian’s needs well in the future.
Roger Murray, joint Managing Partner at Callan Tansey solicitors – speaking at a conference on medical negligence with solicitors, medical professionals and patients in attendance in September – said that roughly 1,000 unnecessary deaths are caused every year in Ireland due to medical negligence.
The legal expert went on to add that up to 160,000 hospitals visitors suffer injuries due to human error. Mr Murray was speaking at the Pathways to Progress conference on medical negligence and stressed that there is “no compo culture” to be seen when it comes to Irish medical negligence compensation legal cases, saying that he believes that what we are seeing currently is just “the top of a very murky iceberg”.
From his experience in working on a number of high-profile medical error compensation cases, Mr Murray said that he believes that not all people suffering due to medical negligence report it while the HSE is made aware of 34,170 “clinical incidents” every year. Of these 575 resulted in compensation claims against the HSE, a rate of less than 1.7 per cent.
Mr Murray told those at the conference that the most often experienced cases are involving surgery (36 per cent) medicine (24 per cent), maternity (23 per cent) and gynaecology (7.5 per cent).
He also stressed that while injured parties and families do have empathy for medical workers who make errors what “they cannot abide is systemic and repeated errors”.
The legal expert called for thorough reviews when mistakes are experienced, saying that he had witnessed many inquests where families of those who had died learned that desktop reviews had been completed after a death, and the results were not presented to the appropriate staff members.
A settlement of compensation for the misdiagnosis of meningitis has been approved at the High Court in favour of a fifteen-year-old girl from County Cork.
The young girl was just three years of age when, on the morning of 10th July 2005, her concerned parents called the South Doc out-of-hours doctor´s service in Cork to expressed concerns about their daughter´s condition. As she was suffering from a rash on her stomach, a high temperature, drowsiness and vomiting, her parents were told to bring the girl into the medical centre.
Arriving at 5:00am, the girl was examined by Dr Leon Britz, who diagnosed tonsillitis and told the family to go back home. However, within a few hours, the young girl´s condition deteriorated and her parents brought her back to the medical centre at 9:30am when she was examined by another doctor who diagnosed meningitis.
The girl was taken to the Emergency Department of Cork University Hospital, where antibiotics were administered before she was transferred to Our Lady´s Children´s Hospital in Crumlin. Tragically, the girl had to have both legs amputated below the knee and subsequently underwent 132 operations to resolve other health issues that could have been avoided if her condition had been correctly diagnosed initially.
Through her mother, the girl claimed compensation for the misdiagnosis of meningitis against Dr Britz and South West Doctors on Call Ltd – alleging that she had suffered “profound consequences” as a result of the initial misdiagnosis. Had antibiotics been administered at an earlier stage, it was alleged, many of the consequences of her condition could have been avoided.
Liability was admitted by the defendants, and a settlement of compensation for the misdiagnosis of compensation amounting to €5.6 million was agreed between the parties. As the claim had been made on behalf of a legal minor, the settlement of compensation for the misdiagnosis of meningitis had to be approved by a judge to ensure it was in the girl´s best interests.
At the approval hearing at the High Court in Dublin, Mr Justice Kevin Cross was told the sequence of events on 10th July 2005 and of the “profound consequences” suffered by the girl. After hearing the girl was doing well at school and just about to sit her Junior Cert exams, Judge Cross approved the settlement of compensation for the misdiagnosis of meningitis – praising the girl´s parents for the care they had provided for their daughter.
A young girl has received €23,000 in compensation for psychological abuse she suffered while attending creche at the Giraffe Childcare and Early Learning Centre.
Towards the end of 2012, a young girl attended the Giraffe Childcare and Early Learning Centre in Stepaside, County Dublin. During her time in the “Toddler’s Room” at the creche, her parents were alarmed at their child’s distress about attended the creche, and they claimed that she would cry “No creche. No creche” each morning as they were preparing to drop her off. Their concerns increased when she started showing signs of anxiety and distress. Furthermore, it was claimed that when she returned in the evening, she was lethargic and experienced disturbances to her sleep pattern.
Her mother brought her concerns to her daughter’s carer in the facility. The carer told the girl´s mother she was receiving an appropriate level of care under her supervision and there was no reason to be concerned.
Several months after noticing the change in their daughter’s behaviour, the RTE documentary “A Breach of Trust” showed the same carer abusing children at the creche. Distraught, the girl´s parents sought legal counsel, and claimed compensation for the abuse of a toddler at a creche on the grounds she had suffered stress and emotional upset due to the negligence of the creche and the creche´s failure to adequately supervise its staff.
The creche initially denied liability, and in July 2015, an offer to settle the claim for €15,000 without an admission of liability was made. As the girl was a minor at the time of the incident, the offer went to the Circuit Court for approval to ensure that it was in the girl’s best interests. However, the case was thrown out by Judge James O´Donohue, who said the proposed settlement of compensation for the abuse of a toddler at a creche was inappropriate in relation to the level of injury the girl was alleged to have suffered.
The two parties entered negotiations, a new offer of settlement for €23,000 was made. Details of the offer and the circumstances of the girl´s injury were related to Mr Justice Raymond Groarke at the Circuit Civil Court earlier this week and – after he was assured there was no serious risk to the young girl´s future psychological development – the judge approved the settlement of compensation for the abuse of a toddler at a creche.
Birth defect claims have started to be filed against French manufacturer of Epilim, by parents whose unborn children were exposed to toxic chemicals in the womb.
Depakine was introduced into France in the 1960s as an anti-epilepsy drug. Eventually, it started to be introduced into Ireland under the trade name Epilim. The drug has also been prescribed to treat bipolar disorder, migraine and other chronic pain conditions. The active ingredient in the sodium valproate-GABA-stabilises electrical activity in the brain.
However, when taken by woman during pregnancy, the sodium valproate is broken down into valproic acid. When this molecule enters the bloodstream, it can cause serious health issues to unborn children. The birth defects, generally called “foetal valproate syndrome”, take the form of a range of congenital and development issues including autism and spina bifida.
The risks of foetal valproate syndrome due to taking Epilim during pregnancy were first identified by doctors in the 1980s. However, the evidence was considered not sufficiently conclusive of a link between the drug and the abnormalities, The link was allegedly hidden to prevent “fruitless anxiety” in parents who were taking the drug. Sanofi later informed the medical profession of the risks in 2006, but did not provide much information on the adverse health effects.
Only recently has France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the birth defect claims against Sanofi, and the agency has just published a report revealing that up to 4,100 children were born between 2007 and 2014 with “severe malformations” due to their mothers having taken the French version of Epilim. It also recognised that the drug caused hundreds of children to die in the womb.
The report has prompted the children´s parents to seek legal counsel. They formed a class action making birth defect claims against Sanofi on the grounds that the drug manufacturer failed to adequately advise the medical professional of the risks associated with Epilim or print warnings on the packets of the drugs. The French government has also got involved and is discussing a compensation package.
In Ireland, Epilim is still sold without a warning on the packet, and it is not known how many children have been diagnosed with foetal valproate syndrome due to being exposed to valproic acid in the womb. If a family member has been affected by this issue, and you would like to know more about birth defect claims against Sanofi, please do not hesitate to speak with a solicitor.
The HSE has finally admitted liability for a birth injury case in which a series of errors around a baby boy’s birth left him with a debilitating disability, after nearly a decade of denying fault.
The boy was born by emergency Caesarean Section at Kerry General Hospital on May 25th 2006. The hospital staff in charge of his birth committed a series of grave errors surrounding his birth. The baby boy´s delivery being delayed by two hours, depriving him of oxygen in the womb. Furthermore, despite an abnormal heart-rate pattern being observed, the consultant obstetrician was not informed. The possibility of foetal hypoxia was not considered by hospital staff, and no action was taken on a CTG trace indicating foetal distress.
Due to oxygen deprivation, the baby suffered devastating brain damage. He was diagnosed with mixed dyskinetic spastic cerebral palsy, a devastating disability. The boy (now ten years of age) requires 24-hour support from his parents, He us unable to speak or walk, and must always use a wheelchair. To exacerbate the family’s suffering, the HSE failed to admit liability for nine years. The boy´s family were forced to care for him relying entirely on their own resources, without the support they were entitled to from the state.
The HSE finally liability early last year after the family’s legal team threatened them with aggravated damages. After initial negotiation, an interim settlement of €2.7 million compensation for brain damage at birth was rushed through the courts. Recently, the family was back in court for the approval of a final lump sum settlement of compensation for brain damage at birth amounting. The two parties had agreed that €15 million was a sufficient sum. The judge presiding over the case described this as an amount that was described as “commercial common and legal sense”. As the boy is a ward of court, the settlement of compensation for brain damage at birth will be paid into court funds and managed by court authorities.
Approving the settlement, Judge Kelly paid tribute to the boy´s parents for the care of their son, and added while no money would compensate the boy and his family, but it was the only form of redress the law could provide. He hoped it would give peace of mind that there is a fund to care for the boy´s needs into the future.
The HSE has paid compensation to a boy who suffers from Erb’s palsy as a result of medical negligence surrounding his birth.
The six-year-old boy was born via a natural delivery on 22nd March 2010 at Kerry General Hospital despite his mother having requested a birth by Caesarean section because of his size in the womb. During the delivery process, the boy´s shoulder got trapped in the birth canal and he had to be extracted with the assistance of a vacuum cup.
Due to the force applied to free his shoulder, the boy suffered a brachial plexus injury and has since been diagnosed with Erb´s palsy. Due to his birth injury, the boy has a weak right arm that will permanently affect him for the rest of his life. After seeking legal advice, the boy´s father made a claim for an Erb´s palsy birth injury against the HSE on his son´s behalf.
The Health Service Executive (HSE) initially denied liability for the boy´s birth injury but after a period of negotiation agreed to a €530,000 settlement of the claim for an Erb´s palsy birth injury without an admission of liability. As the claim had been made on behalf of a child, the proposed settlement had to be approved by a judge to ensure it was in the child´s best interests.
Consequently at the High Court in Dublin, Mr Justice Kevin Cross was told that the boy had been identified as a big baby two months before his birth and that his mother had requested a Caesarean section delivery on two consultations and again when she was admitted to Kerry General Hospital in labour.
Judge Cross also heard that the boy attends mainstream school, has learned to write with his left hand and is very good at maths. An expert witness testified that the boy is unable to tie shoes or close buttons and will struggle at sports, after which the judge approved the settlement of the boy´s claim for an Erb´s palsy birth injury against the HSE and wished the family well for the future.
The High Court has approved a €1.35 million settlement for a young boy who suffered serious birth injuries after a hospital’s failure to operate on his mother.
The claim for medical negligence compensation was made on behalf of a child from Bantry, Co. Cork. Born in March 2010 at the Cork University Maternity Hospital, the boy sustained severe birth injuries after an alleged failure to correctly interpret the results of a CTG scan. The scan showed that the boy was suffering from foetal distress syndrome.
As the staff did not believe the foetus was in danger, there was a delay in performing a Caesarean section. Consequently, the boy suffered from a lack of oxygen and contracted hypoxic ischaemic encephalopathy in utero. He was born with severe brain damage.
The boy, now six years old, is blind and unable to speak. He also suffers from daily seizures and is reliant on round-the-clock care. His parents and extended family provide constant care, and he receives additional support from the Jack and Jill Foundation.
Acting on her son’s behalf, the boy’s mother made a claim for medical negligence compensation against the Health Service Executive (HSE). Though the HSE denied the allegations of negligence, they agreed to pay an interim settlement of compensation of €1.35 million without admitting liability. The settlement allows for an assessment of the boy’s condition and future care needs.
As the claim was made on behalf of a minor, the settlement had to be approved in court before it could be awarded. At the High Court in Dublin, Mr Justice Kevin Cross was told of how hard it was for the boy’s family to get compensation for the delayed Caesarean section, and of their relief that the process was over. Wishing the family the best for the future, Judge Cross approved the settlement and adjourned the case for three years.