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.
A cerebral palsy claim against the HSE has been heard in the High Court for the approval of a compensation settlement without an admission of liability.
On 5th October 2010, a woman from Midleton in County Cork gave birth to twin boys at Cork University Maternity Hospital. One of the boys was delivered in good health during the emergency Caesarean Section procedure, but the second was born in a poor state due to being starved of oxygen in the womb. He was diagnosed shortly after with spastic diplegic cerebral palsy.
On the second twin´s behalf, his mother made a cerebral palsy claim against the HSE, claiming that there had been a failure to diagnose a vasa praevia condition during her pregnancy after scans conducted in June and September had revealed a low-lying placenta. The woman claimed that the Cork University Maternity Hospital had failed to exercise reasonable care in the antenatal stage of the pregnancy.
The Cork University Maternity Hospital and HSE contested the claim on the grounds it was not normal practice to conduct further investigations or take precautions against the risk of a vasa praevia condition causing complications. However, after a period of negotiation, an interim settlement of cerebral palsy compensation amounting to €1.98 million was agreed without an admission of liability.
As the cerebral palsy claim against the HSE had been made on behalf of a child, the interim settlement had to be approved by a court to ensure it was in the boy´s best interests. The approval hearing took place at the High Court, where the circumstances leading up to the boy´s delivery were explained, along with the reasons why it was believed that medical staff the hospital had acted negligently.
The High Court also heard how, in 2014, the boy had won a National Children of Courage Award, and that last year enough funds had been raised by family and friends to fly the family to Missouri so that the boy could undergo Selective Dorsal Rhizotomy surgery. As a result of the surgery, the boy has been able to learn to walk, although he still has to often rely on a walker or a wheelchair for his mobility.
The High Court approved the interim settlement of the cerebral palsy claim against the HSE after hearing that the funds will be used to pay for physiotherapy, speech, language and occupational therapy. The case was then adjourned for five years so that reports can be compiled into the boy´s future needs. When the family returns to the High Court in five years, it is hoped that a system of periodic payments will be in place so that his future wellbeing is guaranteed.
A claim for medical negligence compensation, made after a man was deprived of oxygen during a surgery on his spine, has been settled in court for €7.1 million.
The claim was made on behalf of a former barrister, aged forty-six, who visited the Sports Surgery Clinic in North Dublin concerning pain in his back. In 2014, he elected to have surgery on his cervical spine due to the pain. However, though the back pain was relieved, during the surgery the patient was deprived of oxygen and as a result sustained severe brain damage.
Since the surgery, the ex-barrister has been reliant on twenty-four-hour care as the mismanaged anaesthetic left him with a hypoxic brain injury. The patient can smile at his children and has certain reactions around his family, but cannot otherwise communicate. Though he is currently in a resident care home, his family hope that he will be able to return home to them in Clonee, Co. Meath, in the future.
Acting on her husband’s behalf, the patient’s wife made a claim for medical negligence compensation against Deirdre Lohan, the anaesthetist on the day of the surgery. However, the medical practitioner did not concede liability until October 2016, at which point a settlement of €7.1 million was negotiated between the families. However, before the settlement could be awarded it first had to be approved by a High Court judge, as it was made on another’s behalf.
The approval hearing was held earlier this month, where Mr Justice Kevin Cross oversaw proceedings. The judge was informed of that, to date, the victim’s care costs were being funded by a trust fund established by his friends and former colleagues. He also heard of the wife’s distress, and her eagerness to accept the settlement to finish with proceedings. The judge proceeded to approve the €7.1 million settlement for surgical negligence, offering his own sympathies towards the family after the “terrible tragedy” they had endured.
Mr Simon Harris, current Minister of Health, has announced a new National Patient Safety Office will be established, and among its first actions it will conduct a review of the medical negligence compensation claim procedures.
The announcement was made at a patient safety conference in Dublin. The Minister for Health announced the new National Patient Safety Office will report to the Department of Justice and Equality, and was established to “lead a program of significant patient safety measures”.
The new office, set up to help secure more rights for patients across Ireland, will establish a nationwide patient advocacy service, set up a new patient advisory council and also establish a patient safety surveillance system. However, it will also conduct a much-needed review of the processes required to claim for medical negligence compensation in Ireland.
The proposed Health Information and Patient Safety Bill will be greatly aided by this review. It outlines procedures that can be established to allow patients and their families to disclose adverse medical events.Such measures have been discussed before: the HSE had established guidelines for this open disclosure in 2013, though they are not actually being practiced in Irish healthcare facilities.
Many patient advocacy groups have been campaigning for such change for many years, and greatly welcome the news of the review. The patient representatives claim that without a statutory duty of candour, any new medical negligence claims are “unworkable”. The former Minister for Health, Leo Varadkar, is heavily criticised by these groups for his failure to enforce open disclosure in 2015’s Civil Liberty (Amendment) Bill.
The new Health Information and Patient Safety Bill has many other goals to help bolster patient safety and privacy; it hopes to halt the unauthorised disclosure of health information, to establish the use of new medical technologies to safely exchange health data and to extend the Health Information and Quality Authority’s (HIQA) authority over private healthcare providers. However, the European Union is currently reviewing its data protection laws, and until that is completed these new measures will not be enacted.
The High Court in Dublin has awarded a man an interim settlement of compensation who was left in a coma after medical staff failed to diagnose his organ failure in 2011.
When Robert Bolton, aged seventy-one, he underwent an operation to treat his oesophagus that was initially declared successful in St James Hospital, Dublin. However, the next morning, Robert suffered a heart attack because of respiratory failure.
After Robert was transferred to intensive care his condition continued to deteriorate, and as Robert was suffering from sepsis, he sustained a hypoxia ischaemic brain injury. This left him in a comatose state since 2011, interspersed with brief moments of minimal consciousness.
Angela, Robert’s wife, consulted a solicitor concerning the standard of care Robert received at the hospital after his operation and during his period in intensive care. After this, she proceeded to make a claim for compensation for the misdiagnosis of organ failure for her husband. She claimed that St James Hospital did not diagnose her husband’s sepsis or manage to meet the accepted criteria for systemic inflammatory response.
The hospital contested the claim for Robert’s condition, though they did partially admit liability for the substandard level of care Robert received at the hospital.
Negotiations lead to an interim settlement of compensation of €550,000, aiming to pay for the round-the-clock specialist care required by Robert for two years.
However, as Angela was making a claim for compensation on behalf of her husband, the settlement needed to be approved by the High Court. Mr Justice Kevin Cross oversaw proceedings and heard evidence of Robert’s heart attack, alleged failings by the hospital and the impact of those alleged failings.
Angela informed the judge that, though no amount of money would compensate for what happened to her husband, the money would ensure Robert was properly cared for. Judge Cross approved the settlement, adding that the figure was evidently the result of hard bargaining. He wished Angela and her family the best.
The High Court has found in favour of a seven-year-old girl in a hydrocephalus medical negligence claim against the Health Service Executive.
Ava Kiernan developed the symptoms of hydrocephalus (“water on the brain”) when she was just a few months old. Hydrocephalus is a condition in which cerebral spinal fluid fails to drain from the brain and is often identified in young children by a rapid expansion of the head´s circumference or bulges appearing as “soft spots” around the skull.
According to Ava´s mother – Ruth Kiernan from Duleek in County Meath – a public health nurse failed to spot the symptoms of hydrocephalus in April 2008 despite Ruth raising concerns about her daughter´s condition. The nurse also failed to recall Ava for a further examination and mistakes were made in the measurement of Ava head in September of the same year.
As a result of the public health nurse´s failure to act, Ava developed mental and physical disabilities from which she will never recover. On Ava´s behalf, Ruth made a hydrocephalus medical negligence claim against the Health Service Executive (HSE), claiming that the nurse´s negligence was a contributory factor in her child´s lack of development.
The hydrocephalus medical negligence claim was contested by the HSE and the case was heard by Mr Justice Kevin Cross at the High Court. Judge Cross found the HSE liable for Ava´s injuries after three weeks of testimony, and said that if Ava had been recalled four weeks after the initial head circumference measurement, her condition would have likely been identified and Ava would have been referred to a specialist.
Had Ava been referred to a specialist, the judge continued, the hydrocephalus could have been treated by a shunt which would have prevented the brain damage from occurring. Judge Cross said that the public health nurse´s failure to act was “materially causative” to Ava´s present condition and he adjourned the hydrocephalus medical negligence claim in order that an assessment of Ava´s future needs could be conducted to determine an appropriate compensation settlement.
The Medical Protection Society has proposed a “pre-action protocol” on a trial basis, which it hopes will be a long-term solution to the costs of medical malpractice claims in Ireland.
Due to the expenses involved in supporting legal action, the costs of medical malpractice claims in Ireland can be sky high. A recently proposed “pre-action protocol” by the Medical Protection Society (MPS)– an organisation that provides legal help to medical professionals – aims to cut the costs of medical malpractice claims and reduce the length of time it takes for claims to be resolved.
The protocol encourages openness and transparency between solicitors acting on behalf of plaintiffs and defendants, so that the opportunity exists for medical malpractice claims to be investigated and resolved before court action is necessary. If successful, it should cut the costs of medical malpractice claims by creating a less adversarial process and by using mediation to settle claims quicker.
The MPS´s Director of Claims – Emma Hallinan – is proposing that the protocol be trialled voluntarily before legislation is introduced to compel solicitors to take advantage of this option. She said “We recognise the important role that the MPS must play, and have committed to trialling procedural reform before it is introduced in statute. We are in the process of writing to plaintiff lawyers with large medical negligence practices to request that they work with us to pilot this.”
Currently in England and Wales financial penalties are imposed on solicitors who go straight to litigation without first attempting some form of mediation. In the MPS´s proposed trial, a tariff of general damages would be used – similar to the Book of Quantum – to calculate the “value” of an injury caused by medical malpractice.
The tariff would provide a scale of general damages for specific physical injuries from dental damage to catastrophic brain injuries. General damages for loss of amenity and emotional injuries – as well as special damages for the financial costs of medical malpractice – would still have to be resolved by negotiation, but many observers looking at the MPS´s proposals are in agreement that it is a step in the right direction for lowering the costs of medical malpractice claims in Ireland.
A High Court judge has allowed a claim for steroid side effect compensation to proceed after denying the manufacturer of the steroid an application to dismiss.
Mr Justice George Birmingham denied Pfizer´s application to dismiss the claim for steroid side effect compensation after hearing how forty-three year old Lorna Savage from Cobh in County Cork had been prescribed Deltacortril by her GP in 1997 to treat vasculitis – a skin disorder in blood vessels are damaged and group together to form an unsightly and irritable rash.
The judge was told that after taking the steroid tablets for several years, Lorna developed Avascular Necrosis – a rare but well-chronicled side effect of Deltacortril – a condition which prevents blood from reaching the bones, which consequently disintegrate as the bone tissue dies. Judge Birmingham heard that, by 2001, Lorna had undergone surgery to have one hip and both knees replaced, was confined to a wheelchair and was taking morphine to manage the pain.
Lorna made a claim for steroid side effect compensation against the GP who originally prescribed the steroid – Dr. Michael Madigan – and her consultant doctor at Cork University Hospital – Dr. M Molloy – who continued to prescribe Deltacortril after Dr. Madigan´s death in 1999. Lorna alleged that her Dr. Madigan had not sufficiently investigated her skin condition and had negligently prescribed Deltacortril when he should have been aware of the potential side effects.
Lorna´s claim for steroid side effect compensation against Dr. Molloy alleged that he had continued to negligently prescribe Deltacortril after Dr. Madigan´s death and had failed to recognise the symptoms of Avascular Necrosis despite her deteriorating condition. A claim for compensation was also made against Pfizer on the grounds that the pharmaceutical company had failed to advise the continued use of Deltacortril could result in Avascular Necrosis and that Pfizer did not give any indication on their literature that drinking alcohol while taking the steroid tablets increased the risk.
The two living defendants and the estate of Dr Madigan denied liability, and Pfizer made an application to have Lorna´s claim for steroid side effect compensation thrown out on the grounds that there had been an “inexcusable delay” in bringing her case to court. After hearing arguments from both sides, Mr Justice George Birmingham determined that the delay in bringing the case to court was “excusable” as the delay had been attributable to Lorna having to undergo more surgery.
The judge said that the prolonged recovery period from her recent surgery had prevented Lorna from instructing her solicitors and this, he considered, was a valid reason for the delay. Judge Birmingham refused Pfizer´s application to throw out the case and ordered that Lorna´s claim for steroid side effect compensation be scheduled for a hearing in the High Court later this year.