Claims for birth defects due to taking Epilim while pregnant have been made in France on behalf of up to 4,100 children with foetal valproate syndrome.
Epilim is the trade name of an anti-epilepsy drug that uses the active ingredient sodium valproate to control electrical activity in the brain. Introduced in France in 1967, Epilim was passed for use in Ireland in 1983, and is now also often prescribed to treat bipolar disorder, migraine and chronic pain.
At the time it was introduced into Ireland, claims for birth defects due to taking Epilim while pregnant were being investigated in France. It was alleged that the sodium valproate entered the bloodstream as valproic acid, which caused foetal congenital and development issues.
The evidence of birth defects due to taking Epilim was considered inconclusive, and the drug continued to be prescribed to pregnant mothers. It was only in 2006 that the manufacturers of the drug – Sanofi – warned that sodium valproate may have adverse effects and advised the medical profession to advise pregnant mothers of the potential risks.
Research conducted several years later by France´s social affairs inspectorate – IGAS – found the majority of doctors and pharmacists were unaware of the risks associated with Epilim. The research prompted the inspectorate to conduct a small scale study in the Rhone-Alpes region last year, where a much higher than expected rate of birth defects due to taking Epilim while pregnant was discovered.
France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the issue and researched the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken Epilim during their pregnancies. ANSM identified up to 4,100 children suffering from foetal valproate syndrome and discovered hundreds of Epilim-related stillbirths.
ANSM´s study has resulted in the families of those affected by the adverse effects of sodium valproate to form a class action in order to jointly make claims for birth defects due to taking Epilim. The families claim that Sanofi did not do enough to adequately inform the medical profession of the risks associate with the drug. It also claims the drug manufacturer failed to put adequate warning on its packaging.
In Ireland, the Disability Federation has called on the government to conduct an audit of children diagnose with foetal valproate syndrome. The organisation claims the scale of the problem in Ireland should be identified in order that adequate support measures are provided for families. If a member of your family has been affected by foetal valproate syndrome, and you would like to know more about claims for birth defects due to taking Epilim while pregnant, you should speak with a solicitor.
A report compiled for the Royal College of Surgeons in Ireland (RCSI) indicates that the majority of GP malpractice claims for compensation are due to missed or delayed diagnoses.
The report, which was prepared by the Centre for Primary Care Research in Dublin, was undertaken to identify which areas of primary care should be focused on when planning future educational strategies and developing risk management systems for primary healthcare professionals.
It revealed that GP malpractice claims often featured missed diagnoses and medication errors, with the delayed diagnosis of breast cancer and colon cancer being responsible for more malpractice claims against GPs than any other form of medical negligence.
Lead researcher of the report – Dr Emma Wallace – acknowledged that family doctors are practicing more defensively as the number of malpractice claims in Ireland increases, and this has led to more patients being unnecessarily referred to consultants – enabling an identifiable condition to deteriorate.
In addition to the misdiagnosis of breast and colon cancer, the report identified other cancers which were often misdiagnosed or identified later than they should have been. These included cancers of the skin, female genital tract and lungs; while children with appendicitis and meningitis were most likely to be misdiagnosed.
Admitting that GP malpractice claims are “not a perfect substitute for adverse events”, Dr Wallace – who is herself a GP – said that when malpractice claims are made against GPs, the doctors facing litigation often experience higher levels of stress – reducing the level of service they are able to offer and placing more patients at risk of a missed diagnosis or medication error.
She commented “this systematic review is timely considering the increased interest in focusing on primary care as a way of improving patient care and safety” and hoped that the review provided an insight into the types and causes of adverse effects in clinical practice which would reduce the number of GP malpractice claims in Ireland.
An inquest has heard how a Dublin woman died two days after being dispensed the wrong medicine by one of the city´s pharmacies.
Margaret Swaine (64) died due to a heart attack in July 2010 after being mistakenly dispensed Tegretol – an anti-convulsant and mood stabilising drug – instead of Trentol, a drug which had been prescribed for Margaret to assist the flow of blood through her body due to a pre-existing heart condition.
The Coroners Court heard Dr Brian Farrell testify that Margaret´s death was due to her heart condition, but the effects of the Tegretol had constituted an “additional stressor”. His testimony was supported by University College Dublin´s Professor Patrick Murray, who confirmed that the presence of Tegretol had been a contributing factor to Margaret´s heart attack and said “It is very unlikely that she would have passed away on that given day had she not taken the Tegretol.”
The court was also told the circumstances of how Margaret was dispensed the wrong medicine. Margaret´s friend – Ann Murphy – related how Margaret had returned from the Janet Dillon Pharmacy in Stoneybatter with the tablets which Ann believed were for the treatment of depression. Margaret took the Tegretol tablets three times over the course of the day and became groggy, disorientated and unsteady on her feet.
Ann visited the pharmacy and showed the box of tablets to pharmacist Janet Dillon, who was shocked that the pharmacy had dispensed the wrong medicine and who exchanged the Tegretol for the correct medicine. However, Margaret´s symptoms continued and the following morning she was discovered sitting on the side of her bed having difficulty breathing. White foam was coming from her mouth and her pulse deteriorated. An ambulance was summoned but attempts to resuscitate Margaret at the Mater Hospital failed.
In court, Janet Dillon testified that a “picking error” by a trainee assistant had been the reason why the wrong medicine was dispensed, but that she checked the medicine before it was dispensed to Margaret and her failure to spot the mistake was attributable to human error. The DPP has decided not to prosecute the pharmacy, but Margaret´s family may be entitled to claim compensation for being dispensed the wrong medicine.
The Medical Council is investigating claims of doctor negligence against a Dublin GP who allegedly over-prescribed psychoactive benzodiazepines.
It is claimed that Dr Mohammed Ahmed Khan, who practices in Wicklow Street, Dublin, prescribed up to four times the recommended dosage of drugs such as Valium to patients suffering from anxiety and depression. The Medical Council are also looking into claims that Dr Khan failed to make adequate enquiries as to whether any of the patients he was prescribing these drugs to were already being treated by another doctor.
Dr Khan has also been accused of poor professional performance due to his alleged failure to refer patients with a dependency on benzodiazepines to drug treatment centres or specialist substance misuse practitioners and due to his reliance on prescription drugs where an alternative form of treatment may have been more beneficial to the patient or in their best interests.
The Medical Council regulates doctors to practise medicine in the Republic of Ireland. Its statutory role, as outlined in the Medical Practitioners Act 2007, is to protect the public by promoting and better ensuring high standards of professional conduct and professional education, training and competence among registered medical practitioners.
An error in the dosage of flu vaccine given to the public and the Health Service Executive´s own staff has the potential to result in medical negligence claims.
Red-faced officials at the HSE admitted that child dosages of the flu vaccine had been administered to almost 500 members of the public and 850 employees at eleven HSE centres in the Dublin and Mid-Leinster regions – leaving them at risk of contracting a flu virus when the recipients of the vaccine would have believed they were protected against infection.
The error only came to light after a pharmacist queried why so much vaccine remained in the syringe after administering the “recommended” dosage, and it is believed that 75 of 835 pharmacists trained to give flu vaccines to those most at risk from contracting the virus were incorrectly trained by Hibernian Healthcare.
The company has now acknowledged its error and agreed to cover the cost of providing second flu vaccines to ensure recipients are adequately protected. However the question of whether a person who fails to receive a booster vaccine, and then falls ill from the flu, is entitled to make a medical negligence claim for compensation still remains open.
The majority of the incorrect flu vaccine doses have been given to those most at risk from contracting the virus, including people with long-term illnesses, the elderly and front-line HSE staff. Should any of these people fall ill from the flu due to being given an inadequate dose of flu vaccine, the consequences could be fatal.
Professor John Crown, a consultant oncologist, writing recently in The Irish Independent, said that the HSE and Department of Health and Children together “comprise one of the least ethical organisations that I have ever dealt with”. Professor Crown goes on to describe the HSE as “secretive, self-serving, dishonest, incompetent and unintelligent.” He concludes, with an interesting historical comparison, that the “corruption and incompetence” of the HSE is effectively a form of Stalinism.
These comments are interesting from the point of view of anyone trying to make a medical negligence claim or hospital negligence claim related to one of the HSE’s services. The management problems that increase the likelihood of negligence are compounded by the way the HSE deals with its own negligence. It’s really no surprise that the Injuries Board Ireland refuses to deal with cases against the HSE.
The family of Miriam Jackson of Navan, County Meath, has received a €564,000 High Court settlement following her death in September 2004 in Our Lady’s Hospital, Navan, two weeks after being admitted with a small bowel obstruction. The case was taken by her husband, Derek Jackson, who also sued on behalf of his three children for damages for the loss of Mrs Jackson and the resulting mental distress. The lawsuit outlined over twenty claims of medical negligence and hospital negligence – mostly an unfortunate list of ignored symptoms. It was alleged that that urine analysis results were ignored – results that found an E coli infection and therefore septicemia was allowed develop and go untreated for a significant period of time. It was alleged that Mrs Jackson complained of abdominal pain and was feverish. It was claimed that her rising temperature was ignored by the surgical team. It was alleged that a medical consultation requested by the surgical registrar did not take place, despite multiple symptoms, including a temperature of 38.2 degrees, chest tightness, shortness of breath, and light-headednes.
The hospital admitted liability in the case, so the High Court case under Mr Justice Iarfhlaith O’Neill was only to determine the amount of compensation.
Jim Reilly of Patient Focus has claimed today that international figures show that 4-16% of patients in hospitals are exposed to “potentially dangerous adverse events”. Mr Reilly was speaking at a conference organised by the charity Action Against Medical Accidents. Peter Walsh, chief executive of Action Against Medical Accidents, claimed that more people are killed or permanently disabled in hospitals due to medical incidents than were injured in road traffic accidents.
State Claims Agency data for 2008 reveals that there were 83,661 “adverse incidents” recorded by Irish hospitals, where an medical incident could range from something as simply as slips, trips, and falls to more serious treatment errors such as medication errors.
The figures include both major and minor incidents ranging from slips, trips and falls to medication and treatment errors. The figures also demonstrate how badly exposed the Irish health services are to medical negligence claims and hospital negligence claims.
Data from the State Claims Agency reveal that there were 8,250 ‘medication incidents’ (incorrect dosages or simply wrong medication given to patients), some 5,559 ‘treatment incidents’ (which includes mistakes like leaving surgical swabs in patients’ bodies after operations), and poor documentation (which lead to anything from a simple ‘near miss’ to a catastrophic incident).
The State Claims Agency runs a clinical indemnity scheme for Irish hospitals that paid out almost €50 million in medical negligence claims and hospital negligence claims last in 2009, with an average award of €63,000.
A truely tragic story in the Sunday Independent today highlights the dangers posed to pregnant women by antidepressants. Lisa McGillin reached a settlement of €500,000 with two doctors involved in her care during pregnancy – although there was no admission of liabilty or guilt in the case. McGillin was given medication for her bipolar condition, without any warning about the dangers of taking antidepressants while pregnant. In fact, McGillin claimed that she was also advised that Epilim (a brand of sodium valproate) was safe during pregnancy provided she also took folic acid in adequate amounts.