It is now emerging that many serious birth defects and developmental disorders have been caused due to exposure of women to the drug Epilim during pregnancy.
What is Epilim?
Epilim, a trade name for sodium valproate, is manufactured by Sanofi. It is used in Ireland to treat epilepsy, seizures, migraine and bipolar disorder.
What are the consequences?
It is estimated that many tens of thousands of children have been born in Europe with developmental disabilities and birth defects as a result of exposure to the drug while in the womb.
A link with autism, ADHD and low IQ has been established. The drug also causes physical deformities. The drug has further been linked to miscarriage and stillbirths.
The most recent analysis states that babies exposed to the drug in pregnancy have a 30 to 40% risk of serious developmental disorders and are at 11% risk of congenital malformations.
Some recent research has suggested that the disabilities caused by Epilim could be passed through generations within families.
According to Epilepsy Ireland, it is estimated that the drug has affected at least 400 Irish children with birth defects and developmental issues.
When were the risks known?
Concerns have been raised as to why women were not warned of the risks associated with Epilim, despite the fact that those risks have been well known for many years.
Laboratory studies that were available to Sanofi and to health regulators in the 1970s, showed that the drug was teratogenic in animals, meaning it could harm the human fetus.
The Oireachtas Health Committee heard in 2018 that the risks were well established and accepted by the scientific community by the mid-90s.
Despite this, the drug was licenced for use in Ireland in 1983 and prescribed for many years to pregnant women with little or no warnings provided to women about the risks.
When were warnings given?
It was only in the 2000s that Sanofi advised the medical profession to warn pregnant women of the risks.
Experts told a recent hearing by the European Medicines Agency that a decision was made not to publish these warnings and that information given to women on the issue over the years had been “sparse and inconsistent” and most doctors and specialists “were unaware of or chose not to give out the information.”
Evidence was given at this EMA hearing that certain Irish patients who were on Epilim long term, were, as recently as 2017 receiving their medicine loose in plastic bags, with no accompanying information or warnings about the medicine.
What support is the State providing?
Thousands of Irish women are still receiving Epilim through community drug schemes.
However, European Health regulators have stated that as of 2018, women were still not always receiving the right information in a timely manner.
It is not clear that the scandal is receiving the attention it merits from the various state bodies who ought to take responsibility, including the Health Service Executive, the Department of Health, and the Health Products Regulatory Authority.
Families report that there are few supports and services for those affected by the drug.
Although some of the women affected by the scandal have been contacted by the State with information about the safety implications of the drug, it is understood that there are others who have received Epilim who have not received any contact.
WHAT INITIAL STEPS DO YOU TAKE?
These claims, in a similar way to personal injury claims, are made up of a series of hurdles.
If you do not clear the first hurdle you cannot move on to the next.
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Take up copies of all medical records and check them. In some cases, we may even send them to a medical records expert for analysis.
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Write to the doctor, health care professional or institution we believe is responsible for the injuries caused.
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Medical experts specialising in the particular area of medicine involved will then be asked to consider whether or not the treatment received was negligent or substandard and if so the extent of the damage it caused.
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If we consider that we have enough evidence to prove a case of medical negligence, then we advise starting court proceedings immediately.
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These cases can be settled by negotiation without the need to proceed to a full trial but they are rarely resolved without starting court action.
Is there a time period for bringing these cases?
The Statute of Limitations (Amendment) Act 1991 introduced the ‘date of knowledge’ for personal injury cases. The date of knowledge is applied when the date the wrong/injury takes place differs from the date the wrong/injury is discovered. This means that in situations where the injury may not be obvious at first the time limit for actions does not begin until the injured party is aware of the injury.
While, generally speaking, a person has two years to make a claim for negligence, the date of knowledge has been applied in medical negligence type cases.
A person who receives a negligent medical treatment or prescription may not have knowledge of the injury at first until the injuries cause problems or they become aware that such problems arose as a consequence of such procedures.
The ‘date of knowledge’ ensures that the time limit does not run out before a person knows that they have an injury.
How can we help?
Our medical negligence and product liability department has experience in assisting families who have been affected by defective and harmful medication and medical products.
During the last 30 years, the office has probably dealt with most types of medical negligence and product liability cases.
We are currently representing a significant number of people who have been affected by the DePuy ASR hip implant recall and narcolepsy arising out of the swine flu vaccine.
If you or a member of your family have been affected by Epilim we will be happy to meet with you to explore the legal options available and to assist you in arriving at a resolution.