Mother Sues Medical Professional For Not Warning Of Risks From Epilepsy Drug


The Law Of... giving informed consent

The mother of a girl diagnosed with a number of severe and debilitating disorders is taking a consultant neurophysiologist to court, claiming that the medical professional's negligence caused her daughter's condition.

Mother Sues for Medical Negligence over Epilepsy Drug

Victoria Clark, a Medical Negligence Solicitor at Simpson Millar, examines the case and discusses the importance of 'informed consent' when it comes to prescribing treatment.

Unaware of the risks

Although it has been labelled as a drug that has harmed more children than Thalidomide, Epilim – the brand name for sodium valproate – is widely used in the management of epilepsy and, in the vast majority of cases, without any adverse effects. But problems can arise if the recipient of the treatment falls pregnant.

Sodium valproate poses a risk to foetuses, with up to 40% of children born to women who have taken it while expecting going on to develop a neurological condition.

The mother who is suing for damages on behalf of her Fetal Valproate Syndrome-afflicted daughter claims she was unaware of these risks and had she been, as a woman of child-bearing age, would have sought an alternative form of treatment for the epilepsy she had suffered since the age of 15.

Research by Liverpool University has found that foetuses exposed to sodium valproate are 6 times more likely to have a neurodevelopment disorder than those born to mothers who have used other forms of anti-seizure medication or none at all. A third of these suffer with learning difficulties, low IQ and conditions related to the autism spectrum.

Informed Consent

Central to the mother's claim in this tragic case is the issue of informed consent and whether she was made fully aware of the potential dangers from taking Epilim if she were to become pregnant.

Informed consent is one of the fundamental principles of medical ethics and, except in certain cases such as emergencies which need quick, decisive action, a legal requirement prior to a patient commencing treatment.

This involves the medical professional providing all the information regarding the suggested method of treatment, including:

  • How necessary it is to the patient's condition
  • The benefits it will have
  • The risks of any common or serious consequences
  • Whether there are alternatives available
  • The possible outcome if the treatment fails to go ahead

The mother involved in this case alleges that she remained ignorant to the potential harm of sodium valproate until she fell pregnant, by which time it was too late to safely change her medication, meaning she had no choice but to continue taking it, effectively 'poisoning' her unborn daughter in the womb.

Victoria Clark comments:

"To bring a claim for medical negligence it is not enough to simply prove that the care was of a poor standard. It must also be proved that the level of care is directly responsible for an identifiable injury or loss."

"There are cases where a poor level of care, although provable, has no bearing upon any injury sustained, which would mean there were no grounds for a claim."

"In a case concerning consent, the key issue is whether the patient would have changed their mind had they been informed of all the risks beforehand. This can arise in any area of medicine, not just where drugs are concerned."

"The claimant in this instance maintains she was not warned about the consequences of Epilim in regards to her ever starting a family. The defence's argument hinges on whether these risks were actually known within the profession at the time the treatment started."

If you believe you have agreed to undergo a treatment without being in possession of the all the facts and as a result have suffered an injury or loss, you should seek professional legal advice. You may be entitled to compensation.

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