Before we go any further, can we remind readers that we are NOT doctors or medics and we cannot advise on the use or otherwise of any medications.  The drug sodium valproate, known here under a brand name of Epilim, is a very widely used and effective drug for epilepsy when used appropriately.  If you recognise the name and/or are taking this medication and have any concerns, your first port of call MUST be your GP or consultant and not lawyers.

However, we can’t ignore the fact that it is in the news once again.

Many people will remember the thalidomide scandal, when women were given the drug in the 1950’s and 60’s for morning sickness, thinking and being told it was safe. It wasn’t. It caused physical defects in babies, with them being born with shortened limbs and sometimes limbs missing altogether, amongst other injuries.  Many of the children born this way have gone on to live successful and fulfilling lives despite their injuries, but the point is their injuries shouldn’t have happened in the first place.  Compensation was eventually put in place for the children born this way, but it proved insufficient and in 1972, the Sunday Times campaigned for further –“enhanced” compensation.

The paper is back campaigning again, this time in respect of the drug sodium valproate/Epilim.  The drug is alleged to cause similar physical injuries to thalidomide and organ malformations but is also alleged to cause developmental injuries such as being on the autistic spectrum.

The paper alleges that the drug is not so much defective in itself,  but that possibly as far back as 1972, the decision was made by the then newly formed Committee on Safety of Medicines not to alert the public to the possible dangers of the drug when given to pregnant women for fear of causing “fruitless anxiety” that the drug could harm foetuses. The injuries and the connection with the drug began to make themselves more widely known in the 80’s.

What we have to remember (though this is not an excuse), is that the 70’s are, unbelievably to a lot of us, 50 years ago now and medicine had a much more “Doctor knows best” approach.  And usually they did -that’s what they were trained for and we were entitled and right to trust their judgment. But it did mean that sometimes patients were not told about things they really should have been informed about in order to make their own decisions on treatment, or at least be part of the decision making process. It seems that with Epilim,  the drug companies did not even put information leaflets in the medication packages and may even have covered up warnings on the packs.

Patients could still, have course have chosen to just go along with the advice given, as not everyone wants to have the responsibility of choice, or is capable of making decisions for themselves. But at least they would be making those choices with “informed consent” as opposed to being kept in the dark, however well-meant.

But things change and now we have the Scottish case known informally just as “Montgomery” (the full Supreme Court judgment is at ).

Montgomery tells us, very basically, that we are now entitled to be “fully informed” about our treatment before we consent to it. We have to be told about the risks-but also the benefits- and whether there are in fact any alternatives or any other options or medications, including the option of no treatment or not taking medications. As long as we are fully informed about the consequences of such choices, we can make them and the risk then becomes ours.  Doctors can put the favourable arguments to you and give you their advice, but they can’t force treatment on anyone who has the capacity to make those decisions for themselves after weighing up the options.

“Patient autonomy” is now very much to the fore, but we would still recommend thinking very carefully before actively going against medical advice. Emergency situations are of course different, where things have to be done quickly and in that event, you could not expect a doctor to be able to sit and discuss options with you.  It is more important to save a life or arrest deterioration.

Of course, the vast majority of people WILL go along with their doctor’s advice and would be sensible to do so. Doctor are trained and experienced and they have to act in their patient’s best interests.  But in the case of sodium valproate, it is alleged that the women who were prescribed it were not advised of the dangers of taking it in pregnancy and there were other drugs available. Perhaps they may not have been so effective, but still-it would have been their choice. They needed that information and they allegedly didn’t get it.

Back in 2010, a “class action”, which is a legal action brought on behalf of a number of Claimants arising out of the same issues, had to be abandoned when Legal Aid was withdrawn shortly before trial. This usually happens when the Legal Aid Board/Committee, as it was then, decide that a case no longer has a better than 51% prospect of success.  By then, about £3 million pounds in Legal Aid money had been incurred for legal costs.

The action had begun before then, in the mid-2000’s and was against the multinational drug company Sanofi-Aventis. It was brought under the Consumer Protection Act 1987, which is an Act to protect people from products that are defective in some way.  But the problem was believed to be not so much that the product-Epilim medication-was defective in itself,  but that there was a failure to warn of the dangers of it if taken in pregnancy.  The drug itself is safe and widely used for appropriate patients on medical advice.

This was devastating for the approximately 80 families involved in the action over about 6 years. To avoid being responsible for legal costs, they had to undertake not to try making a claim again in the future.

There is currently a legal action under way in France, where the drug is often known as Depikane.  The French government has set up a compensation scheme managed by their national accidents compensation body.  Sanofi, the maker of the drug, does not contribute to this and according to the Sunday Times, will only do so if compelled to by a court order.

In January of this year, the French court ruled:

             “That the manufacturer ‘was at fault because it failed to meet the obligation for vigilance and the obligation to inform” concerning the risks of the drug for the foetus’”

Sanofi have said they will appeal and of course, French law is different to English/British law.

Of note is that the French court will allow Irish families affected by the drug to join in an action should it go ahead.

It is very much a “watch this space” situation.

What we can repeat is that if you are concerned about any treatments or medication, you should discuss this fully with your doctors, especially if there’s things you don’t understand.  In the main, they get it right.


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