A €500m class action lawsuit has been filed against the manufacturer of a popular Spanish painkiller following the deaths of several Irish and British holidaymakers and expatriates.
Last week it was announced by the Spanish medicines regulator that tourists were banned from taking the drug Nolotil – linked to the death of three Irishmen and seven Britons – after an investigation.
According to the Spanish law firm De Micco and Friends, who have opened the suit, more than 200 victim reports are currently been evaluated. The firm estimate damages at more than €500m.
Nolotil, the most common brand name of metamizole, was seen to be the root cause of many deaths, bouts of illness, blood poisoning and amputations over a period of 16 years.
In August, the Irish World reported that the medicines regulator in Spain – the AEMPS (Spanish Agency of Medicines and Healthcare Products) – had launched an inquiry following concerns that Nolotil was disproportionately affecting northern Europeans.
A review published last week by the AEMPS has said that tourists will no longer be permitted to take Nolotil or any other drugs containing Metamizole. It also said that Spanish citizens who have been prescribed the drug – after a detailed analysis of the patient’s medical history – must be closely supervised.
Previously, the drug Nolotil was as widely available as paracetamol but healthcare professionals in Spain will now be forced to ensure that the drug is only prescribed on a short-term basis of up to seven days and that, “special precaution is taken in the case of elderly patients”.
Cristina Garcia del Campo, a medical and legal translator based in Javea, Alicante, started collecting medical reports after hearing of Irish people being diagnosed with sepsis. “All the Irish there seemed to be having this problem,” she told The Irish World in August.
She found upward of a hundred cases of Irish and British holidaymakers and expatriates who suffered severe side effects after taking the drug.
Ten deaths apparently associated with Nolotil discovered by Ms Garcia Del Campo, three of which were of Irish men. Another Irish man fell gravely ill, said Ms Garcia Del Campo, but he eventually made a full recovery.
One such fatal case involved the sudden death of an Irishman in 2016. William “Billy” Smyth, 66, from Mullingar, was visiting Torrevieja, Spain while on holidays and died after he was prescribed Nolotil for shoulder pain.
Derek Smyth, William’s son, hailed Cristina’s restless activism and “incredible service” and said that the controls outlined by the AEMPS were a huge improvement.
“The majority of stories have condensed the risk group as to British and perhaps Irish people will not take note. While it seems to [affect] Northern Europeans from some of the information I heard, the strongest trend had to do with [those from] an Irish background,” Smyth added.
Metamizole is an anti-inflammatory drug highly popular in Spain – each EU member state has the freedom to authorise the drug – for the treatment of mild pain, including toothaches and headaches.
It has been in use in Spain for over fifty years and is available in some other EU countries but is banned in Ireland, the UK, US, Australia.
Nolotil is known to be associated with a risk of blood disorders, including agranulocytosis, also known as low white cell count, which proved fatal for William Smyth.
The manufacturer, says Ms Garcia Del Campo, does mention the risk of agranulocytosis as a very rare but potential side-effect in its labelling. The side-effects and implications of the painkiller’s use vary from the irreversible to the benign.
The AEMPS recognised in its report that known side effects of the drug were agranulocytosis, a condition in which the bone marrow does not produce enough white blood cells, can result in fatal blood poisoning.
Ms Garcia Del Campo, who had campaigned tirelessly for the drug to be regulated, said she was relieved that the Spanish regulatory body had taken action.
“After much hard work, visits to Madrid for meetings with the AEMPS and submitting cases to them, I have been listened to and the problem has been acknowledged and dealt with,” Ms Garcia del Campo said of the campaign.
From speaking to those who had been affected by the drug, Garcia del Campo also found a lineage pattern: Many of the British patients who had taken the drug had been shown to have either an Irish mother, father or grandparent.
De Micco and Friends, the firm who launched the lawsuit, are planning an international press conference in the coming weeks.