JacksonVille Free Press
A French victims association representing pregnant mums given a dangerous epilepsy drug that killed their babies or caused them to develop autism says Europe should be “ashamed” because “the Americans have already compensated a lot of victims a long time ago”.
The French authorities have just ruled to limit compensation for families who were given a dangerous drug called Depakine – which was used to treat people suffering from epilepsy, migraines and bipolar disorder – that in many cases led to children dying, developing conditions such as autism, or being born deformed.
The head of the victims association in France told Real Press in an exclusive interview that the French government’s decision to only accept responsibility from 2004 onwards goes against their own, prior admission they knew about the problems with the drug in 1984. She said this latest ruling is “disappointing” because it will “deny compensation to 80 percent of the victims”.
But Depakine, also known as valproate, had been prescribed to pregnant mums since the 1960s. And Marine Martin says that by the government’s own admission, it knew about the problems with the drug as far back as 1984, adding: “How can we understand that the ministry of health wrote into law that as early as 1984 in the mechanism for compensation for victims, that the state knew about the neurodevelopmental disorders related to in utero exposure to Valproate.
“It is incomprehensible, immoral. [The judiciary] is leaving thousands of children without humane assistance in priority to save money.
She says it also sets a dangerous precedent for other countries with ongoing legal procedures against their governments and against billion-dollar drug manufacturer Sanofi.
Marine Martin, the head of APESAC, said that Europeans should be embarrassed about the decision, especially considering that “the Americans have already compensated a lot of victims a long time ago”.
She accused Sanofi of “lying to the consumer for 30 years” by claiming that the drug posed “no problem for pregnancy.” She added: “They are criminals. They killed children.”
She explained that while “this decision recognises the responsibility of the French government at 40 percent, which is important symbolically”, it only does so regarding the malformation that her child developed, and not regarding the child’s neurodevelopmental disorder.
Martin, 48, who lives in the town of Pollestres, in the Pyrenees-Orientales department in southern France, had her daughter Salome, now 21, in 1999. She was born with autism. At first, she did not realise that her daughter's condition was linked to the Depakine drug. But then in 2002, she had a son, Nathan, now 18, who was also born autistic. That is when Marine started to wonder if there was a connection with the drug.
Martin said that this latest decision is dangerous for legal action taking place in other countries, saying: “This decision is important for other countries. It sets a date on which the state is [saying it became] aware of the risks of autism caused by valproate.
“In countries where [legal] procedures are underway, in the UK, in Belgium, Switzerland and Spain, Sanofi will use this decision, which is not favourable to the victims. Since this date, they will not be able to be compensated.
“It is a clever way to reduce compensation. It is shameful, scandalous from the French government to do that because the Americans have already compensated a lot of victims a long time ago and it is embarrassing that we have not done so in Europe.”
In the United States, a large number of cases linked to the drug have been settled and the victims have been compensated.
Last year, the French authorities charged Sanofi with “involuntary homicide” amidst a scandal that has seen the firm accused of failing to disclose risks to pregnant women that their babies could be born deformed, with neurological problems, or with autism.
The "involuntary homicide" charge came after repeated pressure from the APESAC, the French Association des Parents d'Enfants Souffrant du Syndrome de l'Anti-Convulsivant' which means 'Association of Parents of Children Suffering from Anti-Convulsant Syndrome'.
French health authorities have admitted that pregnant women who took the drug faced an increased risk that their babies would be born with birth defects, learning difficulties and autism.
Martin said: "We don't contest the efficacy of the drugs, we contest the fact that we had no information about the dangers of the drug during pregnancy. We did not know that it could cause autism and malformations. That is the problem. Sanofi lied about the side effects of the drug during pregnancy."
Sanofi, meanwhile, claim they met their responsibility to inform the public about the potential side effects of their drug.
France's Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM; the body responsible for assessing potential risks linked to health products) estimates that between 2,150 and 4,100 children may have been affected with birth defects, while 16,600 to 30,400 children may have suffered neurological development issues since 1967.
Real Press contacted Sanofi with a request for comment but had not received a reply at the time of writing.
Real Press also spoke to Emma Friedmann (FACSaware Campaign Director) and Deborah Mann (one of the Founders of the UK's Organisation for Anti-Convulsant Syndrome; OACS) in the UK, as well as Karen Keely (Chairperson Organisation Anticonvulsant Syndrome (OACS) Ireland).
Emma Friedmann, 48, says she has been campaigning against Sanofi and Depakine since 1999, but their legal proceedings have all but come to a standstill after the government “withdrew legal aid in 2010”. She added: “We were granted a costs holiday by Sanofi if we signed discontinuance notices saying we would never pursue Sanofi or a third party in court again."
Deborah Mann, speaking about the charge of "involuntary homicide" in France, said: "It is an important move. Identifying the concept that a baby has died due to the mother having taking the medicine without knowing the potential outcome is essential when unravelling the full consequences of Valproate, and other teratogens."
But she added: "Despite the brilliant document ‘first do no harm’ from the IMMDS [ed.: the Independent Medicines and Medical Devices safety] review, the government in the UK is avoiding action."
Karen Keely, 51, of OACS Ireland, told Real Press that “the Irish government has not taken concrete steps to examine the historical use of valproate in Ireland or to address issues of accountability."
There have also been cases in the United States, where AbbVie Inc. (formerly known as Abbott Laboratories) makes the drug under the name Depakote, Depakine, and Depacon. In 2012, Abbott made a deal with the federal government and 45 states to pay 1.6 billion USD (1.23 billion GBP) for illegally marketing Depakote.
In 2015, a jury in the state of Missouri awarded 38 million USD to 25 plaintiffs and in 2017, a federal jury in Illinois ruled that Abbott had not correctly warned doctors of congenital birth defects that could affect babies whose mothers had taken Depakote and sentenced Abbott to pay 15 million USD in compensation to Stevie Gonzalez, a 10-year-old Californian boy with spina bifida.
There have been hundreds of cases against Abbott Labs in the United States, with many settled out of court, but many more are also still ongoing.
Speaking about the next step she plans to take, Martin said: “I will appeal this decision. I will go to the Council of State. I will not let it go. This decision makes you lose faith in justice because if the state doesn’t ensure their future, what will they become?”
SOURCE : JACKSONVILLE PRESS