PARIS: French prosecutors have indicted pharma giant Sanofi for manslaughter over birth defects linked to an epilepsy drug, the company said Monday, in a long-running case that has also seen it charged with fraud.
The charges relate to the drug valproate, marketed as Depakine among other trade names, which studies say has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant.
On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder.
But research found that when pregnant women took the drug, their children had an elevated risk — between 10 to 40 percent — of congenital malformations, autism and learning difficulties.
Sanofi is facing separate charges of aggravated fraud and unintentionally causing injury in 42 cases filed by families, but insists it had warned health authorities of the drug’s risks already in the 1980s.
On Monday, the company confirmed a report in Le Monde newspaper that prosecutors have now also charged it with manslaughter.
But in a statement sent to AFP it insisted it had “fulfilled its obligation” of providing information on the drug and its side-effects, and said it “contests the validity of these proceedings.”
Sanofi said it has filed a legal challenge to the indictment.
Under the French legal system, charges do not automatically result in a trial as prosecutors can decide not to proceed based on a lack of evidence.
Last month, a French court ordered the state to pay thousands of euros in damages over the scandal, saying officials should have ensured the drug was not taken by pregnant women.
The court found that health officials knew about the risk of birth defects from Depakine already in 1983, and of learning disabilities and autism from 2004.
Another 500 complaints have been lodged with France’s national compensation agency for medical accidents, which has already proposed a 6.5-million-euro ($7.6-million) package for Depakine victims.
Sanofi, a France-based multinational, is working on a candidate vaccine against the novel coronavirus with Britain’s GSK, for which it will receive up to $2.1 billion from the US government.
Pharma giant Sanofi charged with manslaughter in birth defects case
https://arab.news/n23eq
Pharma giant Sanofi charged with manslaughter in birth defects case
- Studies say a Sanofi drug has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant
- On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder
Europeans push back at US over claim they face ‘civilizational erasure’
- “Contrary to what some may say, woke, decadent Europe is not facing civilizational erasure,” Kallas told the conference
MUNICH: A top European Union official on Sunday rejected the notion that Europe faces “civilizational erasure,” pushing back at criticism of the continent by the Trump administration.
EU foreign policy chief Kaja Kallas addressed the Munich Security Conference a day after US Secretary of State Marco Rubio offered a somewhat reassuring message to European allies. He struck a less aggressive tone than Vice President JD Vance did in lecturing them at the same gathering last year but maintained a firm tone on Washington’s intent to reshape the trans-Atlantic alliance and push its policy priorities.
Kallas alluded to criticism in the US national security strategy released in December, which asserted that economic stagnation in Europe “is eclipsed by the real and more stark prospect of civilizational erasure.” It suggested that Europe is being enfeebled by its immigration policies, declining birth rates, “censorship of free speech and suppression of political opposition” and a “loss of national identities and self-confidence.”
“Contrary to what some may say, woke, decadent Europe is not facing civilizational erasure,” Kallas told the conference. “In fact, people still want to join our club and not just fellow Europeans,” she added, saying she was told when visiting Canada last year that many people there have an interest in joining the EU.
Kallas rejected what she called “European-bashing.”
“We are, you know, pushing humanity forward, trying to defend human rights and all this, which is actually bringing also prosperity for people. So that’s why it’s very hard for me to believe these accusations.”
In his conference speech, Rubio said that an end to the trans-Atlantic era “is neither our goal nor our wish,” adding that “our home may be in the Western hemisphere, but we will always be a child of Europe.”
He made clear that the Trump administration is sticking to its guns on issues such as migration, trade and climate. And European officials who addressed the gathering made clear that they in turn will stand by their values, including their approach to free speech, climate change and free trade.
British Prime Minister Keir Starmer said Saturday that Europe must defend “the vibrant, free and diverse societies that we represent, showing that people who look different to each other can live peacefully together, that this isn’t against the tenor of our times.”
“Rather, it is what makes us strong,” he said.
Kallas said Rubio’s speech sent an important message that America and Europe are and will remain intertwined.
“It is also clear that we don’t see eye to eye on all the issues and this will remain the case as well, but I think we can work from there,” she said.
