The appeal trial of the Mediator health scandal opens this Monday, January 9 for six months before the Paris Court of Appeal.
Two years ago, on March 29, 2021, Servier laboratories were sentenced to 2.7 million fine For “aggravated deception” and “manslaughter and manslaughter” in the Mediator scandal, this antidiabetic hijacked as an appetite suppressant. “Despite the knowledge that they had of the risks incurred for many, many years, (…) they never took the necessary measures and thus deceived” the consumers of the Mediator, had then declared the president of the criminal court, Sylvie Daunis.
Why an appeal?
If the Paris Criminal Court had found that the Servier laboratories had concealed the risks associated with the Mediator, the French laboratory had, on the other hand, been acquitted of the offenses of improperly obtaining marketing authorization andscam, to the detriment of social security in particular. In short, the notion of “fraud” had not been recognized. It is on the last point that the Paris prosecutor’s office and civil parties appealed in April 2021.
The criminal court also acquitted the Servier group of the charge of improperly obtaining marketing authorization, considering that the facts were time-barred. The Paris prosecutor’s office also appealed this release.
“This appeal was a decision wanted by my clients”, had at the time greeted, in reaction to the decision of the Paris prosecutor’s office, Charles Joseph-Oudin, who represents several hundred victims. “In the court’s decision, there was a very disturbing element: the fact that Social Security and mutual insurance companies were not reimbursed for very large sums”, added the lawyer to AFP. However, it is on the basis of the offense of fraud to the detriment of Social Security, which reimbursed 65% of the Mediator, and mutual insurance companies, “what were the claims (…) for compensation for damages related to the reimbursement of the drug”it was specified in a press release dated 6April 2021.
THE Servier laboratories announced in a press release to take “deed” of this call. They announce in a press release that they have taken the decision to “appeal their convictions for the offenses of aggravated deception and manslaughter and involuntary injury.”
Mediator case: what is it?
It all started in 1976, when Servier laboratories market the Mediator (whose active ingredient is benfluorex), an anti-cholesterol and anti-triglyceride drug, intended for patients who are overweight and/or suffering from type 2 diabetes. But, due to its anorectic properties, Mediator is widely prescribed as appetite suppressant (for slimming purposes, therefore) to patients who are neither diabetic nor suffering from hypercholesterolemia…
The first alerts were issued in 1999: a cardiologist practicing in Marseille evoked the potential impact of Mediator on cardiovascular health and suspected an increased risk of heart valve disease in patients treated with this antidiabetic. The Mediator was successively withdrawn from the market in Switzerland (in 1998), in Spain (in 2003) and in Italy (in 2004); in France, it remains marketed.
In 2007, suspicions against the Mediator only increased and the Dr. Irene Frachonpulmonologist in Brest, began a vast epidemiological study: three years later, she published Mediator 150 mg, how many deaths?.
It was not until November 2009 that the health authorities decided to withdraw the Mediator from sale: between 1976 and 2009, 5 million people in France have used this drug. The CNAM, seized by the National Agency for the Safety of Medicines and Health Products (ANSM, called “Afssaps” at the time) estimated in 2010 that the Mediator caused between 1000 and 2000 deaths and 3,500 hospitalizations.
The first trial of the Mediator
The first Mediator trial began on September 23, 2019, before being suspended between March and June 2020 due to the coronavirus epidemic, to end in March 2021. In total, 11 legal persons (including Servier laboratories which market the Mediator and the ANSM, responsible for the marketing authorization of the drug) and 12 natural persons appeared at the Paris Criminal Court. Servier laboratories are accused of having deliberately concealed the dangerous side effects of Mediator: the pharmaceutical company is being prosecuted for “aggravated deception”, “fraud” and “involuntary homicides and injuries”. For its part, the ANSM is accused of having been slow to withdraw the drug from sale.
At first instance, Servier laboratories and their former number two, Jean-Philippe Seta, were found guilty of aggravated deception and manslaughter and involuntary injury. Servier was fined 2.7 million euros, Jean-Philippe Seta a four-year suspended prison sentence and a fine of 90,600 euros. The group was also ordered to pay a total of more than 183 million euros in damages to the victims.
In its judgment, the Paris Criminal Court considered that the Servier laboratories “had from 1995, enough elements to become aware of the mortal risks“, related to the Mediator.
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- Mediator: reimbursement contested by Health Insurance in 1998
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