Servier laboratories were found guilty on Monday “aggravated deception” and “manslaughter and unintentional injury” in the Mediator scandal, this anti-diabetic used as an appetite suppressant. And sentenced to pay a fine of 2.7 million euros, according to AFP.
“Despite the knowledge that they had the risks incurred for many, many years, (…) they never took the necessary measures and thus deceived” consumers of the Mediator, declared the president of the criminal court, Sylvie Daunis.
Picks case: what is it?
It all started in 1976, when Servier laboratories market the Mediator (the active substance of which is benfluorex), an anti-cholesterol and anti-triglyceride drug, intended for patients who are overweight and / or suffering from type 2 diabetes. However, due to its anorectic properties, Mediator is widely prescribed as appetite suppressants (for slimming purposes, therefore) to patients who are neither diabetic nor suffering from hypercholesterolemia …
The first alerts were launched in 1999: a cardiologist practicing in Marseille thus mentioned the potential impact on 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 The Mediator was successively withdrawn from the market in Switzerland (in 1998), in Spain (in 2003) and in Italy (in 2004); in France, it remains marketed.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, the suspicions against the Mediator only increased and the Dr. Irène Frachon, pulmonologist 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 medicine. The CNAM, seized by the National Agency for Medicines and Health Products Safety (ANSM, called “Afssaps” at the time) estimated in 2010 that the Mediator caused between 1000 and 2000 deaths and 3,500 hospitalizations.
Mediator trial: what are the requisitions?
The Mediator trial began on September 23, 2019, before being suspended between March and June 2020 due to the coronavirus epidemic. In total, 11 legal persons (including the Servier laboratories which market the Mediator and the ANSM, responsible for the marketing authorization of the drug) and 12 natural persons appear at the Paris Criminal Court. The Servier laboratories are accused of having deliberately concealed the dangerous side effects of the 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 delayed in withdrawing the drug from sale.
In April 2019, 3,993 patients had received an “offer of compensation” from Servier laboratories, and 115 million euros had already been paid.
On June 23, the public prosecutor requested, this Wednesday, June 24, fines of 375,000 euros to 1.875 million euros for legal persons and sentences of one to two years in prison suspended for physical persons. In addition, 3 years in prison were required against the ex-number 2 of the company, Jean-Philippe Seta, who is the main defendant in this case. A fine of € 200,000 was finally requested from the National Medicines Safety Agency (Ansm) for having delayed in withdrawing the medicine from sale.
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