Ten years after withdrawing a drug from the French market that has been linked to as many as 2,000 deaths, Servier is facing its day in court.
In the landmark trial, Servier is accused of manslaughter, causing injury and deception in connection with the sale of Mediator (benfluorex), an appetite suppressant approved for weight loss in diabetics that has been shown to damage the vales in the heart and cause pulmonary arterial hypertension (PAH).
First launched in 1976, Mediator was not taken off the market in France until 2009, several years after being withdrawn from other European countries, including Spain in 2003 and Italy in 2004.
By that time it had caused the deaths of somewhere between 500 and 2,000 people, according to prosecutors, who have also levelled charges against 21 defendants, including the company, the French medicines regulatory authority (ANSM) and 14 individuals.
Lawyers representing the 2,684 plaintiffs claim that Servier and the ANSM allowed the drug to remain on the market even though its side effects had been known for several years, and did not do enough to prevent deaths and injury from the drug.
The ANSM was formed in 2012 after the former regulator AFSSAPS was dissolved as a result of the Mediator scandal and allegations that it hadn’t done enough to protect women from defective breast implants manufactured by Poly Implant Prothese (PIP).
Mediator was widely prescribed off-label in France to non-diabetics seeking to shed a few pounds, and whilst on the market was used by around five million people.
Servier has denied the charges of deception, saying in a statement that “it is undeniable that patients suffered undesirable effects linked to taking Mediator,” but that there are only three deaths clearly linked to the drug.
It added: “The Servier laboratories repeat their sincere regrets to patients touched by this tragedy and their families. They are the first concern of Servier laboratories which, from 2011, made a commitment to indemnify the victims, a process that has almost been completed today.”
The company has paid out some €132m (around $145m) in compensation to people injured by the drug, but is accused of making at least €1bn in revenues from the drug during its 33 years on the market.
The side effects caused by Mediator were uncovered by French pulmonologist Irene Frachon, who highlighted the link between the drug and its side effects in 2007 after systematically reviewing records of patients taking it.
She told Reuters that the start pf the trial was a “huge relief. Finally, we are to see the end of an intolerable scandal”.
The trial is expected to take several months to be heard.