France's Servier laboratories group, which marketed Mediator – a drug used as an appetite suppressant and accused of causing serious cardiovascular damage – has been fined more than €7 million on appeal and ordered to repay more than €415 million to social security bodies and insurance companies.
Servier was on Wednesday found guilty of all offences with which it was charged earlier this year – including fraud – for which it had been acquitted at the first court hearings.
During the trial, which ran from January to June this year, the public prosecutor demanded that France's second-largest medical laboratory be fined €13.5 million and that its profits linked to Mediator – totalling €182 million according to its calculations – be "confiscated".
Marketed in 1976 as a contributory drug to anti-diabetic treatments, Mediator was often wrongly prescribed as an appetite suppressant until it was banned in 2009.
One of Servier Laboratories flagship drugs, it caused serious cardiovascular damage in thousands of patients and is deemed responsible for hundreds of deaths.
[Thread] On aura mercredi le verdict du procès en appel du Mediator. Alors pourquoi @signalarnaques en parle ?
— Signal-Arnaques (@SignalArnaques) December 18, 2023
Parce que c'est un dossier où la tromperie des laboratoires Servier est omniprésente. Avec des milliers de victimes à la fin. Rappel. 🧵 pic.twitter.com/izUgWdWqKp
Aware of 'fatal risks'
In March 2021, the Paris Criminal Court fined Servier's six companies €2.7 million, ruling that it had "sufficient evidence from 1995 onwards [that Servier was aware] of the fatal risks" associated with Mediator.
Today's ruling will see that fine rise to over €7 million.
The court found the pharmaceutical manufacturer guilty of aggravated deception and manslaughter, but was acquitted of fraud, as the statute of limitation had expired on the offence of improperly obtaining a marketing authorisation.
The prosecution accused Servier of continuing to market Mediator without informing patients of the risks involved and the aggravating circumstances that could damage their health.
However, now the medical laboratory has been convicted of deception, insurance companies and social security operators will be compensated by the laboratory to the tune of €415 million.
'Assessment error'
Prosecuting lawyers have asked for up to €200,000 per victim for non-material damage linked to the deception, up to €50,000 for anxiety (the fear of seeing Mediator-related illnesses appear in the future) and a further €50,000 for the damage caused by the "systematic denial" of Servier's representatives at the trial.
For their part, Servier's lawyers the laboratory acted "in good faith" and "never wanted to deceive anyone".
Admittedly, they said, Servier had made "an error in assessing the risk" associated with Mediator, but "there was never any conscious decision to expose patients to risk".
For Jean-Philippe Seta – the former right-hand man of the group's all-powerful founder Jacques Servier who died in 2014 and the only individual accused at the appeal trial – the public prosecutor's office has requested five years' imprisonment, including a three-year suspended sentence, and a fine of €200,000.
At first court hearing, Seta was given a suspended four-year prison sentence and fined €90,600.
During the trail, representatives for Servier and Jean-Philippe Seta repeated that the danger posed by the drug had not been established until 2007 – or even 2009 – and that the French medicines agency ANSM had shared their analysis.
The ANSM was fined €303,000 for manslaughter and unintentional injury, but has not appealed.
A total of 7,650 people filed civil claims in the trial – most of them in the "deception" case.
A further 5,000 cases of manslaughter or unintentional injury are still being investigated by the Paris public prosecutor's office, paving the way for a second Mediator trial within the next few years.
