The appeal trial for Mediator, an antidiabetic drug used as an appetite suppressant, will reach its conclusion on Wednesday with the decision of the Paris Court of Appeal concerning the Servier laboratory, judged in particular for aggravated deception and homicide and involuntary injuries. During this trial, which took place from January to June, the public prosecutor’s office demanded a fine of 13.5 million euros against the second French medical laboratory and the “confiscation” of its profits linked to Mediator, i.e. 182 million euros according to his calculations.
Marketed in 1976 as an adjuvant to antidiabetic treatments, but often unduly prescribed as an appetite suppressant until its ban in 2009, Mediator, a flagship molecule from Servier, has caused serious cardiovascular damage in thousands of patients. He is held responsible for hundreds of deaths.
Towards compensation for civil parties
In March 2021, during the trial at first instance, the Paris criminal court sentenced the six companies of the Servier laboratory to a fine of 2.7 million euros, estimating that it had “from 1995, sufficient “elements to become aware of the mortal risks” linked to the Mediator. The court found him guilty of aggravated deception and homicide and involuntary injuries, but acquitted him of the offense of fraud and declared the offense of improperly obtaining marketing authorization to be time-barred.
The prosecution accuses Servier in particular of having continued to market Mediator without informing patients of the risks involved, with the aggravating circumstance that this risk affected their state of health. If the medical laboratory is convicted of deception, civil parties deemed admissible may be compensated by the laboratory, even if they have not developed adverse effects.
“Evaluation error”
Their lawyers requested up to 200,000 euros per victim for moral damage linked to the deception, up to 50,000 euros for anxiety damage (the anxiety of seeing illnesses linked to Mediator appear in the future) and 50,000 additional euros for the aggravation of their damage which would have caused the “systematic denial” of Servier’s representatives at the trial.
For Servier’s lawyers, on the contrary, the laboratory acted “in good faith” and “never wanted to deceive anyone”. Certainly, they admitted, Servier made “an error in assessing the risk” linked to Mediator. But “there was never an awareness of exposing patients to risk”.
Against Jean-Philippe Seta, former right-hand man of the all-powerful founder of the group Jacques Servier (died in 2014) and the only natural person accused in the appeal trial, the public prosecutor’s office requested five years’ imprisonment, including three years suspended and 200,000 euros fine. At first instance, Jean-Philippe Seta was sentenced to four years in prison and a fine of 90,600 euros.
7,650 civil parties
At the hearing, the representatives of Servier and Jean-Philippe Seta repeated that the dangerousness of the drug was not established before 2007, or even 2009, and that the Medicines Agency (ANSM, formerly Afssaps) had shared their analysis .
In accordance with the “precautionary principle”, “simple doubts about the deleterious effects should lead to carrying out all the necessary safety studies (…) without waiting for the drug policeman, this sleeping beauty, to turn on a red light”, had however noted the advocates general Agnès Labreuil and Jean-Philippe Rivaud.
Sentenced to a fine of 303,000 euros for homicide and involuntary injuries, the ANSM did not appeal. In total, 7,650 people became civil parties to the trial, most of them in the “deception” section. Some 5,000 other cases for homicides or involuntary injuries are still being investigated by the Paris prosecutor’s office, paving the way for a probable second Mediator trial in the coming years.