The large light wood room which hosted the debates on the November 2015 attacks in Paris and Saint-Denis and July 2016 in Nice is preparing to host a new river trial. For six months, from this Monday and until June 24, it will be a question this time, before the judges of the Paris Court of Appeal, of a resounding health scandal: the Mediator affair.
This drug from Servier laboratories, marketed as an antidiabetic since 1976 and unduly prescribed as an appetite suppressant until 2009, has caused the death and left disabled thousands of patients with serious heart and lung pathologies. It is estimated that this amphetamine derivative with anorectic properties has been consumed by nearly 5 million people in thirty-three years.
After seven months of a first trial and a judgment of the Paris court on March 29, 2021, justice is therefore once again looking into this tragedy where the practices of the second French pharmaceutical laboratory play the leading role – its founder Jacques Servier died. in 2014.
Sentenced at first instance for “aggravated deception” and “involuntary homicides and injuries”, the Servier group (which had been fined 2.7 million euros) and its former No. 2 Jean-Philippe Seta (four years suspended prison sentence and a fine of 90,600 euros) will this time be the only defendants.
The National Medicines Safety Agency (ANSM, ex-AFSSAPS), fined 303,000 euros “for having failed in its role as drug policeman”, and the “network” aspect of the file (experts, doctor , ex-senator…) are not retried. “We focus on the delinquency of the firm”, notes Irène Frachon, this pulmonologist from Brest “whistleblower” at the origin of the revelation of the dangers of the Mediator.
“Fraud of a considerable and unprecedented scale”
The Servier laboratories “had, from 1995, sufficient elements to become aware of the mortal risks they posed to patients”, had ruled the 31st correctional chamber, qualifying the facts as “fraud of a considerable scale and unprecedented”.
Its decision, which also condemned the group to compensate the victims to the tune of 180 million euros (including 158 for deception), on the other hand acquitted Servier of the offenses of “undue obtaining” of marketing authorization. and “fraud” to the detriment of the National Health Insurance Fund (Cnam) – which estimates the Mediator’s reimbursement expenses at 322 million euros.
After the appeal of the Paris public prosecutor’s office (on these partial releases), which had requested more severe penalties, and that of Servier, which disputes any deception or fraud, the group and its former general manager therefore appear again for the whole of the alleged offenses – their lawyers declined to comment.
The debates therefore reopen the entire heart of the case: either the question of the criminal liability of a flourishing pharmaceutical company (4.7 billion euros in turnover in 2022) which only admits “an error of assessment at some point about side effects [du Mediator] », in the words of its current CEO Olivier Laureau (the Tribune of June 22, 2022).
“Laboratories will no longer be able to use the flaws of the drug agency”
“Nothing that has been judged can be taken for granted”, underlines Me Charles-Joseph Oudin, who represents 1,200 of the approximately 6,700 civil parties. “The battle will be as bitter as in the first instance, predicts Me Jean-Christophe Coubris, counsel for 2,500 victims of the Mediator with his partner Me Anne-Laure Tiphaine. Otherwise that the laboratories will no longer be able to use the flaws of the drug agency as a means of defence, ”he adds.
For these lawyers engaged early on alongside patients, the challenge is to obtain confirmation of Servier’s criminal conviction on the offense of deception but also the reversal of the release of the group on that of fraud. And the minimum maintenance of compensation (already paid to their customers).
VIDEO. Victim of the Mediator: “I hate… They stole my life! »
“These laboratories took advantage of a product without taking into account its dangerousness and were reimbursed by Social Security. The release for fraud is in my opinion inconceivable, ”insists Me Coubris. “We want to consolidate our gains in terms of conviction and compensation while obtaining more,” summarizes Mr. Oudin, who intends to seek “the confiscation of industrial profit” generated by the Mediator.
Beyond the low fines and penalties, limited in fact by law, the first judgment had shocked its clients by “its lack of financial impact” on Servier. “Sanctions need to be more dissuasive, including to send a signal to other laboratories,” he insists.
Irène Frachon, always at the side of the victims
Present every day at the first trial, Irène Frachon, who is among the more than 80 witnesses cited, will not be able to go there this time as assiduously. The doctor, whose testimony marked the debates, has just published a comic book that looks like a thriller (“Mediator, a chemically pure crime”, co-written with the writer Éric Giacometti, former journalist at Le Parisien, François Duprat in drawing and Paul Bona in color, at Éditions Delcourt.)
Always engaged alongside the victims of “this deadly poison”, Irène Frachon retraces the history of the Servier laboratories and its founder (a “house” where the boss ordered his executives “to lie about the chemical nature of the Mediator”). , that of the Mediator (and the appetite suppressant Isomeride) and its investigation. “The Mediator affair is not just a toxic drug scandal, it reveals serious dysfunctions in our health democracy”, assert its authors in the preamble.
PODCAST. Mediator: “I want Servier to close”
The album opens with the unexplained death of Pascale, who died suddenly in March 2004, aged 51. “Acute heart failure,” said the medical examiner’s certificate. “It was only six years later, with the publication of Irène Frachon’s book (“Mediator 150 mg, how many deaths?”, Editions Dialogues, 2010) that we said with my father that it could have a link”, confides his daughter Lisa Boussinot.
“The civil party bench is not empty”
Present throughout the first trial, she will attend every day on appeal. “I need to see how justice is going to be done in my mother’s case and it’s also a civic approach: this public health scandal affects everyone,” she explains. Many victims are disabled. Broken in their health. I also want to show by my presence that the civil party bench is not empty. »
Operated for valvulopathy in 1999 at the age of 45, Nathalie Meunier, 57, on disability, is one of those who will not be able to travel (other than to follow the debates via web radio). From this second trial, this woman whose life was shattered by the Mediator expects above all this: “That we become aware of our suffering, of the daily ordeal that we undergo. We are poisoned for life. »