One of the biggest French health scandals is back on the legal scene. The appeal trial in the Mediator case began on Monday January 9 for a period of six months. The Paris prosecutor’s office and a good number of civil parties hope that Servier laboratories and its former manager will this time be convicted of fraud, in addition to being found guilty of aggravated deception and manslaughter and involuntary injury.
To date, the Mediator is accused of having caused the death of 1,500 to 2,100 people, not counting patients suffering from serious side effects.
Harmfulness known to the manufacturer
This product was marketed by Servier laboratories from 1976 to 2009. It was classified as antidiabetic, but in reality, was massively distributed as an appetite suppressant.
However, doctors were never alerted to its harmfulness, even though the manufacturer was aware of it. Indeed, taking Pick has led to a multiplication of cases of pulmonary arterial hypertension and valvular heart disease – pathologies similar to those triggered by Isomeride, another dangerous appetite suppressant withdrawn from sale in 1997.
The laboratories have always denied any proximity between these two drugs. Despite this “concealment”although admitted by the court, the pharmaceutical group and its manager escaped the charge of fraud in the first instance.
The defendants acquitted of the offense of fraud at first instance
On March 29, 2021, the Paris Criminal Court sanctions Servier laboratories and their former number two Jean-Philippe Seta for aggravated deception, homicides and involuntary injuries, considering that they “had, from 1995, enough elements to become aware of the mortal risks” related to the Mediator – but he releases the offense of fraud.
The former leader received a four-year suspended prison sentence and a fine of 90,600 euros. Servier must pay him the sums of 2.7 million euros in fines and 183 million in damages. For information, the newspaper The Doctor’s Dailyreports in an article published on January 19, 2022 that the consolidated turnover of the group for the financial year 2020/21 reached 4.725 billion euros.
“The court decision was not at all up to the drama and the seriousness of the offenses committed”, denounces whistleblower Irène Frachon. Aggravated deception is a violation of the Consumer Code, while fraud is classified as an offense under criminal law. Thus, the pulmonologist does not understand the acquittal of the offense of fraud pronounced by the court.
A misunderstanding shared by the public prosecutor of Paris at the time, Rémy Heitz, who explains that it is also on the basis of the offense of fraud to the detriment of Social Security “that the requests (…) related to the reimbursement of the drug were based”.
“The Servier laboratories continue to deny their responsibilities”
On April 6, 2021, the Paris prosecutor’s office therefore announced that it was appealing this partial release, which “concerns the former operational director and certain companies of the Servier group”without putting back “in question the convictions made on other grounds, in particular manslaughter and involuntary injury or aggravated deception, nor the other acquittals pronounced by the court” .
Two days later, the Servier laboratories declare in a press release to take « act »of the decision of the prosecution, while they “were willing to accept the judgment of the court in order to bring this legal case to a definitive end, despite their condemnation which they consider to be unfounded”.
And to add: “As a result, Servier laboratories have decided to appeal their convictions (…)”. For Me Charles-Joseph Oudin, lawyer for civil parties, the challenge of the trial is also to confirm “the acquisition”. “We will even ask for a little more”he adds,“by focusing on the persistence of denial by Servier laboratories, which continue to deny their responsibilities, which is particularly hard for my clients to live with” . The National Agency for the Safety of Medicines (ANSM) indicates for its part, on January 9, 2023, to have“heard the suffering of the victims and their families”and accept his sentence without appeal.
The court will also have to decide whether the circumstances surrounding the obtaining of the marketing authorization for the Mediator fall within the scope of the prescription. The various hearings will be held until June 28 in the room of the “Grands trials” of the Palais de Justice in Paris, which hosted those of the attacks of November 13 and Nice.