Paris (AFP)

Can Servier laboratories avoid a conviction?

And what will happen to the Medicines Safety Agency?

More than ten years after one of the biggest French health scandals, the Paris Criminal Court delivers its judgment on Monday in the Mediator case.

It is an extraordinary trial which will be concluded: the debates started in September 2019 and ended in July 2020, after a suspension during the first confinement against the coronavirus.

The court worked on deliberation for nine months.

More than 6,500 people have become civil parties.

Irène Frachon, the pulmonologist from Brest who revealed the scandal in 2010, will be present on Monday.

"I am waiting for the court to give us an autopsy of a health drama. During the trial, everything has been detailed since the 1960s. It is a unique opportunity," she told AFP.

"I hope that the court will give us the keys to understand how such a deception could have held up for so long."

The question was at the heart of the debates: how could this drug, presented as an antidiabetic but widely used as an appetite suppressant, be prescribed for thirty-three years despite repeated alerts on its dangerousness?

Used by around 5 million people, reimbursed by Social Security at the maximum rate of 65%, it was not withdrawn from the market until November 2009.

However, the first alerts on its dangerousness were issued in 1995 and the first cases of serious heart disease reported in France in 1999. The Mediator is held responsible for hundreds of deaths.

- "Extreme gravity" -

During the requisitions pronounced in June, the prosecution called on the court to sanction misconduct of "extreme gravity".

Around 10 million euros in fines - the maximum penalty - were required against six companies in the Servier group prosecuted for "aggravated deception", "fraud" and "unintentional homicide and injury".

The company Servier, the second largest French pharmaceutical group, "made the deliberate, cynical choice not to take into account the risks that it could not ignore" and "made the sinister bet that these risks would be minimal in terms of patients affected. ", vilified the prosecutor.

The laboratories "did not identify a significant risk signal before 2009," told AFP as the judgment approached one of the laboratories' lawyers, François de Castro.

A phrase hammered out during the debates.

The prosecution also requested five years in prison, three of which are closed and a fine of 200,000 euros against Jean-Philippe Seta, the former right-hand man of Jacques Servier, the all-powerful founder-boss of the laboratories, who died in 2014.

At trial, he apologized.

"It is clear that we made mistakes," he admitted.

Against the National Medicines Safety Agency (ANSM, ex-Afssaps), prosecuted for having delayed in suspending the marketing of Mediator, the prosecution requested a fine of 200,000 euros.

For the prosecutor, she "seriously failed in her health police mission".

- "Financial impact" -

The ANSM did not ask for the release and assumed at the hearing a "share of responsibility" in the "human drama" of the Mediator.

At the helm, victims came to tell about their life after the Mediator, for many women who wanted to lose weight.

Too tired, out of breath, most of them had to testify seated.

Among them, Stéphanie who took Mediator between 2006 and 2009. "They said that this drug was extraordinary. I lost 10 kilos the first month".

But at the end of 2009, she learned that she was suffering from valve disease, a lesion of the heart valves.

The civil parties, who hope for an "exemplary judgment", have claimed a total of "one billion" euros in damages in compensation for the losses suffered, including more than 450 million for the only health insurance funds which have taken action. charge the reimbursement of the Mediator and consider themselves victims of "fraud".

"It is essential that Monday's decision has sufficient financial impact for the Servier laboratories and other economic operators to cease their unacceptable practices," another civil party lawyer, Charles Joseph-Oudin, told AFP.

The total amount of fines required against Servier laboratories represents for the group, recalls the lawyer, "around two days of turnover today".

© 2021 AFP