Jail Terms and Hefty Fines Recommended in French Servier Trial 

Philippe Anaton

July 10, 2020

Jean-Philippe Seta, former number two of the Servier group, should spend at least 2 years in prison and be fined a total of more than €10 million (around £9 million, $11 million) for his part in the Mediator scandal, the prosecution said in their closing arguments at the Servier trial.

However, the court will not deliver its judgement until 2021, reports Medscape's French Edition.

More Than 10 Hours of Indictment

The criminal trial over the weight loss drug Mediator, which began on 23 September 2019, was delayed in March 2020 due to the COVID-19 epidemic.

It was only on 2 June that the case resumed at the High Court of Paris, and not until 23 June that the prosecutor gave the closing arguments, for more than 10 hours, against Servier Laboratories, as well as against the National Medicines Safety Agency (ANSM).

Previously, on 22 January, the lawyers for the plaintiffs (numbering 6500 individuals, including 4500 victims of the drug) reached the end of their pleas and claimed a total of €1 billion in compensation from Servier Laboratories.

In addition, the primary health insurers responsible for the reimbursement of Mediator asked for more than €450 million, reported Le Monde.

Mediator was first marketed in 1976 as an adjunct to diabetes treatment, but it was diverted from its primary indication to be prescribed as an appetite suppressant.

It was taken by more than five million individuals, and was only withdrawn from the market in 2009, due to its toxicity. Servier Laboratories were prosecuted for knowingly hiding the dangerous nature of Mediator, on charges of "aggravated deception", "murder/homicide and involuntary injuries". ANSM was in turn prosecuted for having not taken the decisions that would have led to the withdrawal of Mediator long before 2009.

Deception, Murders, and Involuntary Injuries

The prosecutor, Aude Le Guilcher, at the end of her indictment, requested fines for "deception, murders and involuntary injuries, fraud" of €10.3 million against the six companies of the Servier group being prosecuted.

Against the former number two of Servier Group, Jean-Philippe Seta, Aude Le Guilcher asked for a prison term of 5 years, 2 suspended, and a €200,000 fine. The same amount was demanded of ANSM for murders and involuntary injuries.

Mediator Should Never Have Been Reimbursed

In her indictment, Aude Le Guilcher recalled that Servier Group had acquired market authorisation for Mediator as an anti-diabetic by concealing its similarity with fenfluramines, which were banned in 1990.

The prosecutor claimed Servier Laboratories went on to deceive the doctors who prescribed it and the patients who consumed it by hiding the drug’s toxicity. Servier’s guilt became evident for the prosecution from 1995, when the international IHPPS study made the link between fenfluramine and pulmonary arterial hypertension.

The prosecutor also dwelled on the injuries of 95 plaintiffs (including four deaths), highlighting Servier’s failure to fulfil its obligations by concealing the pharmacological nature of Mediator.

As for the fraud, the prosecutor estimated that the losses to the primary health insurers runs to several hundred million euros. Mediator should never have been reimbursed, as "it should never have received market authorisation, and was only granted it due to the fraudulent actions of the company".

Experts and Revolving Doors

On 24 June, the indictment moved on to tackle the second part of the lawsuit, against nine individuals tried for corruption or operating in both the public and private sector: experts paid by Servier also sat at Afssaps (the forerunner of ANSM), supposedly to control products put on sale by the laboratories.

As reported in Le Monde, the prosecutor Christina Mauro spoke, for 7 hours, against Michel Detilleux, former member of the market authorisation committee, François Lhoste, a Ministry of Health executive, Jean-Michel Alexandre, director of drug evaluation, Christian Bazantay, director of Servier’s German subsidiary, Jean-Roger Claude, former member of the market authorisation committee, Charles Caulin, former member of the AMM commission, Jacques Massol, former technical advisor to the Directorate General for Health (DGS), Bernard Rouveix, former member of the Transparency Commission of the High Commission on Health (HAS), Marie-Ève Ibar wife of Eric Abadie, now deceased, for the offence of illegal taking of interest (or acting on a conflict of interest).

Against these nine people, the prosecution asked for suspended prison sentences of 1 to 2 years and fines ranging from €30,000 to €160,000. The highest fine was imposed on Marie-Ève Ibar.

Michel Detilleux, Charles Caulin, Jean-Roger Claude, François Lhoste, Christian Bazantay, Jean-Michel Alexandre were given 2-year suspended sentences, with fines ranging from €30,000 to €75,000.

The same prosecutor demanded fines for the same crimes against four Servier companies, ranging from €370,000 and €1.875 million. Pleadings for the defence will be heard from 29 June to 6 July.

The judgement will be given in 2021.

3700 Patients Also Compensated

Alongside the criminal proceedings, Servier has already compensated 3700 patients via a mutual agreement managed by the National Office for Compensation of Medical Accidents (Oniam).

On 29 May 2019, 3837 patients received offers of financial compensation totalling €192.68 million, of which €162.71 million has already been paid. One victim received one million euros, Servier says on its website. Victims who opted for the mutual settlement cannot then take part in litigation.

Translated and adapted from Medcape's French Edition.

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