CHRONOLOGY

• The National Pharmacovigilance Committee identifies and validates the signal of valvulopathies in patients treated with Mediator.
• The CAMM (Marketing Authorisation Committee) concludes that Benfluorex has a negative benefit-risk ratio
• Suspension of the marketing authorisation of Mediator® and its generics by AFSSAPS

Afssaps estimates the number of Mediator®-related deaths to be 500

• The IGAS (General Inspection of Social Affairs) report is handed to the Minister of Health
• Opening of two legal investigations brought against X for “deception and unlawful acquisition of an interest” and “manslaughter”
• Servier proposes the setting up of a compensation fund for patients
• Creation of a compensation fund managed by ONIAM (French National Office for Compensation for Medical Accidents)
• Indictment of Doctor Jacques Servier and 5 Servier companies for “deception and fraud”

Servier indicted for “manslaughter and unintentional injury”.

ANSM (National Drug Agency) indicted (previously Afssaps) for “manslaughter and unintentional injury”.

Death of Doctor Jacques Servier, Olivier Laureau appointed President of Servier Group

Investigation resumes, considered incomplete by the Investigation Chamber

State’s responsibility confirmed in the Mediator case

Referral order for Servier to appear before the Criminal Court

Announcement of the beginning of the trial (from September 2019) by the Paris Criminal Court

On 18 April 2019, the Court announced that the Mediator trial would be held from 23 September 2019 for a period of 6 months.