What Can We Expect From the French Mediator Drug Court Case?

Aude Lecrubier

September 26, 2019

Paris - Ten years after the withdrawal of Mediator from the market the trial of the antidiabetic drug, prescribed as an appetite suppressant for 33 years and responsible for heart valve damage and pulmonary arterial hypertension, opened this week at the Regional Court in Paris.

Representatives of Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM) took their place on the defendants' bench to answer the charges, including aggravated deception with endangerment of health, fraud, and homicide.

This is an extraordinary trial with about 100 witnesses, nearly 400 lawyers, and 5000 victims.

Mediator was taken off the market in France in 2009, 6 years after Spain, 12 years after Switzerland, and more than 30 years after Belgium.

The number of deaths due to heart valve damage related to this drug has been estimated at between 220 and 300 deaths in the short-term (2.5 years) and between 1300 and 1800 long-term deaths in France.  In addition, the drug has been responsible for between 3100 and 4200 hospital admissions for valvular insufficiency.

What can the victims hope for now, 10 years after the scandal first broke? We asked Nicolas de la Taste, a lawyer at the French law firm Cornet Vincent Segurel.

Q&A

How will this trial unfold?

This trial will take place over several months. We are talking about 6 months. It is absolutely exceptional but there are an enormous number of victims. The various charges will be studied one after the other in the order decided by the judge. Most likely, the court will decide to review the criminal charge first. During this phase, victims will be heard first, before the prosecutor and then the defence.  Compensation will most probably be examined later.

The National Medical Accident Compensation Board has received more than 9000 claims since the outbreak of the scandal in 2010.  Can 9000 victims really be compensated?

There is no legal obstacle, no limit to the number of victims to be compensated.

What are the legal risks for the Servier laboratory and the French National Agency for the Safety of Medicines and Health Products?

It's hard to say. If all the charges, which are very serious for some, were made, they would risk extremely high fines, several million euros, bans for directors, and suspended prison sentences, or sentences without parole.

On a technical level, crimes such as fraud or the illicit use of connections are hard to prove for the prosecution. It is easier to convict for manslaughter or unintentional harm.

When can we expect definitive answers?

After this first criminal trial, the Public Prosecutor and the defendants can appeal (the victims cannot appeal), which can take about a year and a half.

A further appeal could arise, which is not rare in this type of case. It would take several years.

It would not be surprising if it took 10 years.

This will not necessarily prevent victims from being compensated because advance payments can be made to victims.

Translated and adapted from Medscape's French Edition

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