Servier facing €431m penalties in new Mediator judgment

The Paris Court of Appeals has handed down its judgment against Servier in the case involving its weight-loss therapy mediator, finding the company guilty of fraud and ordering it to pay €431 million (around $470 million) in fines and reimbursement orders.

The judgment includes reimbursement of just under €416 million to France’s social security system and healthcare organisations, plus €9 million in criminal fines, €1 million in damages, and €5 million to cover legal costs. Those come on top of compensation already paid by Servier to victims.

Mediator (benfluorex) is thought to have caused between 500 and 2,000 deaths between 1976 and 2009 from heart and pulmonary failure, which was approved for diabetes but widely used as an appetite suppressant.

It was eventually withdrawn from sale in France in 2009, around a decade after being taken off the market in the US, Spain and Italy, and after being prescribed to around five million people since it was first launched in 1974.

A trial brought by plaintiffs representing those affected by the drug started in 2019, and resulted in convictions against the company and former head of operations Jean-Philippe Seta, including for manslaughter with wilful misconduct and involuntary injury, two years later. It was fined €2.7 million, while Seta received a four-year suspended prison sentence.

The drugmaker was however acquitted of fraud and deception by the lower court, while the French regulatory authority, the ANSM, was fined €303,000 for having “seriously failed in its health policing mission.”

Now, the appeals court found Servier guilty of fraud and deception, as well as improperly obtaining marketing authorisations and their renewals, which the company said rescinded the earlier judgment. That part of the judgment is central to the size of the fines and reimbursement orders.

Prosecutors also sought stiffer penalties for Seta, seeking five years’ imprisonment, including a three-year suspended sentence, and a fine of €200,000.

As a result of the discrepancies with the earlier ruling, Servier plans to lodge an appeal with the Court of Cassation, France’s supreme court, so there is still another chapter to play out in the case. Meanwhile, the company is also facing the possibility of a second trial in connection with cases of manslaughter or unintentional injury that are still under investigation.

In a statement, Servier said that “despite the severity of the conviction, the group is in a position to face this decision, which is disputable and disappointing in many respects.”