Servier on the hook for €471 million over Mediator diet pill scandal
21 Dec 2023
Drug ApprovalPriority ReviewPatent Infringement
A court in France ruled Wednesday that Servier owes more than €430 million ($471 million) in connection with the diabetes treatment Mediator (benfluorex), finding the company guilty of aggravated deceit and involuntary manslaughter/unintentional injury, for knowingly selling a potentially harmful drug.
The Paris court of appeals ordered Servier to reimburse €415.6 million to social security services, and also imposed a criminal penalty of close to €9 million – an amount higher than the €2.7 million fined by a lower court in 2021 – as well as €1 million in damages, plus another €5 million in legal costs.
At least 500 people in France are estimated to have died between 1976 and 2009 as a result of heart valve problems due to exposure to the active ingredient in Mediator, which was widely prescribed as an appetite suppressant.
Hid risk of harm
The Paris court found that the company hid the risk of harm and heart problems from patients and doctors, and ruled that the drug's initial 1974 approval and its subsequent renewals until 2007 had been obtained illegally. France withdrew the drug in 2009, around a decade after Spain, Italy and the US halted sales.
The new ruling, which came after both Servier and some victims of the drug had lodged an appeal, also found the drugmaker guilty of fraud and improper market approval, partially overruling the lower-court verdict from 2021 that had acquitted it of those charges.
However, the court did not rule on the confiscation of profits from the sale of Mediator, as the public prosecutor had proposed, citing concerns about putting Servier at risk of financial "peril." The attorneys general had valued the confiscation at €182 million, and also sought a fine of €13.5 million.
In addition, former CEO Jean-Philippe Seta received a suspended prison sentence of four years, one of which must be served through house arrest, and a fine of close to €90,000.
"Despite the severity of the verdict, the Group is able to cope with this disappointing decision," Servier said, adding it would appeal the decision to France's top court.
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