A major pharma scandal in France has culminated in a ruling against domestic firm Servier for its role in the hundreds of deaths caused by weight-loss drug Mediator.
In a landmark ruling wrapping up decades of controversy around the amphetamine-derived drug, a Paris court found Servier guilty of “aggravated fraud” and “involuntary manslaughter” for marketing Mediator, Deutsche Welle reported.
The court handed Servier a €2.7 million ($3.2 million) fine and issued former Deputy Chairman Jean-Philippe Seta a suspended prison sentence of four years. The court further fined France’s drug regulator, Agence nationale de securite du medicament (ANSM), €303,000 for failing to act promptly on the drug’s safety risks.
In a statement Monday, Servier said it’s still reading over the the ruling. “In the next few days and after a thorough reading of the judgement, Les Laboratories Servier will make a decision on the appropriate response to this judgment,” it said.
The case drew more than 6,500 plaintiffs who had sought €1 billion in damages from Servier. They allege that the company deliberately concealed Mediator’s dangers and covered up negative medical findings.
The pill was introduced in France in 1976 as a diabetes drug for overweight people, but it was widely prescribed as an appetite suppressor. It was never approved in the U.S.
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Questions over the drug’s potential heart toxicity emerged around the late 1990s, when a similar drug by American Home Products—which later became part of Pfizer—used in a combo called fen-phen was pulled from the market due to cases of heart disease and related death. But Mediator was still on the French market until 2009, and Servier has said it didn’t know about the drug’s problems until then.
The case drew furor from the public and prompted reforms at ANSM. The drug has been linked to at least 500 deaths from heart valve problems in France, while other research put the estimate at around 2,000 deaths.
The French drugmaker has been offering compensation to Mediator victims. As of March 1, the company has received nearly 11,000 claims, though some were ruled to be not attributable to Mediator. Altogether 3,884 patients have received offers of compensation for a total of €199.6 million, according to Servier.