Court reverses Servier verdict on Mediator, ⁠orders payment of €430M

Two years ago, with a favorable ruling and a slap-on-the-wrist fine, Servier hoped its decades-long litigation surrounding weight-loss pill Mediator was finally over.

But an appeal from prosecutors has kept the French drugmaker in court for another 33 months and now has produced the reversal of one verdict, leaving the company facing a new judgment of 430 million euros ($470 million).

Servier was found guilty of fraud and improperly obtaining marketing authorizations and renewals, upending the 2021 decision, which at that time only led to a fine of 2.7 million euros. Additionally, the court upheld a previous conviction for aggravated deception and involuntary manslaughter.

Sevier has been ordered to reimburse health organizations 415.6 million euros for fraud. Under the ruling, the company also owes 9 million euros in criminal fines, 5 million euros in legal costs and 1 million euros in damages.

“Despite the severity of the conviction, (Servier) is in a position to face this decision, which is disputable and disappointing in many respects,” Servier said in a statement. “This conviction is, in part, contradictory to the judgment handed down by the judges of the first instance. Consequently, we have made the decision to lodge an appeal.”

The litigation surrounds Mediator, which was approved as a diabetes treatment in 1974. But because its active ingredient worked as an appetite suppressant, it gained popularity for its ability to reduce weight. At least 500 users died of heart valve problems, so several countries, including the U.S., forced Mediator from the market. In 2009, France pulled it off shelves.

The unaddressed safety issues damaged the reputation of France’s drug regulator, Agence nationale de securite du medicament (ANSM), which was fined 303,000 euros in 2021 for failing to act promptly.

On Wednesday, the court upheld its four-year suspended sentence—with one year of house arrest—against Servier’s former CEO Jean-Philippe Seta and fined him 90,000 euros.

The penalties come on top of the company dealing with the claims of individual victims. In 2021, offers of compensation to nearly 4,000 patients came to roughly 200 million euros.

Separately on Thursday, Servier and CStone of China announced that the French company had acquired the rights to the blood cancer drug Tibsovo in China and Singapore for $50 million.

In 2018, Servier acquired the oncology business of Agios Pharmaceuticals, which developed Tibsovo. Before that deal, Agios had already arranged a licensing agreement with CStone to develop and commercialize Tibsovo in China and Singapore.

“This milestone underscores Servier's commitment to fortifying our oncology presence in Asia.” Philippe Gonnard, Servier’s global product strategy chief, said in a release.