Perhaps the longest-running drug safety saga in France is being resurrected as prosecutors bring new charges, including manslaughter, against French drugmaker Servier as well as more than a dozen people and the country’s drug regulator.
The indictment focuses on the marketing of Servier’s diabetes drug Mediator, which was often prescribed off-label as a weight-loss drug but was tied to heart valve issues. The new charges are against 14 individuals as well as 11 institutions, including Servier and ANSM, Reuters reported.
France’s drug regulator ANSM pulled Mediator from the market in 2009 after reports of at least 500 deaths—some reports put the number over 2,000. That action didn’t come until a decade after other EU countries had withdrawn the medication over safety concerns, leaving the government open to claims of shielding a French company.
The case led France’s ANSM to overhaul its drug oversight. Observers at the time pointed out that less than a year before Mediator was withdrawn, Servier was awarded France’s highest state honour, the Legion d’Honneur, by France’s former president Nicolas Sarkozy—who also once acted as Servier’s personal lawyer.
There have been other cases in the past, including one that pulled Servier Founder Jacques Servier into court a couple of years before his death in 2014 at age 92. A French court in 2015 found the drugmaker negligent for having left a “defective” drug on the market.