Servier faces courtroom in long-running Mediator death investigation

gavel
Servier Laboratories faces a Paris courtroom on charges it illegally marketed diabetes med Mediator. (Pixabay)

Over the course of a long-running probe, plaintiffs have accused French pharma Servier Laboratories and a national drug regulator of illegally marketing diabetes med Mediator, which has been tied to fatal heart valve issues. Now those charges will be tested in court.

Servier is among 11 institutions and 12 individuals facing trial over claims Mediator—tied to at least 500 deaths—was marketed as safe even though the company knew its harmful side effects. The drug stayed on the market in France long after other countries stopped selling it.

The trial opened Monday in Paris and is expected to last seven months.

On-Demand Webinar

De-Risking the Solid Form Landscape of an API

This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. Attend to hear about two case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

In a decades-long investigation, plaintiffs complained that Mediator was kept on French shelves until France’s drug regulator ANSM pulled it in 2009, despite safety warnings that cropped up in the early 1990s. The diabetes med, allegedly marketed off-label as an appetite suppressant, had been pulled in other countries such as the U.S., Spain and Italy years earlier, France24 reported.

According to the outlet, 5 million French patients used the drug over a 30-year period, including 3 million patients who used it for stretches longer than three months. At least 500 people are believed to have died from heart problems after using Mediator, and legal experts estimated the drug could ultimately be responsible for some 2,100 deaths, France24 said.

RELATED: France files new charges against Servier, drug regulator in Mediator saga: report

Once left for dead, the Mediator case won new life in 2017 after French prosecutors indicted 14 individuals and 11 institutions on new charges, including manslaughter.

Public outrage over the Mediator case led ANSM to overhaul its drug oversight after facing accusations it shielded a national company. Observers at the time pointed out that less than a year before Mediator was withdrawn, Servier founder Jacques Servier was awarded France's highest state honor, the Legion d'Honneur, by France’s former president Nicolas Sarkozy—who also once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 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.

Suggested Articles

Another major drugmaker is recalling in the U.K. 10 batches of its Zantac generics because they contain a possible carcinogen.

With diagnosis rates on the rise, Pfizer's Vyndaqel franchise could collect $157 million in 2019 U.S. sales, well above consensus, SVB Leerink says.

Merck is chopping 500 jobs nationwide as part of a continued shift to focus more on innovative drugs. The cuts are effective Jan. 3.