The investigators accuse Servier of having knowingly concealed the risks posed by Mediator for years
PARIS – A French court will decide on Monday whether the pharmaceutical company Servier deliberately ignored warnings about a diabetes and weight loss pill, which has been blamed for hundreds of deaths, in one of France’s worst health scandals.
Mediator drug was in the market for 33 years and used by approximately five million people before it was withdrawn in 2009 for fear of causing serious heart problems – more than a decade after such concerns were first raised.
Over 6,500 plaintiffs, including French health insurance companies, are seeking $ 1 billion (US $ 1.2 billion) in damages from Servier on charges of manslaughter and causing accidental injury, grave deception and fraud.
The investigators accuse the drug manufacturer of knowingly concealing the risks posed by Mediator for years. The first cases of heart disease related to the drug were reported in 1999, a decade before the drug was discontinued.
A total of 12 people and 11 legal entities – Servier, nine subsidiaries and France’s medicine watchdog – were tried in late 2019 and early 2020 for their alleged role in a scandal that contributed to widespread suspicion of the pharmaceutical industry in France.
– Ten kilos a month –
Servier’s former deputy, Jean-Philippe Seta, who may face jail if convicted, admitted during the trial that Servier had “made mistakes”.
Originally intended for obese people with diabetes, Mediator was prescribed to healthy individuals as an appetite suppressant.
Many of the victims who testified in court about the effects of the drug on their lives were women. Exhausted and out of breath, they told their stories while sitting.
“The drug was said to be exceptional. I lost ten pounds in the first month,” said a plaintiff, Stephanie, who took the drug for three years before being diagnosed with heart disease in 2009.
About 500 people are believed to have died as a result of the drug, although experts say it could ultimately cause up to 2,100 deaths.
According to Servier, thousands of victims have already reached an agreement with the company that amounts to almost 200 million euros.
France’s second largest pharmaceutical company also faces a fine of around € 10 million if found guilty of staging a cover-up.
– Watchdog error –
The mediator affair was the subject of the French film “150 Milligrams” from 2016 about the work of the lung specialist Irene Frachon, who made a significant contribution to bringing the alleged misconduct to light.
“I hope the court will give us the tools to understand how fraud like this could have lasted for so long,” Frachon, who will be in court on Monday to hear the verdict, told AFP.
Servier and his former executive Seta claim they didn’t know the drug was dangerous until it was withdrawn in 2009.
At this point it was already banned in the US, Spain and Italy.
France’s medicine watchdog ANSM, who has been brought to justice for its delay in stopping sales of the drug, has admitted that it was “partly responsible” for the scandal.
Other defendants include several consultants who worked in public institutions while they were on Servier’s payroll and a former right-wing senator accused of altering a report on the scandal to reflect the company’s role in the Downplaying matter.