A French court will on Monday rule whether pharma giant Servier deliberately ignored warnings over a diabetes and weight loss pill blamed for hundreds of deaths, in one of France's worst health scandals.
The drug Mediator was on the market for 33 years and used by about five million people before being pulled in 2009 over fears it could cause serious heart problems -- more than a decade after such concerns had first been raised.
Over 6,500 plaintiffs, including France's health insurance funds, are seeking one billion euros ($1.2 billion) in damages from Servier, which is charged with manslaughter, causing unintentional injury, aggravated deceit and fraud.
Investigators accuse the drugmaker of knowingly concealing the risks posed by Mediator for years, allegations it denies. The first cases of heart disease linked to the drug were flagged in 1999, a decade before the drug was withdrawn.
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 over their alleged role in a scandal that contributed to widespread distrust in France of the pharmaceutical industry.
- Ten kilos in a month -
Servier's former second-in-command, Jean-Philippe Seta, who faces possible jail time if convicted, admitted during the trial that Servier had "made mistakes".
Initially intended for overweight people with diabetes, Mediator was widely prescribed to healthy individuals as an appetite suppressant.
Many of the victims who testified in court about the impact of the drug on their lives were women. Exhausted and out of breath, they recounted their stories sitting down.
"It was said that the drug was extraordinary. I lost ten kilos the first month," said one plaintiff, Stephanie, who took the drug for three years before being diagnosed with heart disease in 2009.
About 500 people are thought to have died as a result of the drug, though experts say it may eventually cause as many as 2,100 deaths.
Thousands of victims have already reached settlements with the company, totalling nearly 200 million euros ($236 million), according to Servier.
France's second-biggest drug company also faces criminal fines of around 10 million euros if found guilty of orchestrating a cover-up.
- Watchdog failure -
The Mediator affair was the subject of the 2016 French film "150 Milligrams", about the work of lung specialist Irene Frachon who was instrumental in bringing the alleged wrongdoing to light.
"I hope the court will give us the tools to understand how such deceit could have gone on for so long," Frachon, who will be in court on Monday to hear the verdict, told AFP.
Servier and its former executive Seta claim they did not know the drug was dangerous until 2009 when it was withdrawn.
By then it had already been outlawed in the United States, Spain and Italy.
France's medicine watchdog ANSM, which was tried over its delay in halting sales of the drug, has admitted to its "share of responsibility" in the scandal.
The other defendants include several consultants, who served on public bodies while being on Servier's payroll, and a former right-wing senator accused of modifying a report on the scandal to downplay the company's role in the affair.