France’s medicines watchdog joins pharmaceutical firm Servier in the dock Monday on fraud and negligence charges linked to the deaths of hundreds of people who were prescribed a diabetes pill for weight loss despite safety concerns.
At least 500 people are thought to have died of heart valve problems in France after taking the drug Mediator, in a major health scandal that was the subject of a 2016 French movie called “150 Milligrams”.
The film is based on the work of real-life pulmonologist Irene Frachon who was instrumental in bringing the alleged wrongdoing to light through her campaigning and investigation.
She is expected to testify against the company and the medicine, which was on the market for 33 years and was used by about five million people.
Experts have projected it may cause as many as 2,100 deaths in the long term.
The criminal trial against Servier, nine subsidiaries, and the ANSM medicines watchdog—known at the time as Afssaps—is expected to last six months.
It will focus on 91 victims, four of them deceased, for whom lawyers believe a link can be shown between their illness and Mediator.
Twelve individuals in the dock will include former Servier number two Jean-Philippe Seta, doctors who were members of Afssaps commissions while also being paid as pharma company consultants, and former senator Marie-Therese Hermange who produced a report said to be favourable to Servier.
Initially intended for overweight people with diabetes, the drug was widely given to healthy individuals as an appetite suppressant.
Safety alerts were first flagged in the mid-1990s, but Mediator was banned in France only in 2009—long after being outlawed in the United States, Spain and Italy.
Victims “want to understand how this medicine could have been left on the market for so long,” said Charles Joseph-Oudin, who will represent about 250 complainants in the trial in the Paris criminal court.
Servier, one of France’s biggest pharma firms, is charged with fraud for allegedly concealing Mediator’s risks, while the ANSM is being pursued for negligence and allegedly dragging its feet in suspending the drug. They risk a fine or an order to compensate victims.
“Servier knew that it was selling poison,” said 71-year-old Joy Ercole, who took Mediator for six months 10 years ago, and said she suffered heart damage as a result.
“The unlucky ones, like me, are condemned to a slow death. My life is ruined.”
Servier says it did not know about the risk before 2009.
Frachon had alerted French health authorities of heart problems among patients who had taken the drug. She published a book in 2010, which became the basis of movies made about her.
The ANSM in 2010 linked at least 500 deaths to Mediator.
In 2015, a civil court found Servier negligent for having left “defective” medicine on the market.
Victims have submitted nearly 10,500 claims for compensation from Servier, and many have accepted payment in return for not taking part in criminal proceedings.
Servier’s website states it has made offers of compensation to more than 3,700 sickened people for a total amount of 164.4 million euros ($182 million), of which 131.8 million euros have been paid out.
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