Victims of a diabetes drug suspected in hundreds of deaths pleaded for justice as a massive trial involving more than 4,000 plaintiffs opened Monday for French pharmaceutical giant Servier Laboratoires and France’s medicines watchdog.
The company and the oversight body stand accused of involuntary manslaughter, fraud and other charges in their handling of the drug Mediator.
“My life is just not the same,” said Paquita Guardiola, who suffered severe health complications requiring a heart transplant after taking the drug. “Now it’s hard for me to even get dressed. My children dress me, my husband dresses me. He helps me in the shower, he does everything.”
Although marketed as a diabetes drug, Mediator was also prescribed as a hunger suppressant and was taken by millions of people before sales were suspended in France in 2009.
A 2010 study said Mediator was suspected in 1,000-2,000 deaths, with doctors linking it to heart and lung problems.
The closely watched trial that opened in Paris is expected to last six months and is one of France’s biggest in years.
The trial dossier runs to nearly 700 pages — with around 300 pages taken up by plaintiffs’ names. The trial was spread across five rooms, connected by video-link, at the Paris courthouse. Nearly 400 lawyers were working on the case.
Guardiola, who has already received compensation from Servier, will testify as a witness. She said the drugmaker “ruined my life.”
Irène Frachon, a lung specialist who was among the first in France to sound the alarm about Mediator, said the scandal could not be simply brushed aside.
“You can’t ‘Put it behind you’ when 2,000 people died,” she said. “I’m really counting on this criminal case to put an end to this collective blindness to white collar crimes, especially with regards to what I call pharma-criminality.”
She added: “Whatever the financial stakes, there are red lines that need to be redrawn and that’s why this trial is crucial.”
Investigating magistrates concluded that Servier for decades covered up Mediator’s harmful effects on patients. The national medicines agency is suspected of colluding in masking its dangers.
François de Castro, a lawyer for Servier, said the pharmaceutical firm wasn’t aware of risks associated with Mediator before 2009 — 33 years after it first went on sale.
Speaking at the courthouse, the president of Servier, Olivier Laureau, expressed “our deepest and sincerest regrets” to “the patients who have suffered from Mediator” and “to their families who have gone through a tragedy.”
Servier is being tried on charges of manslaughter, unintentional harm, fraud and deceit about the chemical makeup of Mediator and the risks of taking it.
France’s medicines agency, meanwhile reformed and renamed, is also accused of manslaughter by negligence and causing unintentional harm.
Also on trial are 12 representatives of the pharma giant and the medicines agency.
“This trial is a victory for the victims,” said Dominique-Michel Courtois, head of a Mediator victims group. He said they want answers on how Servier obtained a license to market the drug and how it “hoodwinked the authorities.”
Headquartered in a suburb of Paris, Servier employs 22,000 people worldwide and generated 4.1 billion euros ($4.5 billion) in turnover last year.