PARIS – Accused of favoring profits over patients’ lives, French pharmaceutical company Servier Laboratories is facing millions of euros in potential fines and damages after a huge trial involving 6,500 plaintiffs who say the company allowed a diabetes drug to be widely and irresponsibly prescribed as a diet pill — with deadly consequences.
The popular drug, called Mediator, became one of France’s biggest modern health scandals, and the trial is wrapping up Monday after more than six months of proceedings targeting both Servier and France’s medicines watchdog. Servier says it didn’t know about the drug’s risks.
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The trial was interrupted by another health crisis: the coronavirus, which has prompted new scrutiny of health authorities and of drugs being rushed out as treatments or vaccines.
In the 33 years that Mediator was on the market, it was suspected in 1,000-2,000 deaths among millions who took it as an appetite suppressant, according to a 2010 study. Doctors linked it to heart and lung problems.
One doctor flagged concerns as far back as 1998, and testified that he was bullied into retracting them. Facing questions about the drug's side effects from medical authorities in Switzerland, Spain and Italy, Servier withdrew it from those markets between 1997 and 2004.
But it took an independent investigation by another worried French doctor before the company suspended sales in its main market in France in 2009. It wasn't sold in the U.S.
“There are men and women who put a deadly poison on the market,” the whistleblower, Dr. Irene Frachon, told the court. She published a book detailing her findings, and her efforts were profiled in a 2016 film, “The Girl from Brest.”
Servier is accused of manslaughter, involuntary injury, fraud, influence trading and other charges. Investigating magistrates concluded that Servier for decades covered up Mediator’s effects on patients. The national medicines agency is suspected of colluding in masking its dangers.
Lawyers for Servier argued that the company wasn't aware of the risks associated with Mediator before 2009, and said the company never pretended it was a diet pill. They argued for acquittal.
Prosecutors asked last week for nearly 15 million euros (around $16.9 million) in fines for Servier, and a three-year prison sentence and 278,000-euro fine for the only surviving Servier executive accused of involvement, Dr. Jean-Philippe Seta.
In addition, the 6,500 plaintiffs want a total of 1 billion euros in damages.
Lisa Boussinot, whose mother died after taking Mediator, wants more — she wants the company’s labs shut down. She said she wants a strong signal “that shows that our justice system protects us" from powerful companies that don't brook criticism.
Prosecutor Anne Le Guilcher asked for a fine of 200,000 euros against the French medicines agency, accusing it of failing to take adequate measures to protect patients and of being too close to Servier.
The agency, since reformed and renamed, is accused of manslaughter by negligence and causing unintentional harm. The agency's lawyers said it acknowledged some responsibility but said Servier misled medical authorities.
Also on trial are 12 representatives of the pharma giant and the medicines agency.
“Patient safety was not at the heart of Servier’s policy,” the prosecutor told the court last week, saying the drug should have been withdrawn in the 1990s. “The firm was only interested in money.”
The central witness in the extensive trial was Frachon, a pulmonologist in the western city of Brest who investigated Mediator's effects after treating an obese patient in 2007 who later died.
“What I did was not a scientific feat, it was just a clinical trial. As I did not have the correct information from Servier, I turned into an investigator, “ Frachon said. She maintains that Servier knew about problems with the drug since 1993.
After she spoke out, she said, “One of the drug agency experts said to me, you’re going to pay for this. He wanted to punish me ... Servier’s pressure was omnipresent. I become persona non-grata in many scientific events.”
She wasn’t the first to ask questions about Mediator.
In 1998, Dr. Georges Chiche, a cardiologist in Marseille, received an overweight colleague with heart problems who had been prescribing himself Mediator for weight loss.
Chiche filed a report expressing his concerns, and testified that two people from Servier pressured him to withdraw it. Then, Chiche told the court, a former professor told him the same thing, calling his report shoddy “nonsense.”
“After that, I didn’t report again,” he said.
He later learned that his former professor had organized jazz festivals paid for by Servier.
The company's CEO and founder, Jacques Servier, was indicted early in the legal process but died in 2014.
The exceptional trial was spread across five rooms at the Paris courthouse, connected by video link, and nearly 400 lawyers were working the case.
It’s expected to take several months to reach a verdict, expected early next year.
Headquartered in a suburb of Paris, Servier employs 22,000 people worldwide and generated 4.6 billion euros in revenues last year.