French pharmaceutical Servier Laboratories has been found guilty of aggravated deceit and involuntary manslaughter and ordered to pay hundreds of millions of euros in damages and fines for for selling a drug or use in overweight diabetics a blamed for up to 2,000 deaths over 33 years.
According to Servier’s website, 3,884 patients received offers of compensation totalling €199.6m on 1 March this year. The company claims €177.6m of compensation relating to Mediator has already been paid out.
AP News reports the ruling capped a judicial marathon involving more than 6,500 plaintiffs. The Paris tribunal took nearly three hours to read out its verdict totalling 1,988 pages. The huge trial was spread over 10 months in 2019 and 2020, and nearly 400 lawyers worked on the case.
Servier was accused of putting profits ahead of patients’ welfare by allowing the drug to be widely and irresponsibly prescribed as a diet pill – with deadly consequences. Servier argued that it didn’t know about the drug’s dangers.
The court found Servier guilty of manslaughter, involuntary wounding and aggravated deception. The judges’ ruling said the firm hid the drug’s hunger-suppressant side effects from medical regulators. The court acquitted Servier of fraud.
Also found guilty and fined €300,000 for manslaughter and unintentional injury was the French medicines agency, now reformed and renamed. It was accused of failing to take adequate measures to protect patients and of being too close to Servier. Lawyers for the agency said it acknowledged some responsibility but also was misled by Servier.
Judges handed Servier a fine of €2.7m (nearly $3.2m) and ordered it to pay hundreds of millions more in damages to be shared out among plaintiffs. Damages for aggravated deception alone totalled nearly €159m euros. And other hefty payments were awarded for the manslaughter and wounding charges. The court also handed a suspended four-year prison sentence and fines to the only surviving Servier executive accused of involvement, Dr Jean-Philippe Seta.
A 2010 study said Mediator was suspected in up to 2,000 deaths, with doctors linking it to heart and lung problems, in the 33 years that it was on the market. Some survivors suffered severe health complications, requiring heart transplants and other medical procedures, after taking the drug as a hunger suppressant.
Irene Frachon, a whistleblowing doctor who was among the first to raise the alarm about the drug’s effects, welcomed the guilty verdicts. “The court clearly said there was deception and that Mediator was a hunger suppressant, an amphetamine, whose properties and, above all, toxicity were very deliberately hidden from consumers,” Frachon is quoted by AP News as saying. “This, very clearly, is white-collar crime.” The pulmonologist in the western city of Brest investigated Mediator’s effects after treating a patient in 2007 who later died. Frachon was a witness in the trial.
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. The company suspended sales in its main market in France in 2009.
Lawyers for Servier argued that the company wasn’t aware of the risks associated with Mediator before 2009, and said the company never claimed it was a diet pill. They had argued for acquittal.
AP News reports that the company’s CEO and founder, Jacques Servier, was indicted early in the legal process but died in 2014.
The amphetamine derivative was licensed as a diabetes treatment, but was widely prescribed as an appetite suppressant to help people lose weight, reports The Guardian. Its active chemical substance is known as Benfluorex.
The French health minister estimated it had caused heart-valve damage killing at least 500 people, but other studies suggest the death toll may be nearer to 2,000. Thousands more have been left with debilitating cardiovascular problems. Servier has paid out millions in compensation.
“Despite knowing of the risks incurred for many years, … they (Servier) never took the necessary measures and thus were guilty of deceit,” said the president of the criminal court, Sylvie Daunis.
In the 677-page French indictment, magistrates accused Servier of having “knowingly concealed the medication’s true characteristics” from the 1970s and hidden medical studies unfavourable to the product, perpetrating a long-term fraud.
The court case involved 21 defendants and more than 6,500 plaintiffs.
Full AP News report (Open access)
Full report in The Guardian (Open access)
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