France — An appeal in the case related to the antidiabetic drug benfluorex, which was sold under the brand name Mediator in France, was launched on Monday, January 9. The process will continue until June 28.
With 692 trial exhibits, more than 7500 plaintiffs, and a court of first instance ruling of more than 2900 pages, this is no ordinary trial.
Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off-label as an appetite suppressant.
On March 29, 2021, the correctional court of Paris found some companies held by Servier Laboratories and the former director of operations at Servier, Jean-Philippe Seta, guilty of "aggravated deceit" and "involuntary manslaughter and injury" for their roles in concealing, for years, the pharmacological properties of Mediator (benfluorex), which is now known to be associated with a risk of valvular heart disease and pulmonary hypertension.
The pharmaceutical group was accordingly fined 2718 million euros and Jean-Philippe Seta was handed a 4-year suspended sentence and fined 90,600 euros. The fines have been paid (provisional execution of the judgment ordered), and it is now difficult for the victims to accept that the sum of money they have already received and that they may have to return, could be called into question.
Nevertheless, the court acquitted Servier and Jean-Philippe Seta of the offenses of "fraud" and "improperly obtained marketing authorization," mainly because of statutory limitations.
The defendants quickly appealed the first two judgments, while the Paris public prosecutor's office and the victims appealed the partial acquittal of the offenses of fraudulently obtaining marketing authorization and fraud. This means that both offenses are being re-examined.
It should be noted that France’s health watchdog, the French National Agency for Medicines and Health Products Safety (ANSM), which was condemned for failing to immediately suspend marketing of Mediator, was fined 303,000 euros for their part in the scandal. The agency has not appealed this ruling.
Invited by Marina Carrère d'Encausse, MD, to participate in France's topical health panel show Magazine de la Santé just before the launch of the new trial, respiratory medicine specialist Irène Frachon, MD, (Brest Regional University Hospital), a pioneer in the fight to ban Mediator who is particularly committed to the plight of the victims of this case, has once again shared her outrage at the turn of events. "Five million French people have been exposed to poison, yet Servier is now a household name. How is this possible? How could they be offered a government grant last year? Why are we rewarding former Servier employees, not current ones, who hatched plots to protect Mediator? Why is this still going on? Change needs to happen."
Thousands of Victims
According to a study conducted by the French Institute of Health and Medical Research (Inserm) and published in 2012, there have been at least 3000 hospital admissions and 1300 deaths caused by valvular heart diseases linked to Mediator between 1976 and 2009. The number of deaths linked to pulmonary hypertension is, however, not known.
Also, according to a report by the ANSM, from the time that the amphetamine derivative was put on the market until April 30, 2015, 6743 cases of valvular heart disease and 1273 cases of pulmonary hypertension have been attributed to benfluorex in France. "The majority of reports of valvular heart disease were made between 2011 and 2012. The number of reports started to slow in 2014, with only 664 (10.3%) cases reported between January 1, 2014, and April 30, 2015," specified the watchdog.
Between 2015 and 2020, 126 new cases of pulmonary hypertension were attributed to benfluorex, according to a 2022 ANSM report.
According to the Court of Appeal's referral, the main punishment now ordered concerning "the offense of involuntary manslaughter with willful misconduct" is 5 years' imprisonment, a 75,000-euro fine for the relevant individuals, and a 375,000-euro fine for the legal entities involved.
The main punishment for "the offense of unintentional injury causing complete incapacity for work of more than 4 months with willful misconduct" is 3 years' imprisonment, a 45,000-euro fine for the relevant individuals, and a 225,000-euro fine for the legal entities involved.
The main punishment for "the offense of unintentional injury causing complete incapacity for work of less than 3 months with willful misconduct" is 1 year's imprisonment, a 15,000-euro fine for the relevant individuals, and a 75,000-euro fine for the legal entities involved.
The main punishment for "the offense of unintentional injury not causing incapacity for work with willful misconduct" is an administrative fine of 1500 euros for the individuals and legal entities involved. The main punishment for the legal entities is a 7500-euro administrative fine.
Regarding "the offense of fraudulent marketing causing a danger to health," the main punishment handed out is 2 years' imprisonment, a 30,000-euro fine for the relevant individuals, and a 375,000-euro fine for the legal entities involved.
For "the offense of fraudulently obtaining an administrative document" [MA], the main punishment is 2 years' imprisonment, a 30,000-euro fine for the relevant individuals, and a 150,000-euro fine for the legal entities involved.
Finally, for "the offense of fraud," the court ordered a main punishment of 5 years' imprisonment, a 375,000-euro fine for the relevant individuals, and a fine of 1,875,000 euros for the legal entities involved.
After a 5-day appeal hearing on the Mediator case, French comic publishing house Delcourt published a graphic novel decrying the scandal. In Mediator: A Chemically Pure Crime, Irène Frachon recounts the story of Mediator, but also that of Servier laboratories, and of another of its drugs that was banned in the '90s: dexfenfluramine, which was marketed as Isomeride.
The graphic novel was written with former investigative journalist Eric Giacometti (who also scripted the Belgian comic book series Largo Winch) and illustrated by François Duprat.
"The cartoon recounts the rise of this criminal-to-the-core organization since the '60s, the tragedies lived by its victims, and the subsequent scandals of appetite suppressants Isomeride and Mediator," said Irène Frachon on Magazine de la Santé, before adding, "If you are incensed, there is a petition in France to have Jacques Servier posthumously stripped of his title of grand officer of the Legion of Honor, which was awarded to him by Nicolas Sarkozy in 2009. [This step] is currently not allowed by law."
This article was translated from the Medscape French edition.
Lead image: FRED TANNEAU / AFP / Getty Images
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Cite this: What's Happening in France in Diet Drug Mediator Scandal? - Medscape - Jan 23, 2023.