An appeal in the case related to the anti-diabetic drug benfluorex, sold under the brand name Mediator in France, will hear some 692 trial exhibits, more than 7 500 plaintiffs, and a court of first instance ruling of some 2 900 pages, reports MedPage.
On 29 March 2021, the correctional court of Paris found some companies held by the drug maker 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, now known to be associated with a risk of valvular heart disease and pulmonary hypertension.
Mediator was launched in 1976 to treat hyperlipidemia and for overweight patients with type 2 diabetes but was used off-label as an appetite suppressant.
The pharmaceutical group was accordingly fined €2 718m and Seta was handed a four-year suspended sentence and fined €90 600.
The fines have been paid (provisional execution of the judgment ordered), and it is now difficult for the victims to accept that the 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 offences of “fraud” and “improperly obtained marketing authorisation”, 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 offences of fraudulently obtaining marketing authorisation and fraud. This means both offences are being re-examined.
Additionally, 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 its part in the scandal. The agency has not appealed this ruling, reports Medscape.
Respiratory medicine specialist Dr Irène Frachon of Brest Regional University Hospital, a pioneer in the fight to ban Mediator, is outraged at the turn of events.
“Five million French people have been exposed to poison… How is this possible?”
Thousands of victims
According to a study by the French Institute of Health and Medical Research (Inserm) in 2012, at least 3 000 hospital admissions and 1 300 deaths were 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 the amphetamine derivative was put on the market until 30 April 2015, 6 743 cases of valvular heart disease and 1 273 cases of pulmonary hypertension have been attributed to benfluorex in France.
“Most reports of valvular heart disease were made between 2011 and 2012. …they started to slow in 2014, with only 664 (10.3%) cases reported between 1 January 2014, and 30 April 2015,” specified the watchdog.
Between 2015 and 2020, 126 new cases of pulmonary hypertension were attributed to benfluorex, showed a 2022 ANSM report.
The punishments
According to the Court of Appeal’s referral, the main punishment now ordered concerning “the offence of involuntary manslaughter with wilful misconduct” is five years’ imprisonment, a €75 000 fine for the relevant individuals, and a €375 000 fine for the legal entities involved.
The main penalty for “the offence of unintentional injury causing complete incapacity for work of more than four months with wilful misconduct” is three years’ imprisonment, a €45 000 fine for the individuals, and a €225 000 fine for the legal entities involved.
The main punishment for “the unintentional injury causing complete incapacity for work of less than three months with wilful misconduct” is one year’s imprisonment, a €15 000 fine for the individuals, and a €75 000 fine for the legal entities.
The main punishment for “unintentional injury not causing incapacity for work with wilful misconduct” is an administrative fine of €1 500 for the individuals and legal entities involved. The main punishment for the legal entities is a €7 500 administrative fine.
Regarding “fraudulent marketing causing a danger to health”, the main punishment is two years’ imprisonment, a €30 000 fine for the individuals, and a €375 000 fine for the legal entities.
For fraudulently obtaining an administrative document” (MA), the punishment is two years’ imprisonment, a €30 000 fine for the relevant individuals, and a €150 000 fine for the legal entities involved.
Finally, for “fraud”, the court ordered five years’ imprisonment, a €375 000 fine for the relevant individuals, and one of €1 875 000 for the legal entities.
Medscape article – What’s Happening in France in Diet Drug Mediator Scandal? (Open access)
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