French drug maker Servier and its founder went on trial accused of misleading patients and authorities about a drug that officials blame for at least 500 deaths.
Licensed as a diabetes treatment, Mediator was widely prescribed as an appetite suppressant to help people lose weight.
It is now suspected of causing heart valve disorders and was withdrawn in France in November 2009, approximately a decade after being pulled in Spain, Italy and the United States.
The case has put authorities under enquiry for allowing the sale of Mediator long after the medicine had been pulled in other European countries.
Several hundred civil plaintiffs argue that Servier intentionally misled doctors about the drug, even though the dangers had been known since the 1990s.
State health inspectors agree that the drug should have been withdrawn in France a decade earlier, and the plaintiffs are seeking damages and interest of €100,000 each.
The Nanterre trial focuses on whether Servier made misleading claims, while a second, broader trial in Paris, due after an investigation, will examine allegations of manslaughter and corruption.
The defendants in Nanterre deny the allegations against them and are seeking to stop the trial on grounds that they should not be tried in two separate cases.
Servier’s founder and president, 90-year-old Jacques Servier, and four other executives risk custodial sentences of up to four years plus fines. The privately-owned company and its subsidiary Biopharma also face fines and the possibility of being banned from some activities.
Mediator was designed as a treatment for diabetes patients who were overweight and was sold to as many as 5 million people in France between 1976 and November 2009.
However, many of those sales were not to diabetics but simply to those seeking help to lose weight.
The offices of the AFSSAPS healthcare regulator were searched by investigators in February in connection with the case. Concerns about the agency have grown following the PIP breast implant scandal.
The Mediator case has also drawn attention to pharmaceutical companies’ influence in France’s public health system as well as their sway over politicians.
It has triggered a push at European Union level to step up monitoring of drug safety.
According to the health ministry, at least 500 people died of heart valve trouble in France because of exposure to Mediator’s active ingredient, benfluorex. Other estimates put the death toll closer to 2,000.
Less than a year before the drug was pulled, Servier was awarded France’s national merit medal, the Legion d’Honneur, by President Nicolas Sarkozy.
(Text published in AnFocal.ie 21 May 2012 http://www.anfocal.ie/lifestyle/4053/weight-loss-pill-to-have-caused-over-500-deaths)