The Court of Cassation considered that the laboratory should have informed patients of the risks associated with the Mediator.
In the Mediator affair, Servier could not but know. This was ruled by the Court of Cassation, which for the first time validated the civil liability of the laboratory for having maintained the marketing of a drug which “presented a defect”, for lack of information on its risks.
According to the decision made Wednesday, consulted by AFP, the manufacturer of the Mediator could not “invoke a risk of development to exempt himself from [sa] liability ”for the defective nature of the drug.
A “seriously documented” risk
The Court considers that “the state of scientific knowledge did not make it possible to ignore the risks of PAH (pulmonary arterial hypertension) and valve disease induced by benfluorex”, the active principle of Mediator. “In view of the scientific data at the time and the benefit-risk ratio that was expected from it, this drug did not offer the safety that it could legitimately expect, particularly given the lack of information appearing on the notice ”, specifies the Court of Cassation.
Thus, while the risk was “seriously documented”, the producing laboratory should have informed patients and healthcare professionals. However, the magistrates note, until 2009, the date of the late withdrawal of the Mediator, the information on adverse effects did not mention the risks of the appearance of PAH and valve disease.
By rejecting the appeal from the laboratories, the Court of Cassation confirms Servier’s conviction to compensate a patient up to 7,650 euros – she asked for more than 40,000 -, decided at first instance in Nanterre in October 2015, then on appeal to Versailles in April 2016.
1,500 to 2,100 deaths
Prescribed for more than 30 years to five million people in France, this anti-diabetic, widely used as an appetite suppressant, could be the cause of 1,520 to 2,100 long-term deaths, according to a legal expert opinion.
This health scandal, revealed in 2007 by the doctor Irène Frachon, had at the end of August the epilogue of a long criminal justice series with the referral to the correctional court of the Servier laboratories and the National Medicines Safety Agency (ANSM). In total, 11 legal persons and 14 natural persons will be judged.
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