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Servier wins delay in Mediator trial

This article was originally published in Scrip

Servier, the French pharmaceutical company at the centre of the Mediator scandal, has won the postponement of a trial in which it faces claims that it misled patients and the regulatory authorities over the drug's safety.

The tribunal correctionnel (criminal court) in the Parisian suburb of Nanterre said that the trial should not continue until legal issues raised by Servier's lawyers had been clarified by the Supreme Court (Cour de Cassation). A decision on when the trial should continue is likely to be taken around the end of this year.

Mediator (benfluorex) was belatedly withdrawn from the French market in 2009 because of its serious adverse effects, notably the development of heart valve defects in patients taking the product.

Servier is facing legal action alleging that it issued misleading statements about the product's mechanism of action, presenting it as an antidiabetic when it was partly related to the anorectic drug fenfluramine, which was withdrawn in 1997, also because of heart valve problems (www.scripintelligence.com 22 December 2012).

Some 600 suits have been filed against the company in Nanterre, alleging "aggravated deception" and seeking compensation, and the trial opened on 14 May. However, separate proceedings relating to Mediator are under way in Paris, investigating allegations of deception and fraud by Servier.

The company's lawyers said that there was a legal conflict in that the same facts were being examined in two separate courts, which they said could prejudice the interests of both defendants and plaintiffs. For example, documents disclosed in the Paris proceedings would not be available to the Nanterre court.

Nanterre has therefore decided to refer the question to the Supreme Court, which will have three months to decide whether to reject it – in which case the trial can go ahead – or to refer the matter to the Constitutional Court, which will also have three months to reach a decision. A hearing has been set for 14 December to decide when the trial should continue.

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