After a change in formula of this medication, in 2017, patients had deplored side effects. Justice suspects the German laboratory of having been aware of the non-equivalence of the two versions of its product.
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It was the company Merck itself that took care to announce it, in a statement published Wednesday October 19 at dawn: the pharmaceutical firm was indicted for “aggravated deception” in the case Levothyrox. The president of Merck France, Thierry Hulot, had been heard the day before, by the investigating judge of the public health center of the Marseille judicial court.
A criminal investigation had been opened in March 2018 for aggravated deception, involuntary injury and endangering others, extended a year later to the manslaughter, after the death of a 48 -year -old woman attributed by his loved ones when changing the medication formula. Merck is ultimately indicted only of the aggravated deception manager. In the civil component of the case, the German laboratory has already been ordered to compensate more than 3,300 complainants for “moral prejudice” – Merck was provided in cassation, but was dismissed in March.
The laboratory was placed under judicial supervision after its indictment. As part of this judicial control, Merck must pay a deposit of 4.3 million euros to be paid in two stages in December and January: 4 million to guarantee the payment of fines and the repair of the damage caused by the Infraction and 300,000 euros to guarantee its representation in justice and procedural acts. In addition, Merck must guarantee the rights of the victims, in this case constitute a safety in the form of a banking guarantee of 7 million euros. The sprawling case totals 10,500 complaints and 3,000 constitutions of civil parties.
influx of side effects.
“We have not previously had access to the investigation file because we were not involved in the framework of the judicial information, said the firm in its press release. We will therefore now be able to read of all the elements of this file and provide any necessary precision in order to establish that no criminal offense, of any kind whatsoever, has been committed. “
set up in March 2017, the change in formula of Levothyrox was accompanied throughout the following year with an influx of reports of adverse effects, sometimes very disabling: digestive disorders, headache, Cognitive disorders, severe asthenia, hair loss, etc. Several tens of thousands of patients – a small fraction of the more than two million thyroid patients treated with this drug – have thus declared effects which they attribute to the replacement of an excipient in the new formula. The German firm, opinion doctors of opinion, and the health authorities have largely accredited, for several months, the thesis of a “Nocebo” effect powered by the media noise around the case.
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