“The president of Merck in France was heard” Tuesday at the health center of the Marseilles court, explains the group in a press release, hearing at the end of which “the examining magistrate decided to put the company Merck in examination for aggravated deceit”.
The indictment is linked to “information procedures put in place at the time of the transition from the old to the new formula in 2017”, for this drug prescribed against hypothyroidism, specifies the company.
The new composition of the drug, modifying some of its excipients in order to provide more stability to the product, was incriminated, between March 2017 and April 2018, by some 31,000 patients suffering in particular from headaches, insomnia, or dizziness.
A criminal investigation for aggravated deception, homicide and involuntary injuries was opened in 2018.
“This indictment does not in any way concern the quality of the new formula of Levothyrox”, assures the laboratory, stressing that it wants to “provide all necessary clarification in order to establish that no criminal offense, of any nature whatsoever, has been committed.”
In the civil part of the case, the Court of Cassation had rejected in March the appeal of the group, condemned in 2020 to compensate more than 3,300 users who suffered from side effects following the change of formula.
In its judgment, the highest French court had considered that “when the composition of a drug changes and this change in formula is not explicitly indicated in the leaflet, the manufacturer and the operator can be accused of a lack of ‘information’, capable of ‘causing moral harm’.