New chapter of the pharmaco-judicial series of Levothyrox. It is by voice of press release that the French subsidiary of the German pharmaceutical laboratory Merck announced, Wednesday, October 19, its indictment for “aggravated deception” in the case of the change of formula of the drug Levothyrox.
The indictment is related 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 president of Merck in France has been heard” in Marseilles, Tuesday, explains the group, adding that it is following this hearing that the indictment was decided by the examining magistrate.
Already sentenced in 2020 to compensate more than 3,300 patients
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. .
“This indictment does not in any way concern the quality of the new Levothyrox formula”assures the laboratory, Tuesday, emphasizing wanting “provide all necessary details to establish that no criminal offense of any kind has been committed”.
A criminal investigation for “aggravated deception”, “homicide and involuntary injuries” had been opened in 2018. In the civil part of the case, the Court of Cassation had rejected last March the appeal of the group, sentenced in 2020 to compensate more than 3 300 users who suffered from side effects following the change in 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 blamed for a lack of information”can “causing moral harm”.