“The president of Merck in France was heard” Tuesday at the health center of the Marseilles court, the group announced in a press release on Wednesday. At the end of this hearing, “the investigating judge decided to put Merck on trial for aggravated deception”.
This decision is linked to the “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, adds the company.
This is an additional step in the legal drama opposing the laboratory to many patients.
At the heart of this case, the new composition of Levothyrox, which arrived on the French market at the end of March 2017. This new formula still uses the same active ingredient, levothyroxine, but with new excipients, to make its composition more stable.
However, patients quickly complained of many side effects: cramps, headaches, dizziness or hair loss. To the point that a petition to demand the return of the old formula then collected more than 170,000 signatures.
A criminal investigation for aggravated deception, homicide and involuntary injuries and endangering the lives of others had been opened in Marseille in March 2018, resulting in the indictment made public on Wednesday.
This announcement was welcomed by Marie-Odile Bertella-Geffroy, a lawyer representing some 3,000 Levothyrox patients.
“It has been several years since the judicial investigation has been open and we have been waiting for this indictment. We said to ourselves that it would never happen. My clients no longer believed in it. Finally it is moving”, reacted Wednesday this former examining magistrate at the health center of the Paris court, questioned by AFP.
The laboratory indicates for its part that it wants to “provide all necessary clarification in order to establish that no criminal offense of any kind has been committed.”
Merck also adds in its press release that this indictment “in no way concerns the quality of the new formula of Levothyrox”.
– Court of Cassation –
This is one of the many aspects of this case. In June 2019, the ANSM, the French National Agency controlling the safety of medicines, had carried out a study on more than two million patients and concluded that the switch to the new formula of Levothyrox had not caused “problems of serious health”.
This agency is now the target of a collective action by some 1,100 plaintiffs for “lack of vigilance” and “lack of anticipation”, an action launched in September 2021 before the administrative court of Montreuil (Seine-Saint-Denis).
In another part, in civil matters, the Court of Cassation rejected in March this year the appeal of Merck, which had been ordered 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 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’.
In France, some 2.5 million patients use the new Levothyrox formula daily, according to Merck, and less than 100,000 patients are now treated with the old formula imported into France since the end of 2017 under the name Euthyrox.
The distribution of the old formula, which was to stop in 2020, was finally extended several times and will continue at least until the end of 2022.