Merck indicted for “aggravated deception” in Levothyrox case

“The president of Merck in France was heard” Tuesday on the well being heart of the Marseilles courtroom, the group introduced in a press launch on Wednesday. On the finish of this listening to, “the investigating decide determined to place Merck on trial for aggravated deception”.

This choice is linked to the “info procedures put in place on the time of the transition from the previous to the brand new method in 2017”, for this drug prescribed towards hypothyroidism, provides the corporate. That is a further step within the authorized drama opposing the laboratory to many sufferers.

Many unintended effects

On the coronary heart of this case: the brand new composition of Levothyrox, which arrived on the French market on the finish of March 2017. This new method nonetheless makes use of the identical energetic ingredient, levothyroxine, however with new excipients, to make its composition extra secure.

Nevertheless, sufferers rapidly complained of many unintended effects: cramps, complications, dizziness or hair loss. To the purpose {that a} petition to demand the return of the previous method had then collected greater than 170,000 signatures (it even has greater than 300,000 at the moment).

A prison investigation for aggravated deception, murder and involuntary accidents and endangering the lives of others was opened in Marseille in March 2018, ensuing within the indictment made public on Wednesday.

This announcement was welcomed by Marie-Odile Bertella-Geffroy, a lawyer representing some 3,000 Levothyrox sufferers: “The judicial investigation has been open for a number of years and we now have been ready for this indictment. We stated to ourselves that it might by no means occur. My purchasers now not believed in it. Lastly it is transferring, “reacted Wednesday this former analyzing Justice of the Peace on the well being heart of the Paris courtroom.

The laboratory signifies for its half that it desires to “present all vital clarification with a view to set up that no prison offense of any type has been dedicated.” Merck additionally provides in its press launch that this indictment “under no circumstances issues the standard of the brand new method of Levothyrox”.

An extended struggle

This is without doubt one of the many points of this case (learn framed). In June 2019, ANSM, the French Nationwide Company for Drug Security, carried out a examine of greater than two million sufferers and concluded that switching to the brand new Levothyrox method had not brought on any ” severe well being issues”.

This company is now the goal of a collective motion by some 1,100 complainants for “lack of vigilance” and “lack of anticipation”, an motion launched in September 2021 earlier than the executive courtroom of Montreuil (Seine-Saint-Denis).

In one other half, in civil issues, the Courtroom of Cassation rejected in March this yr the attraction of Merck, which had been condemned in 2020 to compensate greater than 3300 customers who suffered from unintended effects following the change of method.

In its judgment, the very best French courtroom thought-about that “when the composition of a drug adjustments and this variation in method just isn’t explicitly indicated within the leaflet, the producer and the operator will be accused of a scarcity of ‘info’, able to ‘inflicting ethical hurt’.

Previous and new method

In France, some 2.5 million folks use the brand new Levothyrox method day by day, in accordance with Merck, and fewer than 100,000 are actually handled with the previous method imported into France for the reason that finish of 2017 underneath the title Euthyrox.

The distribution of the previous method, which was to cease in 2020, was lastly prolonged a number of instances and can proceed at the very least till the top of 2022.

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