"A criminal trial in the near future": the indictments of Merck and the ANSM confirmed on appeal in the Levothyrox case

"The investigating chamber (...) has, in accordance with the requests of the public prosecutor, rejected the three requests for annulment of their respective indictments filed by the counsel for the companies Merck Serono, Merck Santé (the two entities responsible for the development and distribution of Levothyrox, Editor's note) and the ANSM (National Agency for the Safety of Medicines and Health Products, Editor's note)" , according to three judgments handed down on Wednesday, May 7.

"The Court of Appeal's decision provides a damning inventory of the charges against Merck and the ANSM. The motivation for this decision could be that of a correctional judgment. This is a major turning point in the case which paves the way for a criminal trial in the near future," rejoices Nice lawyer Jean-Denis Flori, who represents several hundred clients throughout France.

"Merck has committed no offense"

"We regret this decision and firmly maintain that Merck has not committed any infringement. Neither the quality of the drug nor the information given to patients during the transition from the old to the new formula of Levothyrox allows us to implicate the companies of the Merck group in France," Merck reacted in a press release sent to AFP, the company specifying that it would appeal to the Court of Cassation.

"An appeal in cassation does not have suspensive effect, so they can do what they want. That is to say, it does not suspend the execution of the contested decision," warns Mr. Flori.

Cascading side effects

The case, which has given rise to several legal proceedings, began in 2017 with the arrival on the French market of a new formula of Levothyrox, a treatment indicated in cases of thyroid disorder or ablation.

The new composition of Levothyrox, which was then used daily, according to Merck, by 2.5 million patients in France, included the same active ingredient, levothyroxine, but with new excipients.

Between March 2017 and April 2018, some 31,000 patients suffering from headaches, insomnia, dizziness and other side effects blamed the new formula, leading to the opening of a criminal investigation in Marseille in March 2018.

The ANSM was indicted in December 2022 for "deception", a month and a half after that of the French subsidiary of Merck, for "aggravated deception".

The distribution of the old formula, imported into France since the end of 2017 under the name Euthyrox and which was due to end in 2020, has been extended several times, including for 2024 and 2025.