The Court of Cassation rejects Merck’s appeal, the lab will have to compensate users

Merck lost, the Levothyrox victims won. The Court of Cassation on Wednesday rejected the appeal of the German pharmaceutical company which had been sentenced in 2020 by the Lyon Court of Appeal to compensate 3,329 consumers subject to side effects following a change in the formula of the drug. At that time, the court recognized a lack of information from Merck – a Lyon-based subsidiary of the German group Merck KGaA – in the distribution of a new formula of this drug prescribed against hypothyroidism.

In its judgment, the Court confirms that “when the composition of a medicinal product changes and this change in formula is not explicitly indicated in the leaflet, the manufacturer and the operator may be accused of a lack of information”, capable of “causing moral harm”. And for this famous moral damage, the laboratory will have to pay compensation of 1,000 euros.

The criminal case for manslaughter and manslaughter

The new formula of the drug, modifying some of its excipients in order to bring more stability to the product, was incriminated, between March 2017 and April 2018, by some 31,000 patients suffering from headaches, insomnia, dizziness, etc.

During the appeal trial, the pharmaceutical company kept the same line of defense and reaffirmed that it could not directly inform patients, arguing that the law prohibited it from doing so. But according to the Court of Appeal, the laboratory “had the legal obligation to inform the patients directly, in particular by the box and the instructions”.

In addition, in criminal matters, the case is the subject of a judicial investigation against X for alleged acts of aggravated deception, homicide and involuntary injuries and endangering the lives of others. She is educated by the health center of the TGI of Marseille.