The German pharmaceutical company Merck has been ordered to pay damages in France because of a change in the composition of its thyroid drug Levothyrox.
The Court of Cassation in Paris confirmed on Wednesday a decision by the Court of Appeal in Lyon. Merck must now pay each of the more than 3,000 plaintiffs €1,000 ($1,100) in damages. They had accused Merck of not sufficiently informing them about the side effects of the changed composition of the drug.
The Court of Cassation came to the conclusion that the pharmaceutical manufacturer had mentioned the new ingredients on the package leaflet as required. However, the small print had not been sufficient to properly inform the patients about the changed formulation.
Without that information they would not have been able to counteract the side effects and consult a doctor. In this respect, they had suffered non-material damage.
The pharmaceutical company denied the accusations. Doctors and pharmacists, as well as Merck itself, had provided information about the reformulation, the company explained. According to Merck, the vast majority of those affected made the transition to the new mixture well.
Merck had developed the new composition at the request of the French medicines authority ANSM.
This new formula was available in pharmacies from the end of March 2017. Some patients complained about adverse side effects including fatigue, hair loss or weight gain.
Around 3 million people in France rely on the drug.
