An appeal trial opens this Thursday at the Lyon district court where more than 3,300 plaintiffs dismissed at first instance will try to obtain satisfaction against the Merck laboratory, manufacturer of the drug Levothyrox.
The Merck laboratory was summoned on appeal by 3329 of the 4113 complainants dismissed in March 2019, for “lack of information” when the new Levothyrox formula was marketed in 2017. All parties are expected this Thursday at 1:30 p.m. at the Lyon district court for a reopening of the file.
€10,000 per complainant
The court had ruled at first instance that the German laboratory (whose French head office is based in Lyon) had committed “no fault” when changing the formula of Levothyrox: the law prohibiting it from communicating directly with patients, that -it would indeed have done what was necessary to inform the French pharmacies. However, 3,329 patients do not agree and are once again claiming €10,000 in damages for the moral damage caused by the new formula of the drug, i.e. a total envelope of €33 million.
As a reminder, the new formula of Levothyrox, intended to regulate thyroid problems, was put on the market in March 2017. After which, the ANSM has identified 17,000 side effects (weight gain, hair loss, nausea, dizziness, etc.) in 31,000 patients. However, the magistrates ruled at first instance that “the quality and therapeutic value of the new formula drug” were “certain”, but also that the leaflet contained information “sufficiently precise and relevant”.
Better understand the role of the thyroid and the Levothyrox crisis
In 2018, Dr. Magali Caucol-Andre was the guest of our show Questions to Experts. Endocrinologist at the Hotel Dieu hospital in Paris, she explained to us that there were a number of alternatives to replace Levothyrox in a case where the patient could not bear the new formula and that these side effects probably did not result a dosing problem.
Could the Levothyrox crisis come from a lack of patient follow-up? “Not at all,” she replied. It is our duty to listen to what patients tell us. They all had between one and three symptoms with the new Levothyrox formula, I think you really have to listen to them”. According to Dr. Cocaul-André, these symptoms of intolerance were not the result of a dose problem: “Their assessment was perfect,” she explains. “Their levels were the same with the old and new formula, so there’s something else” to explain these side effects. Something that the Lyon district court will try to define today.
.
