42 Levothyrox consumers sued the Merck laboratory before the Toulouse tribunal de grande instance. They claim 15,000 euros for anxiety damage and the same amount for moral damage.
“For several months, the patients were unaware that the drug had been changed. It is an extremely painful matter because it concerns a large number of people”, pleads Me Jacques Lévy. Through him, 42 plaintiffs brought proceedings against the Merck laboratory on Monday, September 10, before the Toulouse tribunal de grande instance. They are claiming € 15,000 for the anxiety prejudice and the same amount for non-pecuniary damage, as well as the maintenance of the marketing of the old formula of levothyrox and the realization of an expert report, in order to be able to fix the bodily harm suffered by the patients.
For his part, the lawyer of the laboratory Me Antoine Robert asked the court to reject all of these requests. He believes that the prejudices were not demonstrated in the majority of the cases presented. The Toulouse tribunal de grande instance will deliver its decision on November 5.
Undesirable side effects
The Levotyrox case began in February 2017, when the formulation of the drug was changed. This change consisted of replacing the lactose, which coated the thyroid hormone, levothyroxine, with mannitol. This modification had been requested by the Medicines Agency (ANSM) in order to guarantee the stability of the product over time, which was not the case with the old formula.
Problem: the patients felt unwanted side effects (fatigue, headaches, insomnia, dizziness, joint and muscle pain and hair loss). In total, 17,000 cases of side effects were identified, of which 5,062 were classified as serious and 14 deaths were recorded by the ANSM, without a direct link with the new formula being able to be formally established. According to the Ministry of Health, 500,000 people have abandoned the new formula of the drug.
Nocebo effect
In a report recently handed over to the Minister of Health Agnès Buzyn, the team of Dr Gérald Kierzek and Magali Leo have identified seven recurring problems in this type of crisis. Among them, “the lack of anticipation” of the public authorities, “the absence of reaction to the many signals easily spotted on the Web”, the “badly chosen” moment to communicate, and the “minimization of the feelings of patients and the legitimacy of their reports “. “The nocebo effect was very quickly mentioned to explain the side effects […] Even such an effect cannot disqualify the reality of the complaints expressed by the thousands of patients, ”the report said.
From 2019, the Merck laboratory plans to market the new formula of Levothyrox in 21 countries of the European Union. “Several official expert reports published in recent days have once again confirmed the quality of the new formula of Levothyrox® and reassured the 2.5 million French patients who, for more than a year, have found their thyroid balance thanks to it. This renewed confidence in the new formula of Levothyrox® in France also echoes the positive opinion delivered at European level on July 18, after an in-depth evaluation phase within the framework of the regulatory procedure. aimed at enabling 21 member states to market the new formulation of Levothyrox®, “the company said in a press release.
Availability of the old formula
Spain, where many French patients dissatisfied with the new formula had gotten into the habit of getting supplies, is also concerned. In fact, the thyroid drug will no longer be available anywhere in Europe, since the 7 countries not concerned by the measure, such as Italy, market slightly different compositions. The Council of State also rejected the request of French patients who urgently demanded measures to ensure the availability of the old formula. Today, four competitors to the new formula Levothyrox are available: L-thyroxin Henning, Thyrofix, L-thyroxine SERB and TCAPS.
In June, the Toulouse Court of Appeal confirmed the conviction handed down in November which ordered Merck laboratories to deliver “without delay” the old formula of the drug to 25 patients in Haute-Garonne. The third pharmacovigilance report on Levothyrox, unveiled in early September by the Medicines Agency, still does not explain the wave of adverse reactions attributed by some patients to the new formulation of this drug for thyroid.
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