Levothyrox: Merck laboratory condemned for lack of information

Merck's legal director, Florent Bensadoun, leaving the Lyon Court of Appeal on June 25, 2020. JEFF PACHOUD / AFP

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The new formula of the drug prescribed against hypothyroidism was incriminated between March 2017 and April 2018 by some 31,000 patients suffering from headaches, insomnia, dizziness, etc.

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At first instance, the Lyon judges had ruled out any failure by the pharmaceutical laboratory in the launch in 2017 of the new Levothyrox . But the Court of Appeal recognized this time “a fault” of Merck during the change of formula of his treatment against hypothyroidism. 

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

One thousand euros for each of the 3,329 complainants

Chantal Garnier is president of the French Association of Thyroid Patients (AFMT). According to her, it is a first step, but the patients expect more, and it is not a question of financial compensation. "  For the association and for the patients - we are talking about all the patients in France - it is already a first step that Merck recognizes that there has been a problem with the new Levothyrox formula  ", underlines- she.

The German laboratory, whose headquarters in France is in Lyon, was ordered Thursday to pay 1,000 euros to each of the 3,329 plaintiffs, for "  moral damage  ", or more than 3.3 million euros. They claimed 10,000 euros each. “  I still ask myself questions: 1000 euros for a sick life with what they have experienced, what does this mean? It's a little bit aberrant, she points out. There is something else to expect. I think that if the truth were revealed about what happened with the new formula, people might be less reluctant about this drug. Because now, to make them swallow another thyroid hormone, it's not that simple. We want the truth. We need the truth about this drug. We are entitled, sick, consumers - 3 million patients at the time in 2017 - to know the truth about this medicine.  "

A “  totally incomprehensible  ” decision for Merck

But the matter should not stop there. The legal director of Merck in France Florent Bensadoun has indeed announced the appeal of the company in cassation, judging this decision "  completely incomprehensible  ". The judicial debate is not closed, this decision is in total contradiction with the decision rendered at first instance by the Lyon district court which had recognized a relevant information system and compliant with the regulatory framework in force  ", a he recalled.

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