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The Merck laboratory is accused of having hidden the side effects of the new formulation of the drug Levothyrox prescribed against hypothyroidism.
New episode in the Levothyrox soap opera. This Wednesday, the French subsidiary of the German laboratory Merck announced its own indictment for “aggravated deception” in the case of the change of formula of Levothyrox – a drug against thyroid disorders. The laboratory had indeed been accused of having hidden the side effects.
Headaches, insomnia and dizziness
While in 2019 the president of commercial activities France of the Merck laboratory assured that “90% of patients had no problem with the new Levothyrox“, justice decided this Tuesday on the side of the patients.
“The president of Merck in France was heard“Tuesday in Marseille, explains the group in a press release, hearing at the end of which”the investigating judge has decided to indict Merck for aggravated deception.”
According to the company, this indictment follows the “information procedures put in place at the time of the transition from the old to the new formula in 2017“, for this drug prescribed against hypothyroidism.
And for good reason “when the composition of a drug changes and this change in formula is not explicitly indicated in the leaflet, the manufacturer and the operator can be blamed for a lack of information“, can “cause moral harm“, specifies the highest court of civil law.
In 2020, the group had indeed been definitively condemned by the Court of Cassation to compensate more than 3,300 people who suffered from side effects (headaches, insomnia, dizziness, etc.) following the change in formula.
The group had justified itself by specifying that the modification of the drug followed “at a request from the Health Agency” and that it was intended to bring more stability to the product.
Merck must pay 4.3 million euros
According to the newspaper The world, the Merck laboratory must now pay a colossal deposit – nearly 4.3 million euros – to be paid in two instalments, in December and January (4 million for fines and compensation for damage and 300,000 euros to guarantee its legal representation and pleadings). It remains to be seen how and when the victims will be able to be compensated.
Gérard Bapt, medical adviser of the French Association of Thyroid Patients welcome this indictment and challenges the laboratory but also the health authorities regarding the management of this file: “It is appalling to note today that the Merck laboratory, the Medicines Safety Agency (ANSM) as well as the ministry have locked themselves in denial which has aggravated the torments of very many patients. This health crisis, which could have been avoided by simply examining past identical crises concerning levothyroxine, shows that we are far from the theme displayed by the authorities of the “patient actor of his health”. Health democracy remains to be built!“.