In 2020, the pharmaceutical company Merck was sentenced to pay damages. Patients had complained about side effects after a new composition of a thyroid drug. Now further investigations begin. The company further denies consumer deception.
The judiciary in France has opened further investigations against the French branch of the German pharmaceutical company Merck for “serious deception” in connection with the formula change of the thyroid drug Levothyrox. The head of Merck in France had been heard by a court in Marseille, the French branch said. As a result, “the investigating judge decided to initiate preliminary proceedings against the Merck company for serious fraud.”
The investigations “in no way affect the quality of the new Levothyrox formula,” the laboratory assured. It wanted to “make all the necessary clarifications to ensure that no criminal offense of any kind had been committed”. On the other hand, the investigations were related to the type of information “at the time of the switch from the old to the new formula in 2017,” the company said.
In 2018, a criminal investigation was launched into aggravated fraud, negligent homicide and negligent bodily harm. In the civil part of the case, a court in France rejected an appeal by Merck in March this year after it had been sentenced to pay damages for side effects of Levothyrox. The Court of Cassation ruled at the time that if a manufacturer changes the composition and does not “explicitly indicate this in the package leaflet”, he is in breach of his duty to provide information.
In 2020, Merck KGaA was sentenced to millions in damages for non-reported side effects of the hormone replacement drug Levothyrox. In the first instance, the class action was dismissed. Between 2017 and 2018, around 31,000 users complained about the new composition of the drug. The plaintiffs sought compensation for unreported side effects of levothyrox, including headache, insomnia and dizziness. Merck had denied the allegation of consumer deception.
Levothyrox was launched in France in 2017 with a new formulation. The pharmaceutical company thus complied with a request from the French drug safety authority that the drug should become more reliable against hypothyroidism. About 2.5 million people used it.
