The French branch of the German pharmaceutical group Merck announced on Wednesday that it had filed charges in a “fraud” case in the criminal part of a case involving a change in the composition of the drug levothyrox, which is used to treat hypothyroidism.
“The President of Merck in France was heard on Tuesday in a criminal court in Marseille, and “the investigating judge decided to charge Merck with aggravated fraud,” the group said in a statement.
The issue is related to “the way information was presented during the transition from the old dosage form to the new dosage form in 2017” for this drug, according to the company.
And complained about the new drug combination, which was designed to provide greater product stability, between March 2017 and April 2018, about 31,000 patients suffered particularly from headaches, insomnia or dizziness.
In 2018, a criminal case was opened for fraud, murder and unintentional infliction of bodily harm.
The company clarified that “this case has nothing to do with the effectiveness of the new formulation of levothyrox”, noting that it wants to “provide all the necessary explanations to prove that no criminal offense was committed.”
In the civil case, the Court of Cassation in March rejected an appeal by a group sentenced in 2020 to pay compensation to more than 3,300 users who experienced side effects after the formula change.
In its ruling, France’s highest court ruled that “when the composition of a medicinal product has changed and this formula change is not explicitly stated in the prospectus, the manufacturer and the investor can be accused of not having” information that could “cause non-pecuniary damage”.
