A global pharmaceutical company accused of cheating after changing drug formula for hypothyroidism

The French subsidiary of the German pharmaceutical group “Merck” announced Wednesday its indictment of a case of “fraud” in the criminal part of a file relating to the modification of the composition of the drug Levothyrox, used to treat hypothyroidism.

“The president of Merck in France was heard “on Tuesday at the Criminal Court of Marseille and” the investigating judge has decided to accuse Merck of aggravated fraud “, reads in a press release from the group.

This issue is related to the “method of presenting information that was developed during the transition from the old formulation to the new formulation in 2017” for this drug, according to the company.

And complaining about the new combination of the drug, which was developed to provide greater stability to the product, between March 2017 and April 2018, some 31,000 patients suffered mostly from headaches, insomnia or dizziness.

In 2018, a criminal investigation was opened for fraud, murder and accidental injury.

The company made it clear that “this case is not in any way related to the effectiveness of the new formulation of Levothyrox “, noting that he wanted to” provide all the necessary clarifications in order to prove that no crime of any kind has been committed “.

In the civil case, the Court of Cassation in March rejected an appeal by the group which in 2020 was sentenced to pay compensation for the more than 3,300 users who experienced side effects after changing the formula.

In its ruling, the highest French court held that “when the composition of a drug has changed and tale formula change is not expressly indicated in the prospectus, the producer and the investor may be accused of lacking “information which could” cause non-pecuniary damage “.