The French subsidiary of the German pharmaceutical company Merck announced on Wednesday its own indictment for “aggravated deception” in the case of changing the formula of the drug Levothyrox.
The accusation is linked to “information procedures put in place at the time of the transition from the old to the new formula in 2017”, for this prescription drug against hypothyroidism, the company specifies.
The new composition of the drug, which modifies some of its excipients to provide the product with greater stability, was reported, between March 2017 and April 2018, by some 31,000 patients who especially suffered from headaches, insomnia or dizziness.
In 2018, a criminal investigation was opened for aggravated deception, homicide and involuntary injury.
In the civil part of the case, the Court of Cassation had rejected in March the appeal of the group, condemned in 2020 to compensate more than 3,300 users who suffered collateral effects after the change of formula.
In its ruling, the highest French court had considered that “when the composition of a drug changes and this formula change is not explicitly indicated in the package insert, the manufacturer and the operator can be accused of lack of ‘information’, capable of ‘causing moral damage’.
Source: BFM TV
