The Court of Cassation on Wednesday, March 16, dismissed the appeal of the German pharmaceutical laboratory Merck, which in 2020 had been ordered by the Lyon Court of Appeal to reimburse more than 3,300 Levothyrox-treated claimants who suffered side effects as a result of a change in the formula.
In its judgment, which definitively puts an end to these proceedings, the court confirms that, “when the composition of a drug changes and this change in formula is not explicitly stated in the package insert, the manufacturer and operator may be accused of lack of information”can “cause moral damage”†
Individual compensation of 1,000 euros
At first instance, in March 2019, the Lyon judges dismissed any infringement committed by Merck – a Lyon-based subsidiary of the German group Merck KGaA – in the launch of the new Levothyrox in 2017.
As of June 2020, 3,329 consumers of this drug had finally been admitted on appeal for a lack of information from the pharmaceutical group in the distribution of a new formula of this drug prescribed for hypothyroidism.
The Court of Appeal recognized ” an error ” and convicted Merck for “moral damage” with individual damages of 1,000 euros, a total of more than 3.3 million euros, while the plaintiffs claimed 10,000 euros per person.
Headache, insomnia and dizziness
The drug’s new formula, which modified certain excipients to give the product more stability, was accused between March 2017 and April 2018 by about 31,000 claimants suffering from headaches, insomnia or even dizziness.
During the appeal process, the pharmaceutical company reaffirmed that it could not inform patients directly, arguing that the law prohibits this. But according to the court, the laboratory “had a legal obligation to inform the patients directly, in particular through the box and the package insert”†
The Court of Cassation, in turn, ruled that: “The mere mention of mannitol and citric acid in a dense text printed in small letters is insufficient to inform patients about an evolution of the formula”†
Likewise, with regard to immaterial damages, the court considers in its finding that, “Because they were not aware of the evolution of the drug’s composition, the users could not handle it” immediately to side effects. “They suffered temporary moral damage as a result, which lasted until they became aware of this change in formula”†
Criminal case still pending
“First of all, it is a relief, because everyone feared partial cassation, but the ruling 100% confirms the ruling of the court”welcomed the plaintiffs’ lawyer, Christophe Lèguevaques, to Agence France-Presse, “affirmation of responsibility” from Merck and the recognition of “fact that plaintiffs suffered moral damage”†
Merck has for his part “note taken” of this “attitude”but complained in a statement “that no medical expertise has been ordered and performed † to confirm whether or not there is a causal relationship between the switch to the new Levothyrox formula and the reported symptoms”†
If this extensive proceeding is now closed, the Levothyrox case will be the subject of a criminal investigation against X for alleged acts of aggravated deception, manslaughter and involuntary injury and endangering the lives of others. It was opened in 2018 and is still under investigation by the health department of the tribunal de grande instance of Marseille.
In June 2019, the National Agency for the Safety of Medicines and Health Products published a survey of more than two million patients, which concluded that switching to the new Levothyrox formula does not “serious health problems”†
The agency is now the target of a class action for “lack of vigilance” and “lack of anticipation” of some 1,100 plaintiffs, filed last September in the Montreuil Administrative Court.
2.5 million patients take Levothyrox
In France, according to Merck, about 2.5 million patients take the new Levothyrox every day and less than 100,000 patients are now treated with the old formula, which has been imported since the end of 2017 under the name Euthyrox.
The distribution of the old formula, which was to stop, has been extended several times and will continue at least until the end of 2022, while the diversification of the therapeutic offer with other laboratories continues: there are six other levothyroxine drugs on the market.
Merck ensures that “the transition to the new formula has taken place in more than 40 countries around the world † without generating a noticeable increase in the number of reported side effects”†