The Court of Cassation rejected on Wednesday March 16 the appeal of the German pharmaceutical laboratory Merck, which was sentenced in 2020 by the Lyon Court of Appeal to compensate more than 3,300 plaintiffs treated with Levothyrox who suffered from side effects at the due to a change in formula.
In its judgment, which puts a definitive end to this procedure, the court confirms that, “when the composition of a drug changes and this change in formula is not explicitly indicated in the leaflet, the manufacturer and the operator can be blamed for a lack of information”can “causing moral harm”.
Individual compensation of 1,000 euros
At first instance, in March 2019, the Lyon judges dismissed any breach by Merck – a Lyon-based subsidiary of the German group Merck KGaA – in the 2017 launch of the new Levothyrox.
In June 2020, 3,329 consumers of this drug had finally obtained, on appeal, recognition of a lack of information from the pharmaceutical group in the distribution of a new formula of this drug prescribed against hypothyroidism.
The Court of Appeal recognized ” a fault ” and condemned Merck for “moral damage” with individual compensation of 1,000 euros, a total of more than 3.3 million euros, while the plaintiffs claimed 10,000 euros per person.
Headaches, insomnia and dizziness
The new formula of the drug, which modified certain excipients in order to bring more stability to the product, was incriminated, between March 2017 and April 2018, by some 31,000 plaintiffs suffering from headaches, insomnia or even dizziness.
During the appeal trial, the pharmaceutical company had reaffirmed that it could not directly inform patients, arguing that the law prohibited it from doing so. However, according to the Court of Appeal, the laboratory “had the legal obligation to inform the patients directly, in particular by the box and the leaflet”.
The Court of Cassation for its part rules that “The mere mention of mannitol and citric acid in a dense text printed in small characters is insufficient to inform patients of an evolution of the formula”.
Similarly, with regard to non-pecuniary damage, the court considers in its judgment that, “having not been informed of the evolution of the composition of the drug, its users were not able to cope” immediately to side effects. “They therefore suffered temporary moral damage, which lasted until they became aware of this change in formula”.
Criminal case still pending
“It is first of all a relief, because everyone feared a partial cassation, but the judgment confirms 100% the decision of the Court of Appeal”welcomed to Agence France-Presse the plaintiffs’ lawyer, Christophe Lèguevaques, welcoming “confirmation of responsibility” of Merck and the recognition of “fact that the plaintiffs suffered moral damages”.
For its part, Merck has “taken note” of this “stance”but lamented in a statement “that no medical expertise has been ordered and carried out (…) to confirm whether or not there is a causal link between the switch to the new Levothyrox formula and the symptoms reported”.
If this extensive procedure is now closed, the Levothyrox case is the subject of a criminal investigation against X for alleged acts of aggravated deception, homicide and involuntary injuries and endangering the lives of others. Opened in 2018, it is still being investigated by the health department of the Marseille tribunal de grande instance.
In June 2019, the National Agency for the Safety of Medicines and Health Products published a study of more than two million patients which concluded that switching to the new Levothyrox formula had not caused any “serious health problems”.
The agency is now targeted by a class action for “lack of vigilance” and “lack of anticipation” of some 1,100 plaintiffs, launched last September before the administrative court of Montreuil.
2.5 million patients take Levothyrox
In France, some 2.5 million patients swallow the new Levothyrox daily, according to Merck, and less than 100,000 patients are now treated with the old formula 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 continues with other laboratories: six other levothyroxine drugs are available in the market.
Merck ensures that “the transition to the new formula has taken place in more than forty countries around the world (…) without generating a noticeable increase in the number of reported side effects”.