Merck KGaA said yesterday it had been placed under formal investigation by a French court for possibly issuing misleading information regarding its thyroid drug product Levothyrox.
The ruling by a judge in the French city of Marseille did not concern in any way the new formula for the Levothyrox product, but the way the company provided information when changing from the old to the new formula, Merck said in a statement.
It is part of criminal proceedings launched in March 2018.
Merck has already been condemned in civil litigations for not providing sufficient information when changing the drug’s formulas.
Mario-Pierre Stasi, the lawyer for Merck, said yesterday the company would continue to co-operate with authorities on the matter and that full legal proceedings must be allowed to run their course.
Merck also confirmed that the Marseille judge had placed the company under court supervision, asking it to pay a deposit of 4.3 million euros and provide a banking guarantee of up to seven millon euros, which its lawyer said was “totally unjustified.”
In March 2022, France’s highest court, the Cour de Cassation, confirmed a 2020 Lyon appeal court ruling ordering Merck to pay 1,000 euros ($982.30) each to compensate more than 3,300 people suffering from thyroid problems in France after it changed the formula of the drug in 2017.
The plaintiffs had accused Merck of not providing sufficient information regarding changes to the product.
They had said Merck’s decision to remove lactose from the drug to make it easier to handle had resulted in side effects such as memory loss, weight gain and palpitations.
Edits by EP News Bureau