Merck KGaA under investigation by French court due to thyroid drug
Merck KGaA has been placed under formal investigation for “aggravated deceit” by French courts, after being charged with failing to inform patients that changes to Levothyrox (levothyroxine sodium hydrate) could cause new side-effects.
The origins of the case date back to 2017 when Merck introduced a new formulation of the drug, which is a thyroid treatment that is used to replace the hormone normally produced in the thyroid gland.
After the formulation alteration, thousands of patients complained about adverse effects after taking the treatment. The reported problems included fatigue, memory loss, weight gain, and nausea, among others.
At the time, over 300,000 individuals signed a petition demanding that the formulation change be reversed.
In March 2022, France’s highest court ruled that Merck had to compensate more than 3,300 people users of the drug who had experience side effects following the change of formula. The company was ordered to €1,000 to each of the plaintiffs, thereby upholding the sentence decided by the Lyon Court of Appeal in 2020.
France was the first country where the new formulation of the drug was introduced. At the time of the launch of the updated formulation, there were more than 2.5 million patients receiving the treatment in the country.
The latest case does not relate specifically to the formulation change itself, but to the manner of communication following.
A spokesperson for the company provided a statement to Outsourcing-Pharma on the proceedings: “Based on the case file and following the hearing, the investigating judge has decided to indict Merck’s French affiliate. No judgment has been rendered at this stage. Merck has now full access to the investigation file and will be able to demonstrate that no criminal offences of any kind have been committed in this case.
“Merck intends to keep cooperating with the justice in a fully transparent manner and reaffirms its commitment and dedication to the wellbeing of patients.”
According to the company, the new formulation of Levothyrox (also known as Euthryrox in other countries) has been approved and launched in more than 40 countries. In Europe, more than 18 million patients have been prescribed the treatment.
Not long prior to the case emerging, Merck announced that it had opened a new 2,700-square-meter facility in Martillac, France, for the commercial supply of monoclonal antibodies and other recombinant proteins.