This Monday, December 3 opens an extraordinary trial. More than 4,000 plaintiffs attack the Merck laboratory for “lack of information” on the new formula of Levothyrox, a drug for thyroid problems.
“Levothyrox is a drug with a narrow therapeutic margin, that is to say that any change has repercussions. This scientific data is known to Merck, but the company wanted to save money on patient information” . Me Christophe Lèguevaques, plaintiffs’ lawyer in the Levothyrox case, accuses the Merck group of a “lack of information” on the new formula of the drug. The lawsuit, brought in civil by 4,113 consumers of thyroid treatment, opens this Monday, December 3 in Villeurbanne, just next to Lyon.
“I thought it was cancer”
The Levotyrox affair began in February 2017, when the drug’s formula was changed at the request of the ANSM. The lactose has been replaced by mannitol, in order to guarantee the stability of the product over time. Problem: many patients have experienced undesirable side effects (fatigue, headaches, insomnia, dizziness, joint and muscle pain or even hair loss).
“I thought I had cancer, I was in a really bad psychological state. I had tests and my TSH (hormone that regulates the secretion of thyroid hormones, editor’s note) had fallen to a very critical threshold”, says Aude, 32, who has been living without a thyroid for more than 10 years. “I had been doing well for ten years and overnight, everything collapsed,” laments the young woman.
10,000 euros claimed for each plaintiff
A total of 17,000 cases of side effects were recorded, of which 5,062 were classified as serious, and more than 500,000 people abandoned the new formula of the drug. A fixed compensation of 10,000 euros is claimed for each plaintiff.
“Has Merck failed in its duty to inform? No, we are categorical”, defends in AFP the legal director of the pharmaceutical group Florent Bensadoun. He indicates that an “extremely broad” communication plan consisted of sending “300,000 communications by post, fax and email, to 100,000 health professionals” at the time of the launch in France of the new formula.
Three million patients take this drug
In total, three million patients take this drug in France. And while some are now sourcing from abroad, the contested formula is going to be rolled out in 21 EU countries from 2019, drastically reducing treatment options. In Switzerland, better communication and the existence of drug alternatives have made it possible to switch to the new formula of Levotyrox without any complaint being lodged for the moment.
Located at the base of the neck, the thyroid is a small gland controlled by the pituitary gland. Sometimes it produces too many hormones, causing hyperthyroidism. Conversely, hypothyroidism is the inability of the thyroid gland to produce enough thyroid hormones.
Thyroid hormones
Thyroid hormones are very important because they regulate the metabolism of cells in our body, control muscle energy and body temperature, modify mood, affect heart rate and motricity of the digestive tract, have a role in the use and transformation of carbohydrates, lipids and proteins from food, and participate in the growth and development of the body in children. Thyroid dysfunction affects nearly 10% of the French population.
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