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  • Judges in France faulted pharma giant Merck's French affiliate Thursday for failing to adequately inform patients of changes to a popular thyroid drug, and ordered it to pay compensation to more than 3,300 complainants. The appeals court in Lyon, where the German company's French operations are headquartered, held that "Merck committed an error" in its communication on the matter, a lawyer for the plaintiffs, Christophe Leguevaques, told reporters. Judges ordered Merck to pay each of the 3,329 parties 1,000 euros ($1,121) each. They had asked for ten times that. Some 30,000 people in France reported side effects from a new version of Levothyrox, a drug used to treat underactive thyroids or following surgery for cancer of the organ, which regulates the body's metabolism. France is the world's leading consumer of Levothyrox, with almost three million users, and was the first country where the new version of the drug was introduced in 2017. But after people started reporting side effects, including cramps, dizziness and hair loss, the government moved to restore the old version of the drug to the market. A criminal investigation was launched into alleged misleading of customers, involuntary bodily harm and endangering lives. It is ongoing. According to the plaintiffs, Merck had reneged on a legal obligation to inform users of changes to the drug formula. But the company's legal officer Florent Bensadoun described Thursday's judgement as "totally incomprehensible" and said Merck would lodge a further legal challenge. According to him, the company had fulfilled its obligations by communicating the formula change to medical professionals. The plaintiffs had lost their initial case in a lower court, which found Merck blameless in the matter. "The important thing for the plaintiffs is that their situation, their pain, their misfortune is recognised by justice," said Leguevaques. "Of course we should have been informed, since the slightest change in the formula changes our condition," said 67-year-old Aline Bonanno, one of the plaintiffs. "We will go to the end even if it lasts 20 years, 30 years. I was in bed for nine months and I almost died," she said of the ongoing legal drama. Fellow complainant Beatrice Benzama, 55, said users of the drug felt like "guinea pigs". In June 2019, France's ANSM drug watchdog published the results of a study conducted among some two million patients, which found that the switch to a new formula did not lead to "serious health problems". Merck says about 2.5 million people are using the new version of the drug, and fewer than 100,000 the original. Five alternative medicines are also available on the market. After its introduction to France, the new form of the drug was rolled out in two dozen other European countries, without any problems, according to Merck. It insists that any side effects are "normal and comparable to the old" formula. ag/mlr/sjw/rl
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  • French court faults Merck for lack of information on drug change
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