Ending a five-year saga, France’s highest court ordered Merck KGaA to pay more than $3.6 million to more than 3,000 patients to settle a long-standing dispute over the reformulation of one of his medications.
The French High Court, the Cour de cassation, was Merck’s last resort to appeal its case.
In March 2017, Merck KGaA removed lactose from the drug, a widely used replacement drug for the hormone thyroxine in patients with hypothyroidism, in an effort to make it more tolerable. Merck KGaA then replaced the lactose with mannitol and citric acid. The change, according to plaintiffs’ attorneys, caused patients serious side effects such as memory loss, hair loss, weight gain and even thyroid cancer. On top of that, patients claimed that the drug was no longer as effective.
The new formulation had been requested by the ANSM in 2012, according to Reuters. Merck KGaA denied at the time making any major changes to the drug, citing only “very slight changes” to some non-active ingredients under ANSM requirements. The pharmaceutical company also claimed that the newly revised formula was “bioequivalent” to the original and would work the same way. However, the French group AFMT (the association French for Thyroid Patients, or the French Association of Thyroid Patients) disputed the finding, saying the new formulation of the drug had “anomalies”.
Then-health minister Agnès Buzyn made the old formula, now known as Euthyrox, available after widespread furor. Half of the 130,000 boxes put back on the shelves of pharmacies sold out in two days.
Merck KGaA did not respond to a request for comment.
The pharmaceutical industry must pay 1,000 euros each, or $1,110.97, to the more than 3,300 plaintiffs who remained on the case. And that amount was only a tenth of what the plaintiffs’ lawyers originally wanted – 10,000 euros per person.
French justice clarified in its judgment that “when the composition of a drug changes and this change of formula is not explicitly indicated in the instructions, the manufacturer and the operator can be blamed for a lack of information” .