France’s highest court – la Cour de Cassation – has ordered Merck KGaA to make a payout of over $3.6m to over 3,000 patients. The order will end a five-year dispute concerning the reformulation of one of the company’s drugs. The appeal at la Cour de Cassation was the last chance for the company to make its case.
Merck KGaA removed lactose from the drug in March 2017 – a widely-used replacement treatment for hormone thyroxine in patients diagnosed with hypothyroidism – in an attempt to make it easier to tolerate. The lactose was replaced with citric acid and sugar alcohol mannitol.
According to lawyers working on behalf of the plaintiffs, the replacement caused patients to experience severe side effects, including hair loss, memory loss, weight gain and in some cases, thyroid cancer. Moreover, patients asserted that the treatment was no longer as effective.
The court ruled that ‘when the composition of a medicine changes and this change in formula is not explicitly indicated in the package leaflet, the manufacturer and the operator may be reproached for a lack of information’.
In 2012 – according to Reuters – the new formulation had been requested by French medicines regulator L’Agence nationale de sécurité du médicament et des produits de santé (ANSM).
Merck KGaA had denied that it had made any significant changes to the drug and claimed only ‘very slight changes’ to specific non-active ingredients as part of requirements issued by ANSM.
The company added that the new formula was ‘bioequivalent’ to the original formula and would work in the same way.
Despite the company’s claims, French group l’Association Française des Malades de la Thyroïde, or the French Association of Thyroid Patients (AFMT), countered Merck KGaA’s comments, disputing that the new formulation had ‘anomalies’.
When former health minister Agnès Buzyn made the original formula, Euthyrox, available after a public outcry, half of the 130,000 boxes that were put back on pharmacy shelves sold out within 48 hours.
Merck KGaA is set to pay out just over $1,100 (€1,000) to more than 3,300 plaintiffs who remained involved in the case. This amount is considerably less than the amount originally outlined by the plaintiffs’ lawyers, which was €10,000 per person.