Three French laboratories were ordered to pay more than 300 thousand euros to a patient with brain tumors attributed to Androcur medicine, for “failure in the duty of information”. It was a case considered unprecedented in France.
A Bayer Healthcare, Sandoz e Viatris Health were, this Monday, sentenced to pay more than 300 thousand euros of compensation for Tumors attributed to the medicine Androcur.
“The court declares the responsibility of Bayer Healthcare, Sandoz and Viastris Santé for the damage suffered,” wrote the judges of the Poitiers Civil Court, who also condemned the doctor’s doctor and pharmacist.
According to the complainant lawyer, Romain Sintèsthis decision may pave the way to a similar “process multiplication”.
Concerned is the hormonal medicine Androcur. The woman, currently 55, took for over 20 years the medicine prescribed to treat the hyperpilosity and endometriosis.
Can cause neurological deficiencies
Since 2013, the woman developed multiple meningiomasthat is, benign tumors of the membranes surrounding the brain and can cause severe neurological deficiencies.
Currently, the patient suffers from visual disturbances, memory and extreme fatigue and ensures that It was never informed about the associated risks to the drug.
Still, as early as 2008, a scientific article suggested a link between the active substance of Androcur (ciproterone acetate) and the development of meningiomas.
The causal relationship was confirmed in 2018 and, according to the court, “the damages effectively result from the followed treatments” by the patient.
During the hearing, held in April, pharmacist Bayer claimed that the patient only took Androcur until 2004, and then passed to generic medications.
Bayer, Viatris and Sandoz condemned
However, the judges concluded that the Bayer “did not take all measures Necessary to ensure rapid and effective information with consumers, current or old users of Androcur ”, violating the duty of information.
As to Viatorwhich produces a generic version of the drug, the court considered that “did not make the proper effortssince 2008 and, above all, from 2011, to allow consumers to know the risk of meningiomas associated with the prolonged drink of the drug. ”The same assessment was applied to pharmacist Sandoz.
The laboratories were held responsible for 97% of the total amount of compensation, of about 325 thousand euros, to pay jointly with the doctor and the pharmacist, being 25% of this amount required with immediate effects.
For the complainant lawyer, this is, so far, “the first decision of this type in France” and represents “the recognition of the information failure by the medical community”.
“Despite what the laboratories told us, they had the means to warn of particularly serious, disabling and irreversible side effects, they have known since 2008,” Sintès told France Presse.
