Link between a drug and tumors: Bayer, Sandoz and Viatris condemned in civil proceedings in France, a first

By The New Obs with AFP

Published on June 2, 2025 at 9:03 p.m.

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A woman suffering from meningiomas (brain tumors), after taking Androcur for two decades, has won a civil lawsuit against three laboratories manufacturing this hormonal treatment and its generics , a first.

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"Because of Androcur, I had five brain tumors. I have four left."

"The court finds SAS Bayer HealthCare, SAS Sandoz, SAS Viatris Santé (...) liable for the damages suffered" by the patient, write the judges of the Poitiers court in their decision consulted by AFP, sanctioning a failure to provide information on the risks of the drug.

The laboratories (97%), as well as the victim's doctor (2%) and pharmacist (1%), are jointly and severally ordered to pay him approximately €325,000, including €20,000 for moral damages and €305,000 for loss of opportunity. This compensation is accompanied by partial provisional enforcement, for the laboratories, of 25%.

Multiplication of procedures

The Bayer group , "disagreeing with the court's decision" which "goes against" expert reports that ruled out "any fault or lack of information" about Androcur, announced that it would appeal. The 55-year-old plaintiff, who took this drug and then its generics between 1991 and 2013 to treat polycystic ovary syndrome , developed several meningiomas, non-cancerous tumors of the membranes surrounding the brain that can cause serious neurological disabilities.

Now suffering from visual and memory problems, as well as significant fatigue, she claims to have never been warned of the risks of the treatment, even though a scientific article in 2008 suggested a link between the molecule (cyproterone acetate) and the appearance of meningiomas.

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The damage caused by the pathology she developed, related to the meningiomas diagnosed in 2013, "is indeed the result of the drug treatments based on cyproterone acetate that she continued to take" until that date, "particularly from 2008" , the judges wrote. According to Romain Sintès, lawyer for the fifty-year-old, this decision opens the door to "a multiplication of procedures" for compensation.

"We are currently preparing 750 files," of which "around a hundred are currently being assessed or have been the subject of initial requests and legal proceedings," confirmed Charles Joseph-Oudin, counsel for a victims' association, Amavea, welcoming an "essential" decision. Criminal complaints have also been filed in Paris, according to the counsel, and proceedings have been initiated before the administrative court of Montreuil (Seine-Saint-Denis) to hold the State liable.

Androcur was prescribed to a large number of women from 1980 onwards as a contraceptive pill , to treat acne and hair problems, or to relieve the symptoms of endometriosis . After the 2008 alert, the risk of meningioma was introduced into the leaflet in 2011 by the French National Agency for the Safety of Medicines (ANSM), before its scientific confirmation, in a report submitted in 2018 to the Ministry of Health, led to a drop in prescriptions.

At the hearing in April, Bayer blamed the ANSM, which it said was slow to react, and generic manufacturers, as the patient had only taken Androcur until 2004, before continuing her treatment with Sandoz and Viatris products until 2013. The judges, however, ruled that Bayer, which only informed specialists about the change in the Androcur leaflet and not general practitioners or pharmacists, had failed in its duty to inform patients.

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The same goes for Viatris and Sandoz, which only changed the instructions for their generics after 2013, the date of the plaintiff's meningiomas diagnosis. "Despite what the laboratories told us, they had the means to communicate about particularly serious, disabling and, above all, irreversible side effects, which they had known about since 2008," points out Mr. Sintès.

"It's a big victory," added her client, satisfied with the responsibilities attributed to the laboratories, more than to her doctor and pharmacist. "I was afraid they would pay for themselves," she told AFP, "more ready than ever" to continue her fight on appeal.

Le Nouvel Observateur

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