On 11 May 2022, the Paris Court of Justice (Tribunal Judiciaire) ruled against the group action brought by the association RESIST against the pharmaceutical laboratory, declaring it inadmissible.
The decision comes up within the proceedings regarding the Essure® contraceptive implant, marketed since 2002 by the company Conceptus, which was bought by the laboratory Bayer Healthcare. As a precaution, the device had been withdrawn from the market in 2017 in France and in 2018 in the United States. The implant, namely made of heavy metals such as iron, tin and iridium, is said to be the cause of “gynaecological, ophthalmic and gastroenterological problems, as well as significant muscle and joint pain”.
After having counted 3700 victims, and in reaction to the increase in undesirable effects that the association Réseau d’Entraide, Soutien, Informations sur la Stérilisation Tubaire (RESIST) was created to help women who had opted for the Essure® permanent contraceptive device in France.
On 8 March 2018, RESIST filed a group action lawsuit seeking recognition of the device’s defectiveness and the characterisation of a lack of vigilance on the part of Bayer. In support of its claim, it invoked 19 individual cases of women who had used the ESSURE medical device for permanent sterilisation, fitted between 2007 and 2016 and who had presented various problems between 3 days and 1.5 years after the device was fitted.
To determine whether the action was admissible, the court had to verify that these 19 cases were similar or identical situations with a common origin.
In support of the similarity of the situations, the association argued that these 19 cases represented victims of the same defective product, marketed by the same laboratory, and having caused individual damage to each of the victims. However, the court rejected this similarity by listing a series of discrepancies such as the date of implant insertion, the time between the insertion of the implant and the appearance of the disorders, the conditions under which the implant was inserted and removed, the patients’ medical history and the nature of the disorders claimed.
Moreover, the court challenged the common origin of these situations, as most of the patients presented in the test cases had already suffered, before the implant was inserted, from health problems similar to those attributed to the Essure device. Furthermore, contradictory scientific studies were invoked by the plaintiff and the defendant as to the danger of the device, one confirming the potential for undesirable side effects, the other rejecting it. Thus, the court noted that, of the 19 victims presented by the association in support of its claim, 13 had been the subject of a judicial medical expertise concluding that there was no causality link between the implant and the victims’ pathologies, and 4 others had not been the subject to any medical expertise.
Consequently, for reasons relating to the dissimilarity of the situations and the absence of demonstration of a common origin, the court declared the group action inadmissible.
The decision is to be confronted to the settlement Bayer Healthcare would have concluded, in April 2022, for 1.6 billion dollars with the victims of the Essure device, in view of the side effects that were attributed to it.