On 29 January 2019, in an instance brought by a victim in the infamous case of defective (Poly Implant Prothèse) PIP breast implants, the Administrative Court of Montreuil held the French State liable, considering that AFSSAPS, the predecessor of the current National Agency for Medicines and Health Products Safety (ANSM), did not “take the necessary control and investigative measures” between April and December 2009.
The Court was requested to rule upon the State’s liability in the years which preceded the suspension of placing the implants on the market, recorded in March 2010, by a decision of the General Director of the AFSSAPS due to an abnormal rate of breakages and the use of a gel “different from that declared at the time of placing on the market”.
The Court recognised the liability of the State given that the vigilance data for 2008 had already shown a significant increase in PIP incidents and that these data should have been usefully processed as from April 2009, when “these incidents were brought to [AFSSAPS] attention”. The Court concluded that the AFSSAPS wrongfully failed to act between April and December 2009, and thus held the State liable on public health grounds.
This case follows many other cases lodged by victims of defective PIP implants. The German notified body, TÜV, was recently sentenced to compensate more than 400 Swedish victims.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2018 Issue (Thomson Reuters).
This article was co-authored by Thanutshika Jeyarajah.