Over the years, we have seen some victims, both in Belgium and France, go to court to engage the liability of the producer of a drug, on the grounds that the leaflet accompanying the health product was incomplete and / or inaccurate. For many victims, a lack of information on the side effects likely to be incurred when taking a drug or on possible contraindications is comparable to a “product defect”.
An incomplete notice is not automatically indicative of a product defect. However, it can lead the judge to consider that the product does not present the security that one can legitimately expect. Case law has thus retained the defect of a health product in the presence of a lack of information, in particular when serious risks were not mentioned in the instructions. This would be the case for the absence of mention of possible irreversible hearing disorders or the lack of information on the serious harmful effects likely to appear following injections of a product intended to fill the wrinkles. It then only remained for the victims to demonstrate the existence of a causal link between the defect of the product and their damage in order to obtain success.
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