Rejection of claims based on product liability
BCW based its claims primarily on the manufacturer’s strict liability for damage caused by a defect in a product that it has placed on the market. A defect exists if the product does not offer the safety that may be expected under the given circumstances (Article 6:185 et seq. Dutch Civil Code). In assessing whether the implants were defective, the Court considered, among other things, the implants’ usefulness weighed against the risk of harmful side effects and the nature and severity thereof, whether less dangerous alternatives exist, how apparent the danger was and the extent to which the user had been informed of the risks.
The Court first assessed the complaints relating to ASIA. BCW had submitted various expert reports and referred to the opinions of supervisory authorities to demonstrate a causal link between the ASIA complaints and the implants. Although the existence of these complaints was acknowledged, the Court found that the reports did not prove that the ASIA complaints were caused by the implants. The accusation that Allergan provided insufficient or late information about the risks of ASIA was also unsuccessful. Allergan included the current state of affairs in the product information leaflet for doctors in a timely manner, namely that women with implants may experience systemic complaints and that there is no scientific evidence for a causal link between the ASIA complaints and the implants.
With regard to the complaints relating to BIA-ALCL, the Court left the question of causality open, because a causal link between the complaints and the implants would not automatically imply that the implants were defective. The Court concluded that the implants did not contain any design flaws. Research shows that although the consequences of BIA-ALCL are very serious, the absolute risk of developing it is very low, while the chance of recovery, if detected in time, is very high. Furthermore, textured breast implants also have advantages over smooth breast implants, and alternatives to implants are limited and not without risk. The Court did not find that there was a lack of information either. Given the gradual development of the concept of BIA-ALCL and the uncertainty about the exact causes of this rare disease, there was no reason for Allergan to include information about BIA-ALCL in the product information leaflet for doctors in 2015. Nor did Allergan have to inform the women directly, because a doctor usually discusses the risks with the persons concerned and there is a risk of ‘overwarning’, which could cause unnecessary anxiety amongst women.
Alternative grounds
Allergan was not liable on other grounds either. The Court ruled that Allergan did not act unlawfully by placing the implants on the market. After all, the implants were not defective and Allergan had complied with its information obligations with regard to the risks involved. Nor could Allergan be blamed for not withdrawing the implants from the market before 2018. Until then, the information about BIA-ALCL contained too many uncertainties, and the European regulators had likewise not taken any measures.
Finally, BCW’s reliance on Directive 2005/29/EC on unfair commercial practices (UCP Directive, Article 6:193a et seq. Dutch Civil Code) was also unsuccessful. Regulation (EU) 2017/745 on medical devices, which contains specific provisions on information provision and after-sales service obligations, takes precedence over the directive (Article 3(4) UCP Directive). Apparently, BCW had not based its claims on this regulation.
Houthoff Class Action Survey & Morais Leitão & Houthoff Class Actions seminar
Five years after our first Class Action Survey in 2019, we published an extensive update in 2024 in partnership with 11 leading law firms, covering key trends in 12 jurisdictions. As we begin 2026, we are expanding the survey further, introducing a concise executive version and extending its scope to 16 jurisdictions and law firms.
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