Exposure to a medicinal product: confirmation of compensation for multi-causal damage

Published on 26 february 2024


Litigation – Arbitration – Mediation

It follows from article 1240 of the French Civil Code that any damage causally linked to a fault gives rise to a right to compensation, even if the fault is not the sole cause of the damage. The fact that a patient's infertility may be due as much to an infection as to exposure to a medicine is not sufficient to exclude that exposure to the medicine contributed to her infertility. It follows from the same article of the Civil Code that anxiety resulting from exposure to a risk of harm constitutes a compensable loss.

Cass. 1re civ., 18 oct. 2023, n° 22-11.492, Publié au bulletin.

In this case, a woman suffering from infertility claimed that she had been exposed in utero to diethylstilbestrol or Distilbene (hereinafter referred to as "DES"), as a result of her mother taking the drug during her pregnancy.

DES was prescribed to women who suffered repeated spontaneous abortions (or miscarriages).

The expert report noted that the cause of her infertility could be as much due to her exposure to DES as to her Chlamydia infection, and concluded that 40% of the damage suffered was attributable to exposure to DES.

The direct victim of this exposure, as well as her mother and her husband, indirect victims, sought compensation for the various losses suffered from the producer of DES. Their main claim was for compensation for infertility and anxiety to which the direct victim was exposed.

The Court of Appeal dismissed all the plaintiffs' claims for compensation. It considered that the cause of the victim's infertility could be due as much to her Chlamydia infection as to her exposure to DES. Consequently, it ruled that the DES manufacturer could not be held liable because of the uncertainty as to the cause of the victim's infertility.

Lastly, the Court of Appeal rejected the claim for compensation for anxiety-related harm put forward by the plaintiff on the same grounds, namely that there was no link between exposure to DES and her hypofertility.

The Court of Cassation recognises the liability of the producer of Distilbene.

The highest court censured the reasoning of the Court of Appeal.

The Court of Cassation stated that it follows from article 1240 of the Civil Code that any damage causally linked to a fault gives rise to a right to compensation, even if the fault is not the sole cause of the damage.

In other words, from the moment it is established that the victim's exposure to the DES contributed to the occurrence of the damage, the provisions of article 1240 of the Civil Code are applicable.

Consequently, the victim does not have to prove that his or her pathology was caused exclusively by exposure to DES. They must simply prove that they were exposed to the product in question and that the injury was caused by that exposure.

This solution is not new, as the Court of Cassation has already had occasion to rule on the issue: "if it is not established that DES is the only possible cause of the pathologies presented, proof of exposure in utero to this molecule and then of the imputability of the damage to this exposure may be adduced by any means, and in particular by serious, precise and concordant presumptions, without it being required that the pathologies were exclusively caused by this exposure" (Civ. 1st, 19 June 2019, no. 18-10.380).

With regard to the recognition of an anxiety loss, contrary to what the Court of Appeal pointed out, it is not necessary for the feared pathologies to occur for such a loss to be characterised.

Case law has defined anxiety loss as the fact that a person who has been exposed to a toxic substance experiences "a permanent feeling of anxiety generated by the risk of declaring at any time an illness linked to exposure" to such a substance.

This type of loss does not therefore require proof of a triggering event linked to the actual occurrence of damage. It may be characterised by the simple fear of the serious consequences that may result from exposure to a dangerous product.

In this case, since exposure to DES has been established, it is not surprising that the Court of Cassation has found that there is an anxiety loss "resulting from exposure to a risk of harm".

A solution in line with a line of case law favourable to victims exposed to Distilbene

The solution reached by the French Supreme Court is in line with the body of case law it has developed in relation to Distilbene.

The Court of Cassation has consistently shown a degree of flexibility towards victims of DES exposure. The admission of serious, precise and concordant presumptions makes it possible to compensate for the lack of evidence on the part of victims, which could prevent them from receiving compensation.

This reasoning can be explained by the need to ensure that victims are not deprived of their right to compensation if they are unable to provide proof of an exclusive cause of their injury.

The ruling by the French Supreme Court therefore makes it possible to recognise the liability of a drug producer even though there may be several causes of the victim's injury.

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