The fight continues since the beginning of the distilbene case
The system of proof: the Court of Cassation rules
Based on the decision of the First Civil Chamber of the Court of Cassation of 19 June 2019 (FS-P+B, n° 18-10.380)
Diethylstilbestrol (DES) is a synthetic diphenol with very potent oestrogenic properties.
This molecule was synthesised in the United Kingdom in 1938 and was marketed in several countries, including France, under the name of Distilbene, or Stilboestrol, which was prescribed by doctors to "help" women who were suffering repeated miscarriages or who were threatened with premature delivery.
Administered in France between 1955 and 1977, Distilbene was the cause of numerous genital anomalies, a high risk of uterine cancer and sterility in children exposed in utero.
This drug has continued and will continue to cause harm to "distilbene children" for three generations.
In this case, Ms B. had a malformation in her uterus which was related to her in utero exposure to distilbene.
However, she managed to complete her pregnancy after undergoing various operations on her uterus, nine miscarriages and two in vitro fertilisations.
Mrs B. then decided to sue for liability and damages against the compensation one of the molecule's producers, UCB Pharma, which subsequently implicated Novartis Santé familiale, which also marketed the disputed product.
To do so, the plaintiff relied on Article 1240 of the Civil Code (formerly Article 1382 of the Civil Code), the basis for tort liability, to bring her action and claim compensation.
The system of liability for defective products - which is more favourable to the victims of defective products and which includes pharmaceutical products - stemming from Law No. 98-389 of 19 May 1998 on defective products, itself stemming from the transposition of Council Directive 85/374/EEC of 25 July 1985 on liability for defective products, could not be applied because of the date distilbene was placed on the market.
Thus, the Versailles Court of Appeal, in a decision dated 23 November 2017, dismissed Ms B.'s claims on the grounds that the proof of exposure to distilbene on the one hand and the proof of the causal link between the malformation of her uterus and the in utero exposure to distilbene on the other hand, were not established with certainty.
In its decision, the Court of Appeal stated:
The Court stated that "even if we consider that these elements constitute prima facie evidence, they must be corroborated by other clues, drawn from the pathologies presented, which may constitute serious, concordant and precise presumptions both of exposure and of the imputability of the damage to this exposure, but that, in order to fulfil this probative role, the pathologies presented must have no other possible cause than in utero exposure to DES".
In other words, in order to win her case, the plaintiff had to prove not only in utero exposure to DES but also the causal link between the in utero exposure and the damage suffered as a result of the malformation of her uterus.
The judges also required the victims to prove that the exposure to distilbene was unique and exclusive of any other exposure.
Mrs B. appealed against the Court of Appeal's decision, and the Court of Cassation was called upon to rule on this case and to refine its position on the evidential regime applicable in this matter.
As a reminder, other women who had initiated similar liability actions had faced difficulties in obtaining proof of in utero exposure to DES, as the only possible proof would have been to produce in court their mothers' prescriptions or testimonies.
This is why the Court of Cassation has always shown a certain flexibility in previous cases.
In order to establish the causal link, the judges of the High Court either considered that exposure to DES was simply presumed (Civ. 1re, 24 Sept. 2009, No. 08-16.305 and 28 Jan. 2010, No. 08-18.837), or required proof of exposure to DES, even though multifactorial exposure might be present (Civ. 1re, 24 Sept. 2009, No. 08-16.305 and 28 Jan. 2010, No. 08-18.837).
In this case, by its judgment of 19 June 2019, the Court of Cassation reiterates the principles arising from the burden of proof in matters of tort but goes even further by refining its position, as follows:
"If it is not established that DES is the only possible cause of the pathologies presented, the proof of an in utero exposure to this molecule and then that of the imputability of the damage to this exposure can be brought by any means, and in particular by serious, precise and concordant presumptions, without it being required that the pathologies have been exclusively caused by this exposure.
On reading this opinion, it is clear that the Court of Cassation sanctioned the Court of Appeal for requiring the plaintiff to prove that exposure to DES was the sole cause of the damage.
Indeed, this requirement obviously leads to the failure of victims' actions who cannot prove with certainty the absence of a multifactorial exposure.
The Court of Cassation has finally censured the trial judges in order to alleviate the struggle of distilbene victims.
However, although the position of the Court of Cassation seems to be in line with the struggle of these women who were victims of distilbene due to in utero exposure, it does not mean that it has finally been won.
Before the Court of Cassation rules, the system of proof will first be assessed by the trial courts, which will decide whether or not to award compensation for the liability claims against the producer of distilbene.
Will the trial judges then follow the latest position of the Cour de cassation and no longer require proof of single exposure to distilbene?
It remains to be seen how the judgment of 19 June 2019 will be taken into account by trial judges in assessing the evidentiary regime for distilbene exposure disputes.
If there is a risk linked to the use of chemical substances, pesticides or medicines, it is advisable to be well advised on the liability and proof regime applicable under French and European law.
Master Zakine wrote a thesis on REACH compounds She holds a Master's degree in private law and a D.E.S.S. in European and international law. She is a lecturer at the University of Nice, a lawyer at Antibes and labor lawreal estate and construction.
