Court:
Cour de Cassation, 1re civ., 22 May 2008
Topics:
Causation
Defect
Facts:
The Cour de Cassation handed down six judgments on the same day, which concerned two different factual circumstances :
- Five of the cases concerned claimants who were alleged to have suffered pathologies (multiple sclerosis and ulcerative colitis) after being vaccinated for hepatitis B.
- Two other cases concerned different medicines alleged to have caused Lyell's disease.
Legal questions:
Was the Court of Appeals' approach to causation and defect correct ?
Decision:
In its decisions, the Cour de cassation underlined that it was up to the lower court judges (at first instance and appellate level), exercising their sovereign power of appreciation of the facts to assess in each case whether it had been proven that the product was defective and whether the loss was caused by the defect.
In two of the vaccine cases, the Cour de cassation went on to quash appellate decisions rejecting claims for compensation, ruling that the courts had failed to examine whether there were presumptions in favour of the defect or causal link. In an important passage of the judgment, the Court underlined that :
"whilst a product liability claim requires proofs of loss, defect and a causal link between the defect and injury, such evidence can result from presumptions, as longs as these are serious, precise and concordant." (pourvois n° 05-20.317; 06-10.967)
On the basis of this, the Cour de cassation disapproved of the reasoning of one of the Court of Appeal decisions, which had decided that legal causation had not been proved due to the absence of a statistical link. The Cour de cassation ruled that rather than adopting a "probabilistic approach derived exclusively from the absence of a scientific and statistical link", the Court should have examine whether, on the elements provided, there might be presumptions denoting the causal link and defect (pourvois n° 05-20.317).
However, the Cour de cassation did not quash those appellate judgments where the Court of Appeal had clearly indicated that the claimant had not demonstrated the link between the vaccination and the development of the symptoms (eg N° 06-18848).
Comments:
The Cour de Cassation delivered a significant series of judgments on product liability. In previous cases with similar factual circumstances, the Cour de cassation had quashed decisions which had upheld liability in respect of neurological problems suffered subsequent to the hepatitis B vaccination. In particular, in the decision of 23 September 2003 (reported on the database), the Court had overturned a decision of a Court of Appeal finding liability in such circumstances. In a sibylline, one sentence response, the Cour de cassation held that neither the defect of the pharmaceutical product nor the link between the product and the loss had been proven. It was subsequently stated in the 2007 Annual Report of the Court de cassation that "it was precisely because the [causal] link between the hepatitis B vaccination and the appearance of the multiple sclerosis was challenged and was not scientifically proven that the Cour de cassation quashed the [Court of Appeals'] decisions" (page 238).
The position of the French Administrative Courts on this issue differed. In a series of judgments handed down on 9 March 2007, which concerned mandatory vaccinations given to public sector workers, the Conseil d'Etat allowed for a presumption of causation to apply as follows: "given that the expert reports, whilst they had not established [the causation], had not excluded the existence of a causal link." The Court linked this to the fact that (i) a very brief period of time had elapsed between the injection and the appearance of symptoms; (ii) the claimant had been in good health. (See also the broader approach of the civil courts in cases involving mandatory vaccination in an employment context: Cass Soc. 2 avr. 2003,pourvoi n° 00-21.768, Bull. civ. V, n°132).
The difference in approach between the civil and administrative courts on this issue of causation was criticised by some academic commentators and was even referred to by the Cour de cassation in its 2007 Annual Report (page 239). From that perspective, the change in approach was perhaps predictable.
The consequences of decisions of the Cour de cassation in 2008 may well be significant. Whilst it is true that the judgements "do not in themselves mean that the Cour de Cassation will now systematically quash any appellate judgment that has dismissed product liability claims for the alleged side effects of the hepatitis B vaccination" (C.Derycke, "Law Against Science", EPLRev June 2008, page 16), the decisions do indicate a change in approach to proving both causation and defect in French products cases. The reference to both the use of presumptions, as well as the importance of the individual facts of the case rather than generalised probabilistic analysis is important. As Professor Jourdain has noted, the "probabilistic approach premised upon a scientific and statistical link is expressly set aside." (RTD Civ. 2008 p. 492)
Jourdain accepts that the legal causation is not the same as scientific causation, but laments the fact that the Cour de Cassation (unlike the Conseil d'Etat in the cases referred to above) has not indicated the sort of factors that can be taken into account in establishing the presumptions, so as to avoid divergence in approach in similar cases.
There is of course a risk of divergent decisions given the importance now placed upon the lower courts' evaluation of the individual evidence in respect of the causal link : "The Cour de Cassation's decision to hand down on the same day judgments relating to the hepatitis B vaccine and judgments relating to other medications is quite notable. It suggests that the Cour de Cassation's new position will apply to pharmaceutical product liability cases in general." (C.Derycke, "Law Against Science", EPLRev June 2008, page 17). Derycke criticises for this new approach : "it controversially opens the door to plaintiffs being compensated by manufacturers in cases where there is no scientific evidence whatsoever that the product can cause injury, leaving a wide discretion for first instance and appellate courts." (Ibid)
There have been a number of subsequent cases on this theme since the decision of the Cour de Cassation in 2008 : Paris Court of Appeal on 9 January 2009; Bourges Court of Appeal 22 January 2009 and Cour de Cassation 22 January 2009. In the latter decision which again concerned vaccine damage, the Cour de Cassation in essence re-affirmed its earlier 2008 decision, underlining the importance of the sovereign power of assessment, and upholding the lower courts approach, which had analysed the evidence and ruled that it could not be regarded as a serious, precise and concordant presumption that the alleged injuries resulted from the vaccine.
The recent Court of Appeal decisions show that two elements are still referred to in order to reject claims in these circumstances : the lack of time proximity between the vaccination and the resulting injury, and the existence of other risk factors. In particular, the Bourges Court of Appeal interpreted the 2008 Cour de Cassation decision as follows : "in these judgments the Cour de Cassation did not give up on the requirement to demonstrate a causal link between the product's defect and the damage suffered...it considered that evidence of a link between the vaccination and the damage could be made by serious, precise and concordant presumptions... [the Court] wanted to invite trial judges to search other sources other than scientific data for elements that may demonstrate a causal link, and there is no other source than the personal circumstances of each individual." (B.Edery and A.Bourriaud, "France : the Judge and Science" LifeSciences Newsletter, Spring 2009).
