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Court

Cour de cassation, 1re Civ., 29 May 2013, pourvoi n° 12-20.903, Bull. civ. I, n° 116

Topics

Causal link

Defect

Articles

Art. 1147, Code civil

Art. 1386-4, Code civil

Facts

The claimant had been administered two injections of the hepatitis B vaccine Engerix B in July 1995. Shortly after, she started experiencing numbness and tingling and, a few months later, vision impairment. She was diagnosed with multiple sclerosis in 1997. She subsequently brought a claim against the vaccine manufacturer, Glaxosmithkline, in order to get compensation for the alleged vaccine-related pathology she had developed.

After her claim was rejected by the Orléans court of appeal, the plaintiff filed an appeal in cassation. She challenged the fact that the court of appeal had required the proof of the product's participation in the damage (which is known as the general causality or "imputability" requirement) while this condition was not stated in any legal text. She also disputed the fact that the court of appeal had not deemed the evidence at hand to be serious, precise and corroborative presumptions from which the defect and the causal link could be inferred, as judges had examined the elements of fact independently instead of considering them as a whole.

Legal questions

Is the demonstration of imputability (i.e. the general causality between a product and a disease) a prerequisite in strict liability cases?

From which elements of fact can the defectiveness of a vaccine and the causal link between this product and a disease be inferred?

Decision

The Cour de cassation upheld the demonstration of the court of appeal.

On the first hand, the Cour de cassation held that proving the product's participation in the damage is an "implied prerequisite" to the demonstration of the three traditional elements of strict liability (damage, defect and causal link). The court insisted on the fact that the existence of a defect and causal link could not be inferred from the product's mere contribution towards bringing about the damage.

The Cour de cassation then approved the court of appeal's reasoning based on both general observations and case-specific elements to conclude that the product's risk-benefit ratio was favourable and that the product could not be held defective because of its presentation. The elements of fact regarding the plaintiff's family medical history and the uncertainties concerning the exact kind of vaccine which had been administered prevented them from being considered serious, precise and corroborative presumptions from which the defect and causal link could be inferred.

The vaccine's producer was consequently not held liable.

Commentary

With this solution, the Cour de cassation reaffirmed lower judges' discretionary power in considering circumstantial evidence.

In this respect, it is interesting to compare this solution with the decision held on 26 September 2012 (Cour de cassation, 1re Civ., 26 September 2012, pourvoi n 11-17.738). Indeed, in this latter case the Cour de cassation had quashed the court of appeal's reasoning which had based the appreciation of the vaccine's defectiveness only on a risk-benefit general analysis. It appeared from this case that in order to assess whether a product fails to meet the safety standard, the lower judges have to examine all the elements at hand, especially those which can lead to presume the existence of a causal link.

In the 29 May 2013 decision, the Cour de cassation approved the fact that the court of appeal had based its reasoning not on the absence of scientific certainty but on both general and case-specific observations. It thus appears important that lower judges assess all elements at hand when considering the product's defectiveness and the existence of a causal link.

Furthermore, the Cour de cassation reaffirmed in this case that the "imputability" requirement must be met prior to the demonstration of the three elements of strict liability (damage, defect and causal link). This element was acknowledged by the Court of cassation in 2007 (Cour de cassation, 1re. Civ., 27 February 2007, pourvoi n° 06-10.063): the demonstration of "imputability" appeared as a prerequisite to the demonstration of the particular causality.

General causality or "imputability" has been understood as referring to a product's potential to induce a given adverse effect. In other terms, it leads to question the intrinsic properties of the product: is there an established, recurrent link between the administration of a given vaccine or the intake of a drug and a certain type of damages? Such a solution aims at preventing a complete disconnection between causality in the scientific and the legal fields, but it also leads to increase the plaintiff's burden of proof.

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