Markets outside the United States are increasingly important for life sciences companies, and this post includes articles by Reed Smith lawyers regarding two developments in Europe.

The first is by Edward Miller, entitled “Sidestepping the Issue“, republished with permission from the International Clinical Trials e-book (registration required).  This article discusses a ruling by the European Court of Justice, holding that pharmaceutical companies can refuse to fill “unusual” orders from distributors who seek to profit by buying drugs for countries with low reimbursement prices, and shipping them for sale in countries with high prices – but falling short of the standard advocated by the pharmaceutical company defendant in that case.

The second article is by Paule Drouault-Gardrat and Julie Gottenberg regarding French Supreme Court rulings earlier this year on causation in product liability cases.  First published in the August edition of Insights, the conference bleue newsletter, the article is reprinted with permission here:

Product liability case-laws in the pharmaceutical sector: The French Civil Supreme Court held important rulings on the causality issue

On 22 May 2008, the French Civil Supreme Court handed down a series of judgments relating to the liability of pharmaceutical companies for defective products once again focusing on the causal link, one of the legal prerequisites to a successful product liability claim.

According to both French Law and the European Directive 85/374/EEC on defective products, a claim for defective product requires three cumulative conditions: a defective product, an injury and a causal link between the two.

The five case-laws at stake relate to hepatitis B vaccines allegedly connected with multiple sclerosis[1] or ulcerative colitis[2].

Prior case-law

In light of the uncertainties concerning the etiology of multiple scleroses and the absence of clear-cut scientific conclusions, the Civil Supreme Court refused in two decisions dated 2003[3] to recognize any causal link between the hepatitis B vaccine and the occurrence of multiple scleroses.

Accordingly, said Court reversed the rulings of the appellate courts which had wrongly based their holdings on a series of presumptions. The Civil Supreme Court overruled the appellate decisions for “breach of the law” thus asserting that such a causal link is not even demonstrable.

In other words, such overruling did not condemn a failure to demonstrate the causal link in the specific case but was rather based on the theoretical observation that a causal link could not be established.

Hence, the Civil Supreme Court decided that the “judicial truth” should be aligned with the scientific standpoint.

It was unanimously understood from these 2003 precedents that in hepatitis B vaccines cases, the proof of the causal link through presumptions could not be successful.

The 2008 case-laws

The Civil Supreme Court acknowledges for the first time here that in hepatitis B vaccine cases, the causal link can be evidenced by means of presumptions provided that they are “serious, precise and convergent”.

The presumptions must be supported by detailed elements which are appreciated on a case-by-case basis but not through general scientific studies, either statistic or probabilistic.

This new position is less favorable to the pharmaceutical companies since the existence of a causal link is no longer excluded from scratch.

In fact, however, it remains uneasy for the plaintiffs to succeed. Indeed, amongst the five analyzed case-laws:

  • the Civil Supreme Court overruled the appellate rulings only because the appellate courts neglected to assess the presumptions related the causal link[4].
  • the referral to the Civil Supreme Court was rejected in two cases as the appellate judges had rightly assessed the presumptions put forward and concluded to the absence of any causal link[5].

Comparative approach and the French dual legal system

As you may know, France has a dual legal system: the administrative judicial order, headed by the Administrative Supreme Court (« Conseil d’Etat »), dealing with the compliance with Public Law[6] and the civil judicial order, headed by the Civil Supreme Court (« Cour de Cassation »), dealing with the compliance with Private Law[7].

Claims for defective products are filed with civil or administrative courts depending on the factual context (e.g status of the hospitals or of healthcare professionals).

In this regard, still today, the competent civil and administrative courts do not have the same position on the causality issue in hepatitis B cases.

Indeed, in certain circumstances where the scientific experts do not exclude the possibility of a causal link between hepatitis B vaccines and multiple scleroses, the Administrative Supreme Court may conclude to the liability of the manufacturer[8]. The key issue in such a rationale is the acknowledgment, by the Administrative Supreme Court, of the reversal of the burden of proof hereby requiring the manufacturer to establish that its vaccine is harmless.

As for the Civil Supreme Court, it considers that “the absence of scientific certainty on the harmlessness of the vaccine does not lead to a presumption of defectiveness”[9]. Thus, in civil cases, the burden of proof still lies on the plaintiffs.

To summarize the situation as it now, if the latest civil case-law dealing with hepatitis B are less favorable to the pharmaceutical companies than before, they still remain less in favor of the claimants than the current administrative case-law.

[1]  Decisions of the 1 st Civil division of the Supreme Court dated May 22, 2008 n°05-20.317, n°06-10.967, n°06-14.952, n°06-18.848.


[2] Decision of the 1 st Civil division of the Supreme Court dated May 22, 2008 n°05-10.593.

[3] Decisions of the 1 st Civil division of the Supreme Court dated September 23, 2003 n°01-13.063 and n°01-13.64.

[4] Decision of the 1 st Civil division of the Supreme Court dated May 22, 2008 n° 06.10.967, n° 05-20.317, n° 06.14.952.

[5] Decision of the 1 st Civil division of the Supreme Court dated May 22, 2008 n° 06-18.848 and n° 05-10.953.

[6] Law governing relationships between individuals and the State.

[7] Law governing relationships between individuals.

[8] Decision of the Administrative Supreme Court dated March 9, 2007 n° 267635.

[9] Decision of the 1 st Civil division of the French Supreme Court dated May 22, 2008 n° 06-18.848.