Product Liability Cases in Civil Law Countries: A Pro-Plaintiff Approach.

• Author: Gallage-Alwis, Sylvie

PRODUCT liability claims are one of the fastest-growing types of claims in the European Union. This is due both to the will of the European market surveillance authorities to show that their market is safe and also to the increasing number of consumers' associations and plaintiffs' bar. The influence of case law developed in the United States also plays a role, even if some losses are now well recognized in the European Union while not yet fully compensated in the United States, such as the fear of cancer or "anxiety damage" linked to the exposure to a potentially hazardous product. This article will address new trends and risks that companies doing business in the European Union should bear in mind.

1. An Upcoming Reform of the European Directive on Product Liability in the Pro-Plaintiff Direction

   The Court of Justice of the European Union ("CJEU") is the court that provides guidance to all courts of EU Member States on how to interpret European legislation. The main legislation relating to products in Europe is Council Directive 85/374/EEC of July 25, 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (the "Product Liability Directive"). It provides for a strict liability regime which has been increasingly interpreted in favor of plaintiffs on both the liability and the causality criteria, forcing manufacturers to demonstrate the absence of defect.

   This is an important point that shapes the scope of pending discussions on the reform of the Product Liability Directive. These discussions are likely to trigger legislation that implements the CJEU's approach.

   1. The pro-plaintiff approach of the Court of Justice of the European Union

      In recent years, the Court of Justice of the European Union has rendered a number of decisions in the product liability field which have been interpreted as being pro-plaintiff. Two of the most emblematic decisions are the Boston Scientific case and the Sanofi Pasteur case. Both decisions were rendered in the medical device/medicine context and should be limited for now to this industry. Nonetheless, plaintiffs' counsel are trying to have them extended to all consumer products, regardless of industry.

      In Boston Scientific, (1) the CJEU had been requested to rule in a number of disputes relating to medical devices. During quality inspections, the United States corporation Boston Scientific identified that certain of its heart stimulators and implantable automatic defibrillators sold in Germany were likely to be affected by a defect, creating a hazard to the health of implanted patients. Concerned about the safety of these patients, the manufacturer recommended as a precaution to replace the implanted devices with new devices provided free of charge.

      Patients' insurance, which had covered the costs of the replacement surgeries, decided to seek reimbursement from Boston Scientific. However, a difficulty arose, because following the replacement surgeries, the medical devices had been destroyed. The removed devices had not been examined in any way so as to establish whether they had any defects.

      The main question submitted by the German Federal Court to the CJEU was whether a product which had not yet shown signs of a defect in a patient could be deemed defective in light of a risk of failure identified by the manufacturer. In other words, the German court wished to know whether the potential risk of failure of a product, not having yet occurred, could constitute a defect within the meaning of the Directive. The German court also sought guidance whether the replacement cost of the product could constitute a compensable damage within the meaning of the Directive.

      With respect to the first question, the CJEU unambiguously responded in the affirmative. The Court reminded that within the meaning of the Directive, a product is defective when it does not provide the safety that a person is entitled to expect, taking all the circumstances into account, including the presentation of the product, the use to which it could reasonably be expected that the product would be put, and the time when the product was put into circulation. For the CJEU, the safety a person is entitled to expect must be determined in light of the purpose, features, and objective properties of the product in question, as well as the specific nature of the group of users for whom the product is intended.

      In Boston Scientific, with regard to medical devices in particular, the CJEU noted that the particularly vulnerable nature of the patients using the devices in question implied that the safety requirements which the patients were entitled to expect had to be particularly high.

      The CJEU concluded that the defectiveness of a product can result from the mere observation that "such products belonging to the same group or forming part of the same production series have a potential defect, (...) without there being any need to show that the product in question is defective." (2)

      The potential failure of a specific device allows courts to legally consider as "defective products" all products resulting from the same batch without it being necessary to demonstrate on a case-by-case basis the existence of the actual defect of each of the products at stake.

      With respect to the second question relating to damages, the CJEU confirmed that corresponded to "the costs relating to the replacement of [the medical device], including the costs of the surgical operations." (3)

      As a consequence, rather than merely carrying out a concrete examination of the concept of defect (i.e. an effective failure), which would have more clearly met the requirement of a causal link between the defect and the damage required by the applicable legislation, the CJEU abstractively applied the concept more broadly in favor of the victims.

      The consequences will be significant should this case law be extended to all types of products; a manufacturer of products that has identified an isolated failure with respect to a given product would have no choice but to recall all the products of the "same group" or "series".

      In Sanofi, the CJEU again ruled in favor of the victims regarding causality on June 21, 2017. (4) The main question submitted to the Court by the French Supreme Court was whether the French court's ruling on the merits, "in the exercise of its exclusive jurisdiction to appraise the facts," could consider that "certain factual evidence relied on by the applicant constitutes serious, specific and consistent evidence enabling it to conclude that there is a defect in the vaccine and that there is a causal link between that defect and that disease", notwithstanding the finding that medical research does not establish a link between the vaccination and the occurrence of the disease. (5)

      With its answer, the CJEU confirmed the French approach of authorizing proof of a causal link by presumptions:

      notwithstanding the finding that medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim's disease, certain factual evidence relied on by the applicant constitutes serious, specific and consistent evidence enabling it to conclude that there is a defect in the vaccine and that there is a causal link between that defect and that disease. (6)

      Completely to the benefit of the victims, the CJEU considered that the impossibility in the context of scientific uncertainty for an applicant to prove the causal link between the defect attributed to the vaccine and the occurrence of the disease through presumptions "disregards the requirements resulting from that directive."(7) However, the CJEU reminded that the victim must provide evidence of causality. It is not possible to reverse the burden of proof for the benefit of the applicant.

      In Sanofi, the CJEU considered that facts like those brought forward in the case that related to "the temporal proximity between the administering of a vaccine and the occurrence of a disease and the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered" are evidence allowing a court to establish causality. (8)

      When faced with diseases the etiology of which is not well known, the CJEU considered that it was not necessary to rely on irrefutable scientific elements or to require certainty when a set of sufficient clues offers the conclusion of causality and, therefore, a defect in the product.

      Even more surprisingly, the CJEU found that the existence of many similar cases of the same disease following the administering of a vaccine could also establish a causal link.

      The second question, submitted as an alternative question, related to whether "evidentiary rules based on presumptions according to which (...) the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim will always be considered to be established when certain predetermined causation-related factual evidence is presented" could be admitted. (9) Probably for the purpose of being fair, the CJEU concluded that there cannot be a systematic recognition of causality when certain predetermined factual evidence is presented by the...