Hogan Lovells Publications | Life Sciences Newsletter | 28 September 2016

France on the home stretch to implement class actions in health-related matters

The French Government published on 27 September 2016 the implementation decree No. 2016-1249 relating to health-related class actions. It entered into force today.

Introduction

French class actions in health-related matters entered into force on 1 July 2016 but the implementation decree was missing. It has been published on 27 September 2016 and provides some details on the procedure.

Pursuant to the Law, authorised associations are entitled to initiate a class action on behalf of two or more "users of the health system" placed in "an identical or similar situation".

This action may be lodged against producers, suppliers and service providers (hospitals, healthcare professionals, etc.) in relation to any of the products listed in Article L. 5311-1 II of the French Public Health Code (including pharmaceuticals, medical devices and cosmetic products) and/or their civil liability insurers.

Any "breach of their legal or contractual obligations" may give rise to class actions for compensation of any losses resulting from bodily injuries.

For further information on the subject, please refer to our previous newsflashes on the adoption of this new class action.  

Key takeaways from the decree

The decree specifies a few points which are necessary to implement this new type of class actions.

Jurisdiction of civil (TGIs) and administrative courts 

From a civil standpoint, the courts having jurisdiction for private defendants (as opposed to the administration or public bodies) will only be the "general" civil courts (tribunaux de grande instance - TGIs). The decree introduces in that regard a new Article 826-2 into the French Code of Civil Procedure providing that "the claim is brought, heard and ruled upon pursuant to the rules applicable to common proceedings before the tribunaux de grande instance". Health-related class actions shall therefore not be referred to other civil courts such as commercial courts (tribunaux de commerce) or lower courts (tribunaux d'instance). This is a much needed provision as the tribunaux de grande instance have more experience with bodily injury cases and more resources to handle them (even if an exclusive jurisdiction to the biggest TGIs would have been very relevant for such complex cases).

Administrative courts will have jurisdiction for public defendants, such as public hospitals. The decree introduces a new Article R. 779-11 in that regard into the French Code of Administrative Justice.

"Short-circuit" appeal proceedings 

In the event of an appeal before civil appellate courts, the appeal proceedings will unfold pursuant to Article 905 of the French Code of Civil Procedure.

This so-called "short-circuit" departs from the regular procedural rules which include strict deadlines and tough sanctions. For instance, in the regular appeal procedure, the appellant domiciled in France must file its submissions within a three-month period while the respondent domiciled in France must reply within a two-month period. With the "short-circuit" appeal procedural rule, the parties do not have to comply with these compulsory deadlines.

The procedural calendar will then be left for the Court to decide. The latter may accelerate the pace, which is what the short-circuit is for in theory, but it may also grant more time to the parties depending on various factors such as the number of parties involved, the complexity of the case, etc. This flexibility is much needed in mass tort cases.

A list of content for publicity measures 

If the Court holds the defendant liable, it will order publicity measures. According to the decree, the publicity measures will have to include the following information:

• A reproduction of the operative part of the judgment;
• The contact details of the persons to whom claimants may address their request for compensation;
• The form and content of such a request, and the period within which it must be sent by the claimant or the association, at the claimant's choice;
• An indication that, failing receipt of a request for compensation pursuant to the conditions and period set by the Court, claimants will no longer be admissible to obtain compensation on the basis of the class action judgment but will be able to claim compensation through an individual claim;
• An indication that, in case claimants join the group, they will no longer be entitled to request through an individual claim compensation from the person found liable for a loss already compensated in the scope of the class action but that they will still be entitled to request compensation in this way for other losses;
• An indication that claimants must produce all relevant documents to support their request. 

The publicity to be released will therefore be of sizeable length.

The composition of the mediation committee

If the parties agree to the (optional) mediation phase at the beginning of the proceedings, the judge may decide to appoint a mediator and decide whether the latter may work on his/her own or be assisted by a mediation committee which he/she will chair. The composition of this committee is specified in the decree as follows:

• Two healthcare Experts listed with the courts suggested by the chairman of the committee and "qualified in the pathologies that may be attributable to the product at stake";
• One person "qualified in the field of compensation for bodily injuries";
• One healthcare professional "qualified in the pathologies that may be attributable to the product at stake" suggested by the association that initiated the action;
• One healthcare professional "qualified in the pathologies that may be attributable to the product at stake" suggested by the producer or supplier of the product at stake or the service provider using the product at stake;
• One representative of insurance companies providing medical insurance coverage;
• One representative of the National Office for Compensation of Medical Accidents, Iatrogenic Diseases and Nosocomial Infections (ONIAM);
• One representative of the French social security bodies. 

The presence of several healthcare professionals in this committee is particularly welcome, yet it is subject to the appointment of a committee instead of a sole mediator.

A compensation request proving the right to join the group 

Once (and if) a judgment on liability is handed down, the compensation phase begins: users of the health system may request compensation through the association, or directly to the person held liable, as provided for in the law. The implementation decree logically specifies that such request must justify that the user fits the criteria to join the group.

What may the future bring?

Although the law introducing health-related class actions entered into force on 1^st July, the first health-related class-actions have been announced only since the publication of the decree. The efficiency of such actions remains uncertain given the complexity arising from the fact that a single judgment will rule on the liability attached to health products which have sometimes been marketed for decades, without all the while giving in the rigorous application of the concepts of, in particular, defect, fault, causation and damage.

In parallel, the so-called Bill on the modernization of 21^st century's Justice is currently being discussed by the French MPs. This Bill aims at providing a general framework for class actions and streamlining some of the existing class actions. There is now a discrepancy between the French National Assembly and the French Senate regarding the inclusion or exclusion of the health-related class actions from the general framework.

For further information on the Bill on the modernization of 21^st century's Justice, we invite you to refer to our newsflash on this subject.

Do not hesitate to contact us if you wish to get further information on this bill. 

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