Group action: harm related to a health product

Verified 09 December 2022 - Directorate for Legal and Administrative Information (Prime Minister)

Have you suffered harm related to a health product (medicine, cosmetic product, medical device...)? You can get compensation with the group action procedure. Several users of the health system must be affected by similar harm. Such a procedure shall be initiated by an association of users of the health system approved at regional or national level. If the action is successful, the association collects the compensation and then pays it back to the victims.

A group action allows you, if you are affected by damage caused by a fault related to the production, supply, or delivery of a health product, to be compensated.

We are also talking about class action.

Example :

They may be drugs, contraceptives, cosmetic products, products derived from a blood donation and intended to be transfused to a patient, organs, cells, tissues, medical devices.

You can be compensated even if you:

  • Didn't file a complaint
  • Didn't attend the trial
  • Don't come forward pre-trial to the authorities or to an association of health users.

Indeed, at the time of his decision, the judge decides the length of time you can join the group to be compensated.

That period, which may not be less than six months nor more than five years, shall begin to run from the end of the publicity measures ordered by that court.

Only damage resulting from personal injury (examples: injury, illness) may be compensated under this class action.

The group action procedure in the field of health does not provide for compensation for non-material or financial damage.

FYI  

However, you can bring an individual action against the judge to to seek compensation for other damage.

Proceedings may be brought against the following persons/businesses:

  • Health Product Producer (Pharmaceutical Company)
  • Supplier of a health product (pharmacy, wholesaler...)
  • Provider (hospital, doctor...) using a health product (technical error, or misuse of the product for example).

It may be brought directly against those responsible persons or against their insurer.

Warning  

In order for group action to be implemented, at least 2 people must have undergone a similar or identical damage caused by the same failure of the same professional.

The group action can be initiated only by associations.

If you have suffered harm related to a health product and that harm may affect others, you can report your case to a health system user association that can then sue the health care professional.

Two types of associations of users of the health system are competent to initiate the group action procedure:

  • Associations of health system users approved at regional level
  • Nationally accredited associations of health system users.

The judge verifies that the association has the right to initiate this procedure.

Please note

An association which has an ancillary activity in the production of a health product covered by those actions may not initiate a group action.

These associations may seek the assistance of a lawyer and a Commissioner of Justice.

They must enter either:

  • The administrative court if the respondent is a legal person governed by public law (examples: public establishments...) or a body governed by private law responsible for the management of a public service
  • The court of justice if the respondent is a private person, whether natural or legal.

The association shall initiate the procedure for all persons concerned. Membership in the association is not necessary.

Group action is free of charge, but it is advisable to keep all documents proving your harm.

This action has two phases:

  • the delivery of a judgment ruling on the responsibility of the accused person. In that decision, the judge defines the group of users of the health system to whom the compensation relates. It sets out the criteria for joining the group. It determines what personal injury can be repaired.
  • enforcement of the judgment and individual compensation for damage.

The use of mediation is also foreseen.

The judge may, with the agreement of the parties, propose to introduce a mediation.

The mediator shall be chosen by the judge and shall propose to the parties a coconstructed agreement with them providing for the conditions of amicable compensation for damage.

The agreement shall be:

  • Accepted by the complainant association and at least one of the respondents
  • Certified by the judge.

Please note

The duration of the mediation may not exceed 3 months renewable once at the request of the mediator.

The judge must carry out publicity measures to enable victims to be informed. The judge does so after the remedies have been exhausted.

As soon as the decision is made public, make sure that you are part of the group of victims concerned.

If this is the case, you must register with the association that initiated the process to join the group and receive the compensation.

The association will then collect your compensation from the professional and pay it to you.

Be sure to keep any documents proving that you belong to the group that can be compensated.

The judge sets the deadline for you to register with the association.

If you are not reported after this date, you cannot be compensated by the group action. But you can claim compensation on an individual basis.

The amount of compensation shall be determined by the court individually on the basis of the actual damage suffered by each person.

FYI  

Such compensation may also be determined by the mediation agreement approved by the court.

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