Adverse effects of drugs and vaccines in France

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

A.    Manufacturers

Liability for defective products: This is an objective (no fault required) and extra-contractual liability regime (Art. 1245 to 1245-17 of the French Civil Code). Drugs may be considered as defective products if they do not provide the safety that one may legitimately expect.

The application of this liability regime does not exclude the application of other contractual or tortuous liability regimes if they are based on different legal grounds (i.e., the breach or fault triggering liability is not a safety defect). In this respect, French judges hold that an action in tort which is brought against a producer after the product has been put into circulation stems necessarily from a safety defect. Therefore, it cannot succeed and only the defective product regime is to apply (Cass. 1re civ., 11 July 2018, no 17-20154).

Criminal liability:  Art. L. 5421-1 of the French Public Health Code(“PHC”) punishes the violation of good practice rules (e.g., pharmacovigilance) which may result in a serious risk to public health, by a one year's imprisonment and a fine of 150,000 euros. 

Moreover, in practice, several other offences may be observed, in particular "aggravated deceit" and “manslaughter and involuntary injury" as in the Servier laboratories/Mediator case.

B.    Healthcare professionals  

Contractual liability: Physicians who prescribe a drug are bound by a very strict obligation to provide information which must enable the correct use of the said drug. This duty to inform shall also cover the risks and exceptional side effects associated with the drug (R.4127-35 of the PHC). In addition, any physician undertakes to personally provide the patient with "conscientious, dedicated and scientifically sound care" (R.4127-32 of the PHC).  

Tort liability: It is also possible to act on the basis of Art. L. 1142-1 of the PHC which provides that health professionals are only liable for the harmful consequences of acts of prevention, diagnosis, or care in the event of fault (extra-contractual liability). It must be proven that the physician has committed a fault, the patient suffered a damage and that there is a causal link between such fault and damage.

C.    State

Tort liability: In France, the Agency for the Safety of Medicines and Health Products (“ANSM”) is a public institution in charge of ensuring the safety of marketed drugs. Accordingly, the State may be held liable if the ANSM committed a fault in the exercise of its health police mission, which notably consists in controlling and preventing risks associated with drugs (L. 5311-1 of the PHC).

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:

A.    Manufacturers

Liability for defective products: The victim shall prove a damage (e.g., bodily harm), a safety defect and a causal link between the damage and safety defect. The victim shall also prove that he/she has been exposed to the drug in question.

B.    Healthcare professionals  

Contractual liability: The victim shall prove a damage (e.g., bodily harm), a fault (e.g., failure of the healthcare professional to efficiently provide advice and information on the dosage, possible side effects…) and a causal link between the damage and fault.

Tort liability: To act on the basis of Art. L. 1142-1 of the PHC, the patient must prove that the physician has committed a fault, the patient suffered a damage and that there is a causal link between such fault and damage.

C.    State

Tort liability: The victim shall prove that the ANSM committed a fault and that this fault or failure to act caused him/her damage. In particular, this liability may result from a faulty issuance, modification, suspension or withdrawal of a marketing authorisation in light of the evolution of scientific knowledge and information gathered through pharmacovigilance. 

National solidarity: In certain cases where no fault has been committed but an abnormal medical accident occurred, the victim of such accident may be indemnified by the “National Office for Compensation of Medical Accident” (“ONIAM”) without having to prove any fault or harmfulness of a drug but solely that he/she suffers from total or partial incapacity caused by the said drug. For instance, such indemnification scheme has been applied in the context of compulsory vaccination or marketing of a drug called “Mediator”.

2.2 Which are the grounds for exclusion of liability?

A.    Manufacturers

Liability for defective products: A producer is automatically liable unless he proves that:

1° He did not put the product into circulation;
2° Considering the circumstances, there are grounds for considering that the defect which caused the damage did not exist at the time when the product was put into circulation by the producer or that this defect arose subsequently;
3° The product was not intended for sale or for any other form of distribution;
4° The state of scientific and technical knowledge, at the time the product was put into circulation, did not allow to detect the existence of a defect;
5° The defect is due to the conformity of the product to mandatory legislative or regulatory rules (Art. 1245-10 of the French Civil Code).

French law also provides for a potential total or partial exoneration of the producer in the event of a damage caused jointly by a safety defect and a fault of the victim (Art. 1245-12 of the French Civil Code). In contrast, producers’ liability shall not be reduced by the fact that a third party contributed to the occurrence of the damage (Art. 1245-13 of the French Civil Code).

B.    Healthcare professionals  

Contractual liability
The causes of exoneration are those traditionally accepted under French law, i.e., force majeure, acts of a third-parties, victim’s fault.

C.    State

Tort liability
The causes of exoneration are those traditionally accepted under French law, i.e., force majeure, acts of third-parties, victim’s fault.

2.3 Which are the time limits for submitting a claim for compensation?

A.    Manufacturers

Liability for defective products: Except in case of a fault committed by the manufacturer, its liability is extinguished 10 years after the product was put into circulation unless the victim introduced an action during such time period. Moreover, the indemnification action shall be brought by the victim within 3 years as from the date on which the claimant knew or should have known about the defect, damage and producer’s identity (Art. 1245-15 and 1245-16 of the French Civil Code).

B.    Healthcare professionals

Contractual liability: In principle, contractual claims are time-barred after 5 years as from the date on which the claimant has known or should have known the facts allowing him/her to introduce proceedings. 

However, the action resulting from an event that caused a personal injury is time-barred after 10 years as from the “date of consolidation” of the initial or aggravated injury (Art. 2226 of the French Civil Code). The “date of consolidation” shall be understood as the date on which the victim got knowledge of its certain and stabilized injury. If the injury worsens, the limitation period shall start to run as from the date on which the victim got knowledge of such aggravation.

Tort liability: In case of personal injury, claims made against healthcare professionals or health facilities as a result of prevention, diagnosis or care acts are time-barred after 10 years as from the damage consolidation (Art. L. 1142-28 PHC). 

C.    State

Tort liability: In principle, tortuous claims are time-barred after 5 years as from the date on which the claimant have known or should have known the facts allowing him/her to introduce proceedings. However, the action resulting from an event that caused a personal injury is time-barred after 10 years as from the “date of consolidation” of the initial or aggravated injury (Art. 2226 of the French Civil Code).

National solidarity: The limitation period is of 10 years as from the “date of consolidation” of the damage 

2.4 Which damages can be compensated?

Under French law, the principle is that of full compensation of any direct damage suffered by a direct or indirect victim. The courts, the ONIAM and the CCI generally refer to the Dintilhac nomenclature to determine the amounts of the damages to be granted. Indeed, such nomenclature lists all indemnifiable damages amongst which may be found functional deficit, loss of enjoyment (“préjudice d’agrément”), health expenses, aesthetic damage, pain, income losses...).

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

Yes, in principle, a third party who suffers a damage can claim compensation directly against the insurer of the person responsible for such damage. (Art. L.124-3 of the French Insurance Code - Cass. Civ 2, 16 dec 2021, n° 20-16.340).

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

A.    Manufacturers 
In principle, the same rules as those mentioned in sections 1 and 2 shall apply in case of adverse drugs reactions occurring within a compassionate program.

B.    Healthcare professionals  

In principle, the same rules as those mentioned in sections 1 and 2 shall apply in case of adverse drugs reactions occurring within a compassionate program. However, the information obligation lying with the healthcare professionals will be stronger as they will notably have to inform patients that the prescription of the drug is not made within the framework of a marketing authorization but of a compassionate program. 

C.    State

In principle, the same rules as those mentioned in sections 1 and 2 shall apply in case of adverse drugs reactions occurring within a compassionate program.

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

A.    Manufacturers 

In principle, the same rules as those mentioned in sections 1 and 2 shall apply in case of adverse drugs reactions occurring as part of an off-label use.

B.    Healthcare professionals  

In principle, the same rules as those mentioned in sections 1 and 2 shall apply in case of adverse drugs reactions occurring within a compassionate program. However, the information obligation lying with the healthcare professionals will be stronger as they will notably have to inform patients that the drug is used off-label. Their liability will thus be more important, especially in the absence of scientific data as to the off-label use at the time of prescription.

C.    State

In principle, the same rules as those mentioned in sections 1 and 2 shall apply in case of adverse drugs reactions occurring as part of an off-label use.

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

Generally speaking, the conditions for a person to make a claim for compensation as a result of an adverse drug reaction caused by a vaccine are those mentioned in sections 1 and 2 above, i.e., the party claiming compensation shall prove the damage suffered, the defect in the vaccine and the causal relationship between such damage and defect.

Under French law, claims for compensation in relation to a vaccine are often based on the the liability for defective products (Art. 1245 and seq. of the French Civil Code.

There may be exceptions to these principles such as for the Covid-19 pandemic and related vaccination campaign. Indeed, a patient claiming compensation from the ONIAM shall not have to prove the defect in the vaccine nor the health professional’s fault as such vaccination was part of the management of a health crisis situation (Art. L3131-1 and L3131-3 of the French PHC). (cf. section 5.2 below).

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

For compulsory vaccination: Yes, as compensation is paid by ONIAM (cf. section 1). 

For non-compulsory vaccination: French statutory law provides that compensation is usually paid by the person/entity responsible for the damage (practitioner, pharmacist, distributor, manufacturer, ANSM…)

However, in some cases and even if the vaccination is not compulsory, public compensation may be sought. For instance, full compensation of medical accidents attributable to care activities carried out as part of the COVID-19 vaccination campaign shall be ensured by ONIAM.

6.1 Which liabilities can be insured? Is there any compulsory insurance?

Medical liability insurance may cover financial consequences and physical, material or immaterial damage caused to third parties in the course of medical activity.

Medical liability insurance is mandatory for liberal healthcare professionals, health facilities, companies carrying out prevention, diagnosis or care activities, producers, operators, and suppliers of health products (Art. L1142.2. of the PHC).

In addition, some actors of the medical research sector have the obligation to subscribe an insurance covering their civil liability and the financial consequences of any damage caused by specific research activities (Art. L.1121.10 of the PHC).

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

The harmful consequences of a medical act may be compensated by different means such as:

• Mediation – The mediator’s identity and mission is defined by a judge (Art. L1143-6 and L1143-7 of PHC).
• Proceedings before the competent court; or
• Proceedings before the Conciliation and Indemnity Commission (CCI) and, in case of rejection or disagreement with the proposed offer, proceedings before the competent courts.
• Proceedings before the ONIAM and, if the offer proposed by the ONIAM is not satisfying for the patient, he/she may refuse the offer and appeal to the administrative court.