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Public hospital liability

LIABILITY FOR PRODUCTS

Liability for Health Products

 

Medications, vaccines, blood derivatives, and medical equipment are considered health products. There are two types of product liability:

1. Liability for defective products

 

A product is considered defective if it does not achieve its intended purpose or if its presentation does not conform to expectations.

 

For example, regarding a medication, it would be deemed defective if it does not meet its intended goals or if it has effects that were not disclosed in the instructions.

 

It will be necessary to demonstrate a causal link between the use of the product and the damages claimed.

 

Case law holds that the causal link can be presumed if significant, precise, and consistent evidence is presented. For instance, the French Court of Cassation has ruled that a clear and consistent body of evidence could suffice to prove the link between a vaccine and the onset of a disease.

 

The European Court of Justice has upheld this position. In the event of harm caused by a defective product, the responsible parties must compensate all damages suffered by the victims. The liable parties may include hospitals, as they are responsible for health products, and manufacturers, as producers of health products.

2. Liability for non-defective products

 

The liability for health products differs if the product is not considered defective (non-defective products).

 

In such cases, the liability mechanism will be based on medical accidents or therapeutic hazards. Victims of a serious medical accident originating from a preventive measure, diagnostic act, or treatment act will be compensated under medical accident insurance.

 

An accident is considered serious when the victim suffers from:

• A permanent physical or mental impairment greater than 24%,

• A temporary cessation of professional activities for at least six consecutive months or six non-consecutive months within a 12-month period,

• Temporary symptoms leading to a functional deficit of 50% or more for at least six consecutive months or six non-consecutive months within a 12-month period.

 

A serious medical accident can also include an iatrogenic condition or nosocomial infection that causes particularly severe issues, including economic consequences on the victim’s living conditions. Just like non-fault medical accidents, damages resulting from non-defective health products can be compensated under the therapeutic hazard if the consequences are severe, as defined above. Therapeutic hazards are compensated by ONIAM (National Office for Medical Accident Compensation).

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