Legal & Regulatory > Bolivia > Product Liability

The ins and out of product liability in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99

1. What types of liability are recognized in your jurisdiction?

Civil liability occurs when an individual or a legal entity causes harm to another. Given the event, the aggrieved party must claim the reparations for the compensatory damages caused. The complaint must be filed before a judge claiming the reparations proving the existence of these premises:

1. Harm triggering event;
2. The offender ́s assignability;
3. Damage sustained by the aggrieved party;
4. Causal link between the triggering event and the damage caused to the aggrieved party.

If the aggrieved party correctly proves premises and they are not contested or denied, the Judge will order the reparation of the compensatory damages caused by the individual who caused the harm to the aggrieved party. The reparations will grasp the damages caused and the lost profit generated from the harm caused.

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

Administrative and civil responsibility is applied to the company while penal responsibility is applied to the company’s legal representative.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

Laboratories are responsible for the quality of the products. Therefore, they are responsible through their legal representatives to assume all claims and costs due to any claims, adverse effects, etc.

4. How can a liability claim be brought?

The Civil Liability occurs when an individual or a legal entity causes harm to another. Given the event, the aggrieved party must claim the reparations for the compensatory damages caused.

The complaint must be filed to a Public Civil Judge, claiming the reparations proving the existence of these premises:

1. Harm triggering event;
2. The offender´s assignability;
3. Damage sustained by the aggrieved party;
4. Causal link between the triggering event and the damage caused to the aggrieved party.

If the premises are correctly proved by the aggrieved party and they are not contested or denied, the Judge will order the reparation of the compensatory damages caused by the individual who caused the harm to the aggrieved party. The reparations will grasp the damages caused and the lost profit generated from the harm caused

5. What defenses are available?

In the event of a Civil Liability complaint is filed, the claims of the civil liability must be detracted by undermining the presence of the premises noted above. Mainly, point 4 must be detracted, demonstrating that there is no direct relation between the triggering event and the damage caused.