The inside track on product liability in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.

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

In general terms, liability arises from the Civil and Criminal Codes, and it is a personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective or damaged product where the manufacturers, importers, distributors, sellers, or whoever may have put their trademark on the goods, are responsible.

Those jointly liable may repeat the action against the main responsible party.

The proceedings for damages in Ecuador are not common, since it is necessary to quantify and demonstrate the damage and also show the relationship of cause / effect between the actions/omissions and the damages caused using substantial evidence.

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

The law establishes that the holder of the marketing authorization for the medicine or medical device is legally and technically responsible for the quality of the product within the country. It is common that if the owner of the registration and the manufacturer of the product are different companies, agreements are entered into setting out the obligations of each party involved in the event that litigation arises involving the products.

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

Civil liability only extends to the holder of the marketing authorization and jointly to those who take part in the production, manufacturing, and sale of the product, provided they participate directly as individuals. Joint liability does not extend to those individuals who work or represent a legal entity.

4. How can a liability claim be brought?

The affected party can appear before a contraventions court, who will determine the existence of an infringement and order, if applicable, the payment of compensation in favor of the claimant, which must be paid in a new civil proceeding.

The affected party may also go directly before a civil judge. However, they must provide all evidence demonstrating the existence of the infringement, the relationship between the action / omission and the effect, and the responsibility of the defendant.

If there is a group of people who claim to be affected, it will be necessary for each of them to ratify the claim and appear in the proceeding. They could all name the same attorney in fact, thereby creating similar conditions to that of a class action.

Consumer associations duly established in accordance with the Law could also bring this type of action.

5. What defenses are available?

The holder of the marketing authorization is the one who must respond in a proceeding.

Through contractual provisions, the other parties involved in the process of manufacturing and sale of the goods may appear in the proceeding or, in turn, assume the costs of the defense. In the event of being ordered to pay damages, the action can always be repeated through a separate action against the party responsible for the infringement or non-compliance (not the legal representative, as it will always be the holder of the marketing authorization).