Find out about product liability in Colombian pharma. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
Contractual and extracontractual responsibility under the general principle that anyone causing damages to a given person is liable for those damages.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Manufacturers of medicines might be held responsible for damages caused by the use of a drug under extracontractual liability rules, provided that their evidence beyond reasonable doubt that the damage was caused due to the use of a drug with a side effect that the user was not informed of.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
Usually, liability extends to the manufacturer. There is no caselaw extending such responsibility to corporate executives, employees or representatives.
4. How can a liability claim be brought?
Through civil or criminal actions.
5. What defenses are available?
Anyone claiming damages has the burden to prove those damages came as an unannounced side effect of the product. Defenses against clear and convincing evidence are limited to agreement, knowledge of the user, consent, or misuse of the product.