All you need to know about product liability in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
A. LEGAL PROVISIONS
In general terms, liability arises from provisions in federal or local civil codes in Mexico. Liability can also arise from statutory terms. The NOM for good manufacturing practices of medicinal products (NOM-059-SSA1-2015) has provisions regarding liability. Recently, the Federal Consumer Protection Law has been amended to allow class actions.
B. SUBSTANTIVE TEST
Liability claims are mainly regulated by statutes and not by court precedents.
Therefore, there is no clear substantive test. The standards to determine damages are high. According to precedents from the Federal Courts, the cause-effect relationship between actions/omissions and damage has to be fully proved.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Accordingly, the NOM for good manufacturing practices of medicinal products (NOM-059-SSA1-2015) states that, when manufacturing through third parties, the marketing authorization holder has to supervise the manufacturing of the product and establish in agreements the liabilities and duties of each party involved.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
All those involved in selling and/or distributing medicinal products can be liable in civil actions for harm derived from a defective medicinal product.
4. How can a liability claim be brought?
A. LIMITATION PERIODS
Depending on the conduct and cause of action, the limitation periods are two to ten years for civil actions, and one to nine years for certain criminal actions.
B. CITIZEN ACTIONS
The federal procedural laws have been amended to allow class actions before the federal courts. The Federal Agency for Protection of Consumers (Procuraduría Federal de Protección al Consumidor) (PROFECO), the Attorney General’s Office, non-profit associations and a common representative of a group of at least 30 members can now pursue class actions. These amendments are subject to testing in the courts and apparently there are no precedents of class actions for product liability.
In addition, there is an action available called accion popular, whereby any individual with or without proper legal standing can file a complaint before COFEPRIS, arguing and proving that there are certain health risks in a product in the market. However, the claimant’s procedural rights are very limited, and these actions are intended to cease a health risk and not to obtain compensation.
5. What defenses are available?
Equitable defenses are available. Available defenses include:
- Assumption of the risk and contributory negligence.