Product Liability and Safety_2026

PUERTO RICO Law and Practice Contributed by: Mónica Ramos-Benítez and Roberto A. Cámara-Fuertes, Ferraiuoli LLC

2.13 The Impact of Regulatory Compliance on Product Liability Claims To the extent that proof of negligence is not required to establish strict product liability, regulatory compliance will not necessarily preclude a finding of strict liability. However, it could be relevant towards demonstrating the reasonableness of the design in a design defect claim under Article 1544 (b) of the new Civil Code of 2020 if, depending on the particular circumstances, regulatory compliance or industry standards may have had some incidence on the feasibility of a safer design at a reasonable cost given the technological limita - tions or on the adequacy of instructions or warnings. Regulatory compliance can also be a relevant consid - eration against the imposition of punitive damages. In negligence claims, compliance or failure to comply with regulations can be relevant towards negating a breach of duty or establishing the breach. 2.14 Rules for Payment of Costs in Product Liability Claims PR Rule 44.1 of Civil Procedure governs the proce - dure for costs and attorney’s fees, including in the appellate level. The prevailing party is entitled to recover the costs and expenses “necessarily incurred” in the litigation or that the court, in its discretion, deems that one party must reimburse to the other. The prevailing party has ten days from the entry of judgment to file a memoran - dum of costs, which must be either sworn by the party or include an attorney(s) certification that the detailed costs and expenses are correct and were necessary for the litigation. If the adverse party does not oppose the memorandum within ten days of its filing, the court will approve it and may eliminate any amounts deemed inappropriate after affording the requesting party opportunity to justify said amounts. The court’s decision is revisable by the Court of Appeals through a petition for certiorari. Ordinary office expenses, such as postage stamps or messengers, are not recoverable as costs. Recovery of a party’s expert costs is allowed but exceptional, and it will be awarded only when the expert’s costs are reasonable and justified. In determining whether to award expert costs, courts look to the expert’s cre - dentials, and the nature and usefulness of the expert

• Unforeseeable Misuse: A seller or manufacturer is only liable for damages caused by a product that was used in a reasonably foreseeable manner. • Comparative Fault or Negligence: Where the plaintiff’s conduct is found to have contributed to the damage suffered, the award of damages will be apportioned based on the parties’ respective percentages of fault. • Lack of Causation: A seller or manufacturer is only liable when the product defect was the proximate cause of the claimed injury. • Statute of Limitations: Negligence and strict liability claims must be brought within one year from the date in which the plaintiff knew or should have known of the necessary elements to bring their claim. • Economic Loss Rule: The plaintiff may not recover in tort when a defective product harms only the product itself, instead of a person or other prop - erty. While not specifically adopted in Puerto Rico, the US Court of Appeals for the First Circuit has held that the “Puerto Rico Supreme Court would rule that the economic loss rule bars an action under Article 1802 where a defective product harms only itself”. • Isla Nena Air Services , Inc . v Cessna Aircraft Co ., 449 F.3d 85, 88 (1st Cir. 2006). • Learned Intermediary: Manufacturers of prescrip - tion drugs or medical devices fulfil their duty to warn consumers of risks by providing adequate information to the prescribing physician (the “learned intermediary”) rather than the patient directly. It is understood that “the prescribing physician, as the ‘learned intermediary’ standing between the manufacturer and consumer/patient, is generally in the best position to evaluate the potential risks and benefits of ingesting a certain drug and to advise the patient accordingly”. Men- dez Montes De Oca v Aventis Pharma , 579 F. Supp. 2d 222, 229 (D.P.R. 2008). There are other, non-absolute, product liability defenc - es that manufacturers and sellers commonly raise in related actions, like state of the art, compliance with applicable safety standards, lack of defect, among others, but these usually require development and some element of proof.

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