By a judgment dated November 18, 2024 (case file no. VI ACa 379/19), the Warsaw Court of Appeal ruled on liability for an instructional defect in a medicinal product under the product liability regime. This represents a landmark ruling in the Polish legal system, being the first instance where a patient was awarded compensation and damages for adverse effects resulting from a drug. The author provides a detailed analysis of the provisions upon which the Court based its decision, observing that liability under Article 449¹ of the Civil Code is subject to a closed list of entities (numerus clausus). Consequently, passive legal standing is restricted to the actual manufacturer, quasi-manufacturer, or importer, excluding entities performing purely administrative functions, such as the Marketing Authorisation Holder (MAH) or its representative. A pivotal element is the reconstruction of the concept of an instructional defect, defined as a failure to inform the consumer of known risks regarding adverse effects. The author argues that establishing such a defect is autonomous from administrative compliance, such as official approval of the package leaflet by regulatory authorities. Furthermore, the author addresses evidentiary challenges in medical litigation, endorsing prima facie evidence and factual presumptions to establish a causal link between ingestion of the product and the resulting harm. The commentary is affirmative; the author concurs with the Court, asserting that the judgment prioritizes consumer safety without infringing upon the rights of the defendants.