Responsabilidad Civil por Dispositivos Médicos Defectuosos Implantables y de Uso Prolongado en Colombia

Abstract

The rapid production of goods in the global economy, including medical devices, is driven by fluctuating demand and technological advancements. In Colombia, the growth of the medical device market has been significant, fueled by the need for advanced technology and improved healthcare. However, this evolution presents considerable challenges in regulating the safety and quality of these devices. Addressing these challenges is crucial to reducing risks, providing compensation for damages, and evaluating the effectiveness of civil liability in maintaining social and economic order. This research examines the Colombian legal framework on civil liability in cases involving defective medical devices, identifying shortcomings in the regulations and victim protection. A descriptive-analytical, comparative, and sociological analysis is proposed, contrasting international practices and highlighting the importance of health records and technovigilance programs while reinterpreting current law. The research is structured into four chapters. The first chapter examines the evolution and classification of medical devices and the relevance of health records. The second chapter explores the legal relationships in the logistics chain of these devices, including contractual and non-contractual duties and rights, and relevant regulations such as the Civil Code and the Consumer Statute. The third chapter focuses on the concept of defect and the defense mechanisms in civil liability cases, proposing a specific evidentiary standard, a reinterpretation of compensable damages, and flexibility in the causal link. The thesis concludes with a proposal for a special civil liability for defective medical devices, suggesting adjustments in the normative interpretation to balance the interests of victims with innovation and investment in a dynamic market.