Criminal Liability for the Failure to Obtain Informed Consent in Pharmaceutical Malpractices

Abstract

This study aims to analyze criminal liability for failure to implement informed consent in a case of alleged malpractice related to drug administration, and to examine the application of Article 440 of Law Number 17 of 2023 concerning Health to medical personnel negligence resulting in serious patient injury. The study focuses on Denpasar District Court Decision Number 962/Pid.Sus/2024/PN.Dps, which concerns the administration of a drug injection to a patient with a history of drug allergies and subsequent severe allergic reaction. This study uses a normative juridical method with a statute approach, a case approach, and a conceptual approach. The legal material is analyzed descriptively and qualitatively through a review of laws and regulations, court decisions, and the doctrines of culpa lata, res ipsa loquitur, and ultimum remedium. The results of the study indicate that failure to obtain adequate informed consent, administering medication that is not in accordance with the patient's allergy history, and non-compliance with professional standards and medical record management are important elements in assessing the elements of medical personnel negligence. In the case analyzed, this negligence was associated with the occurrence of serious injuries, thus fulfilling the basis for criminal liability as stipulated in Article 440 paragraph (1) of Law Number 17 of 2023 concerning Health. This study also shows that the application of criminal law in medical disputes needs to be placed as the ultimum remedium, while still considering dispute resolution mechanisms through mediation, restorative justice, and professional disciplinary mechanisms. Thus, criminal liability in cases of medical negligence needs to be placed in a balanced manner between the protection of patient rights and legal protection for medical personnel.