All
| TITLE | Supreme Court Decision 2007Da3162 Decided October 14, 2010 [Damages (Medical Liability)] [full Text] |
|---|---|
| Summary | |
| [1] Whether a cell that has been separated from a human body falls under a drug subject to regulation by the former Pharmaceutical Affairs Act (affirmative with restriction) [2] Mesenchymal stem cells are held to be a drug subject to regulation by the former Pharmaceutical Affairs Act [3] The meaning of ""clinical trial"" as stipulated in Article 26-4 (1) of the former Pharmaceutical Affairs Act [4] Mesenchymal stem cell transplantation on humans falls under a clinical trial and that, accordingly, the act of transplanting these stem cells without obtaining permission from the Commissioner of the Korea Food and Drug Administration is a violation of the former Pharmaceutical Affairs Act [5] Whether performing a medical act falling under the category of clinical trial without permission from a supervising government office constitutes a tort in itself (negative) [6] The extent of a doctor's duty of explanation in regard to medical acts at the clinical trial stage, and the extent of a drug supplier's duty of notification when supplying drugs at the clinical trial stage [7] In a case where a doctor performed mesenchymal stem cell transplantation on patients whose liver cirrhosis had advanced to a state which left no other effective treatment method than liver transplant surgery, but violated the duty of explanation toward patients by providing them with false information via a joint press conference with the CEO of the stem cell supplier, etc., and where the CEO of the company supplying these stem cells also violated the duty of explanation, as well as the duty of notification, toward stem cell consumers by ... | |
