[About the settlement of litigations concerning the harm caused by benfluorex (Mediator®)]
| Autor: | Philippe, Nicot, Irène, Frachon, Catherine, Hill |
|---|---|
| Přispěvatelé: | Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Institut Gustave Roussy (IGR) |
| Jazyk: | francouzština |
| Rok vydání: | 2013 |
| Předmět: |
MESH: Mitral Valve Insufficiency
MESH: Expert Testimony Drug Industry MESH: Probability [SDV]Life Sciences [q-bio] Aortic Valve Insufficiency Eligibility Determination MESH: Causality MESH: Fenfluramine Diagnosis Differential MESH: Cross-Sectional Studies MESH: Eligibility Determination Risk Factors MESH: Appetite Depressants MESH: Risk Factors MESH: Diagnosis Differential Appetite Depressants Fenfluramine Drugs Generic Humans Expert Testimony MESH: Drugs Generic Probability MESH: Humans MESH: Compensation and Redress Mitral Valve Insufficiency MESH: Aortic Valve Insufficiency Causality MESH: France Cross-Sectional Studies MESH: Drug Industry Compensation and Redress France |
| Zdroj: | La Presse medicale La Presse medicale, Paris, Masson et Cie, 2013, 42 (4 Pt 1), pp.411-8. ⟨10.1016/j.lpm.2013.02.310⟩ |
| ISSN: | 0032-7867 |
| DOI: | 10.1016/j.lpm.2013.02.310⟩ |
| Popis: | International audience; Since September 1st 2011, the National Bureau for Compensation of Medical Accidents represents a unique portal for out-of-court settlement of litigations concerning the harm caused by benfluorex. In December 2012, its official record is as follows: 7627 patients files have been received, 1378 have been studied, 797 led to a recommendation, and compensation by the drug company Servier has been recommended for 46 cases. The large number of rejections raises a problem which needs to be examined in the light of the available evidence on benfluorex associated heart valve disease. This evidence concerns both the morphological characteristics of the disease and the epidemiology of its association with benfluorex. More than 90% of emergent double valve disease (aortic and mitral regurgitation), of emergent aortic valve regurgitation, and of prevalent grade 2 aortic valve regurgitation are attributable to benfluorex. The proportion of benfluorex-attributable disease is larger than 75% for prevalent double valve disease, or for prevalent aortic valve regurgitation of any grade. This probabilistic information, derived from the available epidemiological studies, needs to be considered as part of the evidence to establish or refute a causal link between benfluorex and valvular disease for a given patient, particularly if the patient has a low grade valvular insufficiency or no morphological anomaly. |
| Databáze: | OpenAIRE |
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