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[About the settlement of litigations concerning the harm caused by benfluorex (Mediator®)]
- Source :
- 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⟩
- Publication Year :
- 2013
- Publisher :
- HAL CCSD, 2013.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- Language :
- French
- ISSN :
- 00327867
- Database :
- OpenAIRE
- Journal :
- 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⟩
- Accession number :
- edsair.pmid.dedup....ebc8a6a7a6ef4ef74b6a4ab69d4be3dd
- Full Text :
- https://doi.org/10.1016/j.lpm.2013.02.310⟩