Causal Effect Relationship in Medical Cases. An Old Problem in a New Scenario. Commentary to CJEU Judgment (Second Chamber) of 21 June 2017, N.W. & Others V. Sanofi Pasteur MSD & Others, Case C-621/15, EU:C:2017:484. Approbative Gloss

Agata Wnukiewicz-Kozłowska

University of Wrocław , Polska
https://orcid.org/0000-0002-4872-3852

Urszula Dorota Drozdowska

Wydział Prawa, Uniwersytet w Białymstoku , Polska
https://orcid.org/0000-0002-7663-1904


Abstrakt

This commentary evaluates the problem in assessing the role of a causal connection between damage and the use of a defective medical product, specifically a vaccine. The judgment of the Court of Justice of the European Union (CJEU) in the Sanofi Pasteur Case, which allowed the possibility of recognizing damage claims, even in cases where the prevailing scientific theory claims that there is no scientific evidence of a causal link between a vaccination and the disease, became a base for consideration. Consequently, procedural solutions (such as the standard of proof required, the admissibility of prima facie evidence reasoning and other solutions in cases of an uncertain causation) remain to be decided by national law. The authors assessed two legal systems: the French and Polish legal systems in the context of how to resolve these dilemmas and to describe the impact of the above-mentioned judgment on the case-law of French and Polish courts as regards the application of Directive 85/374/EEC. As a result, they concluded that the most important interpretative motive has become the individual interest of the vaccination’s victim as a consumer of medical services. It seems to be in accordance with Directive 85/374/EEC, which is motivated by the necessity of approximation of the laws of the Member States concerning the liability of the producer for damage caused by the defectiveness of his products. However, since the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property, in countries belonging to the European Union, the authors wonder how the commented judgment will affect the further development of consumers protection against defective vaccines.

Słowa kluczowe:

uncertain causation, standard of proof, vaccine, damage, defective medical product

Bagińska, Ewa. “Poland.” In European Product Liability: An Analysis of the State of the Art in the Era of New Technologies, edited by Piotr Machnikowski, 377–406. Cambridge-Antwerp-Portland: Intersentia, 2016.

Bagińska, Ewa. “Poland.” In European Tort Law: Basic Texts, edited by Ken Oliphant, and Barbara Steininger, 191–200. Vienna: Jan Sramek Verlag, 2011.

Bagińska, Ewa. Odpowiedzialność deliktowa w razie niepewności związku przyczynowego. Studium prawnoporównawcze. Toruń: TNOiK, 2013.

Bączyk-Rozwadowska, Kinga. “Medical malpractice and compensation in Poland.” Chicago-Kent Law Review 86, Issue 3 (2011): 1217–1261.

Black Corri, Kaye James A., and Jick Hershel. “Relation of childhood gastrointestinal disorders to autism: nested case control study using data from the UK General Practice Research Database.” British Medical Journal 325 (2002): 419–421.

Brosset, Estelle. “Distinguishing between law and science in terms of causation and the hepatitis B vaccine: W. v. Sanofi Pasteur.” Common Market Law Review 55 (2018): 1899–1915.

Brosset, Estelle, and Elsa Supiot. “Le vaccin contre l’hépatite B: l’autonomie de la preuve juridique en l’absence de consensus scientifique devant la Cour de justice de l’Union européenne.” Revue des contrats 4 (2017): 662–668.

Brun, Philippe. “Raffinements ou faux-fuyants? Pour sortir de l’ambiquїté dans le contentieux du vaccin contre le virus de l’hépatite B (á propos d’un arrêt de la Cour de Cassation du 25 novembre 2010).” Receuil Dalloz 5 (2011): 316–322.

Büyüksagis, Erdem. “Arrêt “Sanofi”: la responsabilité du fait des produits défectueux appliquée aux vaccins, une responsabilité objective basée sur des présomptions.” Journal de droit européen 244 (2017): 395–397.

Cairó, Ruiz. “The Lack of Medical Research Does Not Prevent an Injured Person from Proving the Defect of a Product and the Causal Link between the Defect and the Damage.” European Journal of Risk Regulation 4 (2017): 798–803.

Deer, Brian. “How the Case Against the MMR Vaccine Was Fixed.” British Medical Journal 342 (2011): 77–82.

Drozdowska, Urszula. “Odpowiedzialność odszkodowawcza za niezawinione skutki szczepień ochronnych – uwagi de lege lata i de lege ferenda.” Białystok Legal Studies 17 (2017): 99–112.

Duncan, Fairgrieve, Geraint Howells, Peter Møgelvang-Hansen, Gert Straetmans, Dimitri Verhoeven, Piotr Machnikowski, André Janssen, and Reiner Schulze. “Product Liability Directive.” In European Product Liability: An Analysis of the State of the Art in the Era of New Technologies, edited by Piotr Machnikowski, 17–108. Cambridge–Antwerp–Portland: Intersentia, 2016.

Espesson-Vergeat Béatrice, and Pierre A. Morgon. “A propos de la preuve de la défectuosité du vaccin. Regards sur la position de la Cour de Justice de l’Union européenne dans un contexte de la politique vaccinale en pleine ébulition.” Revue générale de droit médical 64 (2017): 123–137.

Godlee, Fiona, Jane Smith, and Harvey Marcovitch. “Wakefield’s article linking MMR vaccine and autism was fraudulent.” British Medical Journal 342 (2011): 64–66.

Goldberg, Richard. “Epidemiological uncertainty, causation, and drug product lability.” McGill Law Journal 4 (2014): 777–818.

Goldberg, Richard. “Vaccine damage and causation: a Franco-American comparison.” Journal de Droit de la Santé et de l’Assurance Maladie 1 (2014): 134–137.

Houézec, Dominique Le. “Evolution of multiple sclerosis in France. B vaccination.” Immunologic Research 60 (2014): 219–225.

Jagielska, Monika. “Odpowiedzialność za produkt.” In System Prawa Prywatnego, t. 6, edited by Adam Olejniczak, 869–934. Warsaw: C.H. Beck, 2009.

Janiszewska, Beata. “Dowodzenie w procesach lekarskich (domniemania faktyczne i reguły wnioskowania prima facie).” Prawo i Medycyna 2 (2004): 104–129.

Kalkbrenner, Amy E., Rebecca J. Schmidt, and Annie C. Penlesky. “Environmental chemical exposures and autism spectrum disorders: a review of the epidemiological evidence.” Current Problems in Pediatric and Adolescent Health Care 44 (2014): 277–318.

Lambert-Faivre, Yvonne, and Stéphanie Porchy-Simon. Droit du dommage corporel. Systèmes d’indemnisation. Paris: Dalloz, 2012.

Madsen, Kreesten Meldgaard, Andres Hviid, Mogens Vestergaard, Diana Schendel, Jan Wohlfahrt, Poul Thorsen, Jørn Olsen, and Mads Melbye. “A population-based study of measles, mumps, and rubella vaccination and autism.” New England Journal of Medicine 347 (2002): 1477–1482.

Maitre, Grégory. “L’intercitude sur la causalité scientifique est indifferente á l’appréciation de la causalité juridique.” Receuil Dalloz 15 (2010): 947–951.

Nesterowicz, Mirosław. “Glosa do wyroku Sądu Okręgowego w Lublinie z 4.07.2002, I C 656/99.” Prawo i Medycyna 3 (2004): 122–130.

Prieur, Stéphane. “Défaut et causalité dans la contentieux de la vaccination contre l’hépatite B : suite, mais (probablement) pas fin.” Gazette du Palais, November 21, 2017, 23–25.

Rao, T.S. Sathyanarayana, and Chittaranjan Andrade. “The MMR vaccine and autism: sensation, refutation, retraction, and fraud.” Indian Journal of Psychiatry 53 (2011): 95–96.

Rizzi, Marco. “A Dangerous Method: Correlations and Proof of Causation in Vaccine Related Injuries.” Journal of European Tort Law 9 (2018): 289–307.

Sackett David L., and Brian R. Haynes. “On the need for evidence-based medicine. EBM Notebook.” Evidence-Based Medicine 1 (1995): 5–6.

Shetreet, Shimon. “On Assessing the Role of Courts in Society.” Manitoba Law Journal 10 (1980): 357–414.

Siddiqui, Mariam, Daniel A. Salmon, and Omer B. Saad. “Epidemiology of vaccine hesitancy in the United States.” Human Vaccines & Immunotherapeutics 9 (2013): 2643–2648.

Smillie, Laura R., Marc R. Eccleston-Turner, and Sarah L. Cooper. “C-621/15 – W. and others v Sanofi Pasteur: an exemple of judical distortion and indifference to science.” Medical Law Review 26 (1) (2018): 134–145.

Smith, Philip J., Sharon G. Humiston, Edgard K. Marcuse. “Parental delay or refusal of vaccine doses, childhood vaccination coverage at 24 months of age, and the Health Belief Model.” Public Health Reports 126 (suppl 2) (2011): 135–146.

Taylor, Brent, Elizabeth Miller, Raghu Lingam, Nick Andrews, Andrea Simmons, and Julia Stowe. “Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: population study.” British Medical Journal 324 (2002): 393–396.

Véron, Paul, and François Vialla. “Contentieux du vaccin contre l’hépatite B : l’autonomie de la causalité juridique validée par la Cour de Justice de l’Union eurpéenne.” Revue générale de droit médical 65 (2017): 223–233.

Viney, Geneviève. “La responsabilité des fabricants de médicaments et de vaccins: les affaire de la prevue.” Receuil Dalloz 7 (2010): 391–396.

Wakefield, Andrew J., S. H. Murch, A. Anthony, J. Linnell, D. M. Casson, M. Malik, M. Berelowitz, A. P. Dhillon, M. A. Thomson, P. Harvey, A. Valentine, S. E. Davies, and J. A. Walker-Smith. “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.” Lancet 351 (1998): 637–641.

Zerbo, Ousseny, Ana-Maria Iosif, Cheryl Walker, Sally Ozonoff, Robin L. Hansen, and Irva Hertz-Picciotto. “Is Maternal Influenza or Fever During Pregnancy Associated with Autism or Developmental Delays? Results from the CHARGE (Childhood Autism Risks from Genetics and Environment) study.” Journal of Autism Developmental Disorders 43, no. 1 (2013): 25–33.


Opublikowane
2021-08-21


Wnukiewicz-Kozłowska, A., & Drozdowska, U. D. (2021). Causal Effect Relationship in Medical Cases. An Old Problem in a New Scenario. Commentary to CJEU Judgment (Second Chamber) of 21 June 2017, N.W. & Others V. Sanofi Pasteur MSD & Others, Case C-621/15, EU:C:2017:484. Approbative Gloss. Review of European and Comparative Law, 46(3), 263–290. https://doi.org/10.31743/recl.12264

Agata Wnukiewicz-Kozłowska 
University of Wrocław

Dr. habil. Agata Wnukiewicz-Kozłowska, Assistant Professor, Faculty of Law, Administration and Economics, University of Wrocław; correspondence address: ul. Uniwersytecka 22-26, 50-145 Wrocław, Poland; e-mail: agata.wnukiewicz-kozlowska@uwr.edu.pl; https://orcid.org/0000-0002-4872-3852.

https://orcid.org/0000-0002-4872-3852
Urszula Dorota Drozdowska  drozdowska@uwb.edu.pl
Wydział Prawa, Uniwersytet w Białymstoku

Dr. Urszula Drozdowska, Assistant Professor, Faculty of Law, University of Białystok; correspondence address: ul. Mickiewicza 1, 15-213 Białystok, Poland; e-mail: drozdowska@uwb.edu.pl; https://orcid.org/0000-0002-7663-1904.

https://orcid.org/0000-0002-7663-1904



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