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Amiodarone, the Court of Cassation sanctions the lack of information in the package insert and engages the responsibility of the laboratory

May 4, 2023

The Court of Cassation confirms the lack of information based on the inadequacy of the information contained in the SPCs and package inserts and holds the amiodarone manufacturer liable (Civ 1ère, March 29, 2023, n°22-11.039).

In its decision of March 29, 2023 on the subject of amiodarone, the 1st Civil Chamber of the Court of Cassation reaffirmed its jurisprudence on the principle of information on health products.

The high court had been seized of a liability action against the laboratory marketing amiodarone, following the death of a patient from pulmonary fibrosis.

In this case, it reminds us of the importance of the relevance of the information communicated and the adequacy of the information contained in the SPC and the package insert of a drug, with regard to the provisions of Article 1245-3 of the Civil Code.

The absence of mention in the package insert of an adverse reaction establishes the safety defect of the product

Following the analysis of the trial judges, the Court of Cassation has confirmed the sanctionable nature of the discrepancy between the information contained in the SPC and the package insert, in that the package insert did not include the adverse effects in question mentioned in the SPC.

It concludes that such information was insufficient under article 1386-4, paragraphs 1 and 2, now 1245-3, paragraphs 1 and 2, of the Civil Code, under which a product is defective when it does not offer the safety that can be expected, which is assessed in light of all the circumstances and particularly the presentation of the product. 1 and 2 of the Civil Code, according to which a product is defective when it does not offer the safety that can be expected, which is assessed in light of all the circumstances and in particular the presentation of the product and the use that can reasonably be expected of it.

The Court thus recalls its constant jurisprudence on the subject, excluding once again the divergences in the degree of information between the documents intended for health professionals and those intended for patients. We recall here the liability recognized by the Court of Cassation of a vaccine manufacturer, whose risk of multiple sclerosis relapse was, admittedly, among the adverse effects mentioned in the SPC but not in the package insert(Cass. civ.1July 9, 2009, n°08-11.073) or that of the manufacturer of sodium valproate, whose SPC mentioned a teratogenic risk when the package insert merely referred to the implementation of specific antenatal monitoring(Cass. civ. 1°, Nov. 27, 2019, n°18-16.537, TJ of Paris, January 5, 2022 n° 17/07001).

Full and complete manufacturer's liability excluding any sharing of responsibility

In any event, the Court rejected the pleas concerning the subsequent modification of this leaflet by the manufacturer and the breach of the doctor's duty to inform, thereby excluding any sharing of responsibility.

This judgment is thus in line with the issue of information relating to drugs, which is still a hot topic in liability litigation. Whether it is still recently the cases of Levothyrox(Cass. Civ 1ère., March 16, 2022) or sodium valproate(Cass. 1re civ., Nov. 27, 2019, n° 18-16.537), questioning not only the impact of information, but also and above all, the conditions of exoneration of the laboratory's liability and the sharing of this liability with the competent authority and the prescribers (TA Montreuil, June 23, 2020 n° 1704275, n°1704392, n°1704394).

The Court of Cassation reminds us here that the absence of mention in the package insert of the risk of an adverse effect establishes a safety defect likely to engage the laboratory's liability, despite the presence of this information in the SPC and the consequent failure of the physician to fulfill his obligation to inform.

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