Healthcare service providers liability, strict liability, defective product, practitioner liability, fault requirement, safety obligation, manufacturer liability, joint and several liability, health product defect, liability for damages, Court of Cassation, Court of Appeal, jurisprudence, Public Health Code, Article L1142-1, European directive 85/374/CEE, product failure, prosthesis rupture, duty of information, liability for lack of information, medical device liability, healthcare law, medical malpractice, patient rights, liability regime, healthcare providers responsibility, medical product liability, EU law, French law, Civil Code, health product safety, medical practitioner liability, manufacturer responsibility, damage compensation, liability for faulty medical devices, healthcare jurisprudence, medical liability law
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Abstract
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Abstract
Analysis of the Court of Cassation's decision regarding the liability of healthcare practitioners and manufacturers in cases involving defective medical products.
Extract
[...] The High Jurisdiction thus takes a very protective position towards healthcare professionals by maintaining fault as the main criterion for engaging their liability. This decision, in contradiction with previous case law, is all the more surprising as it refuses the application of the law of 4 March 2002, transposed to article L.1142-1 of the Public Health Code, which provides for the case where liability is incurred due to a defect in a health product as an exception to the requirement of a fault committed by the professional. [...]
[...] Court of Cassation, Civil Chamber July No. 11-17,510 - To what extent can a practitioner's liability be engaged when he has implanted a prosthesis whose failure has caused harm to the patient, even if he did not commit any fault during his intervention? The activity of providing medical care services, being full of uncertainties, makes it extremely difficult to determine the liability of practitioners in the event of damage suffered during an intervention. This is even more true when the damage is due to the use of a defective product, which constitutes an additional risk to the intervention. [...]
[...] are only responsible for the harmful consequences of prevention, diagnosis or treatment acts in the event of fault.' This principle established by the jurisprudence of the 1990s and repeated by the code includes two exceptions established by the jurisprudence. Firstly, healthcare establishments, services and organizations are responsible for damages resulting from nosocomial infections (Civ. 1st, June 29, 1999) independently of their fault and they cannot free themselves from this responsibility unless they prove a foreign cause. It is also the case when it comes to the use of a defective health product (Civ. 1st, November 1999). [...]
[...] According to the judgment, healthcare service providers 'cannot be likened to distributors of medical products or devices'. They only use these products 'for the practice of their art or for the performance of a medical act'. Thus, 'the Court of Cassation intends to determine the contours of the qualification of healthcare service providers by likening them to simple users'4. If we look at these practitioners as simple users, it is necessary to retain their responsibility only for the manipulation of the products they use and not for the products themselves. [...]
[...] This same condition is taken up by the judgment of February according to which 'the liability in law of a healthcare professional or a healthcare establishment . can only be engaged in the case where the manufacturer could not be identified and where the healthcare professional or healthcare establishment has not designated its own supplier or the manufacturer within the allotted time'5, thus reaffirming the concern to put the patient first by ensuring him a compensation mainly by the manufacturer and subsidiarily by the establishment or the professional. [...]
