Digital age has brought many changes in several industries such as in life sciences industry and policymakers should address new challenges: not only do they have to enact new laws to regulate the applications of new technologies, but they also have to revise the existing regulations in order to keep them updated and efficient.
The existing legal framework for the product liability regime was formed in 1985, meaning more than thirty years ago and it had three specific objectives to achieve: i) the free movement of goods ii) the protection of consumer’s safety and property and lastly iii) the avoidance of competition distortion98. The question that arises is whether the Product Liability Directive remains fit for purpose in the light of new technological developments especially in the field of medical products or it calls for a revision.
In 2018, the European Commission conducted a formal evaluation based on evidences, attempting to assess whether the Product Liability Directive remains an effective instrument and still serves the above purposes in the context of technological advancement. Part of this evaluation was a public consultation, based on stakeholder’s feedback. Stakeholders gave their perspective on the application, the performance of the directive and its relationship with the new digital challenges99.
Particularly, the evaluation pointed out that in general the directive appears to serve its aim to establish the producer’s liability for damages caused by a defective product. As a result, it boosts consumer’s protection and ensure the effective function of internal market. However, the evaluation focused on the difficulties that consumers face when they asked for compensation in medical sector. Some difficulties are related to the burden of proof. Claimants, when proving the defect of the medical product, have to involve arguments about scientific imputation, which is very demanding given the technical nature of these issues. Another difficulty that occurs is linked to the use of leaflets by producers, which enables the latter to remain not imputable if the leaflet mentions the risks concerning the medical product. Even if the risk is not included in the
98 Giorgio Risso, Product liability and protection of EU consumers: is it time for a serious reassessment? 2019, Journal of Private International Law, 15:1, p. 210-233
99 https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/liability-defective-products_en
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instructions, the producer can invoke the risk development defense and not be held liable.
Moreover, the short expiry period limits the patients’ protection taking into consideration the fact that injuries caused by defective medical products may occur in long term. Regarding also the calculation of the limitation of the 10 year-period from the moment in which the product is put into circulation, the evaluation considers vague and unclear the concept of “put into circulation”.
As mentioned in the evaluation, the European Court of Justice has dealt with this concept in three judgments and gave varied interpretations100. In any case, in the field of medical products, the consumer is less protected given that medical products remain long term in the distribution chain101.
Following, after the conduction of the evaluation, in 2020, the European Commission published “a report on the broader implications for potential gaps in and orientations for the liability and safety frameworks for artificial intelligence, the Internet of Things and robotics”102. This report specifies how the existing frameworks are challenged by new technologies and in what way these challenges should be faced.
Regarding Product Liability Directive, the report indicates that although the directive gives a wide definition of product, its scope should be further illustrated to mirror the complexity of emerging technologies and include also software so that consumers can ask for compensation for damages caused by defective digital features. In this point, it should be noted that with respect to medical devices, the new Regulation introduces an updated and more robust EU legislative framework and the provided definition of product includes software. Furthermore, as far as the burden of proof is concerned, the report recognizes that because of the complexity of new technologies, the identification of the liable person and the proof of all the requirements needed can be very difficult for the injured party. Thus, it should be examined the possibility to facilitate
100 In case C-203/99 the Court pointed out that “a defective product is put into circulation when it is used during the provision of a specific medical service”, in C-127/04 a product is put in circulation when it leaves the production process operated by the producer and enters a marketing process in the form in which it is offered to the public in order to be used or consumed and in C-45-13 the expiration term of 10 years starts from the moment when the product has been put into circulation by the producer and not by the retailer
101 Evaluation of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products Accompanying the document Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Application of the Council Directive on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products (85/374/EEC) SWD/2018/157 final, p 28-31
102 https://ec.europa.eu/growth/single-market/goods/free-movement-sectors/liability-defective-products_en
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the burden of proof for victims under the product liability directive. Finally, concerning the concept of “put into circulation”, the report, similarly to the evaluation, states that it should call for a revision taking into consideration that products can probably change and be altered 103..
Furthermore, the wording of the Product Liability Directive does not serve the patient safety approach to risks that aims to achieve. Scholars focus on the notion “product” and the concept of risk development defense. The notion of product covers a wide range of goods such as pharmaceutical products, medical devices, human derivatives (blood). The producer of a defective product should be held liable for damages, regardless of his negligence or culpability. This policymakers’ choice was justified as achieving the fairest apportionment of risks between consumers and producers in the light of technological innovation104. The defectiveness of the product is defined on the ground whether it provides the safety which a person is entitled to expect, taking all circumstances into account including its presentation, its intended use and the time when it was put into circulation. However, no distinction can be found between manufacturing or production defects and defects that may occur because of design or lack of warnings105.
Following, the risk development defense clause reduces substantively the scope of the strict liability regime for producers of defective products106. The wording of this clause is rather ambiguous, especially the concept of scientific and technical knowledge and raises a lot of questions: what state of knowledge is meant, whose knowledge is decisive, when a defect can be discovered etc. The judgement of European Court of Justicein Commission v UK (see chapter 3) did not eliminate all these ambiguities while domestic courts give inconsistent interpretations107. This uncertainty is even more obvious in the field of life sciences and especially in the sector of medical products where risks can be detected either on the preclinical or clinical trial stage or in long term, after its marketing when side effects occur. A patient can suffer side effects with a long latency period caused by a defective medical defect and the producer may avoid liability if he
103 Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics, COM(2020) 64 final, p. 13-16
104 Recital 6 of the Product Liability Directive
105Tamara K. Hervey, Jean V. Mchale, European Union Health Law, Themes and Implications, 2015, Cambridge University Press, p 379-384
106 Richard Goldberg, Julian Lonbay, Pharmaceutical Medicine, Biotechnology and European Law, 2000, Cambridge University Press, p 186
107 Duncan Fairgrieve, Geraint Howells, Marcus Pilgerstorfer, The Product Liability Directive: Time to get Soft?, April 2013, Journal of European tort law, Vol.4 (1), p.1-33
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demonstrates that the risks were undiscoverable when the product was put into circulation. Thus, this advocates the view that the Product Liability Directive does not have a strong patient-safety approach as it intended to108.
From the Commission’s documents and scholars’ estimations, it is obvious that there is a need for revision of the Product Liability Directive. The policymakers should reconsider the effectiveness of the current framework in the light of new technologies. The most important aspects that should be revised are:
a) the notion of product which should expressly include intangible elements such as software.
However, not only software but also artificial intelligence driven products should be covered by the scope of the directive109,
b) the burden of proof in order to facilitate victims to prove the defectiveness of the product and the causality when scientific evidences are needed and lastly,
c) the risk development defense.
108Tamara K. Hervey, Jean V. Mchale, European Union Health Law, Themes and Implications, 2015, Cambridge University Press, p 379-384
109 Tiago Sergio Cabral, Liability and artificial intelligence in the EU: Assessing the adequacy of the current Product Liability Directive, 2020, Maastricht Journal of European and Comparative Law, Vol. 27(5) 615–635
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7. Conclusion
The liability regime for defective medical devices is regulated by the Product Liability Directive which is based on a strict liability regime (without fault). The producer of a defective medical devices should be held liable for damage caused by a defect in a medical device. As producer should be considered the manufacturer, the distributor, the supplier or the importer of a medical device as well. A medical device is deemed defective when it does not correspond on the legitimate expectations of patients regarding its safety, taking into consideration several factors:
its presentation, its use and the time when it was put into circulation. Particularly, a medical device can be defectively designed, manufactured or marketed. Moreover, damages comprise death or personal injuries or destruction of property. In any case, the injured party has the burden of proof for the damage, the defect and the casual relationship between defect and damage. The producer from his side, can invoke one of the seven defenses clauses that the Product Liability Directive provides and avoid liability. In the field of medical devices, the risk development defense which implies that the state of scientific and technical knowledge at the time when the producer placed the product on the market did not enable the discovery of the defect is highly controversial, as analyzed previously.
Moreover, apart from the economic operators of the supply chain, it is likely for a notified body to be held liable in case that they did not assess properly the conformity of a medical device.
In more detail, according to the Court of Justice, notified bodies undertake a general obligation to act with all due diligence when they fulfill their tasks concerning the conformity assessment and under the principles of equivalence and effectiveness, it remains to national legislator to regulate the liability regime of notified bodies for a wrongful act vis-à-vis the end users of medical devices.
Furthermore, Medical Devices Regulation brings new challenges to the regulatory framework of the liability regime for defective medical products and includes provisions that are meant to influence the medical device liability regime under the Product Liability Directive.
Regarding the liability regime of manufacturers, the new regulation introduces a new obligation for financial coverage in respect of their potential liability under the Product Liability Directive.
Following, authorized representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer when the latter fails to fulfill his obligations.
Finally, the notified body should take out appropriate liability insurance for its compliance
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assessment duties in respect of the level and geographic scope of the notified body’s tasks and the risk classification of the certified medical devices.
As follows from the above remarks, the Product Liability Directive constitutes the cornerstone of the product liability regime for medical devices. However, it cannot be disregarded that it is a legal instrument that dates back more than thirty years and it is questionable whether it remains fit for purpose in the light of new technological developments especially in the field of medical products or it calls for a revision. As it is highly discussed, a lot aspects of the existing framework should be updated, the most crucial being the notion of product which should expressly include intangible elements such as software, the burden of proof in order to facilitate victims to prove the defectiveness of the product and the causality when scientific evidences are needed and lastly the risk development defense.
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8. Bibliography
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Cases
A & Ors v National Blood Authority [2001]
Case C 203/99, Henning Veedfald and Århus Amtskommune, Judgement of the Court, 10 May 2001
Case C 219/15 Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH, Judgement of the Court, 16 February 2017
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Case C 300/95 Commission of the European Communities v United Kingdom of Great Britain and Northern Ireland, Judgement of the Court, 29 May 1997
Joined Cases C 503/13 and C 504/13, Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13), Judgement of the Court, 5 March 2005
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Case C 621/15, N.W, L.W & C.W v Sanofi Pasteur MSD SNC, Judgement of the Court, 21 June 2017
Legislation
Directive 85/374/EC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States
Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
Directive 93/42/EEC of 14 June 1993 concerning medical devices Regulation on Medical Devices (EC) 2017/745
Other Documents
Green Paper Liability for defective products, COM(1999) 396 final
Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics, COM(2020) 64 final
The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C 272/01)
Council of the European Union, Interinstitutional File 2012/0266 (COD), Reference 12401/15 ADD 4 (28 September 2015)
Council of the European Union, Interinstitutional File 2012/0266 (COD), Reference 10682/2/15 REV 2 (3 September 2015)
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