by Stephen McGuinness , Conor Morgan February-13-2023 in Healthcare Law

 

 

The Product Liability Directive 1985 has been considered an effective mechanism of civil liability for EU citizens, who have suffered damage as a result of a defective product for over 30 years. It was adopted into Irish law by the Product Liability Act 1991. However, with emerging technologies, the concept of what constitutes a product, and consequently the scope of what is captured within the parameters of the directive has developed. As a result of these emerging technologies the European Commission has published two draft directives, to address the limitations of the current regime, namely:

  1. Proposed Product Liability Directive
  2. Proposed Artificial Intelligence Liability Directive

 

Proposed Product Liability Directive (PL)

According to the European Commission, the new Product Liability Directive modernises the existing strict product liability regime.  It will apply to claims against manufacturers for damage caused by defective products and is limited to claims made by private individuals.

Some key developments can be noted as follows:

Extension of product-concept

The definition of a product under this product liability proposal would capture all movables and extend to include software and digital services, which are affiliated with a product. The proposal provides for a compensation mechanism for damage incurred when digital products are made unsafe by software updates, artificial intelligence or when manufacturers fail to address cybersecurity vulnerabilities.

Time Limits and damage threshold

The draft directive introduces flexibility to the time restrictions to introduce claims and alleviates the burden of proof in complex cases.  The current 10 year period will be extended to 15 years in incidents involving latent personal injuries. The date from which time is deemed running will also include the date on which a product was substantially modified, subsequent to it being introduced to the market or put into service.  Furthermore, the current €500 minimum threshold for property damage is removed.

Defectiveness

Article 6 of the proposed Product Liability Directive states that a product will be considered defective when it does not provide the safety which the public at large is entitled to expect, adding the following circumstances to the current regime:

  1. The effect on the product of any ability to continue to learn after deployment.
  2. The effect on the product of other products that can reasonably be expected to be used together with the product
  3. Product safety requirements, including safety-relevant cybersecurity requirements.

Presumption of causality and defectiveness

Article 9 of the proposed directive also establishes a presumption of defectiveness when:

  1. The defendant has failed to comply with an obligation to disclose relevant evidence.
  2. The claimant establishes that the product does not comply with mandatory safety requirements which are intended to protect against the risk of the damage which occurred.
  3. The claimant establishes that the damage was caused by an obvious malfunction of the product.

There will be a presumption of causality where it has been established that the product is defective and the damage is of a kind typically consistent with the defect in question. Where a domestic court finds that the claimant faces excessive technical or scientific difficulties in proving defectiveness or causation, these will be presumed upon evidence that:

  1. The product contributed to the damage, and
  2. It is likely that the product was defective or that its defectiveness is a likely cause of the damage.

 

Proposed Artificial Intelligence Directive (AI)

 The proposed Artificial Liability Directive is being introduced to support the roll-out of artificial intelligence in Europe. It aims at setting out clear rules and responsibilities for the use of artificial intelligence in the EU. The directive would create a framework for the liability of artificial intelligence providers in the event of damage caused by artificial intelligence systems, while also establishing a set of safeguards to ensure that artificial intelligence is used in a manner that respects fundamental rights and values. It also aims to create a level playing field for artificial intelligence providers and promote trust in artificial intelligence, while supporting innovation and growth in the sector.

In order to simplify the legal process in proving that fault resulted in damage, the directive introduces the following two main features:

  1. Where a relevant fault has been established, there is a rebuttable presumption of causation if it can be considered reasonably likely, based on the circumstances of the case, that the fault has influenced the output produced by the artificial intelligence system and the claimant has demonstrated that this failure gave rise to damage.
  2. The proposal also establishes a right of access to evidence from companies and suppliers when high-risk artificial intelligence is involved.

Again, where a domestic court finds that a claimant faces excessive difficulties due to technical and opaque complexities in attempting to establish defectiveness or causation, these will now be presumed if the claimant can establish certain points based on sufficiently relevant evidence. This presumption is rebuttable but constitutes a noteworthy reform in contrast to the current regime.

 

Conclusion

The Commission has stated that the new rules strike a balance between protecting consumers while fostering innovation. The timeline for implementation of these directives remains uncertain, but it will certainly take a number of years. Further amendments of the proposed directives can be expected as they percolate through the European legislative process.  Thereafter, there will be a two year period to allow transposition into national law before taking effect.  While there is still a significant course for these directives to travel, it is clear that greater certainty in this area is a political priority.  

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About the Authors

Stephen McGuinness
Stephen McGuinness

Stephen is a partner in the Healthcare team at Hayes solicitors. Stephen specialises in the defence of medical and dental negligence claims taken against hospitals as well as individual medical and dental practitioners.

Conor Morgan
Conor Morgan

Conor is a partner in the Healthcare team at Hayes solicitors. He has over nine years’ experience working for leading firms in both Ireland (north & south) and England. Conor advises clinical practitioners and their indemnity bodies on the defence of medical negligence claims.