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Developments in product liability law are always potentially significant for pharmaceutical and medical device manufacturers.

On 13 March 2024, the European Parliament adopted new EU consumer protection legislation to repeal and replace the EU Product Liability Directive 85/374/EEC, which has been in force for almost 40 years.  Once the new legislation has been approved by the European Council it will become law, and is likely to come into force in around mid-2026. The intention is for EU consumers to have easier access to compensation caused by defective products. 

The International Comparative Legal Guide (ICLG) on Product Liability Laws and Regulations 2024 is now available, and we have prepared:

Continue Reading Implications of the New EU Product Liability Directive

Many things have changed since 1985, in particular in the world of technology.  The Commission’s 10 page report and evaluation of 7 May 2018 questions whether the Product Liability Directive of 1985 (“the Directive”) is still fit for purpose.  The Directive was implemented to protect consumer safety and imposes strict liability (i.e. no requirement for the injured party to prove fault) on a producer of defective products for personal injury or damage to property caused by the defect.

The Commission’s Report

Although, historically, the Commission has reported on the implementation of the Directive to the Council and Parliament every 5 years, this is the first time that the report has been accompanied by an evaluation of the relevance of the Directive in the EU today, owing to widespread concerns regarding the invention and everyday use of “products” that were not even imagined back in 1985.  The report recognises the urgent need to consider whether the Directive, in its current form, adequately deals with the challenges posed by “digitisation, the Internet of Things, artificial intelligence and cybersecurity” now and in the future, and, if it does not, what changes would be required to address the shortcomings.Continue Reading Is the EU Product Liability Directive still fit for purpose?