The EU is currently overhauling its product liability laws. Prompted by the perceived risks of new technologies and a desire to make it easier for claimants to bring claims for medical device and pharmaceutical claims, the changes represent a major shift in the litigation landscape in the EU. They will have a profound effect for life sciences companies, especially when taken together with the EU’s new class actions mechanisms. As a result, businesses need to prepare for an increase in the already growing trend of EU consumer claims against life sciences manufacturers and suppliers.
The Clinical Trials Regulation, which came into force last year, has modified (and in some cases increased) responsibilities for sponsors, streamlined reporting processes and improved protection for clinical trial subjects. In light of the regulatory changes, now is a good time to consider best practices when negotiating and performing Clinical Trial Agreements.
European Commission publishes new liability rules to simplify claims for damage caused by AI-systems
New laws allowing groups of EU consumers to launch class actions against traders are to be implemented by 25 December 2022 and will apply from June next year. The EU’s Representative Actions Directive (EU) 2020/1828 represents a major overhaul of the European class actions landscape, introducing mechanisms for group litigation in every one of the EU’s 27 Member States, alongside a new cross-border mechanism for class actions.
A decision of the UK Supreme Court has reaffirmed recent judicial guidance on the approach to defects under the UK’s product liability regime and held that actions including the issuing of official notices and alerts by regulators and the manufacturer, and the voluntary withdrawal of the product range from the market, are not prima facie evidence of a defect alone and should be considered in light of other evidence.
The number of class actions brought in the UK is likely to grow considerably. In particular, we expect Claimant firms to continue making claims for misuse use of data where an issue affects a large number of individuals.
The judgment of the High Court of England and Wales in Cardiorentis AG v IQVIA Ltd & Another appears to be the first common law court’s decision that gives detailed consideration to the duties of companies involved in the conduct of clinical trials and, in particular, the standard of care owed by contract research organisations.