Product liability in the life sciences sector
Product liability in the life sciences sector

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • Product liability in the life sciences sector
  • What is product liability?
  • The EU and UK regulatory framework
  • Consumer Protection Act 1987
  • Relationship with the pharmaceutical regulatory framework
  • Liability for defective products
  • What is ‘damage’?
  • What is a ‘product’?
  • What is a ‘defect’ or defective product?
  • Causal link
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

What is product liability?

Products sold to consumers must be safe. In the UK, product safety is governed by a wide legal and regulatory framework, with certain high-risk products, such as medicines, being subject to additional regulation.

Failure to comply with these laws can lead to both civil and criminal liability.

Civil product liability can be based on:

  1. strict liability (as a result of a defect in a product rather than any fault on the part of the defendant) under Directive 85/374/EEC, the Product Liability Directive

  2. negligence (fault-based liability where a duty of care has been breached and resulted in damage) under the common law of tort

  3. breach of contract