High Court (Queen's Bench Division) · Burton J, sitting alone
Facts
The claimants were people who had been infected with hepatitis C through blood or blood products supplied by the National Blood Authority in the period before screening for the virus was introduced in 1991. The blood came from donors who carried the virus, and at the time the Authority could not detect it in individual donations, although the risk that donated blood could carry it was known in general terms. The claimants sued under Part I of the Consumer Protection Act 1987, which implements the European product liability directive and imposes liability on producers for damage caused by defects in their products without proof of fault.
Issue
Whether the infected blood was defective within section 3 of the Consumer Protection Act 1987, which asks whether the safety of the product is not such as persons generally are entitled to expect; whether the unavoidability of the risk was relevant to that question; and whether the Authority could rely on the development risks defence in section 4(1)(e).
Held
Judgment for the claimants. The infected blood was defective, and the Authority could not rely on the development risks defence.
Ratio
- The test of defect in section 3 of the Act asks what level of safety the public is entitled to expect, not what is achievable; the infected units were non-standard products which fell short of the safety of the normal blood supply, and the public was entitled to expect that blood would be free of infection.
- For a non-standard product whose harmful characteristic is the unintended result of a failure in the process, the avoidability of the risk and the cost of precautions are not relevant to whether the product is defective.
- The development risks defence in section 4(1)(e) protects a producer only where the existence of the risk could not have been discovered given the state of scientific and technical knowledge, and does not apply where the risk was known to exist in the class of products, even though it was not possible to identify the individual infected units.
The judgments
Burton J (lead)
Interpreted section 3 in the light of the directive, held that the public were entitled to expect blood that was free of infection, treated the infected units as non-standard products that were defective whether or not the risk was avoidable, and held that the development risks defence failed because the risk of infection was known.
Key reasoning
- The Act must be interpreted to give effect to the directive, whose purpose is to impose strict liability on producers for defects, so that the focus is on the safety that the public is entitled to expect and not on the producer's fault or what could be done to prevent the defect.
- The public did not accept the risk of infection from a transfusion simply because it knew in general that blood might carry a risk, and the benefit and social utility of transfusions did not alter the expectation of the safety of the particular unit transfused.
- The existence of the risk of infection in donated blood was known, even though no test could identify it in any particular unit, so that the defence for unknown or undiscoverable defects was not available.
Where it fits in the module
On the FHS Tort list under strict liability. A v National Blood Authority is the leading case on whether Part I of the 1987 Act imposes liability that is truly strict, since defect is judged by public expectation and not by fault. It raises the questions of how the expectation test is applied, whether avoidability and social utility are relevant, and how the development risks defence operates, and invites comparison with fault-based liability in negligence and with other strict liability regimes, including vicarious liability and Rylands v Fletcher.
Criticisms
- Defining defect by public expectation allows the court to impose liability for an unavoidable risk and ignores the social utility of blood transfusion, making the producer in effect an insurer, in a way that arguably goes beyond a no-fault regime.
- The distinction between standard and non-standard products is not found in the Act or the directive, which refer only to the safety that persons are entitled to expect, and later courts doubted that it could be relied on generally.
- Reading the development risks defence so that knowledge of the general class of risk defeats it leaves the defence of little value for products with rare random defects, which may undermine the policy that producers are protected where a risk is unknowable.
Written with AI (claude-sonnet-5.5 (Claude Code writer)) on 1 November 2026, reviewed for errors by a second model (claude-sonnet-5.5 (Claude Code checker)). Read the case itself at [2001] EWHC 446 (QB), [2001] 3 All ER 289. Spotted an error? Tell us.