A v National Blood Authority [2001] EWHC QB 446 (26th March, 2001)

Claimants infected with Hepatitis C from blood transfusions between 1988 and 1991 sued the National Blood Authority under the Consumer Protection Act 1987. The court held that infected blood was a defective product under the EU Product Liability Directive, establishing that consumers were entitled to expect blood free from infection regardless of whether the defect was avoidable.

Facts

This case concerned 114 claimants who contracted Hepatitis C through blood transfusions received from 1 March 1988 onwards. The claimants sought damages under the Consumer Protection Act 1987, which implemented the EU Product Liability Directive (85/374/EEC). The blood was supplied by the National Blood Authority and other defendants responsible for blood transfusion services in England and Wales. The defendants had not introduced screening tests for Hepatitis C until 1 September 1991, and had not implemented surrogate testing that might have reduced infections.

Background to the Infection

Hepatitis C (formerly known as Non-A Non-B Hepatitis) had been recognised as a risk in blood transfusions since the 1970s. The virus was identified in 1988, and screening tests became available from 1989. Approximately 1-3% of donated blood in the UK was believed to be infected. The medical profession was aware of the risk, but patients receiving transfusions were generally not warned.

Issues

The court was required to determine several key issues:

Construction of Article 6 of the Directive

Whether the infected blood was ‘defective’ within the meaning of Article 6, which provides that a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account.

Relevance of Avoidability

Whether the fact that the defect was unavoidable (because no screening test existed at the relevant time) was a relevant circumstance under Article 6.

Construction of Article 7(e)

Whether the defendants could rely on the ‘development risks’ defence under Article 7(e), which provides that a producer is not liable if the state of scientific and technical knowledge at the time was not such as to enable the existence of the defect to be discovered.

Judgment

Mr Justice Burton delivered a comprehensive judgment finding for the claimants.

Article 6: Defectiveness

The court held that the infected blood was a defective product. Burton J concluded that the public was entitled to expect that blood used for transfusions would be free from infection. The concept of legitimate expectation was to be assessed objectively by the court, and the public’s expectation was not limited to expecting that legitimately expectable precautions would be taken.

The court distinguished between ‘standard’ and ‘non-standard’ products. The infected bags of blood were non-standard products because they differed from the safe blood that the producer intended to supply. For non-standard products, the question was whether the public accepted that a proportion of products would be defective. Here, there were no warnings to the public, and the risk was not socially acceptable.

Crucially, Burton J held that ‘avoidability’ was not a relevant circumstance under Article 6. The purpose of the Directive was to eliminate fault from the inquiry, and introducing questions of what steps could or should have been taken would reintroduce concepts of negligence by the back door.

Article 7(e): Development Risks Defence

The court held that Article 7(e) was not available to the defendants. Burton J construed the defence as applying only to genuinely unknown risks. Once the existence of a defect in a product category was known (as Hepatitis C infection in blood was known), the defence was unavailable, even if the defect could not be discovered in individual products.

The defence was intended to protect producers from liability for development risks – truly unknown defects that materialise for the first time. It did not protect against known risks that were unavoidable in particular products.

Factual Findings

In the alternative, if avoidability was relevant, Burton J found that surrogate testing should have been introduced by March 1988, and routine Hepatitis C screening should have been implemented by March 1990. The UK was slow compared to other countries in introducing screening.

Implications

This judgment is of major importance for product liability law in the United Kingdom and across Europe. It represents the first detailed judicial analysis of Articles 6 and 7(e) of the Product Liability Directive in English law.

Key Principles Established

The case establishes that product liability under the Directive is truly strict, not merely an enhanced negligence standard. The conduct of the producer and questions of what could or should have been done are irrelevant to determining defectiveness. The focus is on the product itself and whether it provided the safety that the public was entitled to expect.

The distinction between standard and non-standard products provides a useful analytical framework. For non-standard products (those that differ from the producer’s intended design), defectiveness is more easily established.

The development risks defence is narrowly construed and applies only to genuinely unknown risks, not to known but unavoidable risks in particular products.

Practical Consequences

Producers of products with known risks that cannot be eliminated in individual items face liability unless the risk is clearly communicated to and accepted by consumers. Warnings may be important but are not necessarily sufficient under Article 12, which prevents contractual exclusions of liability.

The case has significant implications for blood services, pharmaceutical companies, and other producers of products where complete quality control is impossible.

Verdict: Judgment for the claimants. The infected blood was held to be defective within Article 6 of the Product Liability Directive, and the defendants could not rely on the Article 7(e) development risks defence. The claimants were entitled to damages for their Hepatitis C infections.

Source: A v National Blood Authority [2001] EWHC QB 446 (26th March, 2001)