Country:

UK (England)

Case Name:

A and Others v National Blood Authority and another [2001] 3 All E.R. 289; [2001] Lloyd's Rep. Med. 187

Court:

Queens Bench Division, 26 March 2001

Topics/Issues:

Product Liability

Consumer Expectations

Defect

Development Risks Defence

Knowledge of Risks

Medical Treatment

Strict Liability

Legislation referred:

Consumer Protection Act 1987

Product Liability Directive 85/374/EEC

Cases referred (inter alia):

Abouzaid v Mothercare (UK) Ltd [2002] CA Transcript 2279

Commission v UK, Case C-300/95 [1997] All ER (EC) 481, [1997] ECR I-2649, ECJ

German Bottle Case, The (9 May 1995) NJW 1995, 2162, Bundesgerichtshof

Richardson v LRC Products Ltd [2000] Lloyd's Rep Med 280

Facts:

The Claimants sought damages after being infected with Hepatitis C from blood and blood products through blood transfusions from March 1988. The claims were brought under the Consumer Protection Act 1987 (CPA), implementing the European Product Liability Directive (Council Directive 85/374).

The Claimants submitted that the defendant National Blood Authority, which had taken up responsibility for the administration of blood transfusions, was strictly liable under Article 6 of the Directive, without consideration of the history of testing and despite the absence of fault. The Claimants contended that on the proper construction of Article 6, the blood was defective, the defendants having no basis to claim the development risk within article 7(e) of the Directive. It was common ground of both parties that the Hepatitis C virus had not been discovered or identified at the date when the claims were commenced, and that no screening test to discover the presence of such a virus in a donor's blood was available until 1989.

The defendant Blood Authority submitted that, while such a risk was known to the medical profession, the public were not entitled to expect 100% clean blood. Further, it was contended by the Defendant that the most the public were entitled to expect was that all legitimately expectable precautions had been taken, in light of the fact that no screening tests had been undertaken. The Defendant also submitted that they were required to produce the product and, contrary to the position of commercial producers, had no option of withdrawing the product from the market rather than incurring liabilities.

Legal Questions:

(1) Whether the blood was defective within Article 6 of the Directive

(2) Whether the public's legitimate expectation of the product was that it would not be defective

(3) The true construction of the term 'all considerations' in Article 6 of the Directive

(4) Whether the alleged defect in the blood product was a manufacturing or design defect

(5) Whether the Directive's Article 7(e) defence could be used by the defendant Blood Authority

(6) The quantum of damages in respect of infection

Decisions:

(1) Whether the blood was defective within article 6 of the Directive

The Court stated that, in the assessment of a claim under article 6 of the Directive, the initial step was to identify any harmful characteristics which caused the injury. Consequently, to establish that a defect existed in a product, the next step would be to conclude whether the product was "standard" or "non-standard". Burton J. stated that this could be done by comparing the product with other products of the same type or series, produced by that producer. Where a product differed from the series in such a way that included harmful characteristics, then it was held that it was non-standard for the purposes of Article 6 of the Directive.

Further, the primary issue for non-standard products was whether the public at large accepted its non-standard nature. Thus, the Court held that a product was likely to be unsafe if any error in design or flawed system existed. The harmful characteristic had to be identified, although the primary question for the Court would be the product's safety for its foreseeable use. Since the Court found that testing of the blood should have been in place by March 1988, and thus screening should have been introduced by 1 March 1990, it held that blood infected after March 1988 did not provide the safety that persons were generally entitled to expect. The court was satisfied that the blood supplied to the Claimants was defective within Article 6 of the Directive. The product's defect was the virus in the blood and the damage was the virus in the patient.

(2) Whether the public's legitimate expectation of the product was that it would not be defective

It was stated that the producer was under an obligation to meet the level of safety that the public at large was entitled to expect, as determined by the Court, and not the safety actually expected. The legitimate expectation of the public at large was not that tests had been carried out, or precautions adopted. On the contrary, the Court found that the public's only legitimate expectation was the safety of the product. Thus, the defendant Blood Authority could not argue that the consumer had an actual expectation that the blood being supplied was 100% clean, nor could it be submitted that he had knowledge that it was, or likely to be, infected by Hepatitis C. As a consequence of such a finding, the blood could not be considered a product that carried an inherent risk by its very nature, to which consumers had chosen to expose themselves. The Court thus held that the legitimate expectation of the public at large was the safety of the blood.

(3) The true construction of the term "all considerations" in Article 6 of the Directive

It was held that the term "all considerations" in Article 6 of the Directive meant "all relevant circumstances". It was accepted by both parties that the Directive's aim was to eliminate proof of fault or negligence in order to make life easier for Claimants to prove their case. Thus, a consumer would neither have to prove the producer failed to take reasonable steps to comply with his duty of care, or the producer failed to take all legitimately expectable steps. Furthermore, it was stated that avoidability, impracticality, benefit to society, utility of the product, cost and difficulty in taking precautionary measures were not relevant considerations to be taken into account under Article 6 of the Directive. This was because such considerations did not align with the purpose of the Directive; if they were so then they would have been included in derogation from it. Thus any issues of fault, negligence or conduct of the producer were for consideration under the limited Article 7(e) development risk defence of the Directive.

(4) Whether the alleged defect in the blood product was a manufacturing or design defect

The infected blood products were deemed non-standard products, the Court stating that the primary issue for such a product was to whether the public at large accepted its non-standard nature. It was found however to be immaterial as to whether such products would have been categorised as manufacturing or design defects, as they were in any event, different from the norm which the producer intended for public use. Moreover, it was stated that even in the case of standard products like drugs, some side effects were capable of being "socially acceptable" where they were made known to the customer.

(5) Whether the Directive's Article 7(e) defence could be used by the Defendant

Paragraph 47 onwards of the court's judgment details the provision and arguments of both parties under article 7(e) of the Directive. It states that provided a defect was known, or should have been known, in the light of "non-Manchurianly accessible information", then the producer continued to produce and supply at its own risk. Burton J stated that it would be inconsistent with the purpose of the Directive if, in the case of a known risk, the producer continued to supply products simply because he was unable to identify in which of his products that defect would occur, or where he was obliged to supply, continued to supply without accepting the responsibility for any injuries resulting. However, he asserted that the purpose of Article 7(e) was not to discourage innovation and exclude development risks, that being the reason why a producer was protected from the unknown. Thus in effect, non-standard products were not excluded from falling within Article 7(e) since they could qualify where the problem was not known. The Court stated that once a problem was however known, a non-standard product could not be protected by Article 7(e). It was held that the Claimants were entitled to recover damages since the products were defective, and Article 7(e) of the Directive could not be used as a defence as it was known to the defendant Blood Authority that the existence of a defect was generic, there being a known risk of the virus materialising in any product. The National Blood Authority had continued to supply such products, and that had to be at its own risk, as the public were entitled to expect that the blood products transfused to them would be free from infection.

(6) The quantum of damages in respect of the infection

In the assessment of damages in respect of the infection, the Court stated that it was necessary to identify the condition, conclude whether there had in fact been a clearance of the virus, and if so at what stage, and to decide, accordingly, whether such assessment should be on the basis of provisional damages. After this initial stage of assessment, the court stated that it would then be necessary to assess the prognosis, treatability and treatment symptoms identified and enduring. The quantum basis for the infection was held to exclude any specific liver disease associated symptoms, or identifiable psychiatric disorder, but would include fatigue. Where the claimants could establish suffering, or some prejudice arising out of their condition, it could form part of their damages.

Settlement

A majority of the Claimants resolved their claims on a final basis. Within these settlements, the Court identified five triggers which would allow the Claimant to apply for further damages. Further, there were a number of Claimants who, although carrying the virus, did not experience any side effects and although had declined to undergo any medical treatment at present, did not exclude the possibility of doing so in the future. The Court held that the triggers did not apply to specific factual circumstances where a Claimant's condition did not deteriorate, but only where he wished to undergo treatment.

Comments:

This is the seminal case on the CPA and the Directive and the judgment gives a thorough analysis of the central provisions. It confirms that blood and blood products fall within the definition of "product" and the distinction between standard and non-standard products is significant and likely to be followed.

Original Text:

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