Product Protection – 16 / 17 观点
The High Court has examined the meaning of a defective product under the strict liability regime in the Consumer Protection Act 1987.
Under the Consumer Protection Act 1987 (CPA), a product is defective when in all the circumstances it fails to meet the standard of safety that the public is generally entitled to expect at the time when it is introduced to the market. "Safety" in this regard is in the context of risk of damage to property as well as risk of death or personal injury. The court is entitled to consider a number of factors in respect of the question of consumer safety, including the purpose of the product, instructions for use and warnings, presentation of the product, expected use and time when it was put into circulation.
The court maintains a flexible approach to the assessment of the appropriate level of safety including which circumstances are relevant and the weight to be given to each which will be dependent on the facts of any case. The level of safety that the public is entitled to expect is evaluated at the time when the product was first put on the market by the producer, but when determining whether the product met that level of safety, the court can consider everything now known about the product that is relevant, even if such information was not available at the time it was put on the market or has come to light subsequently. This is to give a claimant the opportunity to establish that a product whose lack of safety only becomes known in a period after it was first put on the market was, in fact, defective at the time of its initial circulation.
In a significant decision for manufacturers, distributors, suppliers of goods and consumers, the High Court has provided welcome clarity on when a product will be considered to contain a "defect" under section 3 of the CPA. In a complex judgment running to over 170 pages, the court considers the interpretation and application of the CPA and particularly those factors to take into account when determining if a product is defective or fails to meet the safety standards generally expected.
The decision is an important one for manufacturers, suppliers and distributors of consumer products as well as consumers themselves. The decision is not only helpful in its consideration of the meaning of a "defect" under the CPA, it also reviews the purpose of the legislation and relevant legal framework under the EU Directive on Product Liability.
The decision provides product liability practitioners with a helpful reminder of the purpose and spirit of this legislation and the objective of setting a balance between the interests of producers and consumers. The balance is said to be struck by providing for no fault liability if a defective product causes damage subject to only a limited number of defined defences (such as the development risks defence).
The CPA creates liability without fault and therefore the claimant need only prove that:
The question of whether the manufacturer was at fault is irrelevant and a manufacturer could be held liable for a defect even if it took all possible precautions to prevent it subject to the development risk defence. Fault or absence of fault has no bearing on the condition or state of the product that makes it fall below the standard of safety that the public is entitled to expect. Further, the court's focus should be on whether the product is safe and not if it contains a specific fault.
Following this decision, it seems clear that where a product has certain underlying risks attached to its normal use as part of the product's normal behaviour, it will not be considered a defective product under the CPA unless that risk is an abnormal risk as compared to other similar products and the levels of safety expected by the public. For the product to be defective, there will need to be an abnormal risk and abnormal potential for harm (which takes the risk beyond the level of safety the public is entitled to expect from the product) which is not found in a comparable product. While this will vary depending on the product, the decision provides helpful guidance to manufacturers whose products may pose an unavoidable risk/potential for damage associated with its normal use but not abnormally which would make the product inherently unsafe.
The court also reiterated the importance of conducting a risk/benefit analysis to the question of product safety – the safety risk may be one which the public would be expected to accept given the perceived benefits of the product and avoidable risks concept. Further, the decision is a helpful reminder of the way in which the court approaches strict liability for manufacturers under the CPA, focusing not on whether there is a failing in the product which makes it defective, but rather whether the product meets the safety standards expected by the public.
Defendant, DePuy International Limited (DePuy), manufacturer of hip prosthesis metal on metal hip implants used in hip-replacement surgery (Pinnacle Ultamet products) has successfully defended group litigation involving 312 individual claimants alleging personal injuries caused by the implants. The Claimants claimed to have suffered an adverse reaction to metal wear debris shed from their prostheses necessitating revision surgery. It was common ground that all hip prostheses have an underlying risk of failure, requiring revision within 10 years, but each claimant needed to prove that the increased risk allegedly contained in DePuy's products was what caused them to undergo the early revision surgery rather than the inherent risk of failure leading to early revision that would arise irrespective of that defect.
This is not the only litigation involving prosthesis hip implants. Almost all manufacturers of the metal on metal prostheses are facing claims which are currently stayed pending the outcome of the DePuy trial. It is hoped by the court that this decision in DePuy, while not binding on the parties in the other proceedings, will provide them with guidance.
The Claimants alleged that the prostheses supplied to them were defective causing them personal injuries for which they were entitled to compensation from DePuy under the CPA. The court dismissed the claims, finding that DePuy's metal on metal prostheses hip implant was not defective and did not pose an abnormal risk to patients so the Claimants were not entitled to recover compensation under the CPA.
The key question before the court was whether a known inherent risk (and potential to cause harm) associated with the product's normal use constituted a "defect" under the CPA. The court held that the product was not defective by virtue of its known risk to shed metal debris during ordinary use which could damage soft tissue and lead to patients suffering an adverse reaction. Further, it did not become a defect simply because of the number of recorded incidences of adverse reactions.
The Claimants argued in the alternative that the product was not as safe as other comparable products and as such posed an abnormal risk to consumers which did not meet the safety standards expected. The court held that the claimants failed to prove that the product did not meet the level of safety that the public were generally entitled to expect at the time when it entered the market. The court said it could not determine on the civil law burden of proof that there was a materially greater risk of DePuy's product failing within the first 10 years after implant than a similar product – the product did not therefore carry an "abnormal risk" as alleged. The court also held that two thirds of the lead claimants did not suffer the adverse reactions in the form of personal injuries alleged.
The patients involved claimed that the implant caused damage to soft tissues as a result of the shedding of metal debris particles which led to varying levels of adverse reaction. The court was told that the propensity of a given patient to suffer an adverse clinical reaction to particles debris varies from one patient to another and it is not medically known why one body can tolerate a particular level of debris when another cannot. Six Claimants were identified as the lead claims in the group litigation and legal submissions were lodged by a number of interested parties (some of those being other defendant manufacturers in the stayed proceedings). The trial lasted four months and a vast number of factual and expert witness evidence was tested in court.
Wilson v Beko  EWHC 3362 (QB)