Following on from Wilkes v DePuy International Ltd  EWHC 3096 (QB), the High Court has confirmed the approach to be taken when determining whether a product is defective under the Consumer Protection Act 1987 (“the Act”).
In Gee & Others v DePuy International Limited  EWHC 1208 (QB) (“the Pinnacle Metal Hip Litigation”), Mrs Justice Andrews OBE found that the Defendant’s product was not defective under the Act. The correct test to be applied was whether the product had an abnormal tendency to result in damage or harm, as compared with appropriate comparator products.
The judgment signals a continuing departure from the approach taken by Mr Justice Burton in A v National Blood Authority  3 All E.R. 289. Most significantly, it confirms that factors such as avoidability of the defect, cost of precautionary measures and the benefit of the product more generally are factors to be taken into account when assessing whether products meet an objective safety standard.
An action was brought by 312 individual claimants in a group litigation against the Defendant DePuy, a manufacturer of hip prosthesis systems. The Claimants claimed to have suffered an adverse reaction to metal debris (“ARMD”) from their prostheses, requiring revision surgery. The Claimants brought their claims under Part 1 of the Act which implements EC Product Liability Directive 85/374/EEC (“the Directive”), alleging that the prosthesis produced by the Defendant, the “Pinnacle Ultamet”, was subject to a “defect” under Section 3.
The Test for Defect
The Act provides under Section 3 that there is a “defect” in a product if the safety of the product is “not such as persons generally are entitled to expect”, taking into account “all the circumstances”, including, but not restricted to:
- the manner and purposes for which the product had been marketed and any instructions given;
- what might reasonably be expected to be done with the product; and
- the time the producer first put the product into circulation.
If damage is caused wholly or partly by the defect, the producer of the product shall be liable for the damage.
The Claimants’ primary case was that the product’s propensity to cause harm in the form of ARMD and consequent revision surgery was a defect. This approach was rejected by Andrews J. It would require the Court to move away from the notion that a product has a “defect” due to some specific flaw or failing in the product and erroneously concentrate on a holistic assessment of whether a product meets an objectively assessed safety standard. This was never the intention behind the Directive.
The Claimant’s alternative case was that the prosthesis was defective as compared with appropriate comparator products, and thus the product carried with it an “abnormal risk” of damage. This alternative formulation was held to be correct in law but was rejected on the basis that the test was not met.
Legally Relevant Circumstances
Avoidability, risk-benefit and cost
In A v NBA Burton J considered that products can be divided between those which are “standard” (a product which performs as the producer intends) and “non-standard” (a product which is different, deficient or inferior in terms of safety from the standard product and where the harmful characteristic causes the damage). Only when considering “standard” products are matters such as the avoidability of the harmful characteristic, the impossibility of taking precautionary measures, the difficulty or cost of such measures and the benefit to society or utility of the product taken into account.
In Wilkes Mr Justice Hickinbottom (as he then was) criticised the use of the distinction to determine the approach to the circumstances which bear on the definition of “defect”. In the Pinnacle Metal Hip Litigation Andrews J agreed with Hickinbottom J that no distinction between standard and non-standard products may be a useful analytical tool but should not be elevated to a rigid classification which dictates what circumstances are and are not to be considered when making the assessment of safety.
As the Pinnacle Ultamet prosthesis was a standard product, the Claimants also argued against the distinction, but contended additionally that factors such as cost, avoidability, utility and public benefit should be irrelevant in all cases. The Court rejected this submission. The use to which a product is put is obviously a relevant consideration and it logically follows that the benefits flowing from its contemplated use must also have a bearing on the evaluation of the level of safety that the public generally is entitled to expect. The Court was also entitled to conclude that the public would not expect the producer to achieve something in terms of safety that is scientifically impossible or prohibitively expensive.
Regulations and Standards
The Court held that whether standards set by a regulatory regime were met was a relevant consideration. The Court agreed that meeting such standards would not be prima facie evidence of the absence of a defect. However, this did not mean that it was irrelevant to the test applied by the Court, even if the Court was applying a statutory test separate to the regulatory regime. In fact, compliance with regulatory standards would have considerable weight (as indicated in Wilkes).
Similarly, if the appropriate mandatory standards had not been met, this would provide evidence that a defect did exist.
The Court in the Pinnacle Metal Hip Litigation agreed with Hickinbottom J in Wilkes – the existence of an intervening healthcare professional and the information and warnings provided to that person were relevant circumstances. Nonetheless, the statutory standard to be imposed is the level of safety the public is entitled to expect, not what healthcare professionals are entitled to expect.
Entitled Expectation of Safety – Time of Assessment
The Claimants sought to use data demonstrating that alternative prostheses carried a much lower risk of failure after the 10 year mark. This was highly relevant given that the Court found the correct test was whether the Pinnacle Ultamet prosthesis had an abnormal tendency to result in damage or harm, as compared with appropriate comparator products.
The Court held that the level of safety the public is entitled to expect should be evaluated at the relevant time, when the product went to market, and not 10 years after its use. The public would not be entitled to expect the prosthesis to have a lower rate of failure simply because hindsight proved an alternative prosthesis performed better than anticipated. In any case, there was insufficient reliable evidence to establish that the Pinnacle Ultamet prosthesis had a materially worse failure rate than a comparator, even taking into account the later data.
The approach to causation is not entirely straightforward in a case where the defect is an abnormal or increased risk of an early failure which could occur even if there was no defect. This was not addressed in Wilkes as it had been found that a defect existed on which to base the causation. In the Pinnacle Metal Hip Litigation, Andrews J suggested that if a defect had been proven to exist the correct question for the Court to ask is whether on the balance of probabilities the claimant would have suffered the damage complained of i.e. undergone an early revision if the product had not carried with it the increased risk of early failure which made it defective.
The Judgment in the Pinnacle Metal Hip Litigation is helpful in confirming the likely approach of the English Courts on the interpretation of defect under the Consumer Protection Act. It is particularly relevant in cases involving pharmaceutical and medical devices product liability claims where it is alleged that the products demonstrate an abnormal susceptibility to cause damage, in comparison with similar products.
In general, Andrews J preferred Hickinbottom J’s approach in Wilkes to that of Burton J in A v NBA and agreed with Hickinbottom’s observations that:
“the court must maintain 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, these factors being quintessentially dependent upon the particular facts of any case.”