Not strictly defective?

Wilkes v DePuy International Limited [06.12.16]

High Court defines ‘defective product’ under the Consumer Protection Act 1987 in landmark case.

Decision

The High Court’s ruling in favour of the defendant removes the hurdles imposed in A v National Blood Authority [2001] when determining the question of ‘defect’ under the Consumer Protection Act 1987 (CPA). It also re-focuses the test, as intended under the CPA, to a consideration of the standard of safety persons are entitled to expect from a particular product, taking into account all of the relevant circumstances, assessed on an objective basis.

The case itself concerned a medical device, but the principles apply to all products used by consumers that come within the CPA, which implements EU Directive 85/374/EEC (the Directive).

Kennedys acted for the successful defendant manufacturer.

Background

A femoral hip stem (part of a total hip replacement prosthesis) manufactured by the defendant, fractured three years post-implantation in the claimant, requiring surgery to remove and replace the prosthesis. The claimant claimed that the failure of the stem through fracture amounted to a defect and that the defendant was liable to him for damages under the CPA.

The stem was manufactured as designed but the claimant alleged that certain features of the design rendered the stem more susceptible to fatigue failure and that these ought to have been removed or ‘designed out’.

The gist of the defendant’s case was that the risk of stem fracture was a known, albeit rare, complication of total hip replacement surgery, for which warnings were provided in the information supplied with the product (of which a number applied to the claimant).

The difficulty with ‘defect’ resolved?

While the Court recognised that the purpose of the Directive and the CPA was to protect the interests of consumers, they do not impose absolute liability or a warranty of performance on the manufacturer. Rather, a manufacturer’s obligation is “liability without fault” if the product fails to meet the standard of safety persons generally are entitled to expect, taking account of all the circumstances. The claimant must still prove the link between defect and damage.

The CPA applies to all products and takes an objective and flexible approach to the standard of safety, taking into account all of the circumstances. The focus must be on the appropriate level of safety, objectively assessed by the Court. Safety is inherently and necessarily a relative concept, so it is not absolute as had been found in A v National Blood Authority in respect of a “non-standard” product. The court found the categorisation of defects into “standard” and “non-standard” as unnecessary and undesirable. Particularly in relation to medical products, the Court emphasised there cannot be a “sensible expectation that any medicine or medicinal product is entirely risk-free”.

As to the circumstances (and the weight attached to them), a “holistic approach” should be taken that will include looking at:

  • Regulatory approval (which requires compliance with various standards).
  • The warnings provided with the products as to the possibility of complications or injury (in this case warnings were provided to the surgeon, not directly to the patient).
  • The risk-benefit analysis that must attach to certain products: do the benefits sufficiently outweigh the risks?

Impact

The Court’s decision provides clarity to producers and claimants as to the correct formulation of the question of defect under the CPA and should offer producers/manufacturers some comfort that courts will not impose strict liability where claimants sustain injury and/or damage in all circumstances. Strict liability will not apply where for example, as occurred here, a known but rare side-effect or complication from the use of a product occurs, but a warning was given as to the risk and the overall benefits outweigh the small risk.

This decision also guides claimants to consider the merits of potential claims against manufacturers whose products have regulatory approval and meet appropriate standards that should reduce the numbers of speculative CPA claims.