High Court sets out steps manufacturers ought to take to protect themselves from potential claims

Wilkes v DePuy International Limited

In January 2007 at the North Manchester General Hospital (“NMG Hospital”), Mr Wilkes (“the Claimant”) underwent a full hip replacement procedure. The artificial hip which was inserted was made up of metal components manufactured by DePuy International Limited (“the Defendant”).

The procedure was a success and the Claimant was able to return to work. However, on 05 January 2010, the Claimant felt his left hip “give way”. Subsequent investigations at the NMG Hospital showed that a part of the prosthetic hip called the “C-Stem” had fractured. The C-Stem was manufactured by the Defendant. The Claimant was admitted to hospital and the C-Stem was replaced with a new model. However, in August 2015 the C-Stem once again fractured causing metal debris to be shed around the hip joint.

The Claimant brought a dual claim against the Defendant alleging that the fracture was caused by the negligence of the Defendant and also that there was a “defect” in the C-Stem as defined in the Consumer Protection Act 1987. The Claimant sought damages against the Defendant.

The High Court’s Decision

In delivering his judgment, Mr Justice Hickinbottom dismissed the Claimant’s argument that the C-Stem had fallen below the level of safety required at the time that it was put into circulation. The Judge commented that the failure of the C-Stem – earlier than was predicted – was unfortunate and expressed his sympathy towards the Claimant who had been required to undergo a revision procedure. However, the Defendant would only be liable under the Consumer Protection Act 1987 if the C-Stem had a defect, as defined by the Act, at the time it was put onto the market. The Judge ruled that the Claimant had failed to satisfy that the C-Stem supplied to him contained such a defect, stating that there could not be a sensible expectation that any medicine or medicinal product is entirely risk-free. Therefore, the Defendant was not liable to the Claimant under the provisions of the Consumer Protection Act 1987.


This judgment demonstrates that the Consumer Protection Act 1987 does not impose a standard of “absolute” safety where claimants sustain injury/damage as a result of a product produced by a manufacturer. The Judge commented that “safety is inherently and necessarily a relative concept.”

Whilst manufacturers that conform to regulatory requirements and who adhere to industry safety standards will not have a complete or automatic defence to claims that their products are defective, the Judge held that “it may be challenging for a Claimant to prove that the level of safety that persons generally are entitle to expect is at a higher level than those which are set out in regulation.”

This judgment may be of some comfort to manufacturers who undertake safety testing practices, comply with regulatory standards and who properly document these steps and ensure that they clearly identify all risks or possible side-effects associated with the use of their product.  The judgment should also serve as a deterrent to claimants intending to bring speculative claims against a product that was manufactured in conformity to regulatory standards.

If you require further advice in relation to claims arising from defective products or if you have any queries in relation to the above, please do not hesitate to call Elizabeth Black on 01524 548 494 or 01228 552 600.

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