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Manufacturers successfully defend Scotland's first metal on metal hip replacement case

Posted on 07 February 2020

In the Scottish case of Hastings v Finsbury Orthopaedics Ltd and Stryker UK Ltd, the Claimant brought a claim under the Consumer Protection Act 1987 against the manufacturers of two component parts of his metal on metal hip prosthesis, claiming the product was defective and unsafe. The legislation imposes no-fault liability on producers and importers if damage is caused by a defective product.

Referring to two leading English authorities of Wilkes v. DePuy International Limited [2017] All ER 589 and Gee and others v. DePuy International Limited [2018] EWHC 1208 (QB), the Court found the test for safety requires an objective approach to what persons are generally entitled to expect (in line with those authorities). However, the Court departed from the English authorities as to the formulation of the entitled expectation of the product. The Claimant argued that he was entitled to expect that it would be at least as good as alternatives, whereas the manufacturers claimed that it should not be materially worse than those it was intended to replace. The Scottish Court set a lower bar, namely: “subject to de minimis considerations, its level of safety would not be worse, when measured by appropriate criteria, than existing non-[metal on metal] products that would otherwise have been used”.

Another issue was the date upon which the alleged defectiveness should be assessed. In basic terms, the English authorities consider defectiveness at the time at which the product in question was put into circulation. However, in Hastings, the parties agreed that the critical date was when the product was implanted. Another potentially interesting aspect of the case for manufacturers is the weight placed upon the instructions and information material supplied with the product. Referred to in the relevant legislation as “any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product”, the court should take these into account when considering what people are entitled to expect with regard to the safety of a product. English authorities suggest that such information is relevant and forms part of the factual matrix a judge will consider when assessing entitled expectation. However, the Scottish Court was sceptical in this case as to whether the instructions and product information, supposed to be read by surgeons, “had (or were expected to have) any real practical value”. The Judge specifically referred to the fact the instructions were in very small typeface and “were in highly general and heavily qualified terms”. The Court essentially disregarded them when applying the entitled expectation test.

While the Court found that the Claimant had established that there may be a link between the creation of metal debris from the product and damage to the body around the site of the prosthesis, it held that the evidence suggested this was present in only a minority of cases and in limited circumstances. Therefore it concluded that it could not determine that the reason for the damage around the site of the prosthesis was necessarily the metal on metal hip replacement on the balance of probabilities. This meant that the claim failed. However, the Court did leave the door open for other claims, stating: “In holding that the [Claimant] in the present action has failed to prove that the product supplied to him was defective, I do not exclude the possibility that another [Claimant] might be able to present evidence in relation to a different product sufficient to establish, on balance of probabilities, that entitled expectation in relation to that product had not been met.

This was the first Scottish case of its kind. Manufacturers will no doubt watch for further decisions clarifying how the relevant defectiveness tests are to be applied in product liability cases and whether this will be consistent across different jurisdictions.

To read the judgment in full, click here.

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