Inner House dismisses consumer protection appeal by man fitted with hip replacement
A man who received a total hip replacement that he alleged was defective has had his appeal against the dismissal of his case refused by the Inner House of the Court of Session.
The pursuer and reclaimer, John Hastings, claimed that the prosthesis he received from the defenders, Finsbury Orthopaedics Ltd and Stryker UK Ltd, was defective in terms of section 3 of the Consumer Protection Act 1987. The defenders were assoilzied by the Lord Ordinary in December 2019.
The appeal was heard by the Lord President, Lord Carloway, sitting with Lord Menzies and Lord Woolman.
The pursuer underwent a left-sided total hip replacement in March 2009 when he was aged 54, which used a “metal on metal” Mitch/Accolade product made using parts manufactured by both defenders. The same prosthesis was later fitted to his right side in November of the same year. On 17 October 2012 the left side prosthesis was revised.
It was agreed by both parties that there were known problems with debris produced by metal wear, which could cause an adverse reaction in patients. The instructions accompanying the product noted the wide range of effects that could be produced by the metal implants.
The safety of metal-on-metal prostheses was covered in national media as well as the British Medical Journal in 2012. On 26 April 2012, the defenders issued an urgent field safety notice which identified a product which may not be performing as intended and advising of steps which should be taken. Metal-on-metal replacements ceased in the UK in the same year.
It was averred by the pursuer that he had suffered loss and damage as a consequence of the use of the metal-on-metal prostheses and that the product was therefore defective under the provisions of the 1987 Act, which implemented an EU Directive on product liability.
The Lord Ordinary, following an English case, Gee v DePuy International (2018), with similar facts, determined that the Act required a flexible approach and did not favour the protection of consumers over any of its other objectives. Whether the product was defective required to be approached on the basis of the reasonable expectation of the public at large, taking into account the intended purpose, the objective characteristics and properties of the product and the specific requirements of the patients.
The Lord Ordinary went on to consider that only a minority of users suffered adverse effects from metallic debris, and that while the pursuer had established a possible causal mechanism for the difficulties he suffered, he had not proved that mechanism on the balance of probabilities. There was no evidence that debris from the head/stem interface was more damaging than debris from the bearing surface.
It was submitted for the pursuer that persons generally were entitled to expect that the prosthesis would remain on the market with its use sanctioned by the orthopaedic community until superseded by a superior product and the manufacturer would not warn against its continuing use. These expectations had not been met. Furthermore, the Lord Ordinary had failed to consider all of the evidence in front of him, including the BMJ study and worldwide medical alerts in relation to the product.
The opinion of the court was delivered by Lord Carloway. He began by noting: “As the Lord Ordinary recognised, the first question is not what persons generally expected from the prostheses. It is not what the pursuer expected from his prosthesis. It is what, objectively assessed, persons generally were entitled to expect in terms of safety from this type of prosthesis. The Lord Ordinary determined that it should have a level of safety which was not worse than the other (non-MoM) prostheses then in use. There is no challenge to that approach as a generality.”
Regarding the purpose of the 1987 Act, he said: “The court will simply proceed on the basis that the 1987 Act is a measure intended to improve consumer protection, whatever the wider purposes of the Directive in terms of competition and the free movement of goods across the European Union might be.”
Addressing the details of the Lord Ordinary’s decision, he said: “The Lord Ordinary decided the case on the basis that the pursuer had failed to discharge the burden of proof upon him to demonstrate the existence of a defect. He concluded that the Mitch/Accolade prosthesis was not ‘less safe’ than persons generally were entitled to expect and therefore not defective. A determination of this nature can leave a first instance judge open to criticism.”
However, he went on to say: “It may be unfortunate that the Lord Ordinary was not able to make a positive finding on whether a defect existed in the Mitch/Accolade product other than by reference to a failure to overcome the burden of proof. This is to a degree compounded by his approach to large head MoM prostheses in general. Nevertheless, determining a case on the basis of onus is a course which is open to a judge.”
Turning to the evidence, Lord Carloway said: “All prostheses have a propensity to create debris. That could not thus be regarded as a defect as it was an inevitable, and, at the time of the supply to the pursuer, recognised problem. The creation of metal debris, and its potential toxic effect with a consequent potential for revision, was, quantum valeat, described in the instructions for use which were issued by the defenders.”
He concluded: “The question which the Lord Ordinary posed was whether [the] evidence had a sound underlying scientific or statistical base. Put another way, were the concerns, alerts and warnings based on accurate facts? The Lord Ordinary has held that they were not.”
For these reasons, the pursuer’s reclaiming motion was refused.