Back in QMLR Issue 4 we covered Hastings v Finsbury Orthopaedics Ltd in the Outer House of the Scottish Court of Session. That case dealt with the question of what happens when medical technology goes wrong and the standard which patients are entitled to expect from medical devices. The unsuccessful Claimant subsequently appealed and the original judgment has now been upheld by the Inner House of the Court of Session in a decision handed down on 16 January 2021.
A former forestry worker brought a claim against the manufacturers of a metal-on-metal total hip replacement (“MoM THR”) prosthesis. The device consisted of a Mitch/Stryker Howmedica uncemented acetabular cup, manufactured by the First Defendant, and an Accolade V40 uncemented femoral stem, manufactured by the Second Defendant. The Claimant had a history of arthritis and underwent hip replacement surgery to both hips in 2009, using the Mitch/Accolade device. There was no suggestion that the hip replacement surgery was carried out negligently, nor that the particular prostheses themselves were made in a negligent or faulty manner. However, the MoM THR shed metal debris which meant the Claimant suffered an adverse reaction and had to have revision surgery on his left hip some three years later.
The claim was brought under the provisions of the Consumer Protection Act 1987, section 2 of which imposes no-fault liability on a manufacturer for damage caused wholly or partly by a defect in a product. Section 3 defines a product as defective if its safety is not such as persons generally are entitled to expect. The trial was therefore to resolve the preliminary issue of whether the Mitch/Accolade device was defective within the meaning of section 3.
At first instance Lord Tyre held that it was not defective, despite the fact that the manufacturers accepted there was an inherent propensity of MoM THR devices of this type to shed metal debris with a risk that some patients may suffer an adverse reaction, and that the devices had been recalled in 2012 and not used since then. The main reason for Lord Tyre’s conclusion was that he considered the revision rate for MoM THRs and the prospects of success of revision surgery compared with other prostheses, which were the two most important ‘safety’ criteria, and was not persuaded that these were worse for MoM THRs at the relevant time.
The Claimant’s appeal had two main strands. First, that Lord Tyre in the Outer House had failed to take adequate account of the strict liability nature of the 1987 Act and its purpose in strengthening consumer protection. He thus applied an inappropriately high threshold on the question of whether the device was defective and placed incorrect emphasis on the fact that the Claimant bore the burden or onus of proof and had not discharged it. The Claimant suggested that in a consumer protection claim such as this there should be a degree of ‘claimant benevolence’ by the court. Second, that Lord Tyre’s decision that the device was not defective was contrary to the prima facie evidence of defectiveness – the concerns, notices and warnings which had been raised, leading to its recall – without adequate basis for departing from it.
The Inner House rejected these arguments. In relation to the first strand of the appeal, it noted that strict liability was a well-known concept in Scots Law (and the same is true of English law). It accepted that the 1987 Act was a measure intended to improve consumer protection (even though the underlying EU Directive had a wider set of aims). It also made the following observation about the imbalance of power in such cases (at ):
“There is considerable force in the contention that the court should not impose excessively exacting standards on pursuers, whatever the nature of the case or the defender. It should not expect the ordinary citizen to be able to mount an in depth challenge which requires a detailed examination of a defender’s manufacturing processes and subsequent product safety analysis of the type which might be seen in a commercial litigation between multinationals. The pursuer must be able to access the courts and have his claim adjudicated upon in a proportionate manner. Insurmountable or excessive obstacles should not be placed in the way.”
However, the court held that whilst the 1987 Act imposes strict liability for a defective product, the Claimant still has to prove the existence of a defect as defined by the Act, and in practice the Claimant was able to secure appropriate expert witnesses and data to pursue his claim. In terms of the burden of proof, the court agreed that a determination based on a party’s failure to discharge the burden can leave a first instance judge open to criticism, because usually a judge should be able to reach a concluded view on the facts and decide where the balance lies. But it held that determining a case on the basis of the burden of proof is nevertheless a course open to a judge, and is not a problem if it is properly reasoned. As for the suggestion that there should be a degree of ‘claimant benevolence’ in this type of case, this was roundly rejected.
That led to the Inner House’s consideration of the second strand of the appeal, and it determined that Lord Tyre’s conclusion had been properly reasoned. He had recognised the power of the prima facie evidence of defect. Whilst his conclusion that the devices were not defective for the purposes of section 3 at the relevant time was perhaps “an unexpected outcome” () it was clear the judge had carefully considered all the data and it was not an unreasonable decision given the comparison with other similar devices and the fact that they too had a tendency to shed debris.
The first instance judgment in this case was a lengthy, detailed analysis of some very complex evidence, and was always going to be difficult to challenge. The outcome was, as the Inner House acknowledged, perhaps a bit surprising given the devices had been recalled after several safety alerts and concerns were raised. However, Lord Tyre’s conclusion was based so much on a careful sifting of the specific facts that it would have been difficult for it to be overturned on appeal. What the Inner House decision does make clear is that defective product claims can be successfully defended, even where there is prima facie evidence of problems. It also affirms that there is no tilting of the scales towards claimants and that the burden of proof remains relevant even in strict liability claims.