The High Court yesterday rejected a group action claiming that a ‘metal on metal’ (MoM) hip replacement implant was defective under the Consumer Protection Act 1987.
According to Kennedys, the solicitors for the defendant manufacturer, Depuy International, the decision has averted “what could have been potentially serious implications for product innovation”.
However, the claimants’ solicitors said it was “genuinely concerning” that Mrs Justice Andrews considered the Pinnacle Ultamet to be safe.
The judge found that, although a MoM product would, by its very nature, produce metal wear debris – which in turn might cause an adverse reaction in some patients – that was not in itself a defect for the purposes of the Act.
She agreed with DePuy’s argument that a known consequence of the ordinary use of a product could not amount to a defect, and said this aspect of the claimants’ case was “untenable”.
The claimants’ secondary argument was that the product had an “abnormal” potential for damage, based on data which they asserted showed that it did not perform as well as other non-MoM prostheses which were introduced at the same time as, or even after.
But Andrews J said the Pinnacle should be compared to other prostheses that were on the market at the time it was introduced. On this basis, the product performed as well as or better than those other prostheses and had no increased risk of harm.
Indeed, Andrews J described it as “a well-designed product with many positive engineering features”.
She also suggested that “increasingly hysterical media reporting” about the implants had a role in increasing the number of ‘revision’ surgeries.
Samantha Silver, the partner at Kennedys who led the work for DePuy, said: “The principles established in this judgment apply to all products used by consumers that come within the Consumer Protection Act.
“The decision will have significance for all manufacturers and distributors, not just those in the life sciences industry, as well as their insurers.
“It provides manufacturers with confidence that the courts can take into account the benefits and the inherent risks of certain products, for example, in cases where there is a known side effect or complication and the overall benefits outweigh the risks.”
“The decision that the safety of new products should be compared to products existing at the time they are introduced to the market also safeguards the position of those developing new, potentially life-enhancing, technologies in the future.”
In a joint statement, the solicitors acting for the 312 claimants – Leigh Day, Irwin Mitchell, Hugh James and Corries – said they were “extremely disappointed” by this judgment.
“It is genuinely concerning that the [Pinnacle], which no clinician would now use, from a product group the orthopaedic profession has rejected for the serious harm it can cause, is deemed safe by this judgment.
“This is a complex and lengthy judgment, the implications of which are being carefully considered. However, the impact it will have on consumer safety and the ability of consumers to get redress, cannot be underestimated.”
James Bell, a clinical negligence partner at London law firm Hodge Jones & Allen, said the ruling would at least allow other cases that have been on hold to proceed.
“I am acting for claimants who were implanted with mix and matched hip components – a stem from one manufacturer used in combination with components from another manufacturer – contrary to the manufacturers’ guidance.
“These hips produced excessive metal debris – well over and above normal levels – which has had life-changing consequences for my clients.
“These cases have been on hold for over two years awaiting the Pinnacle judgment. Many of the claimants are elderly and have waited patiently for the outcome. I sincerely hope the court will now urgently expedite these cases – which are of an entirely different nature to the Pinnacle case.”
The Pinnacle trial took four months trial, involving over 40 witnesses, including 21 experts ranging in discipline from orthopaedics to engineering, and behavioural psychology to statistics.
The judge was critical of some of the evidence called by the claimants.
She found a “minority” of the claimants’ experts were not mindful of their duties to the court.
“Some gave the appearance of acting as advocates in the claimants’ cause. Sometimes that was not entirely the expert’s fault, because of the approach he had been instructed to take, but others were plainly partisan, and their reports lacked the necessary balance and impartiality.
“That has meant that, unfortunately, I have found their evidence unreliable, and I have placed little or no weight upon it or preferred the evidence of DePuy’s experts in matters that were contentious.”
In relation to the six lead claimants, she said: “It was apparent that they were all truthful witnesses who were trying their best to remember events that had taken place a long time ago.
“However, their evidence to the court about the impact on them of the revision (or re-revision) surgery was often very different from the content of their witness statements, which tended to suggest considerable impairment and continuing pain.
“When they were asked to provide an explanation for this they were unable to do so. To give but one example, Mrs Garratt’s witness statement described the effect of her ‘injuries’ as ‘devastating and life changing’, although the claimants’ orthopaedic expert in her case, Mr Smith, agreed at trial that by 2014 there did not seem to be any significant ongoing problems, and this was borne out by her medical notes.
“When Mrs Garratt was asked in cross-examination what she meant by this part of her evidence, she said she did not know.”