DePuy International’s Pinnacle Ultamet total hip replacement prosthesis is not defective under the Consumer Protection Act 1987, the High Court has ruled.
The decision on what was one of the largest product liability group actions in recent years could have a significant effect on all consumer product cases, lawyers for DePuy have said.
DePuy’s Pinnacle Ultamet metal-on-metal (MOM) total hip replacement prosthesis was allegedly defective and caused some recipients to undergo more surgery than was necessary.
More than 300 claimants brought the action against DePuy. They were represented by law firms Leigh Day, Irwin Mitchell, Hugh James and Corries throughout the four-month trial.
Justice Geraldine Andrews DBE issued her more than 340-page judgement today. She 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 Consumer Protection Act 1987.
Samantha Silver, the partner at Kennedys who led the work for DePuy, commented: “The principles established in this judgement 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.”
The law firms representing the claimants said in a joint statement: “We are extremely disappointed by this judgement, and the conclusions reached by the judge.”
“It is genuinely concerning that the DePuy Pinnacle metal-on-metal hip replacement, 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 judgement.”
“This is a complex and lengthy judgement, 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.”
“We are in touch with our clients to discuss what next steps could be taken. At this stage we cannot provide any further information as to what this may entail, as we digest the full impact of this disappointing judgement.”
A number of other cases were put on hold in anticipation of a ruling in the DePuy litigation.
James Bell, clinical negligence partner at Hodge Jones & Allen, said: “While today’s judgement does not give any relief to claimants, a number of other cases that have been on hold can now proceed.”
“These cases have been on hold for over two years awaiting the Pinnacle judgement. 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.”