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Pinn UK Update 7
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UK patients lose legal claim that DePuy metal-on-metal hip implant was “defective”
May 22, 2018 | British Medical Journal
By Clare Dyer
More than 300 people who were fitted with a metal-on-metal hip implant that is no longer used have lost a UK group legal action against the US manufacturer.1
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UK patients lose legal claim that DePuy metal-on-metal hip implant was “defective”
May 22, 2018 | British Medical Journal
By Clare Dyer
More than 300 people who were fitted with a metal-on-metal hip implant that is no longer used have lost a UK group legal action against the US manufacturer.1
The claimants argued that DePuy International’s Pinnacle Ultamet hip replacement released metal debris into the surrounding tissue and was a defective product under the UK’s product liability law.
But at the High Court in London Mrs Justice Andrews ruled that the adverse reactions of some patients to metal wear debris was a known consequence of metal-on-metal hips and did not amount to a defect under the law.
She also dismissed the claimants’ secondary argument that the implant had an “abnormal” potential for damage because it performed less well than other types of implant. She cast doubt on the reliability of data on revision rates and concluded that there was not enough evidence to conclude that rates for the Pinnacle Ultamet, which was withdrawn from the market in 2013, were materially worse.
The case was brought under the Consumer Protection Act 1987, which brought an EU directive on strict liability into UK law. The law made manufacturers liable without the need for negligence to be proved if they put a defective product on the market.
But Andrews said that the claimants had failed to prove that the hip joint “did not meet the level of safety that the public generally were entitled to expect at the time when it entered the market in 2002” or that it “carried with it an ‘abnormal risk’ of damage, as alleged.”
US litigants who sued over metal-on-metal hips have won millions of dollars in damages. But litigation in the UK against other manufacturers of metal-on-metal implants had been put on hold pending the outcome of the Pinnacle case.
The legal teams from four firms of solicitors representing the UK Pinnacle claimants said in a statement, “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. We are in touch with our clients to discuss what next steps could be taken.”
The law firm Kennedys, representing DePuy, said that the judgment “averts what could have been potentially serious implications for product innovation.”
The judge highlighted what she described as “panic” about metal-on-metal hips, fed by “increasingly hysterical medial reporting.” She noted that psychologists who gave evidence in the case “agreed that the sensationalist media reports probably did have some effect both increasing the rate of and accelerating the timing of metal-on-metal hip implant revisions.”
She said that media coverage had included a joint investigation by the BBC programme Newsnight and The BMJ, “which referred to ‘poorly regulated and potentially dangerous’ hip devices, and suggested that wear debris might be carcinogenic.”2
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