Hundreds of claimants lose case regarding “defective” Metal-on-Metal hip replacements
23rd May, 2018
On 21 May 2018, a decision by the High Court ruled that medical device manufacturer DePuy was not liable to the 312 patients who had alleged that they had been injured by DePuy’s “defective” hip replacement product.
This group action was brought under the Consumer Protection Act 1987 (CPA) and was one of a number of group actions brought against producers of Metal-on Metal total hip replacements and resurfacing products that were introduced in the early 2000s.
It was alleged by the Claimants that the Metal-on-Metal hip replacements were defective and had resulted in a number of patients needing more surgery than necessary, due to premature failure of their replacements. It was claimed that the Pinnacle Ultamet replacement released metal particles damaging the surrounding tissues, causing symptoms such as pain and swelling and numbness or loss of sensation in the leg.
The trial took place over a period of four months during which time 40 witnesses, including 21 experts presented evidence. Mrs Justice Andrews heard expert engineering evidence regarding the design and manufacture of the product and concluded that it was a “well designed product with many positive engineering features”.
The Claimants also heavily relied on statistics, particularly from the National Joint Registry, to argue that the cumulative revision rate for Pinnacle Ultamet at 10 years post-implantation was significantly higher to equivalent prostheses. However, the Court found that these statistics were unreliable and subject to a number of limitations and held that the Pinnacle Ultamet device performed as well or better than those on the market and had no increased risk of harm. It was therefore concluded that the Claimants had failed to establish that the product was defective within the meaning of the CPA.
This is undoubtedly a landmark decision in product liability law, providing clarity on the factors to be addressed when deciding whether or not a product is defective. However it will also be a welcome decision for producers and manufacturers who will appreciate the Court’s willingness to acknowledge factors such as risk-benefit when assessing whether the appropriate level of safety is met.
The judgement can be found in full here.
If you have any questions of the above, please contact Jeffrey Keeble.
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