Following Johnson & Johnson’s 2013 announcement of a $2.5 billion settlement to resolve claims for its DePuy ASR hip implant, the company is back under the spotlight this week as the first DePuy Pinnacle hip trial starts in the United States. This first trial is intended to serve as a test case to help gauge the strength of the several thousand other Pinnacle claims, as well as providing guidance on the likely ruling for other similar metal-on-metal hip cases.
Metal-on-metal hips suffer the same basic fundamental flaw regardless of the particular model or system. As the metal components move, they grind up against each other and can release toxic metal particles into the body. As a result, the recipients of the metal-on-metal implants have suffered painful and debilitating complications including metallosis, chronic pain, adverse local tissue reactions and premature hip failure.
DePuy recalled the ASR devices in 2010 due to shockingly high revision rates. In 2012, the Medicines and Healthcare Products Regulatory Agency (MHRA) warned that patients fitted with all metal hips were at risk of premature device failure and advised that patients with metal-on-metal hips should undergo an annual review and blood tests to detect excessive levels of metal ions in their blood.
DePuy has refused to recall its Pinnacle hip but the company stopped producing the metal-on-metal version last year after the US Food and Drugs Administration (FDA) required all manufacturers to submit new metal-on-metal hip products for pre-market approval and to conduct post-market studies for products already being used. The claimant in this first trial received two DePuy Pinnacle hips in 2009 and complained of pain shortly afterwards. Blood tests revealed dangerous levels of cobalt and chromium in her bloodstream so the claimant underwent revision in 2011. When the implant was removed, it was found to have turned black with metallosis.
Elise Bevan, a solicitor in the Penningtons Manches’ product Liability team, said: “If Johnson and Johnson loses the first couple of these Pinnacle trials, it will seriously need to consider a settlement of a similar size to that for the ASR hips. Worryingly, research into other models of metal-on-metal hips show it is not just those manufactured by DePuy which have high failure rates. The statistics seem to be deteriorating each year and it is likely that more products will be recalled leading to more litigation. We are currently instructed in claims concerning the DePuy ASR, the Biomet Magnum M2A and the Corin Cormet.”