The sale of metal-on-metal DePuy hip devices will cease with the announcement by DePuy Orthopaedics Inc that they will terminate production by August this year.
The announcement to cease the production and sale of DePuy Pinnacle metal-on-metal hip replacements has been made in line with the start of the Multi District Litigation being heard in Ohio (DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197) in which over 7,500 claimants are claiming faulty hip replacement compensation for injuries due to the company´s sister products; the DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System.
Depuy’s decision to stop producing Pinnacle metal-on-metal hip replacements is thought to follow the USA’s Food and Drug Administration (FDA) closing the loophole known as the ‘510(k) process’ which allowed the faulty DePuy ASR hip replacement systems being sold in the US without clinical testing first being carried out (the company claim that demand for the implants from orthopaedic surgeons has diminished).
The ASR hip replacement systems were given FDA approval on the grounds that they were “similar to an existing product” – in this case the DePuy Pinnacle metal-on-metal hip replacement devices. After the worldwide withdrawal of the ASR hip replacement systems in August 2010, FDA executives requested DePuy Orthopaedics to carry out further clinical tests on the Pinnacle hip replacements systems to ensure that they were safe medical products. DePuy turned down the FDA´s request.
A second MDL class action has been started in the USA against DePuy Orthopaedics, since this request, in which more than 3,300 claimants allege that they suffered an injury due to the DePuy Pinnacle hip replacement systems, while in the UK, a joint Newsnight and British Medical Journal report found that recipients of the DePuy Pinnacle metal-on-metal hip devices were at risk of system toxicity and criticised the Medicines and Healthcare products Regulatory Agency (MHRA) for permitting the product to be enter the market using the same ‘similar product‘ criteria as the American FDA.
DePuy’s announcement to cease sales of the Pinnacle metal-on-metal hip replacements came at the same time as the start of the MDL court hearing in Ohio, where a jury has now been sworn in and will first be requested to deliberate on a motion argued by solicitors for DePuy Orthopaedics that the size of any award of compensation for injuries due a faulty hip replacement system should be applied in relation to the company’s home state of Indiana – where compensation settlements are significantly lower than Ohio.
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