Medical Negligence News

DePuy to End Sales of Pinnacle Metal-on-Metal Hip Replacements

Posted on: June 4th, 2013 by Medical Negligence

DePuy Orthopaedics Inc has announced that they will terminate production and sales of its Pinnacle metal-on-metal hip replacements by August this year.

The announcement to halt the production and sale of DePuy Pinnacle metal-on-metal hip replacements coincides 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 more than 7,500 claimants are claiming 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.

The company´s decision to stop producing Pinnacle metal-on-metal hip replacements is believed to follow the United States´ Food and Drug Administration (FDA) closing the loophole known as the ‘510(k) process’ which allowed the faulty DePuy ASR hip replacement systems onto the market in the US without clinical testing first being conducted (the company claim that demand for the implants from orthopaedic surgeons has declined).

Although the Pinnacle hip replacement systems passed the FDA´s clinical testing standards in 2000, the ASR hip replacement systems were given FDA clearance on the grounds that they were “similar to an existing product” – in this case the DePuy Pinnacle metal-on-metal hip replacements. After the worldwide withdraw of the ASR hip replacement systems in August 2010, FDA officials asked DePuy Orthopaedics to conduct further clinical tests on the Pinnacle hip replacements systems to ensure that they were safe medical products. DePuy declined the FDA´s request.

Since then a second MDL class action has been started in the States against DePuy Orthopaedics 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 investigation found that recipients of the DePuy Pinnacle metal-on-metal hip replacements were at risk of system toxicity and criticised the Medicines and Healthcare products Regulatory Agency (MHRA) for allowing the product onto the market using the same ‘similar product‘ criteria as the American FDA.

DePuy´s announcement to end sales of the Pinnacle metal-on-metal hip replacements overshadowed the scheduled start of the MDL court hearing in Ohio, where a jury has now been sworn in and will first be asked to deliberate on a motion argued by solicitors representing 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 personal injury compensation settlements are significantly lower than Ohio.