DePuy Orthopaedics has announced that it will cease to produce and sell metal-on-metal Pinnacle hip replacements systems from August 2013
The company´s decision to stop producing and selling Pinnacle hip replacement systems is believed to coincide with the United States´ Food and Drug Administration (FDA) closing the ‘510(k) process’ loophole which allowed the faulty DePuy ASR hip implants onto the market in the USA 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 when they were first launched in the USA, the ASR hip implants which were recalled in August 2010 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 recall of the ASR hip implants, the Food and Drug Administration asked DePuy Orthopaedics to conduct further clinical tests on the Pinnacle hip replacement systems to ensure that the same problems did not exist as with the recalled ASR hip implants. DePuy declined and, in January 2013, new legislation was passed in the States to force all manufacturers of metal-on-metal hip implants to prove through retrospective clinical studies that their products were safe.
The announcement to halt the production and sale of DePuy Pinnacle hip replacement systems also coincides with the scheduled start of the Multi District Litigation being heard at the US Northern District Court in Ohio (DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197) in which more than 7,500 plaintiffs are attempting to recover compensation for injuries caused by the DePuy ASR Articular Surface Hip Replacement System and the DePuy ASR XL Acetabular Hip Replacement System.
A jury has now been sworn in for the court case, but a delay to proceedings has been caused by solicitors representing DePuy Orthopaedics putting forward a motion that any award of compensation for injuries due a faulty hip replacement system should be based on compensation levels in the company´s home state of Indiana – where personal injury compensation settlements are significantly lower than Ohio.
Since the class action against DePuy for the ASR hip implant recall began, a second MDL class action has been started in the States against DePuy Orthopaedics in which more than 3,300 plaintiffs allege that they have suffered an injury due to the DePuy Pinnacle hip replacement systems. In the UK meantime, an investigation by the British Medical Journal revealed that recipients of the DePuy Pinnacle hip implants were at serious risk of system toxicity, while at home there have been calls for the Health Service Executive to initiate a DePuy Pinnacle hip replacement recall in Ireland.