DePuy to Cease Production of Pinnacle Metal-on-Metal Hip Replacement Systems
DePuy Orthopedics Inc has announced it will cease production and sales of its Pinnacle metal-on-metal hip replacement systems by August this year.
The announcement to cease the production and sale of Pinnacle metal-on-metal hip replacement systems coincides with the start of the Multi District Litigation being heard in Ohio (DePuy Orthopedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197) in which more than 7,500 claimants are claiming compensation for injuries sustained due to the company´s sister product; the DePuy ASR XL Acetabular Hip Replacement System.
The company´s decision to end the production of Pinnacle metal-on-metal hip replacement systems is believed to follow the Food and Drug Administration (FDA) closing the loophole known as the ‘510(k) process’ which allowed the faulty hip replacement systems onto the market without clinical testing first being conducted.
Although the Pinnacle hip replacement systems originally 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.
Following the worldwide withdraw of the ASR hip replacement systems in August 2010, FDA officials asked DePuy Orthopedics 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 August 2010, a second MDL class action has been started against DePuy Orthopedics, in which more than 3,300 claimants allege that they suffered an injury due to the DePuy Pinnacle hip replacement systems.
DePuy´s announcement to cease production 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 lawyers representing DePuy Orthopedics that the size of any compensation settlement should be limited an appropriate size relation to the company´s home state of Indiana – where personal injury compensation settlements are significantly lower than in Ohio.