DePuy Orthopaedic Inc.’s metal on metal version of its Pinnacle hip was approved for marketing in March 2009. It was approved through the FDA’s 510(k) process, which means that there were not clinical trials. Instead, it was approved on the basis that it was substantially equivalent to a device or devices on the market prior to 1976.
Over the years, the FDA has received hundreds of reports of complications patients have experienced due to the failure of their DePuy Pinnacle metal on metal hips. These complications include unexplained pain, fluid effusions, pseudotumors, elevated metal ions in the blood, metal debris in and around the hip joint, and loosening of the implant.
To date, nearly 7,000 cases have been filed in federal district courts throughout the country and transferred to the Northern District of Texas into MDL 2244 before Judge Kinkeade who is handling all pretrial matters for these cases. The MDL, or coordinated litigation, was created in May 2011. In the MDL, defendants have produced more than 60 million pages of documents and plaintiffs’ attorney have taken more than 100 depositions, including depositions of DePuy employees and litigation experts.
On September 1, 2014, the lead trial or bellwether trial in the MDL commenced. The idea behind a bellwether trial is to provide guidance to all parties in the hope that it will assist with resolution.
Faraci Lange represents numerous clients who have been forced to prematurely undergo risky and painful revision surgery to remove their failed DePuy Pinnacle metal on metal hip implants, and we continue to investigate and file cases for clients related to these defective hips.