A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law firm of Parker Waichman LLP, which has filed numerous DePuy Pinnacle hip replacement lawsuits on behalf of plaintiffs throughout the U.S.
According to the complaint, which was filed on June 6th in the U.S. District Court for the Northern District of Texas, the DePuy Pinnacle hip implant consists of a femoral stem attached to a metal head that rotates inside a titanium acetabular cup. The inside of the cup is lined with a plastic, ceramic or cobalt-chromium liner; the latter is branded as the “Ultamet.” When the Pinnacle is used with the Ultamet metal liner, it is known as a metal-on-metal hip implant.
As we’ve reported previously, metal-on-metal total hip replacements were introduced for their purported advantages over conventional devices, such as low rates of wear and increased stability. However, Concerns about all-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip devices, after it was found that they were failing in about 12 percent of patients within just five years of implantation. The U.S. Food & Drug Administration (FDA) began studying all-metal hip implants shortly after the DePuy ASR hip implant recall to determine if the devices are shedding dangerous levels of metal ions into patients’ surrounding tissue and blood streams. An FDA advisory panel is scheduled to take up metal-on-metal hip implants during a two-day meeting scheduled for June 27th and 28th.
According to the latest Pinnacle hip implant lawsuit filed by Parker Waichman LLP, the Plaintiff, a resident of Gilmer County, West Virginia, received his DePuy Pinnacle hip implant around June 2010. As a result of its defective nature, he suffered significant pain and elevated cobalt levels. The lawsuit alleges past, present and future physical and mental pain and suffering along with past, present and future medical, hospital, rehabilitative and pharmaceutical expenses, lost wages, and other related damages.
According to the complaint, metal-on-metal hip implants, including the DePuy Pinnacle device named in the lawsuit, were able to circumvent adequate testing due to an approval process known as the 510(k). This clearance protocol does not require that manufacturers present clinical evidence to prove a device is safe or effective so long as they can show it is “substantially equivalent” to a previously approved device, referred to as a “predicate.” DePuy managed to gain clearance for Pinnacle by citing a previous metal-on-metal hip implant as a predicate. The lawsuit alleges that if the Defendants had properly tested the Pinnacle to begin with, then complications such as metallosis, biological toxicity and an early and high failure rate would have been apparent. The suit also claims that the cobalt and chromium ions that accumulate in patients can lead to metallosis, pseudotumors and other serious conditions. Finally, the lawsuit alleges that the Pinnacle has problems similar to the DePuy ASR hip implant, and should have also been subject to a recall.
This latest lawsuit is just one of hundreds of similar DePuy Pinnacle claims that have been filed in a multidistrict litigation now underway in the Northern District of Texas. All of the lawsuits allege that use of the all-metal Pinnacle hip replacement device has caused severe pain, dislocation of the hip implant, early hip replacement failure or the need for additional revision surgery.