New York, NY (PRWEB) June 12, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a West Virginia man who suffered pain and elevated cobalt levels, allegedly due to his DePuy Pinnacle metal-on-metal hip implant, which was used in conjunction with a metal “Ultamet” liner. The suit was filed on June 6th in the U.S. District Court for the Northern District of Texas (Case No. 3:12-cv-01757-N) and named DePuy Orthopaedics and parent company Johnson & Johnson as Defendants.
According to the complaint, the Plaintiff, a resident of Gilmer County, West Virginia, received the DePuy Pinnacle hip implant around June 2010. Allegedly, the Plaintiff developed injuries and complications due to the defective implant, but was initially unaware of this causal relationship due to the Defendant’s inadequate warnings. The plaintiff discovered the link between his injuries and the implant in fall of 2010, the complaint states. The defective and faulty nature of the Pinnacle allegedly caused 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 Parker Waichman LLP, the DePuy Pinnacle hip implant is meant to mimic the ball-and-socket mechanism of the hip joint in patients who suffer from osteoarthritis, rheumatoid arthritis, avascular necrosis (AVN), fracture and other degenerative conditions. It 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.
According to the complaint, the DePuy Pinnacle and other metal-on-metal hip implants were able to circumvent adequate testing due to an approval process known as the 510(k). The 510(k) route allows devices onto the market without clinical evidence to prove its safety or efficacy, so long as manufacturers can argue that it is “substantially equivalent” to a previously approved device, referred to as a “predicate.” DePuy managed to gain clearance for Pinnacle to 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. The lawsuit alleges that the Pinnacle has problems similar to the DePuy ASR hip implant, which was recalled in August 2010 after data from the National Joint Registry of England and Wales revealed a failure rate of 13 percent (1 in every 8 patients) in five years. According to the complaint, over 1,300 Pinnacle-linked adverse events have been reported to the U.S. Food and Drug Administration (FDA). [depuy.com/asr-hip-replacement-recall]
Since DePuy’s global recall, metal-on-metal hips have come under greater scrutiny. In February, the British Medical Journal published an exposé that criticized manufacturers and regulators for potentially exposing hundreds of thousands of metal hip recipients to dangerous complications. The Lancet followed next month, with a study demonstrating a failure rate of 6 percent in five years among metal-on-metal hip patients. The authors concluded that the devices should no longer be used. The suspected harmful effects associated with metallic debris were strengthened last month, when the Journal of Arthroplasty found that adverse local tissue reactions increased significantly with corrosion at the head-taper junction. [http://www.bmj.com/content/344/bmj.e1410; thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext; arthroplastyjournal.org/article/S0883-5403%2812%2900175-1/abstract]
The most recent study, published in the Journal of Bone and Joint Surgery, discovered pseudotumors in nearly 40 percent of metal-on-metal hip recipients. Metal particles were again linked to adverse effects in this study, as the incidence of pseudotumors increased fourfold when serum cobalt levels exceeded five micrograms per liter. [bjj.boneandjoint.org.uk/content/94-B/6/755.abstract]
The effects associated with metal-on-metal hips have certainly not gone unnoticed by regulators. In late February, Europe’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidelines for the devices, advising doctors to perform blood ion tests, ultrasound, magnetic resonance imaging (MRI) and Metal Artefact Reduction Sequence (MARS) as needed. Last May, the FDA asked 21 manufacturers to study the effects of metal-on-metal implants on patient health. On June 27th and 28th the agency’s Orthopaedic and Rehabilitation and Devices Panel will meet to discuss the pros and cons of all-metal hips. [http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm
Parker Waichman LLP continues to offer free legal consultations to victims of DePuy Pinnacle and other metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a DePuy Pinnacle Hip Implant or other metal-on-metal hip implant, please contact their office by visiting the firm's DePuy hip implant injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney