Wright Profemur Hip Neck Problems Discoverable in Conserve MDL
A federal judge is allowing plaintiffs who have filed lawsuits over Wright Conserve metal-on-metal hip replacements to obtain information and discovery from Wright Medical involving problems with their Profemur femoral neck stem, which is a separate hip component that has also been the subject of a number of product liability lawsuits filed nationwide.
All federal lawsuits over the Wright Conserve cup, which is a metal-on-metal implant that has been linked to reports of early loosening and failure, have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation.
The cases have been centralized in the U.S. District Court for the Northern District of Georgia, before U.S. District Judge William S. Duffey, Jr., who is presiding over pretrial proceedings to help reduce duplicative discover in dozens of cases and avoid conflicting pretrial rulings.
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The Wright Conserve system features a metal ball that rotates within a metal acetabular cup. Plaintiffs allege that design problems with the metal-on-metal system cause the release of microscopic metal particles into the body, which can lead to complications and the need for revision surgery within a few years after it is implanted.
The claims are similar to those raised on other metal-on-metal hip lawsuits, including complaints over the DePuy ASR hip, DePuy Pinnacle hip and Biomet M2A-Magnum hip.
In addition to the product liability lawsuits consolidated as part of the Wright Conserve hip MDL, Wright Medical also faces a number of lawsuits over their modular femoral neck stem, which is marketed as the Wright Profemur. Those complaints allege that this component is prone to fret, corrode and ultimately fracture or break, causing catastrophic failure of the hip implant.
Request for Documents Involving Wright Profemur Problems
Plaintiffs in the Wright Conserve litigation have sought certain documents from the manufacturer that relate exclusively to the Profemur stem, which Wright Medical has opposed producing.
At least one of the cases that is part of the MDL includes both a Wright Conserve Cup and Profemur femoral neck, alleging that the neck component was an integral part of the flawed design for the metal-on-metal hip replacement system.
After failing to resolve the discovery dispute between the parties, Judge Duffey issued a Discovery Order (PDF) on September 5, requiring Wright Medical to produce certain documents and information requested by the Plaintiffs.
“The Court finds that information regarding the Profemur neck is relevant to the claims in this action and reasonably calculated to lead to the discovery of admissible evidence,” wrote Judge Judge Duffey in the Discovery Order.
Therefore, Plaintiffs will be entitled to obtain information and documents regarding the function and design of the neck component, as well as information concerning any investigation of Wright Profemur problems, including corrosion, fretting or failure, and the impact of such problems on the implant’s effectiveness.
Wright Profemur Lawsuits Over Femoral Neck Fractures
Outside the scope of the MDL, a number of product liability lawsuits have been filed by individuals who had the femoral neck stem of their hip replacement break during normal activities. Those complaints allege that the Wright Profemur system features an unreasonably dangerous design, making the femoral stem likely to fracture, break, degrade, fret and ultimately fail.
Last month, Wright Medical filed a report with the Securities and Exchange Commission (SEC) providing updated information about Wright Profemur hip lawsuits, estimating that their liability may be between $24 million and $39 million for cases brought by individuals in North America who required a revision surgery following the fracture of a long Profemur titanium modular neck, or who may require revision in the future. The company has estimated that they will pay the majority of any settlements for Wright Profemur fractures within the next four years.
The Wright Profemur is a modular femoral system, which has come under scrutiny in recent years. Unlike most femoral components, which involve a single piece, the Wright Profemur features a neck that fits inside of a separate stem, allowing the surgeon to adjust the device to match the patient. However, increasingly concerns have been raised about the safety of the design.
In July 2012, a Stryker Rejuvenate and ABG II modular hip recall was issued, after that manufacturer indicated that their similar components may be prone to fret and corrode at the modular neck junction, which could cause pain, swelling, local tissue reactions and early failure of the hip replacement.
The Stryker Rejuvenate was approved by the FDA in 2010, and it was submitted as a substantially equivalent design to the Wright Profemur modular hip system, allowing Stryker to gain approval through the FDA’s 510(k) fast-track system because it was similar to the previously approved Profemur design.
Problems identified with the Stryker Rejuvenate hip were similar to those seen with metal-on-metal hips, where the direct contact between the metal neck and metal stem caused debris to be released into the body, increasing the risk of inflammation and loosening of the components.
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