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The U.S. Judicial Panel on Mutlidistrict Litigation (JPML) has decided that all federal hip replacement lawsuits involving Smith & Nephew Birmingham Hip Resurfacing (BHR) components with an R3 metal-on-metal liner will be centralized before one judge in the District of Maryland, for coordinated discovery and pretrial proceedings.
There are currently about three dozen complaints that were originally filed in various different U.S. District Courts nationwide, each involving similar allegations that Smith & Nephew sold a defective and unreasonably dangerous artificial hip system, which has caused users to suffer painful complications that often required surgical removal of the implant.
When combined with the R3 liner, the Smith & Nephew Birmingham Hip Resurfacing System is considered a “metal-on-metal” hip implant, similar in design to other systems that have been found to release microscopic metal debris into the body as the parts rub against each other, increasing the risk of loosening and failure of the hip. Metal-on-metal hip replacements sold by other manufacturers have been the subject of tens of thousands of lawsuits nationwide in recent years, as well as several high-profile recalls.
A request to centralize all Smith & Nephew BHR and R3 hip lawsuits was filed in January, seeking to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial rulings or schedules from different courts and to serve the convenience of the witnesses, parties and the judicial system.
Following oral arguments considered late last month, the U.S. JPML issued a transfer order (PDF), calling for the Smith & Nephew BHR litigation to be transferred to U.S. District Judge Catherine C. Blake in Maryland.
The manufacturer opposed consolidation, arguing that the claims are preempted by federal law and pointing out that some of the cases have been pending since 2010. However, the MDL panel decided that it was appropriate to transfer all cases to one judge for formal coordinated management.
“Most of these actions were filed only recently and remain in their infancy. Centralization of these actions, therefore, is not untimely,” the JPML states in the transfer order. “Nor is informal coordination preferable to centralization in this instance, given the number of involved districts and parties.”
Smith & Nephew Metal Hip Problems
The Smith & Nephew Birmingham hip was one of the first metal-on-metal hip replacement systems on the market, and concerns were raised about its safety even before it was approved.
A competitor, Wright Medical, attempted to stop the devices from getting approved, filing a citizen’s petition with the FDA in 2006, asking the agency to reject the application for the BHR, due to concerns over the adequacy of the clinical trials used to obtain premarket approval.
Plaintiffs allege that Smith & Nephew was misrepresenting the nature of the studies submitted to the FDA and using bad science. For instance, Wright Medical claimed that the company’s data on Birmingham hip safety and effectiveness came from just one orthopedic surgeon.
In 2012, Hong Kong issued a warning regarding Smith & Nephew Birmingham hip systems, indicating that they appeared to be linked to a higher-than-normal failure rate.
In June 2014, Smith & Nephew issued a statement announcing it was recalling smaller size components and changing instructions for use of the Birmingham Hip Resurfacing system due to performance data.
The company warned that it had looked at data submitted to the National Joint Registry of England and Wales and found that “revision rates associated with men requiring femoral head sizes 46mm or smaller and with all women patients exceed the current benchmark established by the U.K. National Institute for Health and Care Excellence (NICE).”
The devices affected by the recall accounted for about 1% of the company’s global hip implant revenue in 2014.
As Smith & Nephew hip replacement lawyers continue to review and file cases in the coming months and years, the size of the litigation is expected to grow.