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A recent motion filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) indicates that there are a growing number of hip replacement lawsuits being filed throughout the federal court system over problems among individuals who received a Smith & Nephew Birmingham Hip with an R3 metal-on-metal liner, seeking to establish centralized pretrial proceedings.
When combined with the R3 liner, the Smith & Nephew Birmingham Hip Resurfacing System is considered a “metal-on-metal” hip implant, which has been linked to problems similar to those associated with other metal-on-metal systems sold by other manufacturers, which have been found to release microscopic metal debris into the body, increasing the risk of loosening and failure of the artificial hip.
Last week, a group of plaintiffs filed a motion to transfer (PDF), indicating that all product liability lawsuits filed in U.S. District Courts nationwide involving a Smith & Nephew Birmingham hip with R3 metal liner should be centralized as part of a federal MDL, or multidistrict litigation.
There are currently at least 31 cases pending in 22 different federal district courts, with at least 32 different law firms involved in the litigation. Most of the claims were filed over the past year, and as hip replacement lawyers continue to review and file cases in the coming months, the motion indicates that the size of the litigation is expected to grow.
“These two devices share a similar mechanism of failure, and the FDA initially approved the R3 to be used as part of the BHR system. Smith & Nephew recalled the R3 in June 2012 due to high failure rates,” the motion states. “The company later withdrew the BHR device from the U.S. market in June 2015 due to similar high failure rates, particularly in women and in patients with smaller hip joints.”
Centralizing the cases before one federal judge for coordinated pretrial proceedings is designed to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings or schedules from different courts and to serve the convenience of witnesses, parties and the judicial system.
“These cases will benefit from consolidated proceedings, as they involve common factual and legal issues,” according to the motion filed on February 1. “Consolidation of other metal-on-metal hip cases has proven to be an efficient and cost-effective tool to resolve products liability litigation where a single manufacturer is connected to hundreds or even thousands of similar claims.”
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.
The petition claimed 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.
Wright Medical suggested that if the FDA approved the Smith & Nephew Birmingham, it would open the floodgates for companies to introduce potentially unsafe metal-on-metal hip replacement systems, with minimal clinical trials and testing.
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.