Smith & Nephew Birmingham Hip Lawsuit Filed Over Pain, Revision Surgery
According to allegations raised in a recently filed product liability lawsuit, the Smith & Nephew Birmingham Hip Resurfacing System was defectively designed and prone to fail, requiring risky revision surgery.
In a complaint (PDF) filed earlier this month in the U.S. District Court for the Eastern District of Wisconsin, Steven Zingler indicates that he has experienced severe pain and complications due to problems with the Smith & Nephew hip resurfacing implant, resulting in the need for the device to be removed after just five years.
Zingler received a Smith & Nephew Birmingham hip in March 2011, which included a 52mm Birmingham Resurfacing Femoral Head, and a 58mm Birmingham hip Resurfacing Acetabular Cup. However, by January 2016, he had to undergo revision surgery to have it removed due to pain in his right hip and other problems.
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The lawsuit indicates the FDA approved the Birmingham hip in May 2006, requiring Smith & Nephew to meet a host of post-marketing surveillance and reporting requirements that were designed to ensure that in real-world use, the hip replacement system was shown it to be safe and effective. However, Zingler indicates that the manufacturer has failed to do so, indicating that Smith & Nephew knew for years about reports of complications with Birmingham hip resurfacing, including revision surgeries and failures, yet failed to adequately inform the medical community or consumers.
“Smith & Nephew received hundreds of adverse reports and complaints regarding the BHR but delayed its reporting to the FDA, and when it did communicate adverse reports, it did not do so properly but, in fact, attempted to blame others for the adverse events,” the lawsuit states. “Smith & Nephew became aware of wide evidence that the BHR systems were wearing down more quickly and severely than anticipated, and failed to take appropriate action to determine the cause and provide a solution, nor did it appropriately advise the FDA.”
Zingler’s lawsuit presents claims of strict liability, negligence, breach of warranty, unfair and deceptive trade practices and fraudulent concealment.
Smith & Nephew 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 to the market, 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.
This new Smith & Nephew Birmingham hip lawsuit was filed as the manufacturer faces new concerns about problems with Modular SMF and Modular REDAPT femoral hip systems, which were removed from the market last month amid concerns about high failure rates and adverse events. The Smith & Nephew modular hip recall was issued due to a risk that microscopic metallic debris may be released into the body as the parts rub against each other, which may increase the risk of loosening and failure within a few years after the artificial hip is implanted.
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