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A lawsuit filed against Smith & Nephew this week indicates that the Birmingham Hip Resurfacing (BHR) system can fail prematurely, and cause metal blood poisoning and the formation of pseudotumors.
Lydia Constantini filed the complaint (PDF) on Monday in the U.S. District Court for the Northern District of California, indicating that Smith & Nephew sold a defective metal-on-metal hip implant and then tried to cover up signs of problems among individuals who received the device.
After undergoing right hip resurfacing surgery in September 2008, which involved use of a 50mm Birmingham Resurfacing femoral head, and a 56mm Birmingham Resurfacing acetabular cup, Constantini indicates that she developed pain and complications. As a result, she underwent hip revision surgery in December 2013, after the Smith & Nephew Birmingham Hip Resurfacing implant failed.
The surgeon who performed the revision noted that there was evidence of metallosis, which is a form of blood poisoning caused by the release of cobalt and chromium metal particles into the blood stream. Both metals are used in the Birmingham Hip Resurfacing implant.
Failure of the Smith & Nephew Birmingham Hip Resurfacing implant also caused the development of a pseudotumor in Constantini’s hip, according to the surgeon, which disrupted and compromised her abductor muscle.
Due to a high rate of problems following Birmingham hip resurfacing, Smith & Nephew subsequently withdrew the system from the marketing in the U.S. market and eventually issued a Birmingham Hip Resurfacing recall.
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.
“At the time of the initial resurfacing procedure, neither Plaintiff nor her surgeon were aware of the myriad of problems associated with the BHR,” the lawsuit states. “In fact…Smith & Nephew continued to promote the BHR as a safe alternative to other metal-on-metal hip devices long after it knew or reasonably should have known of the risk of premature metal-on-metal failure, and did not withdraw the device from U.S. markets until 2015.”
Constantini presents charges of strict product liability, negligence, breach of express warranties, negligent misrepresentation and fraudulent concealment. She is seeking both compensatory and punitive damages.
In May, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all product liability lawsuits over Birmingham Hip Resurfacing be centralized before U.S. District Judge Catherine C. Blake in the District of Maryland.
As hip replacement lawyers continue to review and file cases for individuals nationwide, it is ultimately expected that hundreds of cases may be brought in the coming weeks and months.