According to a new product liability lawsuit, renditions of the Birmingham Hip Resurfacing (BHR) system never received proper approval for sale from federal regulators, resulting in a dangerously defective device prone to premature failure that can permanently disable recipients.

Stephen D. Fleming filed the complaint against Smith & Nephew, Inc. on June 24 in the District of Maryland where nearly 400 similar lawsuits are currently pending.

Fleming received the Birmingham Hip Resurfacing system in November 2008, during total right hip arthroplasty. However, the implant failed within six years, causing severe pain and other significant complications that necessitated additional risky surgery to remove the defective implant. During the surgical procedure, Fleming’s surgeon diagnosed him with a severe metallosis injury after finding high levels of cobalt and chromium deposits in his hip joint. When the Birmingham Hip Resurfacing system failed, it released inordinate amounts of the toxic metal debris into Fleming’s body. Furthermore, there is little indication that Fleming will ever fully recover. Among his numerous injuries. his lawsuit notes that he faces “permanent impairment and disfigurement” from the defective hip device.

Birmingham Hip “Mix and Match” System Deviated from FDA Indications

Fleming indicates that his Birmingham hip was part of a “mix and match” system. This included a modular head and femoral stem that never received FDA approval for use with the BHR acetabular cup. Because of this, when Smith & Nephew withdrew the system from the U.S. market and eventually issued a BHR recall in September 2015, due to the high rate of serious complications from the hip system, Fleming’s implant and many others were never recalled despite having all the same problems as other BHR hips.

“The FDA did not approve the combination of these two components, which creates a metal-on-metal articulation, leading to toxic metal ions of cobalt and chromium being released into the patient’s body, eventually causing metallosis and other damage to the hip joint,” the lawsuit states. “Plaintiff’s unapproved total hip system failed because of the metallurgical and biomechanical interaction between all of its metal-on-metal components, due to tens of thousands of natural articulations of the total hip system components over the course of Plaintiff’s normal daily activity.”

The lawsuit further asserts that Smith & Nephew were fully aware of the BHR’s myriad of problems. But, the company continued to promote it as a safe alternative to other metal-on-metal hip devices despite the BHR “not being a safer alternative and not being approved for sale in the U.S.”

Smith & Nephew’s Birmingham hip was among the first metal-on-metal hip replacement systems to hit the market. However, there were significant concerns about its safety even before it received FDA approval.

Wright Medical even attempted to stop the devices from receiving approval. The company filed a citizen’s petition with the FDA in 2005, requesting the agency to reject BHR’s application due to concerns over the adequacy of the clinical trials Smith & Nephew used to obtain premarket approval.

Birmingham Hip Resurfacing Litigation

In May 2017, the Judicial Panel on Multidistrict Litigation (JPML) centralized all Birmingham Hip Resurfacing lawsuits to avoid duplicative discovery and conflicting pretrial rulings that could further hold up the complex litigation. District Judge Catherine C. Blake is presiding over the multidistrict litigation (MDL) in the District of Maryland.

The latest docket report indicates that there are at least 383 cases currently pending in the federal MDL for coordinated discovery and pretrial proceedings. However, experts project that Birmingham hip lawsuits will ultimately number in the thousands.