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.
Birmingham Hip “Mix and Match” System Deviated from FDA Indications
Stephen D. Fleming filed the complaint against Smith & Nephew, Inc. on June 24 in the District of Maryland where nearly 400 similar lawsuits are 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. There is little indication that Fleming will ever recover. Among his numerous injuries. his lawsuit notes he faces “permanent impairment and disfigurement” from the defective hip device.
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 fully knew 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.
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 there are at least 383 cases pending in the federal MDL for coordinated discovery and pretrial proceedings. However, experts project that Birmingham hip lawsuits will ultimately number in the thousands.
Smith & Nephew asked a Maryland federal court Wednesday to dismiss 55 suits in the ongoing multidistrict litigation (MDL) over the company intentionally misrepresenting the safety of its Birmingham Hip Resurfacing (BHR) metal hip implant, arguing the statutes of limitations on these patients’ claims have expired.
The medical device manufacturer asserted these patients simply hope that the court will not scrutinize their cases. They could slip though the cracks and participate in any potential settlement. However, the motion to dismiss claims that the dates of these patients’ hip surgeries clarify that the statutes of limitations have passed.
The motion came along with several other filings in the MDL. This includes discovery orders from District Judge Catherine Blake, who is overseeing the litigation. One order clarified a March 26 ruling partially granting the company’s motion to dismiss, following push back from Smith & Nephew.
Smith & Nephew BHR Hip Implant Preemption Order
In her March opinion, Judge Blake ruled that federal law preempts strict liability claims, and claims that the manufacturer should have changed its labeling or issue warnings and Smith & Nephew’s false assertions that the BHR metal hip implant was safe. Smith & Nephew then argued that the judge’s order “silently dismissed” any claims she hadn’t noted as preempted. However, Judge Blake indicated this is a clear misunderstanding.
“It was never the court’s intention to expressly identify each of the plaintiffs’ surviving claims and arguments,” she wrote. “It appears Smith & Nephew assumes that all claims and arguments not expressly identified as not preempted are preempted. But the court made clear that the opposite is true — all claims and arguments not expressly identified as preempted are not preempted.”
Judge Blake’s March order trimmed the MDL, including dismissing a manufacturing defect claim. However, she left much at play, including failure to warn, negligent misrepresentation, and state law claims for negligence.
But, with Judge Blake handing the company a discovery win, Wednesday’s order wasn’t entirely bad for Smith & Nephew. Plaintiffs were pushing for depositions to discover parties involved with the device. However, the judge ordered the use of interrogatories instead.
“It is … hard to see how subpoenaing testimony from someone who can identify those people is any more efficient than interrogatory requests to the same end,” the judge wrote.
Smith & Nephew Metal Hip Litigation
There were about 200 lawsuits in the MDL as of March. Plaintiffs allege that friction from the hip implant’s metal parts can cause metallic debris to accumulate in the bloodstream, leading to serious and debilitating medical complications.
In her March order, Judge Blake noted two recalls over the BHR metal hip implant. Smith & Nephew issued the first recall in 2007 due to labeling issues. In 2015, the company issued another hip recall after several competitors recalled similar devices. The company voluntarily recalled some devices due to unreasonably high failure rates. Specifically, these failure rates pertained to women, men over 65, and men with a specific device size.
Smith & Nephew metal hip plaintiffs claim that the company delayed reporting hundreds of device adverse event reports and complaints to the FDA and entirely failed to report the BHR hip implant was wearing down quicker than expected.