Metal-on-Metal Smith & Nephew Hip Associated with High Failure Rates. Plaintiffs who allege injuries due to the Smith & Nephew Birmingham Hip Resurfacing (BHR) and R3 hip replacement implant failure have recently filed a petition with the Judicial Panel on Multidistrict Litigation (JPML) to consolidate all pending federal BHR and R3 cases. The plaintiffs requested a Maryland federal court as the court in which to consolidate and centralize the litigation under one judge.
A multidistrict litigation (MDL) is a proceeding that consolidates similar lawsuits to one court before one judge. Centralizing cases with common questions of fact helps make legal proceedings more efficient by avoiding duplicate discovery and testimony and conserving court resources. The federal judicial system uses MDLs as a mechanism to help manage complex lawsuits related to each other by transferring those cases to one federal judge for pre-trial discovery in advance of trial.
Smith & Nephew is facing hundreds of lawsuits over its BHR and R3 line of hip implant devices. Lawsuits involve allegations of premature failure of the device maker’s BHR and R3 metal-on-metal hip implant devices. Metal-on-metal hip replacement systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hipbone (acetabular component).
Smith & Nephew recalled the R3 in June 2012 due to increased failure rates and took the BHR device off the market in June 2015 over similar increased high failure rates. Failure rates were particularly high in women and in patients with smaller hip joints.
A Texas woman implanted with a Smith & Nephew Birmingham hip in 2007 brought a lawsuit in January 2017 in the United States District Court for the Southern District of Texas over allegations involving premature implant failure, which, in her case, occurred just eight years after receiving the implant. She alleges hip pain and premature hip failure.
The BHR hip implant received U.S. Food and Drug Administration (FDA) clearance in May 2006. Smith & Nephew was required to meet post-marketing surveillance and reporting requirements designed to ensure that the hip replacement system was safe and effective. The lawsuit alleges that the device maker failed to meet these requirements.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation, including litigation involving metal-on-metal hip devices. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip replacement lawsuit.
Other Smith & Nephew Metal Hip System Recalls
Lawsuits are increasing over Smith & Nephew’s Tandem Bipolar Hip System over allegations that the system may detach after surgery. The device maker issued a recall in August 2016 and the FDA deemed the recall a Class II device recall on November 3, 2016 as “some Bipolar shells were manufactured with an out-of-specification retainer groove.” A Class II recall designation means that the recall involves a situation in which “use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote,” according to the FDA.
On September 12, the Australian Department of Health issued a hazard alert that advised patients and health professionals concerning the manufacturing defect and that the defect, “could lead to three potential failures, including the device not assembling properly and the head being too tight and not moving freely. Both of these failures would be identified during preparation before the implantation surgery.” The agency also noted that, “The third potential failure is the device may appear to be assembled properly during the implantation surgery, but parts become detached at a later time. If the third failure occurs, it could result in adverse events and require revision surgery.” The device is meant to click once the device components are properly assembled during surgery. If a device is assembled incorrectly, it may detach.
This recalled Smith & Nephew device is a partial hip replacement that is meant to replace half of the hip joint (hemiarthroplasty) replacing the femoral head or ball of the damaged hip. Some 5,806 units were distributed nationwide and in 23 developed nations, to date.
Metal-on-metal hip implants use all-metal surfaces. When the implant surfaces rub together, even during normal activities such as walking, the devices may release metal debris, leading to complications. When an implant fails due to complications, patients typically undergo a revision surgery to remove the device. Signs of the hip failure include unexpected pain, limited mobility, and/or loss of range-of-motion. When patients must undergo revision surgery, they endure a more complicated, expensive procedure that is riskier and calls for longer healing times. Consumer Union notes that hospital stays are longer and that costs for revision surgeries are not typically assumed by the device maker but, rather, by consumers and insurers, including Medicare.
Health Issues Long Associated with Metal-on-Metal Hips
Metal-on-metal hips were originally developed because of their purported increased durability and longer life. The supposedly stronger parts were supposed to be significantly better when compared to traditional device counterparts constructed with plastic or ceramic. Metal-on-metal devices were hyped to last for at least two decades.
Metal-on-metal hip devices have been associated with an array of adverse events such as tissue necrosis (tissue death), pain at the implant site that may spread to the groin and back, inflammation and swelling, metallosis (metal poisoning), high device failure rates, osteolysis (bone loss), and pseudotumors (fluid collection and solid masses around the hip joint). The issue with these devices appears to be with the metal.
Metal-on-metal devices have come under increasing scrutiny in light of high-profile recalls and litigation and reports of high failure rates. Many lawsuits have also been filed against different metal hip makers over the past few years, and those cases continue to proceed.
Concerns over metal-on-metal hips came to light when Johnson & Johnson’s orthopedic unit, DePuy Orthopaedics recalled its ASR Hip Resurfacing System and the ASR XL Acetabular System in 2010 over high failure rates. J&J reported the ASR failure rate was 12 percent in five years; however, internal documents revealed that 37 percent of the implants failed in 4.6 years. In Australia, the failure rate was reported at 44 percent in seven years.
Metal-on-metal hip implants, as a medical device class, have been the subject of safety concerns for some time. Metal-on-metal hip devices were approved using the FDA’s fast-tracked 510(k) route, which bypasses clinical testing. Research now reveals that metal hip replacements tend to fail more often than other implants.