Plaintiffs injured by the premature failure of the Smith & Nephew Birmingham Hip Resurfacing (BHR) System and R3 Acetabular System have filed a petition with the Judicial Panel on Multidistrict Litigation (JPML) on February 1, 2017 to consolidate all pending federal BHR and R3 cases in Maryland federal court.
Smith & Nephew is a London-based global medical equipment manufacturer which markets products in over 90 countries. They are the world’s fourth-largest producer of orthopedic reconstruction products, including the Smith & Nephew.
Approved by the U.S. Food and Drug Administration (FDA) on May 9, 2006 through its expedited Premarket Approval process for Class III medical devices, the BHR system was one of the first metal-on-metal hip replacement systems on the market, designed relieve pain and improve hip joint function. The BHR system consisted of two parts: (1) a ball-shaped cap called the femoral resurfacing component, and (2) a cup-shaped socket called the acetabular component. The acetabular component was designed to replace the damaged surface of the hip socket, while the femoral resurfacing component was inserted into the top of the thigh bone. This system was created to work modularly, wherein surgeons would have multiple options for individual fit in each patient.
According to the petition filed with the JPML, there are currently 31 actions pending in states across the country involving the BHR. The lawsuits allege that (i) the FDA approval of the BHR required Smith & Nephew to meet several post-marketing surveillance and reporting requirements that were designed to ensure that in real-world use, the hip replacement system was safe and effective, and (ii) the manufacturer has failed to do so, claiming 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 doctors or patients. The company later withdrew the BHR device from the U.S. market in June 2015 due to similar high failure rates, particularly in women and in patients with smaller hip joints.
R3 Acetabular System and Metal Liner
In 2007, Smith & Nephew began producing and marketing optional metal cup liners for its R3 Acetabular System total hip replacement prostheses, and the company began distributing the component globally in 2009. The FDA, in 2008, approved the R3’s metal liner for use with the BHR system, but the FDA claims that the liners were not actually cleared for use with R3 Acetabular total hip replacement systems. About 7,700 R3 Acetabular Systems have been implanted worldwide since 2009. The device experienced a higher than normal revision rate — 6.3 percent in four years compared with the average of 2.89 percent for primary total hip replacements. Between 2009 and 2012, it is estimated that nearly 4,000 R3 Acetabular metal liners were used on patients in the United States.
In August 2010, Smith & Nephew sent recall letters to distributors and hospitals informing them of problems related to the company’s R3 metal acetabular liner and recalling all outstanding stock. After the recall, the company issued a precautionary “hazard alert” to doctors that had prescribed this system to inform their patients of them of the recall. Smith & Nephew also said it was unable to identify one single reason for the device failure, but there were reports of “infection, dislocation, metal sensitivity, loosening/lysis and fracture.” The company sent a second recall notice in September 2010. The devices recalled had been distributed in the United States, Australia and Portugal.
Ater reports of loosening, pain, device failure, infection, metal sensitivity and dislocation, and reviewing Australian and U.K. patient data indicating that the metal liners used in its R3 Acetabular system were not performing as well as expected, Smith & Nephew issued a voluntary global recall of the liners on June 1, 2012. In the recall, Smith & Nephew stated that the metal liner was not “performing as well” as the company expected and that it was “not satisfied with the clinical results.”
Metal-on-Metal Hip Implants
When the metal liners of the individual components rubbed against each other during the course of normal use in patients, the motion would cause erosion of the metal lining. This erosion caused metal particles, including cobalt and chromium, to be released into the patient’s blood stream and surrounding tissues. These metal particles caused tissue and bone death around the surgically implanted hip, which lead to many complications including loosening of the hip joint and other device failures. The elevated concentration of chromium and cobalt in the bloodstream also created a medical condition known as metallosis, which has many severe side effects including severe hip and leg pain, tissue and bone death, drastically reduced mobility in the hip, and pseudotumors around the surgically repaired area. These malfunctioning devices caused many patients to undergo dangerous and extremely painful revision surgery.
Modular SMF and Modular Redapt Femoral Hip Systems Recall
In November 2016, Smith & Nephew recalled its Modular SMF and Modular Redapt hip implants “due to a higher than anticipated complaint and adverse event trend” with the modular necks used in the devices. Smith & Nephew also recalled the corresponding hip stem components.
Tandem Bipolar Hip System Recall
On August 29, 2016, Smith & Nephew recalled certain batches of its Tandem Bipolar Hip System in the United States due to a retainer groove that is out of specifications that can cause the artificial hip joint to disassmeble, usually within the first few weeks of surgery. This necessitates painful revision surgery to remove and replace the defective artificial joint and treat injuries caused by the implant failure. Smith & Nephew stated that the defect will be discovered before the device is implanted in most cases as surgeons will notice that the device did not assemble properly. All unused units have been recalled.