Smith & Nephew Hip Replacement Systems Face Additional RecallsMar 6, 2017
Over 31,000 Smith & Nephew hip replacements are being recalled by the U.S. Food and Drug Administration (FDA) because of the "higher than anticipated complaint and adverse event trend." This follows the Class 2 recall of the manufacturer's Tandem Bipolar hip on November 3, 2016 issued by the FDA. That recall was because "some Bipolar shells were manufactured with an out-of-specification retainer groove."
New Class 2 Recalls
Three new Class 2 recalls from January 4, 2017 involve Smith & Nephew hip systems that were distributed worldwide. These include: 6,266 units of the Modular Redapt Hip Systems that received 510(k) FDA pre-market approval on October 15, 2012; 11,999 units of the Modular SMF Hip System received 510(k) FDA approval on July 31, 2008; and 13,671 units of Modular Necks received FDA 510(k) approval on January 10, 2008.
The FDA 510(k) process is the fast-track approval method that allows a new product to be brought to market faster, without substantial testing, provided it is "substantially equivalent" to a product that has already been FDA approved. There is some controversy about the use of 510(k) approval for certain medical products, especially ones viewed as high-risk such as transvaginal mesh and metal-on-metal hip implants.
A Class 2 recall is a situation in which use of a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Smith & Nephew Lawsuits Mount
Smith & Nephew has an office in Memphis, Tennessee, but is a UK (United Kingdom) company. The Judicial Panel on Multidistrict Litigation (JPMDL) considered consolidating the mounting hip litigations and creating a federal multidistrict litigation (MDL) to expedite the process.
An MDL is a procedure that groups similar lawsuits together in one court. The purpose of an MDL is to make complex litigation more efficient by streamlining the pretrial proceedings such as the discovery process. This would take less time and conserve court resources than if the cases were to proceed on an individual basis in court.
Eight plaintiffs who had the Birmingham Hip Resurfacing (BHR) and R3 metal-on-metal liner (R3) implanted, filed the motion.
Why Do the BHR and R3 Fail?
The BHR is made of two parts, an acetabular cup and a femoral head piece. Both pieces are composed of metal and it has been shown that over time, metal-to-metal contact causes tiny pieces of metal to shed from the two components. These minute particles go into the hip joint and may travel throughout the body. These metal pieces may cause bone or tissue necrosis (tissue death), tumor development, and are basically toxic to the body.
Smith & Nephew issued a voluntary recall in June 2012, of the R3 due to high failure rates. In June 2015, the BHR part of the device was withdrawn also because of similar high failure rates. Documented data reveals that the devices have a ten-year revision rate of 14.5 percent.
On February 1, 2017, the JPMDL consolidated all R3 and BHR cases into a single venue to hold Smith & Nephew accountable for the large number of device failures. There are 31 cases concerning the BHR and R3 devices pending in 22 different districts, with 32 different law firms participating. It was requested by the plaintiffs' attorneys that the cases be consolidated in the U.S. District Court of Maryland.
The JPMDL previously created MDLs concerning six other metal-on-metal hip products. These included: Zimmer Durom Hip Cup Products, DePuy ASR hip implant products, DePuy Pinnacle hip implant products, Wright Medical Technology Conserve hip implant products, Biomet M2a Magnum hip implant products, and Stryker Rejuvenate and ABG II hip implant products.
Injuries Involving Metal-on-Metal Implants
Plaintiffs allege in this case, that Smith & Nephew hip replacement products are defective due to their metal-on-metal design, creating the metallic debris released into the blood stream and local tissue. The alleged injuries include metallosis (metal poisoning), pain, inflammation, bone damage, tissue reaction, and other complications that subsequently require early revision surgery.
Plaintiffs have alleged that device makers neglected to warn patients or the medical community about the risks. Even though hip implants are expected to be long-term devices lasting a decade or more, plaintiffs in the litigation commonly allege that the hip device failed much sooner, forcing them to undergo additional surgery.
Filing a Hip Replacement Lawsuit
If you or someone you know has been injured as a result of a defective medical device, such as a metal-on-metal hip implant, you may be eligible for valuable compensation. Parker Waichman offers free, no-obligation case evaluations. We urge you to call our attorneys at 1-800-YOURLAWYER (1-800-968-7529).